As filed with the Securities and Exchange Commission on October 7, 2026.

Registration No. 333-      ​

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549​

FORM S-1

REGISTRATION STATEMENT

UNDER
THE SECURITIES ACT OF 1933

Centinel Spine Holdco, Inc.

(Exact name of registrant as specified in its charter)​

900 Airport Road, Suite 3B
West Chester, PA 19380
(484) 887-8810

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)​

Steven Murray
Chief Executive Officer
Centinel Spine Holdco, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
(484) 887-8810

(Name, address, including zip code, and telephone number, including area code, of agent for service)​

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED OCTOBER 7, 2026

Preliminary Prospectus

           Shares

Class A Common Stock

This is the initial public offering of shares of Class A common stock, par value $0.0001 per share (“Class A Common Stock”), of Centinel Spine Holdco, Inc. (“Centinel Holdco”).

We are offering           shares of our Class A Common Stock. Prior to this offering, there has been no public market for our Class A Common Stock. We anticipate that the initial public offering price will be between $       and $       per share. We intend to apply to list our Class A Common Stock on the New York Stock Exchange (“NYSE”) under the symbol “CNTL,” and this offering is contingent upon obtaining approval of such listing.

This offering is being conducted through what is commonly referred to as an umbrella partnership-C corporation (“Up-C”) structure, which is often used by partnerships and limited liability companies undertaking an initial public offering. The Up-C structure will allow certain existing owners (the “Continuing Equity Owners”) of Centinel Spine, LLC (“Centinel LLC”) to continue to own their equity ownership in Centinel LLC, in the form of Series B Common Units (as defined below), and to continue to realize tax benefits associated with owning interests in an entity that is treated as a partnership, or “flow-through” entity, for U.S. federal income tax purposes following the offering. We will issue to each Continuing Equity Owner such number of shares of our Class B common stock, par value $0.0001 per share (“Class B Common Stock”), which is equal to the number of Series B Common Units held by such Continuing Equity Owner. As a result, the Continuing Equity Owners will hold economic nonvoting units in Centinel LLC and noneconomic voting equity interests in the form of the Class B Common Stock in Centinel Holdco. Investors in this offering will, by contrast, hold their equity ownership in Centinel Holdco, which is a domestic corporation for U.S. federal income tax purposes, in the form of shares of Class A Common Stock. The Up-C structure provides potential future tax benefits for Centinel Holdco when the Continuing Equity Owners exchange their interests in Centinel LLC for, at our election, cash or Class A Common Stock of Centinel Holdco, since such exchange is expected to result in tax basis adjustments in the assets of Centinel LLC and produce favorable tax attributes for us.

In connection with this offering, we will enter into a Tax Receivable Agreement (as defined herein), which will require us to make cash payments to the Continuing Equity Owners and Blocker Stockholders (as defined herein) in respect of certain tax benefits to which we may become entitled, including as a result of exchanges by the Continuing Equity Owners of their interests in Centinel LLC, as described above. The Tax Receivable Agreement would confer significant economic benefits to the Continuing Equity Owners and Blocker Stockholders. We expect that the payments we will be required to make under the Tax Receivable Agreement will be substantial and could materially affect our liquidity. See “Organizational Structure,” “Risk Factors—Risks Related to Our Organizational Structure” and “Certain Relationships and Related Party Transactions—Tax Receivable Agreement.”

Following the completion of this offering, we will have two authorized classes of Common Stock: Class A and Class B (together, the “Common Stock”). Holders of the Class A Common Stock and Class B Common Stock will be entitled to one vote per share on all matters presented to our stockholders for their vote. All holders of Class A Common Stock and Class B Common Stock will vote together as a single class, except as otherwise required by applicable law. Holders of Class B Common Stock will not have any right to receive dividends or distributions upon the liquidation or winding up of Centinel Holdco.

We will use the net proceeds from this offering to purchase newly-issued Series A common units in Centinel LLC (the “Series A Common Units”). The purchase price for the Series A Common Units will be equal to the initial public offering price of the shares of Class A Common Stock, less the underwriting discounts and commissions referred to below. Centinel LLC will use the net proceeds it receives from us in connection with this offering as described under “Use of Proceeds.” Upon completion of this offering, we will hold           Series A Common Units, representing approximately    % of the economic interest in Centinel LLC (or           Series A Common Units, representing approximately    % of the economic interests in Centinel LLC, if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock), and we will be the sole managing member of Centinel LLC and will operate and control its business. The Continuing Equity Owners will hold           Series B common units in Centinel LLC (the “Series B Common Units” and, together with the Series A Common Units, the “LLC Units”), representing approximately    % of the economic interests in Centinel LLC (or           Series B Common Units, representing approximately    % of the economic interests in Centinel LLC if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock). Upon consummation of this offering, each Series B Common Unit will be, from time to time, exchangeable for, at our election, one share of Class A Common Stock or cash, as set forth in the Exchange Agreement. The holders of Series B Common Units will be required to deliver to us an equivalent number of shares of Class B Common Stock to effectuate an exchange. Any Series B Common Units and shares of Class B Common Stock so delivered to us will be cancelled, and Centinel LLC will issue us a number of Series A Common Units equal to the number of cancelled Series B Common Units.

We will be a holding company, and upon consummation of this offering and the application of the net proceeds therefrom, our sole asset will consist of direct or indirect ownership of Series A Common Units of Centinel LLC. Immediately following this offering, the holders of Class A Common Stock will collectively own 100% of the economic interests in Centinel Holdco and have    % of the combined voting power of our outstanding shares of Class A Common Stock and Class B Common Stock (or    % if the underwriters’ option to purchase additional shares is exercised in full). The Continuing Equity Owners, through ownership of our Class B Common Stock, will have no economic interests in Centinel Holdco and will have the remaining    % of the combined voting power of our outstanding shares of Class A Common Stock and Class B Common Stock (or    % if the underwriters’ option to purchase additional shares is exercised in full).

Immediately following the consummation of this offering, our principal stockholders and management will beneficially own approximately     % of the combined voting power of our outstanding shares of Common Stock (or approximately     % if the underwriters’ option to purchase additional shares is exercised in full), which will allow our principal stockholders and management to exercise significant control over matters subject to stockholder approval.

We are an “emerging growth company” and a “smaller reporting company,” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements in this prospectus and may elect to do so in future filings. See the section titled “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in shares of our Class A Common Stock involves a high degree of risk. See the section titled “Risk Factors” beginning on page 24.

(1)

See the section titled “Underwriting” for additional disclosure regarding the estimated underwriting discounts and commissions and estimated offering expenses.

​

We have granted the underwriters an option for a period of 30 days to purchase up to an additional         shares of Class A Common Stock from us at the initial public offering price, less the underwriting discounts and commissions.

The underwriters expect to deliver the shares of Class A Common Stock to purchasers on or about         , 2026.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is            , 2026.

TABLE OF CONTENTS

​	​	​	Page				​
About This Prospectus	​	​	​	​	ii	​	​
Prospectus Summary	​	​	​	​	1	​	​
Risk Factors	​	​	​	​	24	​	​
Special Note Regarding Forward-Looking Statements	​	​	​	​	97	​	​
Use of Proceeds	​	​	​	​	99	​	​
Dividend Policy	​	​	​	​	101	​	​
Organizational Structure	​	​	​	​	102	​	​
Capitalization	​	​	​	​	110	​	​
Dilution	​	​	​	​	113	​	​
Unaudited Pro Forma Consolidated Financial Information	​	​	​	​	115	​	​
Management’s Discussion and Analysis of Financial Condition and Results of Operations	​	​	​	​	123	​	​

​	​	​	Page				​
Business	​	​	​	​	146	​	​
Management	​	​	​	​	191	​	​
Executive and Director Compensation	​	​	​	​	201	​	​
Certain Relationships and Related Party Transactions	​	​	​	​	215	​	​
Principal Stockholders	​	​	​	​	218	​	​
Description of Capital Stock	​	​	​	​	220	​	​
Shares Eligible for Future Sale	​	​	​	​	226	​	​
Material U.S. Federal Income Tax Consequences to Non-U.S. Holders	​	​	​	​	229	​	​
Underwriting	​	​	​	​	233	​	​
Legal Matters	​	​	​	​	241	​	​
Experts	​	​	​	​	241	​	​
Where You Can Find Additional Information	​	​	​	​	241	​	​
Index to Financial Statements	​	​	​	​	F-1	​	​

We have not, and the underwriters have not, authorized anyone to provide you any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. Neither we nor the underwriters take responsibility for, or provide any assurance as to the reliability of, any other information others may give you. This prospectus is an offer to sell only the shares of Class A Common Stock offered hereby, and only under circumstances and in jurisdictions where it is lawful to do so. We are not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of the shares of our Class A Common Stock. Our business, financial condition, and results of operations may have changed since that date.

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or the possession or distribution of this prospectus or any free writing prospectus in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of Class A Common Stock and the distribution of this prospectus outside the United States. See the section titled “Underwriting.”

i

ABOUT THIS PROSPECTUS

Basis of Presentation

In connection with the consummation of this offering, we will effect certain organizational transactions. Unless otherwise stated or the context otherwise requires, all information in this prospectus reflects the consummation of the organizational transactions and the offering of shares of our Class A Common Stock pursuant to this prospectus, which we refer to collectively as the “Organizational Transactions.” See the section titled “Organizational Structure” for a description of the Organizational Transactions and a diagram depicting our anticipated structure after giving effect to the Organizational Transactions, including this offering.

Unless the context otherwise requires, references in this prospectus to the “Company,” “Centinel,” “we,” “us,” “our,” and similar references refer: (i) following the consummation of the Organizational Transactions, including this offering, to Centinel Holdco, and, unless otherwise stated, all of its direct and indirect subsidiaries, including Centinel LLC, and (ii) prior to the completion of the Organizational Transactions, including this offering, to Centinel LLC and, unless otherwise stated, all of its direct and indirect subsidiaries.

Immediately following this offering and the application of net proceeds therefrom, we will be a holding company and the sole managing member of Centinel LLC, and our sole asset will consist of direct or indirect ownership of Series A Common Units of Centinel LLC. We will operate and control all the business and affairs of Centinel LLC and conduct our business through Centinel LLC and its subsidiaries. Centinel LLC will be the predecessor of the issuer, Centinel Holdco, for financial reporting purposes. Centinel Holdco will be the reporting entity following this offering.

The audited consolidated financial statements for the years ended December 31, 2025 and 2024 and the notes thereto, as well as the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2026 and 2025 and the notes thereto, included in this prospectus represent the operations of Centinel LLC and its consolidated subsidiaries. In addition, except as disclosed in the accompanying prospectus, information related to the compensation of directors and named executive officers, and other information included in this registration statement are those of Centinel LLC and do not give effect to the Organizational Transactions.

The unaudited pro forma financial information of Centinel Holdco presented in this prospectus has been derived from the application of pro forma adjustments to the historical consolidated financial statements of Centinel LLC and its subsidiaries included elsewhere in this prospectus. These pro forma adjustments give effect to the Organizational Transactions, as described in the section titled “Organizational Structure,” including the consummation of this offering and other related transactions. The unaudited pro forma consolidated balance sheet as of June 30, 2026 gives effect to the Organizational Transactions as if they occurred on that date. The unaudited pro forma consolidated statements of operations for the year ended December 31, 2025 and for the six months ended June 30, 2026 have been prepared to illustrate the effects of the Organizational Transactions as if they occurred on January 1, 2025. See the section titled “Unaudited Pro Forma Consolidated Financial Information” for a complete description of the adjustments and assumptions underlying the unaudited consolidated pro forma financial information included in this prospectus.

Certain monetary amounts, percentages and other figures included in this prospectus have been subject to rounding adjustments. Percentage amounts included in this prospectus have not in all cases been calculated on the basis of such rounded figures, but on the basis of such amounts prior to rounding. For this reason, percentage amounts in this prospectus may vary from those obtained by performing the same calculations using the figures in our financial statements included elsewhere in this prospectus. Certain other amounts that appear in this prospectus may not sum due to rounding.

Trademarks, Trade Names and Service Marks

We own or have the rights to use various trademarks, service marks and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names or products in this prospectus is not intended to, and does not, imply a relationship with, or endorsement or sponsorship by, us. Solely for convenience, the trademarks, service

ii

marks and trade names presented in this prospectus may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, service marks and trade names.

Market, Industry and Other Data

This prospectus contains estimates, statistical data and other information concerning our industry, market and competitive position from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies and publicly available information in addition to research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.

Industry data and other third-party information have been obtained from sources believed to be reliable, but we have not independently verified any third-party information. Any such third-party information, except to the extent specifically set forth in this prospectus, does not constitute a portion of this prospectus and is not incorporated herein. In addition, while we believe the industry, market and competitive position data included in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in the section titled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties or by us.

The estimated market opportunities included in this prospectus represent the total overall revenue opportunity that we believe is available for our systems if 100% market share is achieved by us, and are not a representation that we will achieve any such market share. See “Risk Factors—Risks Related to Our Business and Industry—​Our business plan relies on certain assumptions about the market for our implant systems, however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.”

Certain Definitions

As used in this prospectus, unless the context otherwise requires, the following capitalized terms have the meanings set forth below:

•

“Amended and Restated Centinel LLC Agreement” means the Ninth Amended and Restated Operating Agreement of Centinel Spine, LLC, to be effective immediately prior to the consummation of this offering.

​

•

“Assumed Centinel LLC Options” means all outstanding options to purchase incentive units of Centinel LLC that were issued pursuant to the Centinel LLC Incentive Plan and that are outstanding immediately prior to completion of the Organizational Transactions.

​

•

“Blocker Companies” means certain of the owners of limited liability company interests in Centinel LLC prior to the Organizational Transactions that are taxable as corporations for U.S. federal income tax purposes, consisting of Centinel Spine Holdings, Inc. and Delac Spine, Inc.

​

•

“Blocker Stockholders” means the owners of the Blocker Companies prior to the Organizational Transactions, who will exchange their interests in the Blocker Companies for shares of our Class A Common Stock in connection with the consummation of the Organizational Transactions.

​

•

“Centinel Holdco” means Centinel Spine Holdco, Inc.

​

•

“Centinel LLC” means Centinel Spine, LLC.

​

•

“Centinel LLC Agreement” means the Eighth Amended and Restated Limited Liability Company Agreement of Centinel Spine, LLC, as amended, which governs Centinel LLC prior to this offering.

​

iii

•

“Centinel LLC Incentive Plan” means the Centinel Spine, LLC Unit Incentive Plan, as amended.

​

•

“Class A Common Stock” means the Class A Common Stock, par value $0.0001 per share, of Centinel Holdco.

​

•

“Class B Common Stock” means the Class B Common Stock, par value $0.0001 per share, of Centinel Holdco.

​

•

“Class A Preferred Units” means the Class A Preferred Units of Centinel LLC prior to the Organizational Transactions.

​

•

“Class B Preferred Units” means the Class B Preferred Units of Centinel LLC prior to the Organizational Transactions.

​

•

“Class A Warrants” means the warrants to purchase 3,227,300 Class A Preferred Units of Centinel LLC, which warrants have an exercise price of $1.39435 per Class A preferred unit and expire on December 19, 2027.

​

•

“Class B Warrants” means the warrants to purchase 564,779 Class B Preferred Units of Centinel LLC, which warrants have an exercise price of $0.01 per Class B preferred unit and expire on dates varying between April 2033 through August 2033 (depending upon the issuance date of the particular Class B Warrant).

​

•

“Class A Warrant Holders” means the holders of the Class A Warrants.

​

•

“Class B Warrant Holders” means the holders of the Class B Warrants.

​

•

“Common Stock” means the Class A Common Stock and Class B Common Stock.

​

•

“Continuing Equity Owners” means, collectively, the owners of limited liability company interests in Centinel LLC immediately prior to or in connection with the consummation of the Organizational Transactions (excluding the Blocker Companies), which will also be holders of Series B Common Units and shares of our Class B Common Stock immediately following consummation of the Organizational Transactions, who may, following the consummation of this offering, exchange at each of their respective option, in whole or in part from time to time, their Series B Common Units for, at our election, cash or newly-issued shares of our Class A Common Stock. The holders of Series B Common Units will be required to deliver to us an equivalent number of shares of Class B Common Stock to effectuate an exchange, and any shares of Class B Common Stock and Series B Common Units so delivered will be canceled. See the section titled “Certain Relationships and Related Party Transactions—Amended and Restated Operating Agreement of Centinel LLC.”

​

•

“Convertible Debt Holders” means the holders of Convertible Notes.

​

•

“Convertible Notes” means Centinel LLC’s (i) subordinated convertible promissory notes in the aggregate principal amount of $46.0 million, with the maturity date ranging from November 2030 to May 2033 and current interest rate of 4.42% per annum (the “4.42% Convertible Notes”); and (ii) the subordinated convertible promissory note in the principal amount of $10.0 million, which is due on September 1, 2030 and has an interest rate of 6.0% per annum (the “6% Convertible Note”).

​

•

“Holdco Omnibus Plan” means the Centinel Spine Holdco, Inc. 2026 Omnibus Incentive Plan, to be effective upon the consummation of the Organizational Transactions.

​

•

“LLC Units” means the Series A Common Units and Series B Common Units following the consummation of the Organizational Transactions.

​

•

“LLC Unitholders” means the holders of LLC Units.

​

•

“Series A Common Units” means the Series A common units of Centinel LLC following the consummation of the Organizational Transactions.

​

•

“Series B Common Units” means the Series B common units of Centinel LLC following the consummation of the Organizational Transactions.

​

•

“Tax Receivable Agreement” means the tax receivable agreement entered into among Centinel Holdco, Centinel LLC and the TRA Parties.

​

•

“TRA Parties” means the Continuing Equity Owners and the Blocker Stockholders.

​

iv

1

2

3

​

4

5

​	Products	​	​	Description	​	​	Regulatory Overview of Primary Markets	​
​		​	​	• Original cervical design ​ • Flat endplate design ​ • Large midline keel ​	​	​	FDA PMA approved (single-level) CE mark	​
​		​	​	• Anatomically-designed domed endplate ​ • Keel-less design with lateral spikes ​ • One-step insertion ​	​	​	FDA PMA approved (single-level and two-level) CE mark	​
​		​	​	• Flat endplate design ​ • Low-profile tri-keel design ​ • Optimized, simplified keel preparation ​	​	​	FDA PMA approved (single-level and two-level) CE mark	​
​		​	​	• Flat endplate design ​ • Low-profile “small” central keel ​ • Optimized, simplified keel preparation ​	​	​	FDA PMA approved (single-level and two-level)	​

6

​	Products	​	​	Description	​	​	Regulatory Overview of Primary Markets	​
​		​	​	• Flat endplate design ​ • Large central keel ​ • Two-step insertion (endplates + inlay) ​	​	​	FDA PMA approved (single-level and two-level) CE mark	​
​		​	​	• Four endplate constructs ​ • Designed to provide the majority of angulation in the inferior endplate, reducing sacral slope ​	​	​	FDA PMA approved (single-level and two-level) CE mark	​

​

7

​

​

​

Three Months Ended September 30,

​

​

Nine Months Ended September 30,

​

​

​

​

​

​

​

​

2026 (estimated low)

​

​

2026 (estimated high)

​

​

2025 (actual)

​

​

2026 (estimated low)

​

​

2026 (estimated high)

​

​

2025 (actual)

​

​

​

​

​

​

​

​

(unaudited) (in thousands)

​

​

​

​

​

Preliminary estimated financial results:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net revenue

​

​

​

$

​

​

​

​

$

​

​

​

​

$

31,935

​

​

​

​

$

​

​

​

​

$

​

​

​

​

$

91,993

​

​

​

​

​

​

Cost of sales

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

6,292

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

18,375

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Gross profit

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

25,643

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

73,618

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total operating expenses

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

22,272

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

65,776

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Operating income (loss)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

3,371

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

7,842

​

​

​

​

​

​

​

​

​

​

​

​

​

​

8

​

9

​

10

​

11

12

13

​

14

​

15

16

17

18

19

​

20

21

​

​

​

Centinel LLC Historical

​

​

Pro Forma Centinel Holdco

​

​

​

​

Six Months Ended June 30,

​

​

Years Ended December 31,

​

​

Six Months Ended June 30, 2026

​

​

Year Ended December 31,

​

​

​

​

2026

​

​

2025

​

​

2025

​

​

2024

​

​

2025

​

​

​

​

(in thousands, except share, unit, per share and per unit data)

​

Consolidated Statements of Operations Data:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net Revenue

​

​

​

$

85,244

​

​

​

​

$

60,058

​

​

​

​

$

132,163

​

​

​

​

$

95,056

​

​

​

​

$

​

​

​

​

​

$

​

​

Cost of sales

​

​

​

​

15,159

​

​

​

​

​

12,083

​

​

​

​

​

26,143

​

​

​

​

​

22,232

​

​

​

​

​

​

​

​

​

​

​

​

​

Gross profit

​

​

​

​

70,085

​

​

​

​

​

47,975

​

​

​

​

​

106,020

​

​

​

​

​

72,824

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Selling and marketing

​

​

​

​

42,151

​

​

​

​

​

31,801

​

​

​

​

​

67,497

​

​

​

​

​

49,370

​

​

​

​

​

​

​

​

​

​

​

​

​

​

General and administrative

​

​

​

​

12,092

​

​

​

​

​

9,234

​

​

​

​

​

19,157

​

​

​

​

​

16,749

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Research and development

​

​

​

​

2,818

​

​

​

​

​

2,469

​

​

​

​

​

3,660

​

​

​

​

​

4,954

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total operating expenses

​

​

​

​

57,061

​

​

​

​

​

43,504

​

​

​

​

​

90,314

​

​

​

​

​

71,073

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Operating income

​

​

​

​

13,024

​

​

​

​

​

4,471

​

​

​

​

​

15,706

​

​

​

​

​

1,751

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Other income (expense):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Other income (expense), net

​

​

​

​

3,885

​

​

​

​

​

34

​

​

​

​

​

(9,359)

​

​

​

​

​

(5)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Foreign currency gain (loss)

​

​

​

​

(1,058)

​

​

​

​

​

4,089

​

​

​

​

​

4,089

​

​

​

​

​

(1,830)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Interest expense

​

​

​

​

(5,507)

​

​

​

​

​

(5,489)

​

​

​

​

​

(11,070)

​

​

​

​

​

(12,141)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Loss on extinguishment of debt

​

​

​

​

—

​

​

​

​

​

(3,458)

​

​

​

​

​

(3,458)

​

​

​

​

​

—

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total other expense, net

​

​

​

​

(2,680)

​

​

​

​

​

(4,824)

​

​

​

​

​

(19,798)

​

​

​

​

​

(13,976)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net income (loss) before taxes

​

​

​

​

10,344

​

​

​

​

​

(353)

​

​

​

​

​

(4,092)

​

​

​

​

​

(12,225)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Income tax expense (benefit)

​

​

​

​

108

​

​

​

​

​

150

​

​

​

​

​

229

​

​

​

​

​

(102)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Net income (loss)

​

​

​

​

10,236

​

​

​

​

​

(503)

​

​

​

​

​

(4,321)

​

​

​

​

​

(12,123)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Other comprehensive income (loss):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Foreign currency translation

​

​

​

​

396

​

​

​

​

​

(1,434)

​

​

​

​

​

(1,474)

​

​

​

​

​

473

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Comprehensive income (loss)

​

​

​

$

10,632

​

​

​

​

$

(1,937)

​

​

​

​

$

(5,795)

​

​

​

​

$

(11,650)

​

​

​

​

$

​

​

​

​

​

$

​

​

​

Pro forma net loss attributable to noncontrolling interest

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Pro forma net loss attributable to Centinel Holdco

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Basic and diluted net loss per share

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Shares used in basic and diluted per share calculations

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

22

​

​

​

As of June 30, 2026

​

​

​

​

Actual

​

​

Pro Forma(1)

​

​

Pro Forma As Adjusted(2)

​

​

​

​

(in thousands)

​

Consolidated Balance Sheet Data:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Cash and cash equivalents

​

​

​

$

25,106

​

​

​

​

$

​

​

​

​

​

$

​

​

Working capital(3)

​

​

​

​

53,407

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total assets

​

​

​

​

115,229

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Warrant and derivative liabilities

​

​

​

​

6,523

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Convertible note payable

​

​

​

​

62,139

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Term notes payable

​

​

​

​

12,498

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total liabilities

​

​

​

​

168,933

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Redeemable convertible Class A Preferred Units

​

​

​

​

83,019

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Redeemable convertible Class B Preferred Units

​

​

​

​

50,406

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Redeemable convertible Special Member Unit

​

​

​

​

—

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Common Units

​

​

​

​

—

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Incentive Units

​

​

​

​

—

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Total members’ deficit, actual; Stockholders’ equity, pro forma and pro forma as adjusted

​

​

​

​

(187,129)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Six Months Ended June 30,

​

​

Year Ended December 31,

​

​

​

​

2026

​

​

2025

​

​

2025

​

​

2024

​

Adjusted EBITDA(1)

​

​

​

$

15,514

​

​

​

​

$

6,551

​

​

​

​

$

20,153

​

​

​

​

$

5,906

​

​

​

23

RISK FACTORS

Investing in our Class A Common Stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our financial statements and the related notes included elsewhere in this prospectus and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our Class A Common Stock. The occurrence of any of the events or developments described below could have a material adverse effect on our business, financial condition, results of operations, and prospects. In such an event, the market price of our Class A Common Stock could decline, and you may lose all or part of your investment. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Additional risks and uncertainties not presently known to us or that we currently believe are not material may also impair our business, financial condition, results of operations and prospects.

Risks Related to Financial Matters and Our Capital Requirements

We depend entirely on sales of our prodisc products for our revenue. If we are unable to successfully achieve substantial market acceptance and adoption of our prodisc products, or any of our future products, or if confidence in our products is diminished, our business, financial condition, results of operations, and prospects would be harmed.

We expect that revenue from sales of our prodisc products will continue to account for all of our revenue for the foreseeable future. Continued and widespread market acceptance and adoption of our prodisc technology platform are critical to our future success. The size of our hospital and surgeon base, our ability to acquire new hospitals and surgeon users, and our ability to retain existing hospitals and surgeons are critical to our success as well. Thus, our commercial success will depend in large part on further adoption of prodisc technology platform by hospitals and surgeons, and an increase in the number of patients receiving personalized spine surgery with prodisc products.

Various factors can contribute to the growth in market acceptance of our prodisc products and the ability to effectively engage and retain hospitals and surgeons, and their use of the prodisc technology platform. For example, hospitals and surgeons may be reluctant to purchase or use prodisc products due to familiarity with other products that are well established and known to them. Our ability to grow our sales and drive market adoption will depend on the availability of coverage and adequate reimbursement for procedures using the prodisc technology platform from third-party payors, including government payors, or the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including government payors. In addition, successfully educating hospitals, surgeons, and patients of the relative benefits of the prodisc technology platform compared to other products, as well as educating such hospitals, surgeons, and patients regarding the advantages and limitations of the prodisc technology platform, will be essential to our ability to grow sales of prodisc products and drive market acceptance and adoption. If hospitals and surgeons do not perceive our products to be useful, effective, reliable, and trustworthy, or if we are unable to provide sufficient training to hospitals and surgeons, we may not be able to attract or retain customers. Hospitals and surgeons may perceive the prodisc technology platform to be less useful if they lack familiarity or trust in the prodisc technology platform. In addition, negative clinical research results or publicity or an adverse change to published or unpublished guidelines or recommendations from third parties (including, without limitation, medical societies) relating to the use, clinical benefit, or risk profile of the prodisc technology platform in general or particular prodisc products, could result in negative perception by hospitals and surgeons, and could affect our brand and reputation. Similarly, regulatory bodies including notified bodies working with national competent authorities in the EU can add conditions to or suspend our certificates of conformity which can limit the uptake or use of prodisc products. Although subject to strict quality management systems the subject of regulations, issues of product quality can arise which would prevent the continued sale of prodisc products. While we constantly work to improve the prodisc technology platform, the technologies we work with are novel and complex, and we cannot assure you that there will not be negative reports on the prodisc technology platform in the future. Further, patients, hospitals, or surgeons who are dissatisfied with their experiences with any of our prodisc products may post negative reviews, and we may become the subject of blog, forum, or other social media postings that contain negative statements about us, which are outside of our control and may be inaccurate. Any negative publicity, whether real or perceived, disseminated by word-of-mouth, the general media, electronic or social networking platforms, competitor

24

materials, or other methods, could harm our reputation and brand. Lack of support for our products from hospitals or surgeons can affect how receptive other surgeons are to use the prodisc technology platform for their patients and could result in decreased demand for our products. Negative perception by hospitals or surgeons could also render us less attractive to future hospital customers, which could result in decreased sales of our products. A number of other factors, including the impacts of economic conditions and regulatory changes on hospital budgets and spending patterns, could potentially negatively affect the increase in adoption by hospitals and surgeons of the prodisc technology platform and demand for our products.

We have a limited history of commercializing certain of our products and have experienced periods of significant business changes in a short time, making it difficult for you to evaluate our business and future prospects. If we are unable to manage our business and any fluctuations in our business effectively, our business and growth prospects could be materially and adversely affected.

Centinel Spine, LLC was formed in 2017. We have obtained US marketing authorizations for certain of our products, and started the commercialization of two-level prodisc L in 2020, one-level prodisc C Vivo, prodisc C SK and prodisc C Nova in 2022, and two-level prodisc C Vivo and prodisc C SK in 2025, which makes evaluation of our future prospects difficult. Consequently, any predictions you make about our future success, performance, or viability may not be as accurate as they could be if we had more experience or a longer history of successfully developing and commercializing the prodisc technology platform. Since our inception, we have had periods of significant growth in revenue and employees, which have required us to scale the size of our organization as our business rapidly changed. Our growth objectives will require us to further expand our sales and marketing personnel. Our results of operations have fluctuated in the past, and our future quarterly and annual results of operations may fluctuate as we focus on increasing the demand for our products. Among other factors, future changes in the level of reimbursement for procedures using the prodisc products could have a significant impact on our results of operations, either positively or negatively. We may need to make business decisions that could adversely affect our results of operations and prospects, such as modifications to our pricing and reimbursement strategy, business structure, or operations.

The challenges we face in managing our business, including the changing reimbursement and regulatory landscapes, place significant demands on our management, financial, operational, manufacturing, technological, and other resources. We expect that managing our business will continue to place significant demands on our management and other resources and will require us to continue developing and improving our operational, financial, and other internal controls, reporting systems, and procedures. In particular, continued growth increases the challenges involved in a number of areas, including recruiting and retaining sufficient skilled personnel, providing adequate training and supervision to maintain our high-quality product standards and regulatory compliance, and preserving our culture and values. We may not be able to address these challenges in a cost-effective manner, or at all. As we grow, we may also need to invest significant resources to improve and expand our manufacturing partnerships, and we may not be able to do so in a cost-effective manner, or at all. We cannot assure you that any changes in scale, related quality, or compliance assurance, including those related to any future additional improvements and modifications to the prodisc technology platform, will be successfully implemented or that appropriate personnel will be available to facilitate the management of, and changes to, our business. Failure to implement necessary quality and compliance procedures, transition to new manufacturing processes or supply chains, or hire or maintain necessary personnel could result in higher costs or an inability to meet demand. In addition, our business is affected by general macroeconomic and business conditions around the world, including the impacts of inflation, increased interest rates, market instability, geopolitical conditions and conflicts, health crises, and natural disasters. If we do not effectively manage our business through the various challenges we face, we may not be able to execute our business plan, respond to competitive pressures, take advantage of market opportunities, satisfy patient and healthcare professional requirements, or maintain high-quality products, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.

Our quarterly and annual results of operations, including our revenue, profitability, and cash flow, may vary significantly in the future, and period-to-period comparisons of our results of operations may not be

25

meaningful. Accordingly, the results of any one quarter or other period should not be relied upon as an indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the underlying performance of our business. Factors that may cause fluctuations in our quarterly and annual results include, without limitation:

•

the level of demand for our prodisc products, which may vary significantly from period to period;

​

•

the rate at which we grow our sales force, and the cost and level of investment therein;

​

•

expenditures that we may incur to acquire, develop, or commercialize additional products and technologies;

​

•

the degree of competition in our industry and any change in the competitive landscape of our industry;

​

•

the timing and cost of obtaining regulatory approvals, clearances or certifications for future products;

​

•

any regulatory matters which lead to a suspension of sales of prodisc products for any period of time;

​

•

coverage and reimbursement policies with respect to the procedures using our prodisc products and potential future products that compete with our products;

​

•

the timing and success or failure of clinical studies, including clinical trials or clinical investigations, for our current or future products or any future products we develop or competing products;

​

•

the timing and cost of, and level of investment in, research, development, regulatory approval, and commercialization activities relating to our prodisc products, which may change from time to time;

​

•

the timing of medical procedures, the number of available selling days in a particular period, which can be impacted by a number of factors, such as holidays or days of severe inclement weather in a particular geography, the mix of prodisc products sold, and the geographic mix of where prodisc products are sold;

​

•

fluctuations in foreign currency exchange rates between the U.S. dollar (our reporting currency) and the local currency;

​

•

the cost of manufacturing our products, which may vary depending on the quantity of production and the terms of our agreements with third-party suppliers and manufacturers;

​

•

timing and adequacy of supply chain to meet demand;

​

•

natural or man-made disasters, outbreaks of disease or public health crises;

​

•

the timing and nature of any future acquisitions or strategic partnerships; and

​

•

future accounting pronouncements or changes in our accounting policies.

​

Because our quarterly and annual results may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of our business and should only be relied upon as one factor in determining how our business is performing.

In addition, this variability and unpredictability could result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or results of operations fall below the expectations of analysts or investors or below any forecasts we may provide to the market, it may result in a decrease in the price of our Class A Common Stock.

The seasonality of sales of our products creates variance in our quarterly revenue, which makes it difficult to compare or forecast our financial results.

Sales of our products may fluctuate on a seasonal basis, which affects the comparability of our results between periods. In particular, we have experienced and expect to continue to experience seasonality in our business. For example, we have traditionally experienced lower sales volumes in the months in and surrounding summer vacation and winter holiday periods as elective procedures generally decline during the summer months due to warmer weather and its corresponding impact on individual lifestyles, as well as during winter holidays for the international business. We expect these seasonal factors to become more pronounced in the future as our

26

business grows. These seasonal variations may vary amongst different markets and at times may be entirely unpredictable, which introduces additional risk into our business as we rely upon forecasts of demand to build inventory in advance of anticipated sales. In addition, we believe our limited history commercializing our products combined with our rapid growth has, in part, made our seasonal patterns more difficult to discern, making it more difficult to predict future seasonal patterns.

We have a history of net losses, we anticipate increasing expenses in the future, and we may not be able to maintain profitability.

We have incurred net losses since inception in 2017 until the six months ended June 30, 2026, and we cannot assure you that we will be able to sustain profitability in the future. For the six months ended June 30, 2026, we reported net income of $10.2 million compared to net loss of $0.5 million incurred for the six months ended June 30, 2025. As of June 30, 2026, we had an accumulated deficit of $188.4 million. For the years ended December 31, 2025 and 2024, we incurred net losses of $4.3 million and $12.1 million, respectively.

Since inception, we have spent significant amounts to develop our prodisc products, to fund clinical studies and gain FDA marketing authorization and equivalents in other countries for the prodisc products, to develop our manufacturing processes, to scale our commercial operations, and to recruit and retain key talent. Our expected future capital requirements may depend on many factors including the timing and speed of the expansion of our surgeon base and sales force and the timing and extent of spending on the development of our technology to increase our product offerings. We expect to continue to incur significant product development, research and development, clinical and regulatory, sales and marketing and other expenses. In addition, we expect that our general and administrative expenses will increase following this offering due to the additional costs associated with being a public company.

Our revenue may decline or our revenue growth may be constrained for a number of reasons, including reduced demand for our products, increased competition or inability to capitalize on growth opportunities. We cannot assure you that we will be able to sustain or increase profitability to offset our expenses. If our revenue growth does not increase to offset anticipated increases in our expenses, it could adversely affect our business, financial condition and results of operations.

We may need to raise additional funds in the future, and such funds may not be available on acceptable terms or at all.

To date, we have financed our operations principally from the sale of our equity, revenue from our operations and the incurrence of indebtedness. We will need additional funding to fund our operations but additional funds may not be available to us on acceptable terms on a timely basis, if at all. We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt offerings. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our Common Stock, make certain investments, and engage in certain merger, consolidation or asset sale transactions. Any future debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need to curtail planned activities to reduce costs, which will likely harm our ability to execute on our business plan and continue operations.

Our debt financing agreements contain financial and operating restrictions that may limit our flexibility in operating our business. If we fail to comply with financial or other covenants in such agreements, our lenders may declare a default requiring us to immediately repay all of our indebtedness, which could have a material adverse effect on our business, financial condition and results of operations, and you could lose all or part of your investment in our company.

We entered into a Loan and Security Agreement, dated as of February 25, 2025 (the “Loan Agreement”), with SLR Investment Corp. (“SLR”) and the other lenders party thereto, pursuant to which we borrowed an aggregate principal amount of $60.0 million. We also entered into a Credit Agreement, dated as of February 25, 2025 (the “2025 Credit Agreement”), with Gemino Healthcare Finance, LLC d/b/a SLR Healthcare ABL (“Gemino”), pursuant to which we may borrow up to $5.0 million in revolving loans and

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may request Gemino to increase the amount we may borrow up to $10.0 million. The obligations under the Loan Agreement and the 2025 Credit Agreement are secured by substantially all of our assets. As of June 30, 2026, the aggregate amount outstanding under the Loan Agreement was approximately $61.4 million.

We entered into a Credit Agreement, dated as of April 18, 2023, as amended (“2023 Credit Agreement”), with entities and trust controlled by some of our stockholders and board observers, pursuant to which we borrowed an aggregate principal amount of approximately $5.25 million. As of June 30, 2026, the aggregate amount outstanding under the 2023 Credit Agreement was approximately $12.5 million, which includes accrued interest and unamortized premium.

We entered into a Convertible Note Purchase Agreement, dated as of March 29, 2021, as amended, with Vision BioBanc Holdings (“Vision BioBanc”), pursuant to which we issued a convertible note in the principal amount of $10.0 million (the “6% Convertible Note”). As of June 30, 2026, the aggregate amount outstanding under the 6% Convertible Note was approximately $10.1 million. We entered into a Subordinated Convertible Promissory Note Purchase Agreement (the “Note Agreement”), dated November 17, 2021 and from that date to May 2024, we issued Subordinated Convertible Promissory Notes (the “4.42% Convertible Notes”) to various investors, including certain of our officers, directors and entities controlled by our directors under the form of such Note Agreement. As of June 30, 2026, the aggregate principal amount of the 4.42% Convertible Notes issued under the Note Agreement was $46.0 million, and the accrued interest on the 4.42% Convertible Notes was $6.9 million. Our obligations under the 2023 Credit Agreement, the 6% Convertible Note and 4.42% Convertible Notes are unsecured and subordinated to our obligations under the Loan Agreement and the 2025 Credit Agreement. As part of the Organizational Transactions, the outstanding principal amount of the 6% Convertible Note and the 4.42% Convertible Notes and accrued interest thereon will convert into shares of Class A Common Stock in connection with the completion of this offering.

As of the date of this prospectus we are, and upon the completion of the offering, we will continue to be, subject to certain covenants under the Loan Agreement and the 2025 Credit Agreement, imposing certain financial obligations on us, such as maintaining minimum revenue requirements, as well as limiting our ability to engage in specified types of transactions without the lenders’ prior consent, including, among other things, our ability to:

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pay dividends;

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sell, lease, transfer, assign or dispose of all or any part of our business or property, subject to certain exceptions;

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engage in any business other than the businesses currently engaged in by us and our subsidiaries or reasonably related to such businesses;

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merge or consolidate with, or acquire all or substantially all of the capital stock, shares or property of, another entity;

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create, incur, assume, or be liable for any indebtedness, except for certain permitted indebtedness;

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create, incur, allow, or suffer any lien on any of our property, except for certain permitted liens; and

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make any investment other than certain permitted investments.

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Such indebtedness could have significant consequences, including:

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requiring a substantial portion of our cash flows to be dedicated to debt service payments instead of funding growth, working capital, capital expenditures, investments or other cash requirements;

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reducing our flexibility to adjust to changing business conditions or obtain additional financing;

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exposing us to the risk of increased interest rates as borrowings under the Loan Agreement and the 2025 Credit Agreement are at a variable rate, making it more costly to make interest payments if interest rates rise;

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restricting us from making strategic acquisitions or causing us to make non-strategic divestitures;

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subjecting us to restrictive covenants that may limit our flexibility in operating our business; and

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limiting our ability to obtain additional financing for working capital, capital expenditures, debt service requirements and general corporate or other purposes.

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We may not be able to comply with the financial covenants or any of the other covenants described above in the future. Our ability to comply with these covenants may be affected by events and factors beyond our control, and future breaches of any of these covenants could result in a default under the Loan Agreement and/or the 2025 Credit Agreement. In the absence of a waiver from our lenders, any defaults could cause all of the outstanding indebtedness under the Loan Agreement and the 2025 Credit Agreement to become immediately due and payable and the lenders could terminate commitments to extend further credit and foreclose on the collateral granted to it to collateralize such indebtedness, which could adversely affect our business, results of operations and financial position.

If we cannot comply with covenants under the Loan Agreement or the 2025 Credit Agreement and do not have or are unable to generate sufficient cash available to repay our debt obligations when they become due and payable, either upon maturity or in the event of a default, our assets could be foreclosed upon and we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which could have a material adverse effect on our business, financial condition and results of operations. In addition, in such case, we may be unable to continue as a going concern, and you could lose all or part of your investment in our company. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—​Liquidity and Capital Resources—Debt Obligations.”

Risks Related to Our Business and Industry

Our business plan relies on certain assumptions about the market for our implant systems, however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.

Our estimates of our addressable market are based on publicly-available information, a number of internal and third-party estimates and assumptions, including the prevalence of TDR and fusion procedures and management’s knowledge and experience in the TDR market. For example, we believe that the aging of the general population and increasingly active lifestyles will continue and that these trends will increase the demand for effective devices and implant systems to be used in connection with TDR procedures. Furthermore, the United States is the largest market for TDR, and any contraction in this market or incorrect assumptions about the current and future development of the market would have a material impact on our results of operations and financial condition. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and our estimates may not be correct. The projected growth of TDR procedures and demand for our systems could materially differ from actual demand if our assumptions regarding these trends and acceptance of our systems by the medical community prove to be incorrect or do not materialize, or if non-surgical treatments or fusion techniques gain more widespread acceptance as a viable alternative to our systems or products. In addition, even if the number of people who undergo TDR procedures increases as we expect, technological or medical advances could provide alternatives to address DDD and reduce demand for TDR procedures or for our particular systems. As a result, our estimates of the addressable market for our current or future products may prove to be incorrect. Even if the total addressable market for our current and future products is as large as we have estimated, we may not be able to penetrate this market to capture additional market share for the reasons discussed in this “Risk Factors” section. The estimated market opportunities included in this prospectus represent the total overall revenue opportunity that we believe is available for our systems if 100% market share is achieved by us, and are not a representation that we will achieve any such market share. If the actual number of people who suffer from DDD who would benefit from TDR procedures with our systems, the price at which we can sell our current and future products or the addressable market for our systems and future products is smaller than we estimate, or if the total addressable market is as large as we have estimated but we are unable to capture additional market share, it could have a material adverse effect on our business, financial condition and results of operations.

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We operate in a highly competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, it could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Our existing products and technologies are, and any new products or technologies we develop and commercialize will be, subject to intense competition. The medical device industry is highly competitive, subject to change and significantly affected by new product introductions and market activities of industry participants. Our ability to compete successfully will depend on our ability to develop products and technologies that reach the market in a timely manner, receive adequate coverage and reimbursement from third-party payors and are safer, less invasive and more effective than the products and technologies of our competitors. Because of the size of the potential market, we anticipate that our competitors may dedicate significant resources, potentially in excess of what we are able to dedicate towards developing competing products and technologies.

The medical device industry is highly competitive, subject to change and significantly affected by new product introductions and market activities of industry participants. Our products compete directly against TDR products offered by Medtronic PLC, Highridge, Inc., Globus Medical Inc., Spineart SA, Spineway Group, and Synergy Spine Solutions, Inc. and numerous other companies offering spinal implant products. Many of our competitors are large, well-capitalized companies with significantly greater financial, technical, marketing, sales, manufacturing and distribution resources than we have. As a result, they may be able to devote greater resources to the development, regulatory approval, marketing and sale of their products than we can.

At any time, these or other market participants may develop alternative treatments, products or procedures that compete directly or indirectly with our products. They may also develop and patent processes or products earlier than we can or obtain regulatory clearance, certification or approvals for competing products more rapidly than we can.

The frequent introduction by competitors of products that are marketed as alternatives to our existing or planned products may also make it difficult for surgeons and other health care providers to differentiate our products from competing products and may lead some of our competitors to employ pricing strategies that could adversely affect the pricing of our products and pricing in the spine surgery market generally.

In addition, we compete with our competitors to engage the services of distributors, both those presently working with us and those with whom we hope to work as we expand. If we are unable to compete successfully against our existing or potential competitors, our business, financial condition, results of operations, and prospects may be adversely affected, and we may not be able to grow at our expected rate, if at all.

Our long-term growth depends on our ability to market, sell and improve our existing products and technologies, commercialize our existing products and products in development and develop new products and technologies through our research and development efforts, and if we fail to do so, we may not be able to increase our market share in the spine surgery market.

In order to increase our market share in the spine surgery market, we must successfully market, sell and improve our existing products and technologies, commercialize our existing products and develop and commercialize new products and technologies through our research and development efforts in response to changing clinical and patients’ needs and competitive pressures. In the near-term, we plan to advance additional sizing options for both cervical and lumbar applications, develop new and updated instrumentation to support procedural efficiency and reproducibility, and invest in enabling technologies intended to assist surgeons with implant selection and procedural consistency. In March 2026, we engaged with the FDA through the pre-submission program for a hybrid indication (TDR adjacent to fusion) for the prodisc C TDR product family. In May 2026, we submitted the PMA supplement seeking a two-level indication for prodisc C and prodisc C Nova. To secure earlier approval for prodisc C Nova, we withdrew prodisc C from the PMA supplement. On September 9, 2026, the FDA approved the two-level indication for prodisc C Nova.

Our industry is characterized by significant competition, technological and scientific advances, new product introductions and enhancements, as well as evolving industry standards. There can be no assurance that other companies will not succeed in developing or marketing products and technologies that are more effective than our products and technologies or that would render our products and technologies obsolete or noncompetitive.

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Additionally, new spine surgery procedures, medications and other therapies could be developed that replace or reduce the importance of any of our products and technologies. Accordingly, our business prospects depend in part on our ability to develop and commercialize new products and applications for our technology, including in new markets that develop as a result of technological and scientific advances, while improving the performance and cost-effectiveness of our existing products and technologies. Product and technology development is time-consuming and involves a high degree of risk and there can be no assurance that our product and technology development efforts will ultimately result in any commercially successful products. New technologies, techniques or products could emerge that might offer better combinations of price and performance than our existing products. It is important that we anticipate changes in technology and market demand, as well as in practices of healthcare facilities, surgeons and other healthcare providers, to successfully develop, obtain clearance, certification or approval, if required, and introduce new, enhanced and competitive products and technologies that meet clinical and patients’ needs on a timely and cost-effective basis.

We might be unable to successfully commercialize our existing products or develop and obtain regulatory clearances, certifications or approvals to market new products and technologies. Additionally, our products and technologies may not be accepted by the surgeons or third-party payors who reimburse for procedures performed using our products and technologies, or may not be successfully commercialized due to other factors, some of which are outside our control. The success of any new product or enhancement to an existing product or new technology will depend on numerous factors, including our ability to:

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properly identify and anticipate clinical and patients’ needs;

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develop and introduce new products, product enhancements and improvements and technologies in a timely manner;

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adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties;

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demonstrate the safety and efficacy of new products and technologies; and

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obtain the necessary regulatory clearances, certifications or approvals for new products or product enhancements and improvements.

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If we do not develop or obtain regulatory clearances, certifications or approvals for new products or product enhancements and improvements in time to meet market demand, or if there is insufficient demand for these products or product enhancements and improvements, our results of operations will suffer and we will not be able to increase our market share in the spine surgery market. Our research and development efforts may require a substantial investment of time and resources before we are adequately able to determine the commercial viability of a new product, technology, material or other innovation. In addition, even if we are able to develop new products, product enhancements and improvements to existing products or technologies successfully, these new products, product enhancements and improvements or technologies may not produce sales in excess of the costs of development and such products may be rendered obsolete by changing clinical and patients’ preferences, introduction of products embodying new technologies or features or availability of products at lower costs.

Nevertheless, we must carefully manage the introduction and launch of our new products and technologies as well as the expansion of our product offerings. If potential surgeons or patients believe such products will offer enhanced features or be sold for a more attractive price, they may delay purchases until such products are available, which could result in excessive or obsolete inventory as we transition to new products and thereby adversely impact our business, financial condition and results of operations.

We may not be able to successfully demonstrate to surgeons the benefits of total disc replacement surgical approach compared to the traditional fusion procedures.

Surgeons play a significant role in determining the course of treatment and, ultimately, the type of products that will be used to treat a patient. As a result, our success depends, in large part, on our ability to effectively market and demonstrate to surgeons the merits of anterior approach and our products and technologies compared to those of our competitors. Acceptance of our products and technologies depends on educating surgeons as to the distinctive characteristics, clinical benefits, safety and cost-effectiveness of our products and technologies as compared to those of our competitors, and on training surgeons in the proper use of our

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products. If we are not successful in convincing surgeons of the merits of our products and technologies or educating them on the use of our products, they may not use our products or may not use them effectively and we may be unable to increase our sales, sustain our growth or achieve and sustain profitability.

Surgeons may not be willing to move away from their long-lasting practice of fusion surgery procedures and adopt our motion preservation for the following reasons, among others:

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lack of experience with our products and technologies;

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existing relationships with competitors and distributors that sell competitive products;

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lack or perceived lack of evidence supporting additional patient benefits;

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perceived liability risks generally associated with the use of new products, technologies and procedures;

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less attractive availability of coverage and reimbursement by third-party payors compared to procedures using competitive products and other techniques; and

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the time commitment that may be required for training.

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In addition, although we continue to invest in surgeon engagement by providing surgeons with the necessary training in our products and technologies, our efforts to expand surgeon engagement and training may not be successful and the surgeons may choose to use the products of our larger, more established competitors because of their broad and comprehensive product offerings.

We believe recommendations and support of our products and technologies by influential surgeons and key opinion leaders in our industry are essential for market acceptance and establishment of our products and technologies as a standard of care. If we do not receive broad support from such surgeons and key opinion leaders, or if the benefits offered by our products and technologies are not sufficient to justify their cost, surgeons, hospitals and other healthcare facilities may not use our products and we may not remain competitive in the market, our revenue growth may slow or decline, and we may not be able to grow at our expected rate, or at all.

We may not be able to strengthen our brand and the brands associated with our products among patients.

We believe that strengthening the Centinel Spine brand and the brands associated with our products is critical to achieving widespread acceptance of our products, particularly because of the rapidly developing nature of the market for spinal implants. In addition to physician awareness, we have developed and continue to execute our direct-to-patient (DTP) education initiatives designed to increase awareness and understanding of total disc replacement and to support more informed discussions between patients and spine surgeons. To better engage these patients, we have developed a patient education and support program called rediscover, which serves as the central platform for our direct-to-patient education and engagement efforts. The rediscover program is designed to provide patients with educational content, practical guidance, and peer perspectives to help them understand when and how total disc replacement may be considered, how it differs from fusion, and how to prepare for conversations with surgeons trained in motion preservation.

Promoting and positioning our brands will depend largely on the success of our marketing efforts and the reliability of our products, and these brand promotion activities may not help us strengthen our brand and the brands of our products or yield increased sales and, even if they do, any sales increases may not offset the expenses we incur to promote our brand and our products. If we fail to successfully promote and maintain our brands, or if we incur substantial expenses in an unsuccessful attempt to promote and maintain our brand and the brands of our products, our products may not gain broad market acceptance, which would cause our sales to decrease and would adversely affect our business, results of operations and financial condition.

If we are unable to educate hospitals, ambulatory surgery centers and other healthcare facilities on the benefits of using our products, our sales may decrease.

In order for surgeons to use our products at hospitals, ambulatory surgery centers (“ASCs”), and other healthcare facilities, we are often required to obtain approval from those hospitals, ASCs and healthcare facilities. Typically, hospitals, ASCs and healthcare facilities review the comparative effectiveness and cost of products used in the facility. The makeup and evaluation processes for healthcare facilities vary considerably,

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and it can be a lengthy, costly and time-consuming effort to obtain approval by the relevant healthcare facilities. Additionally, hospitals, ambulatory surgery centers, other healthcare facilities and group purchasing organizations, or GPOs, which manage purchasing for multiple facilities, may also require us to enter into a purchase agreement and satisfy numerous elements of their administrative procurement process, which can also be a lengthy, costly, and time-consuming effort. If we do not obtain access to hospitals, ASCs and other healthcare facilities in a timely manner, or at all, via their approvals or purchase contract processes, or otherwise, or if we are unable to obtain approvals or secure contracts in a timely manner, or at all, our operating costs will increase, our sales may decrease and our operating results may be adversely affected. Furthermore, we may expend significant efforts on these costly and time-consuming processes but may not be able to obtain necessary approvals or secure a purchase contract from such hospitals, ambulatory surgery centers, healthcare facilities or GPOs.

Pricing pressure from our competitors or hospitals may affect our ability to sell our products at prices necessary to support our current business strategies.

Medical device companies, healthcare systems and GPOs have intensified competitive pricing pressure as a result of industry trends and new technologies. Purchasing decisions are gradually shifting to hospitals, integrated health networks, or IDNs, and other hospital groups, and away from individual surgeons and other physicians. Changes in the purchasing behavior of hospitals or the amount third-party payors are willing to reimburse our customers for procedures using our products, including those as a result of healthcare reform initiatives, could create additional pricing pressure on us. In addition to these competitive forces, we continue to see pricing pressure as hospitals introduce new pricing structures into their contracts and agreements, including fixed price formulas, capitated pricing and episodic or bundled payments intended to contain healthcare costs. If such trends continue to drive down the prices we are able to charge for our products, our profit margins will shrink, adversely affecting our business, results of operations and financial condition.

In addition, numerous initiatives and reforms initiated by legislators, regulators and third-party payors to curb rising healthcare costs, in addition to other economic factors, have resulted in a consolidation trend in the healthcare industry to create new companies with greater market power, including hospitals. As the healthcare industry consolidates, competition to provide products and services to industry participants has become, and will likely continue to become, more intense. This in turn has resulted, and will likely continue to result in, greater pricing pressures and the exclusion of certain suppliers from various market segments as GPOs, IDNs, and large single accounts continue to use their market power to consolidate purchasing decisions for some of our existing and prospective customers. We expect that market demand, government regulation and third-party reimbursement policies, among other potential factors, will continue to change the healthcare industry, resulting in further business consolidations and alliances among our customers and prospective customers, which may reduce competition among our existing and prospective customers, exert further downward pressure on the prices of our implants and may adversely impact our business, financial condition or results of operations.

The proliferation of physician-owned distributorships could result in increased downward pricing pressure on our products or harm our ability to sell our products to surgeons who own or are affiliated with those distributorships.

Physician-owned distributorships, or PODs, are product distributors that are owned, directly or indirectly, by physicians. Although we do not sell our products to PODs, the proliferation of PODs could result in increased downward pricing pressure on our products or harm our ability to sell our products to physicians who own or are affiliated with PODs. These physicians derive a proportion of their revenue from selling or arranging for the sale of medical devices for use in procedures they perform on their own patients at hospitals that agree to purchase from or through the POD, or that otherwise furnish ordering physicians with income based, directly or indirectly, on those orders of medical devices.

On March 26, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services, or DHHS, issued a special fraud alert on PODs and stated that it views PODs as inherently suspect under the federal anti-kickback statute and is concerned about the proliferation of PODs. Notwithstanding the DHHS’ concern about PODs, the number of PODs in the spine surgery market may continue to grow as economic pressures increase throughout the industry, healthcare facilities, surgeons and other healthcare providers search for ways to reduce costs and, in the case of the surgeons, search for ways to increase their incomes. PODs and

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the physicians who own, or partially own, them have significant market knowledge and access to the surgeons who use our products and the healthcare facilities that purchase our products and thus the growth of PODs may reduce our ability to compete effectively for business from surgeons who own such PODs. Growth in the number of PODs may reduce our ability to compete effectively for business from physicians who own, or partially own, them, which could have a material and adverse effect on our business, results of operations and financial condition.

If we fail to successfully enter into purchasing contracts for our products or engage in contract bidding processes internationally, we may not be able to receive access to certain hospital facilities and our sales may decrease.

In the United States, the hospital facilities where physicians treat patients with our products typically require us to enter into purchasing contracts. The process of securing a satisfactory contract can be lengthy and time-consuming and require extensive negotiations and management time. In certain international jurisdictions, from time to time, certain institutions require us to engage in a contract bidding process in the event that such institutions are considering making purchase commitments that exceed specified cost thresholds, which vary by jurisdiction. These processes are only open at certain periods of time, and we may not be successful in the bidding process. If we do not receive access to hospital facilities through these contracting processes or otherwise, or if we are unable to secure contracts or tender successful bids, our sales may stagnate or decrease and our operating results may be harmed. Furthermore, we may expend significant effort in these time-consuming processes and still may not obtain a purchase contract from such hospitals.

If coverage or adequate levels of reimbursement from third-party payors for procedures using our products, or any future products we may seek to commercialize, are not obtained or maintained, surgeons and patients may be reluctant to use our systems and our business will suffer.

In the United States, health care providers such as hospitals and ASCs who purchase our products generally rely on third-party payors, principally federally-funded Medicare, state-funded Medicaid and private health insurance plans, to pay for all or a portion of the cost of the surgical procedures and products utilized in those procedures. We may be unable to sell our products, or any future products we may seek to commercialize, on a profitable basis if third-party payors deny coverage or reduce their current levels of reimbursement for procedures using our systems. Our sales depend largely on governmental health care programs and private health insurers reimbursing providers for procedures using our products. Significant changes to operations at, funding of, or restructuring of such governmental authorities, including but not limited to a government shutdown, decreases in staff who are able to provide reimbursement services, reductions or other changes in funding provided to such governmental authorities, and changes in policy and enforcement priorities, may adversely affect our business.

Hospitals, ASCs and other health care providers may not purchase our products if they do not receive adequate reimbursement from third-party payors for procedures using our products. Payors continue to review their coverage policies for existing and new therapies and may deny coverage for treatments that include the use of our systems or any future products we may seek to commercialize. Third-party payors, whether governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, no uniform policy of coverage and reimbursement for procedures using our solution exists among third-party payors. Therefore, coverage and reimbursement for procedures using our products can differ from payor to payor.

In addition, some health care providers in the United States have adopted or are considering bundled payment methodologies and/or managed care systems in which providers contract to provide comprehensive health care for a fixed cost per person. Health care providers may attempt to control costs by authorizing fewer elective surgical procedures, or by requiring the use of the least expensive procedure available. In addition, third-party payors increasingly are requiring evidence that medical devices are cost-effective, and if we are unable to meet this requirement, the third-party payor may not cover procedures using our products, which could reduce sales of our products to health care providers who depend upon third-party payor reimbursement for payment. Changes in coverage policies or health care cost containment initiatives that limit or restrict reimbursement for procedures using our systems may have an adverse effect on our business.

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We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.

Our business exposes us to the risk of product liability claims that are inherent in the testing, manufacturing and marketing of our products. This risk exists even if a product is cleared, certified or approved for commercial sale by the U.S. Food and Drug Administration, or FDA, and manufactured in facilities regulated by the FDA or an applicable foreign regulatory authority. Our products are designed to affect, and any future products will be designed to affect, important bodily functions and processes. Any side effects, manufacturing defects, misuse or abuse associated with our products or our products in development could result in patient injury or death. The medical device industry has historically been subject to extensive litigation over product liability claims, and we cannot assure you that we will not face product liability claims. We may be subject to product liability claims if our products or products in development cause, or merely appear to have caused, patient injury or death, even if such injury or death was as a result of supplies or components that are produced by third-party suppliers.

Product liability claims may be brought against us by consumers, healthcare providers or others selling or otherwise coming into contact with our products, among others. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities and reputational harm. In addition, regardless of merit or eventual outcome, product liability claims may result in:

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costs of litigation;

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distraction of management’s attention from our primary business;

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the inability to commercialize existing or new products;

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decreased demand for our products or, if cleared, certified or approved, products in development;

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damage to our business reputation;

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product recalls or withdrawals from the market;

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withdrawal of clinical study participants;

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substantial monetary awards to patients or other claimants; and

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loss of net revenue.

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While we may attempt to manage our product liability exposure by proactively recalling or withdrawing from the market any defective products, any recall or market withdrawal of our products may delay the supply of those products to our customers and may impact our reputation. We cannot assure you that we will be successful in initiating appropriate market recall or market withdrawal efforts that may be required in the future or that these efforts will have the intended effect of preventing product malfunctions and the accompanying product liability that may result. Such recalls and withdrawals may also be used by our competitors to harm our reputation for product safety or be perceived by patients as a safety risk when considering the use of our products, either of which could adversely affect our business, results of operations and financial condition. See “—Risks Related to Government Regulation—Our products may be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could adversely affect us.”

In addition, although we have product liability and clinical study liability insurance that we believe is appropriate, this insurance is subject to deductibles and coverage limitations. Our current product liability insurance may not continue to be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate to protect us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could adversely affect our business, results of operations and financial condition.

We provide a limited warranty that our prodisc products are free of material defects in workmanship and materials and conform to specifications, and offer to repair or replace defective products. Although we have had very few warranty claims to date, we bear the risk of potential warranty claims on our products. If we

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receive a significant number of warranty claims or our products require significant amounts of service after sale, our operating expenses may substantially increase and our business and financial results will be adversely affected. We have a limited history of commercial placements from which to judge our rate of warranty claims, and we expect that the number of warranty claims we receive may increase as we scale our operations and as our existing commercial placements age. If product returns or warranty claims are significant or exceed our expectations, we could incur unanticipated reductions in sales or additional operating expenditures for parts and service.

Our results of operations will be materially harmed if we are unable to accurately forecast demand for our implant systems and maintain adequate levels of inventory.

In order to market and sell effectively, we must maintain significant levels of inventory of systems and surgical instrumentation. As a result, a significant amount of our cash used in operations has been associated with maintaining these levels of inventory. To ensure adequate inventory supply, we must forecast inventory needs and manufacturing orders based on our estimates of future demand. Our ability to accurately forecast demand for our systems could be negatively affected by many factors, including our failure to accurately manage our expansion strategy, product introductions by competitors, an increase or decrease in customer demand for our systems or for products of our competitors, our failure to accurately forecast customer acceptance of new products, unanticipated changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions. Inventory levels in excess of customer demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely affected and could impair the strength of our brand. Furthermore, as we continue to grow and expand, we require increasing levels of inventory which may subject us to greater financial risk in the event of a recall where such inventory is no longer commercially viable. Conversely, if we underestimate customer demand for our products, our manufacturers and suppliers may not be able to deliver products to meet our requirements, which could result in damage to our reputation and customer relationships. In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available to or at our existing manufacturers and suppliers when required on terms that are acceptable to us, or at all, which will negatively affect our business, financial condition and results of operations.

In addition, we are subject to the risk that a portion of our inventory will become obsolete or expire. Multiple sizes of implants are provided for surgery so that the surgeon can pick the appropriate implant size(s) based on the patient’s anatomy. For each surgery, fewer than all of the implants are used, and therefore certain portions may become obsolete before they can be used. In the event that a substantial portion of our inventory becomes obsolete, it could have a material adverse effect on our earnings and cash flows due to the resulting costs associated with the inventory impairment charges and costs required to replace such inventory.

The provision of loaned surgical instrument sets to our customers may implicate certain federal and state fraud and abuse laws.

We typically loan the surgical instrument sets necessary to perform procedures using our products for each surgery at no additional charge. The provision of these instruments at no charge may implicate certain federal and state fraud and abuse laws. Because the provision of loaned surgical instrument sets may result in a benefit to the hospital, surgeon or other healthcare provider, the government could view this practice as a prohibited transfer of value intended to induce hospitals, surgeons or other healthcare providers to purchase our products that are used in procedures reimbursed by a federal healthcare program. For further discussion of these laws, and the potential penalties thereunder, see “—Risks Related to Government Regulation — We are subject to federal, state and foreign laws and regulations relating to our healthcare business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would adversely affect our business, results of operations and financial condition.” Any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.

In the future our products may become obsolete, which would negatively affect operations and financial condition.

The medical device industry is characterized by rapid and significant change. There can be no assurance that other companies will not succeed in developing or marketing devices, and products that are more effective

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than our products or that would render our products obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our products. Accordingly, our success will depend in part on our ability to respond quickly to medical and other changes through the development and introduction of new products. Product development involves a high degree of risk and there can be no assurance that our new product development efforts will result in any commercially successful products.

We depend on third-party contract manufacturers, some of which are single source, to produce and package our products, and if these manufacturers fail to supply us with our products in sufficient quantities or at all, or in accordance with applicable regulatory requirements and our specifications, it will have a material adverse effect on our business, financial condition, and results of operations.

We use third-party manufacturers to produce almost all of our products and instruments, pursuant to multi-year agreements. We may not be able to renew or enter into new contracts with our existing suppliers following the expiration of such contracts on commercially reasonable terms, or at all. If any of our products or the components used in our products are alleged or proven to include quality or product defects, we may need to find alternate supplies, delay production of our products, discard or otherwise dispose of our products, or engage in a product recall, all of which may adversely affect our business, results of operations and financial condition. If our products or the components in our products are affected by adverse prices or quality or other concerns, we may not be able to identify alternate sources of components or other supplies that meet our quality controls and standards to sustain our sales volumes or on commercially reasonable terms, or at all.

We and our third-party manufacturers are required to comply with the Quality Management System Regulation, or QMSR, which is a set of the FDA regulations that establishes current Good Manufacturing Practices, or cGMP, requirements for medical devices and covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of such devices.

There is a limited number of suppliers and third-party manufacturers that operate under FDA’s QMSR requirements and that have the necessary expertise and capacity to manufacture our products or components for our products. As a result, it may be difficult for us to locate manufacturers for our anticipated future needs, and our anticipated growth could strain the ability of our current suppliers and third-party manufacturers to deliver products, materials and components to us. Upon expiration of our existing agreements with these third-party manufacturers, we may not be able to renegotiate the terms of our agreements with these third-party manufacturers in a timely manner and on a commercially reasonable basis, or at all.

If we or our third-party manufacturers fail to maintain facilities in accordance with the FDA’s QMSR, the noncomplying party could lose the ability to manufacture our products on a commercial scale. Loss of this manufacturing capability would limit our ability to sell our products, which are manufactured by single-source third-party manufacturers. See “Business—Manufacturing and Supply.”

We rely on certain single source suppliers to manufacture our products. For example, Hammill Manufacturing Co. is our single source supplier for machining and finishing endplates and inlays used in our prodisc C Vivo, prodisc C Nova and prodisc C SK products and Bricon is our sole supplier for machining prodisc C endplates. Both suppliers support distribution in the United States. Internationally, Medicoat (coating), Bricon (finishing) and Fruh (packaging and sterilization) are sole sourced for prodisc C Vivo and prodisc C Nova products. For certain products, we estimate that it could take up to 24 months to find and qualify a second source. Although we have identified alternate third parties who could provide manufacturing services and expect to reduce our reliance on single source manufacturers, we cannot guarantee that we would be able to contract with such alternate third parties within a reasonable amount of time or at all, or upon similar pricing and volume terms, nor can we be assured that any such third party would be capable of producing products in sufficient volume and quality. For example, a replacement supplier may discover challenges with our products or we may not perfectly specify our product designs for such new suppliers’ manufacturing systems, which may require us to refine our products and/or incur additional research and development expense, which could delay our sales and have an adverse effect on our financial condition and results of operations.

Our reliance on a third-party manufacturer and third-party suppliers also subjects us to other risks that could harm our business that we would not be subject to if we manufactured ourselves, including, among others:

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we may not be a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours, including some of our competitors who use the same manufacturing partners;

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third parties may threaten or enforce their intellectual property rights against our suppliers, which may cause disruptions or delays in shipment, or may force our suppliers to cease conducting business with us;

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we may not be able to obtain an adequate supply of components in a timely manner or on commercially reasonable terms;

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our suppliers may make errors in manufacturing that could negatively affect the efficacy or safety of our systems or cause delays in shipment;

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we may have difficulty locating and qualifying alternative suppliers and our existing suppliers could be acquired by companies that have limiting or exclusive relationships with our competitors;

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switching components or suppliers may require product redesign and possibly submission to and approval by the FDA, or notified bodies, which could significantly impede or delay our commercial activities;

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our single-source supplier may be unwilling or unable to supply components of our systems;

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other customers, including our competitors, may use fair or unfair negotiation tactics or pressures to impede our use of the suppliers;

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the occurrence of a fire, natural disaster or other catastrophe, or the occurrence of geopolitical conflicts, as well as any sanctions or other actions resulting therefrom impacting one or more of our suppliers may affect their ability to deliver products to us in a timely manner;

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the occurrence of pandemics, epidemics and other public health emergencies may impact a manufacturing facility by limiting operating capacity or sideline critical employees involved in the manufacturing processes thereby affecting their ability to deliver products to us in a timely manner;

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our suppliers may encounter financial or other business hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements;

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our suppliers may not maintain the confidentiality of our proprietary information or may mislabel raw materials resulting in inaccurate certifications; and

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higher manufacturing and product costs than more vertically integrated companies.

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Any of these factors could cause delay or suspension of commercialization and marketing, regulatory submissions or required approvals, clearances or certifications, or cause us to incur higher costs. Furthermore, if our contract manufacturers fail to deliver the required commercial quantities of finished products on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality, and on a timely basis, we would likely be unable to meet demand for our systems and we would lose potential revenue. Any difficulties in locating and hiring third-party manufacturers, or in the ability of third-party manufacturers to supply quantities of our products meeting applicable regulatory requirements at the times and in the quantities we need could have a material adverse effect on our business. It may take a significant amount of time and resources (including costs) to establish an alternative source of supply for our products and to have any such new source authorized by the FDA or other bodies. Given our reliance on certain single-source suppliers, we are especially susceptible to supply shortages because we do not have alternate suppliers currently available that we could contract with in reasonable amount of time or at all, or upon similar pricing and volume terms, nor can we be assured that any such third party would be capable of producing in sufficient volume and of sufficient quality.

The loss of any of these third-party manufacturers or the failure for any reason of any of these third-party manufacturers to meet their contractual, regulatory, and other obligations, including a failure to meet our quality controls and standards, or a finding by the FDA of significant violations of the QMSR, may result in disruptions to our supply of finished goods, which will have a material adverse effect on our business, financial condition, and results of operations.

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Performance issues, service interruptions or price increases by shipping carriers could adversely affect our business and harm our reputation and ability to provide our systems on a timely basis.

Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point transport of our products to our customers and for tracking of these shipments that are delivered directly to hospitals and ASCs, employees or independent distributors. Should a carrier encounter delivery performance issues such as loss, damage or destruction of our systems, it would be costly to replace our systems in a timely manner, could cause surgeries using our systems to be delayed or canceled and such occurrences may damage our reputation and lead to decreased demand for our systems and increased cost and expense to our business. Once a product leaves our facilities, we are no longer in control of the care of such shipped products and any damage that may occur during transit may not be readily detectable by the customer, including any penetrations of sterile barriers, temperature swings that may cause package seal rupturing or exposure to fine particulates or other debris that is not easily detectable. In addition, any significant increase in shipping rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters, including fires and hurricanes, or other service interruptions affecting delivery services we use would adversely affect our ability to process orders for our systems on a timely basis.

We, or the third parties we depend on, may be adversely affected by natural disasters and other catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious natural disaster or other catastrophic event. Any interruption in our operations or the operations of third parties who supply components or other materials for our products may have a material adverse effect on our business, financial condition, results of operations, and prospects.

Severe weather, natural disasters and other catastrophic events, including pandemics or other public health crises, earthquakes, tsunamis, hurricanes, floods, fires, explosions, accidents, power outages, cyberattacks, telecommunications failures, mechanical failures, unscheduled downtimes, civil unrest, strikes, transportation interruptions, unpermitted discharges or releases of toxic or hazardous substances, other environmental risks, wars or other conflicts (including wars in Ukraine as well as the Middle East), sabotage, terrorist attacks, or other intentional acts of vandalism or misconduct could severely disrupt our operations, or the operations of third parties who manufacture or supply components or other materials for our products, and have a material adverse effect on our business, financial condition, results of operations, and prospects.

If a natural disaster or other catastrophic event occurs that prevents us or third-party suppliers or manufacturers from using all or a significant portion of our or their headquarters or other facilities, that damages critical infrastructure or that otherwise disrupts operations, it may be difficult or, in certain cases, impossible, for us to commercialize our products and conduct our research and development activities for new products for a substantial period of time, which may result in the inability to continue to supply our products during such periods and the loss of customers or harm to our reputation. We are highly dependent on our corporate headquarters and distribution facility, and any natural disaster or catastrophic event that impacts these facilities could have a material adverse impact on our business, financial condition and results of operations. Moreover, the disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar catastrophic event. The potential impact of any disruption would depend on the nature and extent of the damage caused by a disaster. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

In addition, integral parties in our supply chain are similarly vulnerable to natural disasters or other sudden, unforeseen, and severe adverse events. If such an event were to affect our supply chain, it could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Our insurance may not cover all potential losses or liabilities that may arise.

We are not insured against all potential losses or liabilities that may arise, as insurance coverage may be unavailable, not cost-effective, or subject to significant limitations. For example, we are not insured against business interruptions suffered by third parties that we depend on, environmental liabilities or patent infringement, among other types of risks. Furthermore, no assurance can be given that an insurance carrier

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will not seek to cancel or deny coverage after a claim has occurred. If a loss or liability occurs that is not or not fully covered by insurance, we may be required to pay substantial amounts, which could adversely affect its cash position and results of operations.

If we fail to maintain our numerous contractual relationships, our business, results of operations and financial condition could be adversely affected.

We are party to numerous contracts in the normal course of our business. We have contractual relationships with suppliers, surgeons, hospitals, distributors and agents, as well as service providers. In the aggregate, these contractual relationships are necessary for us to operate our business. From time to time, we amend, terminate or negotiate our contracts. We may also periodically be subject to, or make claims of breach of contract, or threaten legal action relating to our contracts. These actions may result in litigation. At any one time, we have a number of negotiations under way for new or amended commercial agreements. We devote substantial time, effort and expense to the administration and negotiation of contracts involved in our business. However, these contracts may not continue in effect past their current term or we may not be able to negotiate satisfactory contracts in the future with current or new business partners, which may adversely affect our business, results of operations and financial condition.

If we are unable to manage, train, maintain and grow our direct sales team and network of independent distributors, we may not be able to generate anticipated sales or we may be subject to regulatory or enforcement action.

Our operating results are directly dependent upon the sales and marketing efforts of not only our direct sales team, but also our independent distributors. If our direct sales team or independent distributors fail to adequately promote, market and sell our products, our sales could significantly decrease.

We face significant challenges and risks in managing our geographically dispersed distribution network and retaining the individuals who make up that network. If any members of our direct sales team were to leave us, or if any of our independent distributors were to cease to do business with us, our sales could be adversely affected.

If a member of our direct sales team or one of our independent distributors were to depart, we may need to seek alternative independent distributors or increase our reliance on our direct sales team, which may not prevent our sales from being adversely affected. If, in such a situation, a member of our direct sales team or independent distributor were to be retained by one of our competitors, we may be unable to prevent them from helping such competitors solicit business from our existing customers, which could further adversely affect our sales. Because of the competition for their services, we may be unable to recruit or retain additional qualified independent distributors or to hire additional direct sales team members to work with us on favorable or commercially reasonable terms, if at all. Failure to hire or retain qualified members of our direct sales team or independent distributors would prevent us from maintaining or expanding our business and generating sales.

If we launch new products or increase our marketing efforts with respect to existing products, we will need to expand the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled members of our direct sales team and independent distributors with significant technical knowledge in our technologies. New hires require training and take time to achieve full productivity. If we fail to train new hires adequately, or if we experience high turnover in our sales force in the future, we cannot be certain that new hires will become as productive as may be necessary to maintain or increase our sales. If we are unable to expand our sales and marketing capabilities domestically and internationally, we may not be able to effectively commercialize our products, which would adversely affect our business, results of operations and financial condition.

The misuse or off-label use of our systems may result in costly investigations, fines, or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.

In certain cases, federal, state and foreign authorities pursue advisory or enforcement actions, including for false claims, on the basis that manufacturers and distributors are promoting unapproved, or “off-label” uses of

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their products. Pursuant to FDA regulations, we can only market our products for authorized uses. Although surgeons are permitted, in their independent medical judgement, to use medical devices for indications other than those cleared or approved by the FDA, we are prohibited from promoting products for “off-label” uses. Through our direct sales team, we market our products and provide promotional materials and training programs to surgeons regarding the use of our products. Our sales and marketing personnel, as well as our direct sales force, are trained to not promote our devices for uses outside of the FDA-authorized indications for use. If we fail to adequately train new hires or our direct sales team, new hires or members of our direct sales team may engage in practices such as the promotion of unapproved uses of our devices or may assist with the reimbursement process in a manner that results in false or fraudulent claims for reimbursement being submitted to government or private payors. If it is determined that our marketing, promotional materials or training programs constitute promotion of unapproved uses, we could be subject to significant fines in addition to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, criminal penalty, and damage to our reputation, as well as the possible exclusion from participation in federal health care programs. Federal, state and foreign authorities also pursue actions for false claims based upon improper billing and coding advice or recommendations, as well as decisions related to the medical necessity of procedures, including the site-of-service where procedures are performed, which could result in significant penalties. See “—Risks Related to Government Regulation.”

Actual or perceived failures to comply with applicable data privacy and security laws, regulations, standards, and other requirements could adversely affect our business, financial condition, results of operations, and prospects.

The global data protection landscape is rapidly evolving, and we, and the third-party service providers on which we rely, are or may become subject to numerous U.S., state, federal, and/or foreign laws, requirements, and regulations, in addition to contractual obligations and research protocols governing privacy and data security, including the collection, use, disclosure, retention, processing, maintenance, transfer, and security of personal information, such as information that we and our third-party service providers collect in connection with the use and development of the prodisc technology platform and in clinical studies, including patient data. Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future and recently-passed laws, regulations, standards, or perception of their requirements may have on our business. This evolution may create uncertainty in our business; affect our ability to operate in certain jurisdictions or to collect, store, transfer, use, and share personal information; necessitate the acceptance of more onerous obligations in our contracts; result in liability; or impose additional costs on us. The cost of compliance with these laws, regulations, and standards is high and is likely to increase in the future. Our actual or perceived failure to comply with privacy and data security regulation could lead to regulatory inquiries or enforcement actions, litigation, fines and penalties, disruptions to our business operations, reputational harm, loss of revenue, additional costs, business changes or delays, and other adverse business consequences.

In the U.S., HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information. We may obtain health information from third parties, such as research institutions with which we collaborate, that are subject to privacy and security requirements under HIPAA. Although we do not believe that we are directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA. Certain states have also adopted comparable privacy and security laws and regulations, which govern the privacy, processing and protection of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act of 2018, (CCPA) as amended by the California Privacy Rights Act (collectively, the CCPA) requires covered businesses that process the personal information of California residents to, among other things: (i) provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; (ii) receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt out of certain disclosures of their personal information; and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. Additional compliance investment and potential business process changes may also be required. Similar laws have been passed in other states, and are

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continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. For example, Washington State enacted the Washington My Health My Data Act, which broadly defines consumer health data, creates a private right of action to allow individuals to sue for violations of the law, imposes stringent consent requirements, and grants consumers certain rights with respect to their health data, including to request deletion of their information. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition and the costs of compliance would be material.

Further, the Federal Trade Commission (the “FTC”) also has authority to initiate enforcement actions against entities that make deceptive statements about privacy and data sharing in privacy policies, fail to limit third-party use of personal health information, fail to implement policies to protect personal health information, or engage in other unfair practices that harm customers or that may violate Section 5 of the FTC Act. Failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce under the FTC Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information that it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

In 2024, the National Security Division of the U.S. Department of Justice (DOJ) issued a new rule—referred to as the “Data Security Program” ​(DSP)—to implement Executive Order 14117 aimed at preventing access to “bulk U.S. sensitive personal data” and “government-related data” by “countries of concern” ​(including China, Russia, Iran, North Korea, Cuba, and Venezuela) and “covered persons” ​(as all such terms are defined in the DSP). Effective as of April 8, 2025, and fully enforceable as of July 8, 2025, the DSP imposes stringent obligations on companies within its scope and prohibits or restricts “covered data transactions” that grant countries of concern or covered persons access to bulk U.S. sensitive personal data or any amount of government-related data. The DSP is new, complex and has yet to be enforced, and as such, there is a risk that our interpretation of its applicability, scope, and requirements is incorrect, incomplete, or misapplied. Compliance with the DSP may require us to invest heavily in data security and compliance measures, such as implementing and complying with the Cybersecurity and Infrastructure Security Agency’s guidelines and other burdensome recordkeeping, reporting, and auditing requirements. It may also require us to implement new processes, stop or restrict certain data transfers, alter the geographic scope of our operations, cease doing business with certain third parties or using certain tools or vendors, or change how data flows throughout our business, any of which could materially impact our business operations or hinder our ability to grow our business. Finally, non-compliance with the DSP could result in significant civil or criminal penalties, which could materially adversely affect our business, results of operations, and financial condition.

Our operations abroad may also be subject to increased scrutiny or attention from data protection authorities. For example, in Europe, the European Union General Data Protection Regulation (the “EU GDPR”) and in the United Kingdom, the United Kingdom General Data Protection Regulation and Data Protection Act 2018 (the “UK GDPR” and together with the EU GDPR, referred to as the “GDPR”) impose strict requirements for processing the personal data of individuals within the European Economic Area (EEA) or United Kingdom or in the context of our activities within the EEA or United Kingdom (as appropriate). Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance under both the EU GDPR and UK GDPR of up to €20 million/ GBP 17.5 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. In addition to fines, a breach of the GDPR may result in regulatory investigations, reputational damage, orders to cease/ change our data processing activities, enforcement notices, assessment notices (for a compulsory audit) and/ or civil claims (including class actions). Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EEA, and the United States remains uncertain. Case law from the Court of Justice of the European Union (“CJEU”) states that reliance on the standard contractual clauses—a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism—alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis. On July 10, 2023, the European Commission

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adopted its Adequacy Decision in relation to the new EU-US Data Privacy Framework (“DPF”), rendering the DPF effective as a GDPR transfer mechanism to U.S. entities self-certified under the DPF. Because of regulatory challenges in the EU to the validity of the DPF, we choose to rely on standard contractual clauses for most transfers of personal data to which GDPR applies.

In relation to such cross border transfers of personal data, we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue, and international transfers to the United States, China, and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints and/or regulatory investigations or fines; we may have to stop using certain tools and vendors and make other operational changes; we may have to implement alternative data transfer mechanisms under the GDPR and/ or take additional compliance and operational measures; and/or it could otherwise affect the manner in which we operate our business, and could adversely affect our business, operations and financial condition.

As we expand into other foreign countries and jurisdictions, we will become subject to additional laws and regulations that will affect how we conduct business, and we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue. Our operations could suffer additional costs, complaints, and regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. Compliance with applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with new data protection rules. Failure or perceived failure to comply with any such laws or regulations puts us at risk of facing significant fines and penalties that could adversely affect our business, financial condition, reputation, and results of our operations. Furthermore, conflicting requirements across applicable privacy and data security laws would complicate our compliance efforts and increase both legal risk and compliance costs for us and the third parties upon whom we rely.

Although we work to comply with applicable laws, regulations and standards, our contractual obligations, research protocols, and other obligations, any actual or perceived failure by us or our employees, representatives, contractors, consultants, or other third parties to comply with such requirements or adequately address data privacy and security concerns, even if unfounded, could result in, among other adverse impacts, damage to our reputation, loss of customer confidence in our security measures, withdrawal or withholding of customer consent for using patient data, government investigations, and enforcement actions and litigation and claims by third parties, any of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

AI presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.

We are beginning to incorporate AI solutions into our platform, and these applications can become increasingly important to our operations over time. AI presents risks such as inaccuracy, bias, toxicity, intellectual property infringement or misappropriation, data privacy and cybersecurity and data provenance. In addition, AI utilizes machine learning and predictive analytics, which in some cases present flawed, biased, and inaccurate results, and may have errors or inadequacies that are not easily detectable and may also be subject to data herding and interconnectedness (i.e., multiple market participants utilizing the same data), in each case adversely impacting our business. The regulatory framework for AI is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations could affect the operation of our AI. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact of future laws, regulations, standards, or market perception of their requirements on our business and our response. It is possible that new laws and regulations will be adopted in the United States and in other jurisdictions outside the United States, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI for our business, or require us to change the way we use AI in a manner that negatively affects the performance of our technologies, services, and business and the way in which we use AI. We may need to

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expend resources to adjust our technologies or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions. Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition, and results of operations.

These issues, combined with an uncertain regulatory environment, may further result in reputational harm, liability, or other adverse consequences to our business operations. Incorporation of generative AI tools by vendors into their offerings without disclosing this use to us would expose us to potential liability, and the providers of these generative AI tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience. If our vendors, or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative AI, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.

We, along with our suppliers, are dependent on various information technology systems. If our information technology systems or those of third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.

We and our suppliers collect and maintain information, including data about employees, business partners and clinical study participants, in digital form that is necessary to conduct our business, and rely extensively on information technology systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security system and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided or used by third-parties or their vendors, and some of which may be stored outside of the United States. These systems include, but are not limited to, ordering and managing materials from suppliers, converting materials to finished products (suppliers), shipping products to customers, processing transactions, summarizing and reporting results of operations, complying with regulatory, legal or tax requirements, providing data security and other processes necessary to manage our business.

We face numerous and evolving cybersecurity risks that threaten the confidentiality, integrity and availability of our information technology systems and sensitive information. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations. The use of cloud-based computing creates opportunities for the unintentional dissemination or intentional destruction of confidential information stored in our or our third-party providers’ systems, portable media or storage devices. Our internal computer systems and those of our contractors, consultants and collaborators have been and are vulnerable to damage from cyberattacks, “phishing” attacks, intentional or accidental actions or omissions to act that cause vulnerabilities, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

Attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise. Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work. Our information technology systems and those of our third-party service providers, strategic partners and other contractors or consultants are vulnerable to attack, damage and interruption from computer viruses and malware (e.g. ransomware), misconfigurations, “bugs” or other vulnerabilities, malicious code, natural

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disasters, terrorism, war, telecommunication and electrical failures, hacking, cyberattacks, phishing attacks and other social engineering schemes, employee theft or misuse, human error, fraud, denial or degradation of service attacks and sophisticated nation-state and nation-state-supported actors.

We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information. If we or our third-party vendors were to experience a significant cybersecurity breach of our or their information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to counter-parties and data subjects could be material. In addition, our remediation efforts may not be successful. If we do not allocate and effectively manage the resources necessary to build and sustain the proper technology and cybersecurity infrastructure, we could suffer significant business disruption, including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, data loss or the loss of or damage to intellectual property or other proprietary information. There can also be no assurance that our and our third-party service providers’, strategic partners’, contractors’, consultants’, Contract Research Organizations’ and collaborators’ cybersecurity risk management program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems, networks and confidential information. For example, a third-party software provider which we have engaged as part of our advanced implant systems was recently inspected by the FDA, which identified a single observation regarding inadequate validation of the software to address active vulnerability threats. While such a finding may not be material, if not properly remediated, it could affect our brand, business, financial condition, results of operations and prospects.

We and certain of our service providers are from time to time subject to cyberattacks and security incidents. While we do not believe that we have experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, whether due to a loss, corruption or unauthorized disclosure of our trade secrets, personal information or other proprietary or sensitive information or other similar disruptions. We may also experience security breaches that may remain undetected for an extended period. If our systems are damaged or cease to function properly due to any number of causes, ranging from catastrophic events to power outages to security breaches, and our business continuity plans do not effectively compensate timely, we may suffer interruptions in our ability to manage operations, and would also be exposed to a risk of loss, including financial assets or litigation and potential liability, which could materially adversely affect our business, financial condition, results of operations and prospects.

Any adverse impact to the availability, integrity or confidentiality of our information technology systems or sensitive information can result in legal claims or proceedings (such as class actions), regulatory investigations and enforcement actions, fines and penalties, negative reputational impacts that cause significant incident response, system restoration or remediation and future compliance costs. Any or all of the foregoing could materially adversely affect our business, operating results, and financial condition. We cannot assure you that any limitations of liability provisions in our contracts would be enforceable or adequate or would otherwise protect us from any liabilities or damages with respect to any particular claim relating to a security lapse or breach. While we maintain certain insurance coverage, including cyber insurance, our insurance may be insufficient or may not cover all liabilities incurred by such attacks. We also cannot be certain that our insurance coverage will be adequate for data handling or data security liabilities actually incurred, that insurance will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any future claim. The successful assertion of one or more large claims against us that exceeds available insurance coverage, or the occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on our business, including our financial condition, operating results and reputation.

Our business subjects us to economic, political, regulatory and other risks associated with international sales and operations that could adversely affect our business, results of operations and financial condition.

Since we sell our products in many different jurisdictions outside the United States, our business is subject to risks associated with conducting business internationally. For the six months ended June 30, 2026 and the fiscal year ended December 31, 2025, net revenue from international operations represented approximately 15% and 16%, respectively, of our total net revenue, and we anticipate that net revenue from international

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operations will continue to represent a significant portion of our total net revenue. In addition, a number of our third-party manufacturing facilities and suppliers of our products are located outside the United States. Accordingly, our future results could be harmed by a variety of factors, including:

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multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import restrictions, including unexpected changes in tariffs, trade barriers, regulatory requirements and other governmental approvals, permits and licenses;

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the effect of local and regional financial pressures on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

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customers in some foreign countries potentially having longer payment cycles;

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disadvantages of competing against companies from countries that are not subject to U.S. laws and regulations, including the U.S. Foreign Corrupt Practices Act, or FCPA, regulations of the U.S. Department of Treasury, Office of Foreign Assets Controls, and U.S. anti- money laundering regulations, as well as exposure of our foreign operations to liability under these regulatory regimes;

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training of third-parties on our products and the procedures in which they are used;

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reduced protection for and greater difficulty enforcing our intellectual property rights in certain jurisdictions;

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difficulty in staffing and managing international operations, including compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

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foreign tax laws and complexities of foreign value-added tax (“VAT”) systems;

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workforce uncertainty in countries where labor unrest is more common than in the United States;

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international regulators and third-party payors requiring additional clinical studies prior to approving or allowing reimbursement for our products;

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complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

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production shortages resulting from any events affecting material supply or manufacturing capabilities abroad; and

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natural disasters, political and economic instability, including wars, terrorism, political unrest, outbreak of disease, pandemics and epidemics, boycotts, curtailment of trade and other market restrictions.

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In addition, further expansion into new international markets may require significant resources and the efforts and attention of our management and other personnel, which may divert resources from our existing business operations. As we expand our business internationally, our success will depend, in large part, on our ability to anticipate and effectively manage these and other risks associated with our operations outside of the United States.

We are exposed to foreign currency risks, which may adversely affect our business, results of operations and financial condition.

Because some of our revenue, expenses, assets and liabilities are denominated in foreign currencies, we are subject to exchange rate and currency risks. In preparing our consolidated financial statements, which are presented in U.S. dollars, we must convert all non-U.S. dollar financial results to U.S. dollars at varying exchange rates. This may ultimately result in currency gain or loss, the outcome of which we cannot predict.

Furthermore, to the extent that we incur expenses or earn revenue in currencies other than in U.S. dollars, any change in the values of those foreign currencies relative to the U.S. dollar could cause our profits to decrease or our products to be less competitive against those of our competitors. To the extent that our current assets denominated in foreign currency are greater or less than our current liabilities denominated in foreign currencies, we face potential foreign exchange exposure.

To minimize such exposures, we may in the future enter into derivative instruments related to forecasted foreign currency transactions or currency hedges from time to time. Losses from changes in the value of the

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Euro or other foreign currencies relative to the U.S. dollar could adversely affect our business, results of operations and financial condition.

We are subject to differing tax rates in several jurisdictions in which we operate, which may adversely affect our business, results of operations and financial condition.

We are subject to taxes in the United States and certain foreign jurisdictions. Due to economic and political conditions, tax rates in various jurisdictions, including the United States, may be subject to change. Our future effective tax rates could be affected by changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities and changes in tax laws or their interpretation. In addition, we may be subject to income tax audits by various tax jurisdictions. Although we believe our income tax liabilities are reasonably estimated and accounted for in accordance with applicable laws and principles, an adverse resolution by one or more taxing authorities could have a material impact on the results of our operations.

We are subject to VAT and other indirect tax laws in multiple jurisdictions, and the complexity and interpretation of these rules could result in additional tax liabilities and compliance costs.

We are subject to VAT, sales, use, and other indirect tax laws in multiple jurisdictions, including the U.K. and the European Union, which are complex, evolving, and subject to differing interpretations by tax authorities. Determining the appropriate tax treatment of our cross-border transactions and intercompany service arrangements requires judgment, including the characterization of services, determination of place of supply, and application of reverse-charge mechanisms. Disagreements with tax authorities or changes in guidance or enforcement practices could result in additional VAT liabilities, penalties, interest, or the loss of input VAT recovery, which could adversely affect our financial condition, results of operations, and cash flows.

We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.

From time to time, we expect to consider opportunities to acquire or make investments in other technologies, products, and businesses that may enhance our capabilities, complement our current products, or expand the breadth of our markets or customer base. Potential and completed acquisitions and strategic investments involve numerous risks, including:

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problems assimilating the purchased technologies, products, or business operations;

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issues maintaining uniform standards, procedures, controls, and policies;

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unanticipated costs and liabilities associated with acquisitions;

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diversion of management’s attention from our core business;

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adverse effects on existing business relationships with suppliers and customers;

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risks associated with entering new markets in which we have limited or no experience;

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potential loss of key employees of acquired businesses; and

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increased legal and accounting compliance costs.

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We have no current commitments with respect to any acquisition or investment. We do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired business, product, or technology into our business or retain any key personnel, suppliers, or distributors. Our ability to successfully grow through acquisitions depends upon our ability to identify, negotiate, complete, and integrate suitable target businesses and to obtain any necessary financing. These efforts could be expensive and time consuming, and may disrupt our ongoing business and prevent management from focusing on our operations. If we are unable to successfully integrate any acquired businesses, products, or technologies effectively, our business, results of operations, and financial condition will be materially adversely affected.

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We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships with third-parties that may not result in the development of commercially viable products or the generation of significant future revenue.

In the ordinary course of our business, we may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, partnerships, or other arrangements to develop products and to pursue new markets. We have not entered into any such collaboration arrangements to date. Proposing, negotiating, and implementing collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships may be a lengthy and complex process. Other companies, including those with substantially greater financial, marketing, sales, technology, or other business resources, may compete with us for these opportunities or arrangements. We may not identify, secure, or complete any such transactions or arrangements in a timely manner, on a cost-effective basis, on acceptable terms or at all. We have limited institutional knowledge and experience with respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement. In particular, these collaborations may not result in the development of products that achieve commercial success or result in significant revenue and could be terminated prior to developing any products.

It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement, including those related to financial obligations or the ownership or control of intellectual property developed during the collaboration. If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us. In addition, we may have limited control over the amount and timing of resources that any future collaborators devote to our or their future products.

Disputes between us and our collaborators may result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions and arrangements will be contractual in nature and will generally be terminable under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium. If we enter into in-bound intellectual property license agreements, we may not be able to fully protect the licensed intellectual property rights or maintain those licenses. Future licensors could retain the right to prosecute and defend the intellectual property rights licensed to us, in which case we would depend on the ability of our licensors to obtain, maintain and enforce intellectual property protection for the licensed intellectual property. These licensors may determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would. Further, entering into such license agreements could impose various diligence, commercialization, royalty, or other obligations on us. Future licensors may allege that we have breached our license agreement with them, and accordingly seek to terminate our license, which could adversely affect our competitive business position and harm our business prospects.

The loss of any member on our senior management or our inability to attract and retain highly skilled members of our sales management and marketing teams and engineers could have a material adverse effect on our business, financial condition and results of operations.

Our success depends in part on our continued ability to attract, retain, and motivate highly qualified management, sales and marketing. The loss or incapacity of existing members of our senior management team could have a material adverse effect on our business, financial condition and results of operations if we experience difficulties in hiring qualified successors. We do not maintain “key person” insurance for any of our executives or key employees. We have employment agreements with each of the members of our senior management team; however, the existence of these employment agreements does not guarantee our retention of these senior managers for any period of time.

Our commercial, supply chain and research and development programs and operations depend on our ability to attract and retain highly skilled members of our sales management and marketing teams and engineers. Competition for qualified personnel in the medical device field is intense, due to the limited number of individuals who possess the training, skills, and experience required by our industry. We may be unable to attract or retain qualified member of our sales management and marketing teams or engineers in the future due to the competition for qualified personnel among medical device companies. In addition, to the extent

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that we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited, that they have divulged proprietary or other confidential information, or that their former employers own their research output. Recruiting and retention difficulties can limit our ability to support our commercial, supply chain and research and development programs. The loss of key employees, failure of any key employee to perform, our inability to attract and retain skilled employees, as needed, or our inability to effectively plan for and implement a succession plan for key employees could have a material adverse effect on our business, financial condition and results of operations.

Unfavorable global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by global or regional economic, political and health conditions. A global financial crisis or global or regional political and economic instability (including changes in inflation, interest rates and overall economic conditions and uncertainties), tariffs, wars, terrorism, civil unrest, pandemics, epidemics, endemics and other public health emergencies, and other unexpected events, such as supply chain constraints or disruptions, could cause extreme volatility, increase our costs and disrupt our business. Business disruptions could include, among others, disruptions to our commercial activities, including due to supply chain or distribution constraints or challenges, clinical enrollment, clinical site availability, patient accessibility and conduct of our clinical studies, as well as temporary closures of our facilities and the facilities of suppliers or contract manufacturers in our supply chain. For example, these macroeconomic factors could affect the ability of our current or potential future manufacturers to remain in business, or otherwise manufacture or supply components, materials or services relevant to our systems. Any failure by any of them to remain in business could affect the manufacture of our systems or our ability to meet demand for our systems. In addition, if inflation or other factors were to significantly increase our business costs, we may be unable to pass through price increases to our customers. Interest rates and the ability to access credit markets could also adversely affect the ability of our customers to purchase our systems.

The imposition of tariffs and other orders or restrictions impacting trade could adversely impact our business, including by increasing or otherwise impacting the costs and expenses we incur in connection with our operations and supply chain, and by potentially increasing the price of our systems to purchasers. The actual impacts of any tariffs and other orders or restrictions are subject to a number of factors including the effective date and duration of such tariffs, orders and restrictions, the amount, scope and nature of such inputs, any countermeasures that the target countries may take and any mitigating actions that may become available.

In addition, during certain crises and events, patients may prioritize other items over certain or all of their treatments or delay their requisite spine care, which could have a negative impact on our commercial sales.

A severe or prolonged economic downturn, political disruption or adverse health conditions could result in a variety of risks to our business, including our ability to raise capital when needed on acceptable terms, if at all. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could adversely impact our business.

If rising prices or availability of raw materials continues to persist, our business and results of operations may be adversely affected.

Volatility in raw material prices and availability can impact our business and finances due to numerous factors beyond our control, including general, domestic, and international economic conditions, labor costs, production levels, competition, consumer demand, import duties, inflation and currency exchange rates. This volatility can significantly affect the availability and cost of raw materials that our suppliers purchase and are ultimately used in our systems, and may therefore have a material adverse effect on our business, results of operations, and financial condition. The need to use materials which meet regulatory requirements inhibits the company’s freedom of choice of materials and contracting partners for their supply. In addition, the current U.S. administration has expressed strong concerns about imports from countries that it perceives as engaging in unfair trade practices, and has imposed tariffs or other restrictions on products, components or raw materials sourced from those countries. Moreover, these new tariffs, or other changes in U.S. trade policy, have triggered and may in the future trigger retaliatory actions by affected countries. For example, there have been and continue to be further indications that there may be an increase in tariff rates on various types of goods imported from Canada and Europe that could apply to the raw materials we require in our products,

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including certain types of metal powders used for coating our products. In the event that any such possible tariff increases remain in place or become enacted in the future, they could significantly increase the cost of materials and components that our suppliers import and use in our systems, which in turn could increase our supply costs. At this time, there can be no assurance that we will be able to pass any portion of such increases on to customers. We currently do not hedge against our exposure to changing raw material prices and are not aware as to whether our suppliers hedge. As a result, fluctuations in raw material prices could have a material adverse effect on our business, results of operations, and financial condition. Supply shortages or changes in availability for any particular type of raw material can delay supplier volume and production capabilities or cause increases in the cost of manufacturing our products. We may be negatively affected by changes in availability and pricing of raw materials, which could negatively impact our results of operations.

Risks Related to Government Regulation

We, our suppliers, and our third-party manufacturers are subject to extensive governmental regulation both in the U.S. and abroad.

The medical device industry is regulated extensively by governmental authorities, principally by the FDA and corresponding state and foreign regulatory agencies. Complying with these regulations is costly and time consuming. The FDA and other U.S. and foreign governmental agencies regulate, among other things, with respect to medical devices:

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device design, development, and manufacturing;

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materials and components;

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testing, labeling, content, and language of instructions for use and storage;

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clinical studies;

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product safety;

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establishment registration and device listing;

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marketing, sales, and distribution;

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premarket clearance, approval or certification;

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record keeping procedures;

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advertising and promotion;

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compliance with the QMSR and comparable foreign requirements;

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recalls and field safety corrective actions;

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post-market surveillance, including reporting of deaths or serious injuries and device malfunctions that, if they were to recur, could lead to death or serious injury;

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post-market study requirements; and

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product import and export.

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The regulations to which we are subject are complex and have tended to become more stringently applied over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, difficulties achieving new product clearances, certifications or approvals, higher than anticipated costs, or lower than anticipated sales. Before we can market or sell a new regulated product or make a significant modification to an existing product in the U.S., with only limited exceptions, we must obtain FDA 510(k) clearance, PMA approval, or de novo classification.

The FDA enforces its regulatory requirements through, among other means, periodic unannounced inspections. We do not know whether we or any of our third-party manufacturers will be found compliant in connection with any future FDA or foreign inspections. Failure to comply with applicable U.S. requirements may subject us to a variety of administrative or judicial actions and sanctions, such as Form 483 observations, warning letters, untitled letters, product recalls, product seizures, import alerts, total or partial suspension of

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production or distribution, injunctions, fines, civil penalties, and criminal prosecution. The FDA can also refuse to clear or approve pending applications. Any enforcement action by the FDA and other comparable non-U.S. regulatory agencies could have a material adverse effect on our business, financial condition, and results of operations.

Failure to comply with applicable regulatory requirements could result in costly enforcement actions, which could harm our reputation and cause our business to suffer.

We are subject to ongoing and extensive regulatory requirements governing, among other things, the manufacture, marketing, advertising, medical device reporting, sale, promotion, import, export, registration, and listing of devices. For example, medical device manufacturers must submit certain reports to the FDA and other countries’ regulatory bodies and keep required records as a condition of obtaining and maintaining marketing authorization. These reports include information about failures and certain adverse events potentially associated with the device after its marketing authorization. Failure to submit such reports, or failure to submit the reports in a timely manner, could result in enforcement action by the FDA and other countries’ regulatory bodies. Following its review of the periodic reports, the FDA and other countries’ regulatory bodies might ask for additional information or initiate further investigation.

Regulatory changes could result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales. The FDA and other regulatory authorities, including foreign authorities, have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade health care providers from using our products and adversely affect our reputation and the perceived safety and effectiveness of our products.

Failure to comply with applicable regulations could jeopardize our ability to sell our products and results in enforcement actions such as:

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warning or untitled letters;

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fines;

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injunctions;

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consent decrees;

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field safety corrective actions;

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civil penalties;

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termination of distribution;

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recalls, termination of distribution, administrative detention, or seizures of products;

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customer notifications or repair, replacement, or refunds;

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delays in the introduction of products into the market;

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operating restrictions or total or partial suspension of production;

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facility closures;

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delay in or refusal of the FDA or other regulators to grant future clearances or approvals;

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refusal of the FDA to issue certificates to foreign governments needed to export products for sale in other countries;

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withdrawals or suspensions of or the placing of conditions upon current clearances or approvals or certificates, resulting in prohibitions on sales of our products; and

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in the most serious cases, criminal penalties.

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Adverse action by the FDA or another regulatory agency could result in inability to produce our products in a cost-effective and timely manner, or at all, decreased sales, higher prices, lower margins, additional unplanned costs or actions, damage to our reputation, and could have material adverse effect on our reputation, business, results of operations, and financial condition.

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In addition, the FDA may change its marketing authorization policies which may affect future products. The FDA may adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay marketing authorization of any products under development or impact our ability to modify any products authorized for market on a timely basis. Such changes may also occur in foreign jurisdictions where we may market our products in the future. Such changes could impose additional requirements upon us that could delay our ability to obtain future marketing authorizations, increase the costs of compliance, or restrict our ability to maintain any marketing authorizations we have obtained.

Marketing authorization for new or significantly modified devices could be denied or significantly delayed in the USA.

In the United States, before we can market a new medical device, or a new use of, or other significant modification to an existing, marketed medical device, we must first receive either clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”), approval of a premarket approval application (“PMA”), or grant of a de novo classification request from the FDA, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally-marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical study, manufacturing, and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices.

In the de novo classification process, a manufacturer whose novel device under the FDCA would otherwise be automatically classified as Class III and require the submission and approval of a PMA prior to marketing is able to request down-classification of the device to Class I or Class II on the basis that the device presents a low or moderate risk. If the FDA grants the de novo classification request, the applicant will receive authorization to market the device. This device type may be used subsequently as a predicate device for future 510(k) submissions.

The PMA approval, 510(k) clearance and de novo classification processes can be expensive, lengthy, and uncertain. The FDA’s 510(k) clearance process usually takes from three to 12 months, but can take longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA. In addition, a PMA generally requires the performance of one or more clinical studies. Clinical data may also be required in connection with an application for 510(k) clearance or a de novo classification request. Despite the time, effort and cost, a device may not obtain marketing authorization by the FDA. We have obtained PMA approvals and 510(k) clearances for our commercialized medical devices, and we must obtain marketing authorization for any future devices we develop, unless they are exempt. Marketing authorizations for any of our future products, if granted, may include significant limitations on the indicated uses for the device, which may limit the potential commercial market for the device.

The FDA can delay, limit or deny marketing authorization of a device for many reasons, including:

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our inability to demonstrate to the satisfaction of the FDA that our products are substantially equivalent to a predicate device or are safe and effective for their intended uses;

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the disagreement of the FDA with the design or implementation of clinical studies or the interpretation of data from preclinical or clinical studies;

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serious and unexpected adverse device effects experienced by participants in clinical studies;

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the data from preclinical studies and clinical studies may be insufficient to support clearance, de novo classification, or approval, where required;

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our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;

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the manufacturing process or facilities we use may not meet applicable requirements; and

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the potential for marketing authorization regulations of the FDA to change significantly in a manner rendering our clinical data or regulatory filings insufficient for marketing authorization.

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Even if our new products or significant modifications to our existing products receive marketing authorization in the United States, commercialization of our products in foreign countries would require marketing authorization by regulatory authorities in those countries. Marketing authorization procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical studies. Any of these occurrences could have an adverse effect on our business, financial condition and results of operations.

Marketing authorizations for new or significantly modified devices could be denied or significantly delayed in the EU.

Similarly, in the EU, the ability to apply the CE mark to new products, which is accepted not just in the 27 EU member states, but also Norway, Lichtenstein, Iceland, the UK and Turkey and is recognized to varying degrees in other countries globally, depends upon the provision of extensive documentation to regulatory authorities. In the EU, for devices which are in class IIa or above, affixing of the CE mark requires the obtention of a CE certificate of conformity from a notified body which conducts the conformity assessment procedure. Submission to a notified body which undertakes the review and at least two audits and is a time consuming exercise taking from one two three years before providing the necessary certificate. The obtention of the certificate is not a given after submission as up to half of submissions are rejected outright often for lack of adequate clinical data, and such rejection can mean that further clinical data must be obtained ahead a fresh submission.

Material modifications to our devices may require new 510(k) clearance, de novo classification, PMA approval, or PMA supplement approval, or may require us to cease marketing or recall the modified devices until clearances or approvals are obtained.

Material modifications to the intended use or technological characteristics of our devices may require new 510(k) clearance, de novo classification, PMA approval, or PMA supplement approval, or may require us to cease marketing or recall the modified devices until clearances or approvals are obtained. Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, generally requires a new 510(k) clearance or, possibly, a PMA. The FDA requires every manufacturer to make and document this determination in the first instance. A manufacturer may determine that a modification could not significantly affect safety or effectiveness and does not represent a major change in its intended use, so that no new 510(k) clearance is necessary. The FDA may review any manufacturer’s decision and may not agree with our decisions regarding whether new clearances or approvals are necessary. The FDA may also on its own initiative determine that a new clearance or approval is required.

We have modified some of our cleared and approved devices and have determined based on our review of the applicable FDA guidance that in certain instances new 510(k) clearances or PMA approvals are not required. If the FDA disagrees with our determination and requires us to submit new marketing authorizations for modifications to our previously authorized products for which we have concluded that new marketing authorizations are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval. In these circumstances, we may be subject to significant enforcement actions, regulatory fines, or penalties, which could require us to redesign our products and harm our operating results. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing products than we had expected, product introductions or modifications could be delayed or canceled, which could adversely affect our business.

Material modifications to our devices may require a new notified body certificate in the EU

Where substantial modifications are made to the design or quality management system of a device certified by a notified body in the EU, the company would be required to submit an application to the notified body for a

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new certificate. That certificate could be denied or delayed, potentially delaying the roll-out of the modified product until the new certification is achieved. If the modification is one that is necessary whether for regulatory or manufacturing reasons, this could mean that the company would need to cease placing devices on the market in the EU and other countries relying on that certificate until the new certification is achieved.

Our products may be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could adversely affect us.

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in their design or manufacture or in the event that a product poses an unacceptable risk to health.

The FDA’s authority to require a recall for medical devices must be based on a finding that there is reasonable probability that the device would cause serious injury or death. We may also decide to voluntarily recall our products. A government-mandated or voluntary recall could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. We have initiated recalls in the past and may initiate recalls in the future. For example, on December 31, 2025, we initiated a voluntary recall of the prodisc C SK because the product was labeled as including the 6mm device but instead included the 5mm product. This recall affected 20 units in commerce including six that were implanted and was reportable to the FDA as a Class 2 recall. We notified surgery sites and recommend surgeons perform standard post-procedure follow-up. One implanted patient experienced pain, which was transient and resolved without further intervention. We submitted a request to the FDA for termination of the recall on February 13, 2026 and are awaiting FDA’s response.

On March 19, 2026, we then became aware of a similar mislabeling issue with respect to two 30 unit lots of prodisc C SK spinal implants. Specifically, a 30-unit lot of the prodisc C SK PDSXL5, which is an extra-large 5 mm spinal implant, was mislabeled as an extra-large 6 mm spinal implant, resulting in an implant smaller than what is labeled. Additionally, the prodisc C SK PDSXL6, which is an extra-large 6 mm spinal implant, was labeled as a 5 mm spinal implant, resulting in an implant larger than what is labeled. Though the issues were similar, the root causes for this recall and the recall initiated in December 2025 are unique. All affected devices have been accounted for and contained, meaning that they have been returned to us or identified as implanted in patients, of which there were seven patient implants with the incorrectly labeled and sized device. We notified surgery sites and recommended surgeons to perform standard post-procedure follow-up. No patient injury has been identified in connection with the implantation of the recalled devices. A recall report was submitted to the FDA on March 27, 2026 and was reportable to the FDA as a voluntary Class 2 recall. All recall activities were closed on May 15, 2026. We submitted a request to the FDA for termination of the recall on May 15, 2026 and are awaiting FDA’s response.

Companies are required to maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary recalls or corrections for our products in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls and we may be subject to enforcement action.

Similarly, national competent authorities in the EU can require the recall of medical devices and their withdrawal from the market. This is undertaken via a Field Safety Corrective Action to be implemented in each country of sale affected, in agreement with the national competent authorities in these countries, and whereby customers and users of the device are notified via a Field Safety Notice sent by the manufacturer.

We are required to report certain malfunctions, deaths, and serious injuries associated with our products, which can result in voluntary corrective actions or agency enforcement actions.

Under the FDA’s and the EU’s medical device reporting regulations, we are required to report to the FDA and national competent authorities in the EU in which the product is placed on the market when information from any source suggests that our product may have caused or contributed to a death or serious injury or that our product has malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. If we fail to report these events to the FDA or relevant national competent authorities in the

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EU within the required timeframes, or at all, the FDA or national competent authorities in the EU could take enforcement action against us.

Any adverse event involving our products, whether in the U.S. or abroad, could result in future voluntary corrective actions in multiple countries of the world, such as recalls, including corrections or customer notifications, or agency action, such as inspection or enforcement actions. If malfunctions do occur, we may be unable to correct the malfunctions adequately or prevent further malfunctions, in which case we may need to cease manufacture and distribution of the affected products, initiate voluntary recalls, and redesign the products. Regulatory authorities may also take actions against us, such as ordering recalls, imposing fines, or seizing the affected products. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

If we, our suppliers, or our third-party manufacturers fail to comply with FDA’s QMSR or any applicable state or foreign equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer.

We and our third-party manufacturers are required to comply with the QMSR and the applicable regulations of foreign jurisdictions regarding the manufacturing process if we market products in such foreign jurisdictions.

The FDA enforces the QMSR through periodic and announced or unannounced inspections of manufacturing facilities. Similarly, our notified body assesses our quality management system (QMS) and related QMS certificate against the MDR requirements through periodic and announced or unannounced inspections of manufacturing facilities. Our facilities have been inspected by the FDA and other regulatory authorities, and we anticipate that we and our third-party manufacturers will be subject to additional future inspections. If the FDA or our notified body determines during an inspection that our quality management system or the quality management system of our third-party manufacturers does not comply with the QMSR or the MDR requirements concerning QMS, we or the third-party manufacturer could be subject to significant regulatory enforcement actions. Such enforcement actions could include FDA Form 483 observations, warning letters, mandatory product recalls, import alerts, civil monetary penalties, operating restrictions, consent decrees, or suspension or withdrawal of regulatory approvals. In the EU, enforcement action could be suspension or withdrawal of our QMS certificate and/or MDR conformity assessment certificate, preventing the further placing on the market of the relevant device. In addition, any failure to comply with applicable quality system requirements could delay or prevent the clearance or approval of our future products, disrupt manufacturing or commercialization activities, require costly remediation efforts, or result in reputational harm with regulators, customers, and investors.

The FDA’s and other comparable non-U.S. regulatory agencies’ statutes, regulations, policies or interpretations may change, and additional government regulation or statutes may be enacted, which could increase post-approval regulatory requirements, or delay, suspend, prevent marketing of any cleared or approved products or necessitate the recall of distributed products. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

If our operations and activities are found to be in violation of any FDA laws or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal and administrative penalties, damages, fines and other legal and/or agency enforcement actions including conditioning, withdrawal or suspension of authorisations, licenses or certificates. Any penalties, damages, fines, or curtailment or restructuring of our operations or activities could adversely affect our ability to operate our business and our financial results. The risk of us being found in violation of the FDA laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend ourselves against that action and its underlying allegations, could cause us to incur significant legal expenses and divert management’s attention from the operation of our business. Where there is a dispute with a federal or state governmental agency that cannot be resolved to the mutual satisfaction of all relevant parties, we may determine that the costs, both real and contingent, are not justified by the commercial returns to us from maintaining the dispute or the product.

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Various claims, design features or performance characteristics of our medical devices that we regarded as permitted by the FDA without new marketing clearance or approval may be challenged by the FDA or state or foreign regulators. The FDA or state or foreign regulatory authorities may find that certain claims, design features or performance characteristics, in order to be made or included in the products, may have to be supported by further clinical studies and marketing clearances, certifications or approvals, which could be lengthy, costly and possibly unobtainable.

The results of preclinical and clinical studies of our products conducted to date and ongoing or future studies of our current, planned or future products may not be predictive of the results of later clinical studies.

The results of early clinical studies are not necessarily predictive of future results, and any product, or new indication for use, we advance into clinical studies may not have favorable results in later clinical studies.

Regulatory authorities may disagree with our interpretation of data and results from our clinical studies, and favorable results do not ensure that we will achieve similar results in future clinical studies. Preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in preclinical studies and earlier clinical studies have nonetheless failed to replicate results in later clinical studies. Failure can occur at any stage of clinical testing. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and non-clinical testing in addition to those we have planned.

Clinical studies necessary to support a 510(k) premarket notification, de novo classification request, or PMA application or certification by a notified body in the EU can be expensive and may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical studies will prevent us from commercializing modified or new products, or new indications for use for existing products, and will adversely affect our business, operating results, and prospects.

Initiating and completing clinical studies necessary to support a 510(k) premarket notification, de novo classification request, or PMA application or certification by a notified body in the EU for our future products would be time consuming and expensive and the outcome uncertain.

The initiation and completion of any of clinical studies may be prevented, delayed, or halted for numerous reasons. We may experience delays in our ongoing clinical studies for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical studies, including related to the following:

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we may be required to submit an IDE application to FDA, which must become effective prior to commencing certain human clinical studies of medical devices, and FDA may reject our IDE application and notify us that we may not begin clinical studies;

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We may be required to submit an application to EU competent authorities for authorisation to undertake clinical studies in their country and which might be rejected and thus we would be unable to commence the trial;

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regulators may disagree as to the design or implementation of our clinical studies;

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regulators and/or IRBs or ethics committees, or other reviewing bodies may not authorize us or our investigators to commence a clinical study, or to conduct or continue a clinical study at a prospective or specific trial site;

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we may not reach agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

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clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;

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the number of subjects required for clinical studies may be larger than we anticipate, enrollment in these clinical studies may be insufficient or slower than we anticipate, and the number of clinical studies being conducted at any given time may be high and result in fewer available subjects for any given clinical study, or subjects may drop out of these clinical studies at a higher rate than we anticipate;

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our third-party contractors, including those manufacturing products or conducting clinical studies on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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we might have to suspend or terminate clinical studies for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;

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we may have to amend clinical study protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB or ethics committees and/or regulatory authorities for re-examination;

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regulators, IRBs or ethics committees, or other parties may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements;

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the cost of clinical studies may be greater than we anticipate;

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clinical sites may not adhere to the clinical protocol or may drop out of a clinical study;

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we may be unable to recruit a sufficient number of clinical study sites;

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regulators, IRBs or ethics committees, or other reviewing bodies may fail to approve or subsequently find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical studies may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply;

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approval policies or regulations of the FDA or applicable foreign regulatory agencies may change in a manner rendering our clinical data insufficient for approval; and

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our current or future products may have undesirable side effects or other unexpected characteristics.

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Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates.

Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical studies and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical study investigators, support staff, and proximity to clinical sites, and the ability to comply with the inclusion and exclusion criteria for participation in the clinical study and patient compliance. Development of sufficient and appropriate clinical protocols to demonstrate safety and effectiveness are required and we may not adequately develop such protocols to support clearance and approval. Further, the FDA or other regulatory authorities may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical studies.

Delays in patient enrollment or failure of patients to continue to participate in a clinical study may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical study. In addition, despite considerable time and expense invested in our clinical studies, the FDA or other regulatory authorities may not consider our data adequate to demonstrate safety and effectiveness. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.

Our clinical study sites must operate under procedures that govern the conduct and management of the FDA-regulated clinical studies pursuant to Good Clinical Practices (“GCP”). The FDA or other regulatory authorities may conduct Bioresearch Monitoring or equivalent inspections of us and/or our clinical sites to assess compliance with FDA regulations, our procedures, and the clinical protocol. If the FDA or other regulatory authorities were to find that we, our CROs, or our clinical investigators are not operating in compliance with applicable regulations, we could be subject to FDA or other regulatory authorities

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enforcement action, as well as refusal to accept all or part of our data in support of a premarket submission, or we may need to conduct additional studies.

If we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy. Data we generate may ultimately not be favorable, or could even hurt the commercial prospects for our products.

We do not expect to conduct clinical studies to generate long-term data for all of our products and will only do so in the future where we anticipate the benefits will outweigh the costs and risks. For these reasons, surgeons and physicians could be less likely to purchase our products than competing products for which longer-term clinical data are available. Also, we may not choose or be able to generate the comparative data that some of our competitors have or are generating, and we may be subject to greater regulatory and product liability risks. If we are unable to or unwilling to collect sufficient long-term clinical data supporting the quality, safety and effectiveness of our existing products, our business, results of operations and financial condition could be adversely affected.

We may rely on third parties to conduct our clinical studies and to assist us with preclinical development and if they fail to perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval to commercialize our products.

We have relied upon and may continue to rely upon third parties, such as CROs, medical institutions, clinical investigators and contract laboratories to assist in conducting our preclinical development activities and our clinical studies, which must be conducted in accordance with applicable regulations, including GCP. We rely on these parties for execution of our studies, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our clinical studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. GCPs are regulations and guidelines enforced by the FDA and other regulatory authorities for products in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators, trial sites, and CROs. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical studies comply with GCP regulations. In addition, our clinical studies must be conducted with product produced under applicable manufacturing requirements.

If these third parties fail to successfully carry out their contractual duties, comply with applicable regulatory obligations, including GCP requirements, or meet expected deadlines, or if these third parties must be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to clinical protocols or applicable regulatory requirements or for other reasons, our pre-clinical development activities or clinical studies may be extended, delayed, suspended or terminated. Under these circumstances we may not be able to obtain regulatory clearance or approval for, or successfully commercialize, our products on a timely basis, if at all, and our business, results of operations and financial condition may be adversely affected.

If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties or to do so on commercially reasonable terms. In addition, our third parties are not our employees, and except for remedies available to us under our agreements with them, we cannot control whether or not they devote sufficient time and resources to our on-going clinical, nonclinical and preclinical programs. Switching or adding additional third parties involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO or other third-party vendor commences work. As a result, delays occur, which can materially impact our ability to meet our desired development timelines. Though we carefully manage our relationships with our third-party vendors including CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

Disruptions at the FDA and other government agencies caused by funding shortages or staffing limitations could hinder their ability to hire, retain or deploy key leadership and other personnel, prevent new or modified products from being developed, review, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy

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changes, the FDA’s or foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new products or modifications to existing products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities. If a prolonged government shutdown occurs, or if funding shortages or staffing limitations hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

We are subject to federal, state and foreign laws and regulations relating to our healthcare business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would adversely affect our business, results of operations and financial condition.

We are subject to healthcare fraud and abuse regulation and enforcement by federal, state and foreign governments, which could adversely impact our business, results of operations and financial condition. Healthcare fraud and abuse and health information privacy and security laws potentially applicable to our operations include:

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the federal Anti-Kickback Statute, which applies to our operations, including our marketing practices, educational programs, pricing and discounting policies and relationships with healthcare providers, by prohibiting, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or providing remuneration intended to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare or Medicaid programs. A person or entity does not need to have actual knowledge of this statute or specific intent to violate it to have committed a violation;

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the federal civil and criminal false claims laws, including the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government. Suits filed under the False Claims Act, can be brought by any individual on behalf of the government, known as “qui tam” actions, and such individuals, commonly known as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of medical device and other healthcare companies to have to defend a False Claims Act action. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the false claims statutes;

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the federal Civil Monetary Penalties Law, which impose civil fines for, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

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the Health Insurance Portability and Accountability Act, or HIPAA, and its implementing regulations, which created federal criminal laws that prohibit, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to

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healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and certain healthcare providers as well as their business associates and covered subcontractors that perform certain services for or on their behalf involving the use or disclosure of individually identifiable health information;

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in the EEA and United Kingdom, GDPR imposes obligations relating to personal data (including health data) including relating to processing health and other sensitive data, in certain circumstances obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors;

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the federal Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to certain payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, certain other healthcare professionals such as physician assistants and nurse practitioners, as well as ownership and investment interests held by physicians and their immediate family members;

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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and

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state and foreign law equivalents of each of the above federal laws and regulations, such as anti-kickback, self-referral, and false claims and anti-bribery laws that may be broader in scope and apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require medical device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, other governmental regulators or law enforcement officers, or otherwise that restrict payments that may be made to healthcare providers; and state laws that require drug and device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information. Most European countries and/or government hospitals and clinics have laws and rules limiting interactions between the medical device industry and healthcare providers, healthcare organizations, and patient organizations. In some countries, our interactions with these persons and/or organizations are also subject to prior authorization or notification requirements and/or to requirements to publish information detailing these interactions together with the value of support or payments provided. In addition, we follow the MedTech Europe Code of Ethical Business Practice, which sets forth industry standards governing interactions between medical technology companies and healthcare professionals, and we comply with applicable national sunshine and transparency reporting obligations in the EU member states in which we operate. Failure to meet these requirements can lead to criminal, administrative and civil sanctions being imposed, as well as potential exclusion from EU tendering opportunities.

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We have entered into royalty and data license or data provision agreements (collectively, referred to as “data agreements”) with two surgeons, who are customers. The royalty agreement is with one of the inventors of prodisc intellectual property. Pursuant to our data agreements, we licensed certain de-identified data collected by these surgeons and obtained intellectual property rights to any aggregation or summary of such data. In consideration for the data delivered to us under these data agreements, we made certain cash payments, issued options or are obligated to pay a license fee, as applicable. The impact of these arrangements is not significant to our operations.

We typically loan our customers the surgical instrument sets necessary to perform procedures using our products for each surgery at no additional charge. We also engage in co-marketing arrangements with certain

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surgeons who use our products. In addition, certain of our customer surgeons and distributors acquired from us directly or indirectly, in the aggregate, approximately 5.9% of our current outstanding units, which were principally purchased in an arm’s length transaction on terms identical to those offered to others. While all of these transactions were structured with the intention of complying with all applicable laws, including the federal Anti-Kickback Statute, state anti-kickback laws and other applicable laws, it is possible that regulatory agencies may view these transactions as prohibited arrangements that must be restructured, or discontinued, or for which we could be subject to significant penalties and criminal, civil and administrative liability. We would be materially and adversely affected if regulatory agencies interpret our financial relationships with surgeons who order our products to be in violation of applicable laws and we were unable to comply with such laws, which could subject us to, among other things, monetary penalties for non-compliance, the cost of which could be substantial.

The risk of us being found in violation of these laws and regulations is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. We are unable to predict what additional federal, state or foreign legislation or regulatory initiatives may be enacted in the future regarding our business or the healthcare industry in general, or what effect such legislation or regulations may have on us. Federal, state or foreign governments may impose additional restrictions or adopt interpretations of existing laws that could adversely affect us.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including significant administrative, civil and criminal penalties, damages, fines, imprisonment, exclusion from governmental healthcare programs, disgorgement, contractual damages, additional regulatory monitoring and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely impact our business, results of operations and financial condition. Further, if any of the surgeons or other healthcare providers or entities with whom we do business is found to be not in compliance with applicable laws, they may be subject to significant administrative, civil and criminal sanctions, including exclusion from government funded healthcare programs.

Healthcare regulatory reform may affect our ability to sell our products profitably and could adversely affect our business, results of operations and financial condition.

In the United States and in certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the regulatory and healthcare systems in ways that could prevent or delay marketing approval of our products in development, restrict or regulate post-approval activities of our products and impact our ability to sell our products profitably. In the United States in recent years, new legislation has been proposed and adopted at the federal and state level that is effecting major changes in the healthcare system. In addition, new regulations and interpretations of existing healthcare statutes and regulations are frequently adopted.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, was signed into law. While the goal of healthcare reform is to expand coverage to more individuals, it also involves increased government price controls, additional regulatory mandates and other measures designed to constrain medical costs. The ACA substantially changed the way healthcare is financed by both governmental and private insurers, encourages improvements in the quality of healthcare items and services and significantly impacts the medical device industry. Among other things, the ACA established new value-based payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such as bundled physician and hospital payments).

In addition, third-party payors regularly update payments to physicians, hospitals and ASCs where our products are used. For example, the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA,

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ended the use of the Sustainable Growth Rate Formula, and introduced a merit-based incentive bonus program for Medicare physicians also referred to as the Quality Payment Program. Any resulting decrease in payment under the merit-based reimbursement system may adversely affect our revenue and results of operations. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. In addition, the Budget Control Act of 2011, which, subject to certain temporary suspension periods, imposed reductions to Medicare payments to providers per fiscal year starting April 1, 2013, and, due to subsequent legislative amendments, will stay in effect through 2032, unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These and other payment updates could directly impact the demand for our products or any products we may develop in the future, if cleared or approved.

More recently, on July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

Additional federal and state healthcare reform measures may be adopted in the future, which may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and in additional downward pressure on the price that we receive for any cleared or approved products. Further, it is possible that additional governmental action is taken in response to the future pandemics or disease outbreaks.

In the EU, the regulatory landscape concerning medical devices continues to undergo legislative changes. These requirements are in active implementation and may change as the European Commission adopts additional implementing acts and considers targeted revisions to related medical device rules. On December 16, 2025, the European Commission published a targeted revision proposal of the MDR to address structural issues, certification delays, and burdens on small and medium-sized enterprises. The proposal will need to follow the EU ordinary legislative procedure once finalized and is not expected to be adopted before 2027. These amendments, if adopted, may have an effect on the way we conduct our business in the EU and could result in additional requirements, costs, or delays in obtaining or maintaining CE certification for our products.

Further, on December 13, 2021, the EU adopted Regulation No 2021/2282 on Health Technology Assessment (HTA Regulation), amending Directive 2011/24/EU. The HTA Regulation entered into force in January 2022 and has been applicable since January 2025, with phased implementation based on the type of product, including certain high-risk medical devices as of 2026. The HTA Regulation intends to boost cooperation among EU member states in assessing health technologies, including certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. Given that our implant products are, or will be, classified as Class III under the MDR, they may be subject to joint clinical assessments at the EU level under the HTA Regulation, which could affect market access, reimbursement, and the clinical data requirements applicable to our products.

We, our suppliers, and our third-party manufacturers are subject to extensive government regulation in relation to products being placed on the market in Europe, including medical device regulations in the EU which are still in the transitional phase.

We, our suppliers, and our third-party manufacturers are subject to extensive governmental regulation in relation to products being placed on the market in Europe. In the EU, medical device laws are in a transitional

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phase, with new regulations replacing the previous directives (Directive 93/42/EEC (MDD)). Modifications arising from the new EU regulations (Regulation (EU) 2017/745 (MDR)) will affect the regulation of our products placed on the market in all countries accepting CE marked medical devices. These countries include the EU 27 member states, the United Kingdom, or UK (until June 30, 2023), the EEA countries of Norway, Lichtenstein and Iceland, as well as many other countries around the world.

Under MDR there is no grandfathering—all devices must undergo a new regulatory review and rewriting of regulatory documents and processes, all of which are more detailed and rigorous than under the MDD. For devices that require a notified body certificate of conformity, it is necessary for us to supply clinical evidence of safety and efficacy in relation to the manufacturer’s intended purpose, and a much more detailed set of technical documentation. There is a process for “legacy devices”, which are those that were regulated under the MDD and which a manufacturer wants to transition to certification under the MDR. Manufacturers of legacy devices must by May 26, 2024 have a QMS compliant with the MDR in place and applied to a notified body for a conformity assessment. No later than September 26, 2024 we must have in place with a notified body have signed a written agreement for the conformity assessment of each of our legacy devices.

The QMS includes our post-market surveillance, or PMS, system as well as agreements with critical suppliers including QMS allowing the manufacturer some control over communications with competent authorities. As a manufacturer based outside the EU, we must appoint an EU importer whose details must be included with the products, as well as an authorized representative whose contact details must be on the labeling. There are also complex registration and information requirements with a new medical devices database (EUDAMED), and a requirement to include a unique device identifier on every device. Obligations relating to registration will be imposed gradually as the database comes online, which is occurring in a modular fashion, and is obligatory for the first four modules from May 26, 2026.

The MDR has been fully applicable since May 26, 2021. In accordance with the MDR’s recently extended transitional provisions, both (i) devices lawfully placed on the market pursuant to the MDD prior to May 26, 2021 and (ii) legacy devices lawfully placed on the EU market after May 26, 2021 in accordance with the MDR transitional provisions may generally continue to be made available on the market or put into service, provided that the requirements of the transitional provisions are fulfilled. In particular, no significant change must be made to the device, as such a modification would trigger the obligation to obtain a new certification under the MDR and therefore to have a notified body conduct a new conformity assessment of the device. The extended transitional deadlines are December 31, 2027 for Class III and certain Class IIb implantable devices and December 31, 2028 for other Class IIb devices, Class IIa devices and certain Class I devices. However, even during the transitional period, manufacturers must comply with a number of new or reinforced requirements set forth in the MDR with regard to registration of economic operators and of devices, post-market surveillance and vigilance requirements. In the EU, our implant products are currently classified as Class IIb under the MDD (pursuant to certificates issued by BSI, our notified body) and will be classified as Class III under the MDR. Our surgical instruments are classified separately as Class IIa or Class I (reusable) devices. Class III devices under the MDR require the highest level of regulatory controls and the best quality clinical evidence from clinical studies to demonstrate an appropriate risk-benefit analysis in respect of safety and efficacy.

Under the MDR, Class III implantable devices are subject to an additional review by the European Commission’s relevant expert panel as part of the conformity assessment process. For products undergoing MDR conformity assessment, the expert panel issues a scientific opinion which can recommend that a device might or might not be placed on the market, or that the intended purpose of the device be restricted by type of patient or indication and to limit the period of validity for the certificate. The notified body is likely to follow the opinion of the EU regulatory panel when issuing its certificate, and there is no appeal process with respect to the scientific opinion. In the EU, we are required to have a QMS that is documented and maintained and is subject to notified body audit, both at the outset to obtain certification allowing our products to be placed on the market, and periodically thereafter. If there is an unacceptable level of major non-conformities in any audit, national competent authorities in the EU can prohibit the further sale of our products in the EU, as well as requiring a recall of distributed products. This could prevent us from fulfilling our contracts and might lead to breach of tenders, which could detrimentally affect future sales and tender awards. We would be obliged to take remedial action, which could be costly, and our products could be out of the market for a period of time, leading to a decrease in revenues in the EU.

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The MDR requires that before placing a device on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to the European Database on Medical Devices (EUDAMED), unless they have already registered. The MDR also requires that before placing a device on the market, manufacturers must assign a unique identifier to the device and provide it, along with other core data, to the unique device identifier (UDI) database within EUDAMED. These requirements aim at ensuring better identification and traceability of devices. Manufacturers are also notably responsible for entering the necessary data on EUDAMED, which includes the UDI database, and for keeping it up to date. The obligations for registration in EUDAMED will become applicable on May 28, 2026, for the four first modules related to (i) economic actor and (ii) UDI/​devices registrations, (iii) notified bodies and certificates, and (iv) market surveillance. Until EUDAMED is fully functional, the corresponding provisions of the MDD continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators. We are in the process of ensuring compliance with these forthcoming EUDAMED registration obligations. Failure to timely register in EUDAMED or to comply with the UDI requirements could result in enforcement action by EU competent authorities and could adversely affect our ability to place our products on the EU market.

Under the MDR, medical devices must be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and must meet the applicable general safety and performance requirements (GSPR). Only devices that have undergone the applicable conformity assessment procedure allowing the affixing of a CE mark may be marketed and advertised in the EU in accordance with their intended purpose, and off-label promotion is prohibited. Although surgeons may, in their independent medical judgment, use medical devices for indications other than those covered by the CE mark for the particular device, we do not systematically monitor off-label use of our products in the EU or elsewhere. For Class III and Class IIb implantable devices, the MDR specifically requires that the PMS plan provide for proactive and systematic collection and evaluation of data on the quality, performance and safety of devices throughout their entire lifetime, and that this data feed into the manufacturer’s clinical evaluation and risk management processes. Where off-label use is known to occur, this obligation extends to the capture and evaluation of related safety data as part of the PMS system. We conduct annual clinical evaluation reports and monitor complaints on a global basis through our quarterly management review process; however, we do not systematically collect or evaluate data on off-label use of our products. This means that safety signals arising from uses outside our devices’ intended purpose may not be fully captured, which could affect the completeness of our PMS data, clinical evaluation reports, and periodic safety update reports required under the MDR. If EU competent authorities or our notified body, BSI, were to determine that our PMS system does not adequately address off-label use patterns or that our clinical evaluation is incomplete in this respect, we could face non-conformity findings during surveillance audits, requests for corrective action, or delays in obtaining or renewing CE certificates of conformity. In addition, if adverse events were to arise from off-label use that we did not detect or report in a timely manner through our vigilance system, we could be subject to enforcement action by EU competent authorities, which could include suspension of sales, product recalls, or fines and other sanctions.

Significant changes to our devices will require new notified body certificates of conformity, and if our submission is not accepted, our notified body may require us to cease placing affected products on the market or to not implement the change.

In the EU, we are unable to make any significant changes to our medical devices until we receive our new MDR certificate of conformity from our notified body. If technical, operational or regulatory reasons necessitate a substantial change to a product requiring a notified body certificate of conformity, we might have to remove it from the market until we obtain our MDR certificate or decide not to implement the contemplated change.

In the EU, there are continuing obligations for post-market compliance and which, if not complied with, could lead to fines, penalties, criminal sanctions and a requirement to withdraw our products from the market.

The EU regulatory system for medical devices requires a continuous system of vigilance, testing and review. Any potential issues with a device can lead to lengthy and time-consuming correspondence with national competent authorities and investigations by them and by notified bodies. In the EU, national competent

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authorities and notified bodies have the power to request that new instructions are issued to the market regarding a device, or that sales are suspended, products quarantined and, in some cases, withdrawn from the market altogether. Manufacturing sites as well as distribution centers and regulatory activities might also be audited at any time by affected competent authorities and by any relevant notified body. The changes to the PMS under the MDR require that the PMS is proactive rather than simply reactive. The MDR also requires a higher level of engagement with distributors and other economic operators to assure product compliance throughout the supply chain.

In the EU, adverse events must be reported to national regulatory authorities and appropriate market action taken.

Foreign regulatory authorities have very similar reporting requirements to those in the United States for adverse events, and similar enforcement actions where there is noncompliance. All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system, which has been reinforced by the MDR. Under this system, serious incidents and Field Safety Corrective Actions (FSCAs) must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through EUDAMED once functional and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors such as the economic operators in the supply chain will also be informed.

Manufacturers are required to take Field Safety Corrective Actions (FSCAs), which are defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration in the characteristics or performance of a device on the market (e.g., inadequacy in the information supplied by the manufacturer, undesirable side-effect), which, directly or indirectly, might lead to either the death or serious deterioration of the health of a patient, user, or other persons, or to a serious public health threat. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices (FSN). For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or an FSCA implemented or where the incidents are common and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.

Manufacturers (and authorized representatives) must also have available within their organization at least one person responsible for regulatory compliance, or PRRC, who possesses the requisite expertise in the field of medical devices. The PRRC is responsible for all aspects of compliance with the requirements of the MDR and in particular compliance with post-market surveillance and vigilance requirements. Authorized representatives are also required to have their own PRRC.

In the event of a serious adverse event, national competent authorities might require that corrective action is taken, including a withdrawal of the product from the EU market and the notified body might withdraw or suspend their conformity assessment certificate, preventing further products being placed on the market. Corrective actions are required to be notified via FSN issued to every person on the supply chain for the products. Each such person is required to acknowledge the notice and confirm that they have copied with the contents. FSNs are agreed with the competent authorities in each member state where the product is sold. These notifications and tracking of acknowledgements can be a time consuming and expensive exercise. They can also diminish our reputation with customers and generally in the marketplace and might lead to customers not renewing contracts and a decrease in product sales.

As we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy. Data we generate may ultimately not be favorable or could even hurt the commercial prospects for our products.

In order to be able to place new devices on the market in the EU, it is likely we would also have to undertake clinical studies in the EU. The EU similarly imposes regulatory requirements on companies when they undertake clinical studies on investigational medical devices. All types of clinical evaluations are required to meet specific standards of scientific rigor, verifying that the study is conducted in accordance with the study plan, that data is reliable and properly handled and interpreted to ensure accuracy and integrity.

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All applications for clinical investigations must be made through individual member states’ competent authorities pending use of EUDAMED dedicated module for clinical investigations. Once applicable, EUDAMED will allow for a single application to be made for multi-site clinical investigations within the EU. It will also be interoperable with the EU database for clinical trials clinical trials on medicinal products (EU Clinical Trials Register).

Devices for clinical evaluations must comply with the general safety and performance requirements in Annex I MDR, save for the aspects being studied and in respect of which “every precaution” must be taken to protect health and safety. If the safety of participants is ever in question, regulatory authorities can step-in and require a suspension or halt of the clinical evaluation.

Advertising and marketing materials are subject to regulation in individual countries in Europe. Failure to adhere to applicable European regulations could lead to fines or sanctions.

Advertising and marketing materials are subject to regulation in individual countries in Europe, with off-label uses being prohibited in every country, and in some countries, no consumer-facing and promotion of medical devices is permitted for any for prescription-only devices or in some cases devices which are subject to government reimbursement. Within the EU, the requirements are enormously varied as between countries, which can be challenging because reviews need to be undertaken country by country, in particular in relation to any advertising that is likely to be seen by the general public. Failure to adhere to local regulations on the advertising and promotion of medical devices can lead to fines and other sanctions, as well as third-party damages claims for unfair competition in many countries in continental Europe.

Our products are subject to requirements related to pricing and reimbursement in individual European countries.

Our products are subject to requirements of pricing and reimbursement in individual European countries. If we fail to agree a price or the right to receive reimbursement from the government or national insurance agencies, then we will not be permitted to sell our devices to government hospitals in the particular country. Separately, we must gain traction with KOLs in each country so that they accept and prescribe our products for their patients.

As a result of Brexit, we are subject to differing regulatory requirements in the UK compared to the EU regulatory system, which increases our financial cost of European regulatory compliance and may lead to reduced revenue in the UK.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority for medical devices in the UK, however, the EU regulatory regime no longer applies in Great Britain (England, Wales and Scotland), but only in Northern Ireland. Manufacturers based outside the UK must appoint a UK Responsible Person and register devices with the MHRA before placing them on the Great Britain market.

Devices with valid MDD certificates may continue on the Great Britain market until the sooner of certificate expiration or June 30, 2028, and devices with valid MDR certificates until the sooner of certificate expiration or June 30, 2030. The MHRA has consulted on reforms to its pre-market framework and, in its published consultation response (July 22, 2025), confirmed measures including recognition of certain CE-certified devices, replacement of the physical UKCA mark with UDI registration obligations, and other changes to be implemented through UK secondary legislation.

To the extent we market or intend to market in Great Britain, having products separately regulated from the EU increases compliance costs and may divert management resources. Failure to comply with the evolving UK regulatory requirements, including MHRA registration and any future obligations which are additional to those already undertaken for CE marked devices, could result in delays or an inability to place our products on the Great Britain market.

We are subject to governmental regulation and other legal obligations, particularly related to privacy, data protection and information security, and we are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business.

In the course of our business, we collect and store data, including legally protected personally identifiable information. We collect this kind of information for various reasons, including potentially during the course

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of clinical studies and for post-marketing safety vigilance. In doing so, we are subject to diverse laws and regulations relating to data privacy and security, including, in the United States, the California Consumer Privacy Act and its implementing regulations, and, in the European Union, or EU, and the European Economic Area, or EEA, Regulation 2016/679, known as the General Data Protection Regulation, or GDPR. New privacy rules are being enacted in the United States and globally, and existing ones are being updated and strengthened. Complying with these numerous, complex and often changing regulations is expensive and difficult, and failure to comply with any privacy laws or data security laws or any security incident or breach involving the misappropriation, loss or other unauthorized use or disclosure of sensitive or confidential patient or consumer information, whether by us, one of our business associates or another third-party, could adversely affect our business, results of operations and financial condition, including but not limited to: investigation costs, material fines and penalties; compensatory, special, punitive, and statutory damages; litigation; reputational damage; consent orders regarding our privacy and security practices; requirements that we provide notices, credit monitoring services and/or credit restoration services or other relevant services to impacted individuals; adverse actions against our licenses to do business; and injunctive relief. Furthermore, these rules are constantly changing. For example, the California Consumer Privacy Act, or CCPA, took effect on January 1, 2020. The CCPA establishes a new privacy framework for covered businesses and provides new and enhanced data privacy rights to California residents, such as affording consumers the right to access and delete their information and to opt out of certain sharing and sales of personal information. The CCPA imposes severe statutory damages as well as a private right of action for certain data breaches that result in the loss of personal information. The CCPA contains an exemption for medical information governed by the California Confidentiality of Medical Information Act, or CMIA, and for PHI collected by a covered entity or business associate governed by the privacy, security and breach notification rules established pursuant to HIPAA, but the precise application and scope of this exemption is not yet clear, and the law may still apply to certain aspects of our business. In addition, the California Privacy Rights Act of 2020, or CPRA, which went into effect on January 1, 2023, imposes additional obligations on companies covered by the legislation and significantly modifies the CCPA, including by expanding consumers’ rights with respect to certain sensitive personal information. The CPRA also creates a new state agency that is vested with authority to implement and enforce the CCPA and CPRA. Following California’s lead, similar laws have been passed in numerous other states, including Virginia, Colorado, Connecticut, and other states have proposed such laws. The effects of the CCPA, CPRA, and other similar state or federal laws, are potentially significant and may require us to modify our data processing practices and policies and to incur substantial costs and potential liability in an effort to comply with such legislation.

The collection, use, storage, disclosure, transfer, or other processing of any personal data regarding individuals in the European Economic Area (EEA) or in connection with our activities in the EEA, including personal health data, is subject to the EU GDPR, which became effective on May 25, 2018. Equivalent provisions apply in the United Kingdom pursuant to UK GDPR. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, in certain circumstances obtaining consent of the individuals to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million (£17.5 million under UK GDPR) or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. While we limit the amount of personal data collected about EEA and UK residents, if we do not comply with our obligations under GDPR with respect to any personal data we do collect, we could be exposed to significant fines, or subject to litigation and/or adverse publicity, which could adversely affect our business results, results of operations, and financial condition.

Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EEA, and the United States remains uncertain. Case law from the Court of Justice of the European Union (“CJEU”) states that reliance on the standard contractual clauses—a standard form of contract approved by the European Commission as

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an adequate personal data transfer mechanism—alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis. On July 10, 2023, the European Commission adopted its Adequacy Decision in relation to the new EU-US Data Privacy Framework (“DPF”), rendering the DPF effective as a GDPR transfer mechanism to U.S. entities self-certified under the DPF. Because of regulatory challenges in the EU to the validity of the DPF, we choose to rely on standard contractual clauses for most transfers of personal data to which GDPR applies.

In relation to such cross border transfers of personal data, we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue, and international transfers to the United States, China, and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints and/or regulatory investigations or fines; we may have to stop using certain tools and vendors and make other operational changes; we may have to implement alternative data transfer mechanisms under the GDPR and/ or take additional compliance and operational measures; and/or it could otherwise affect the manner in which we operate our business, and could adversely affect our business, operations and financial condition.

As we expand into other foreign countries and jurisdictions, we will become subject to additional laws and regulations that will affect how we conduct business, and we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue. Our operations could suffer additional costs, complaints, and regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. Compliance with applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with new data protection rules. Failure or perceived failure to comply with any such laws or regulations puts us at risk of facing significant fines and penalties that could adversely affect our business, financial condition, reputation, and results of our operations. Furthermore, conflicting requirements across applicable privacy and data security laws would complicate our compliance efforts and increase both legal risk and compliance costs for us and the third parties upon whom we rely.

Although we work to comply with applicable laws, regulations and standards, our contractual obligations, research protocols, and other obligations, any actual or perceived failure by us or our employees, representatives, contractors, consultants, or other third parties to comply with such requirements or adequately address data privacy and security concerns, even if unfounded, could result in, among other adverse impacts, damage to our reputation, loss of customer confidence in our security measures, withdrawal or withholding of customer consent for using patient data, government investigations, and enforcement actions and litigation and claims by third parties, any of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Failure to comply with the FCPA and other anti-bribery, anti-corruption, export control, import, and sanctions laws associated with our activities outside the United States could adversely affect our business, results of operations and financial condition.

We are subject to the FCPA and other anti-bribery and anti-corruption legislation in the countries in which we operate, some of which, including the UK Bribery Act 2010 are similarly extra-territorial. The FCPA generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments, offers or promises to foreign officials for the purpose of obtaining or retaining business or other advantages. In addition, the FCPA imposes recordkeeping and internal controls requirements on publicly traded corporations and their foreign affiliates, which are intended to, among other things, prevent the diversion of corporate funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper payments can be made. As we conduct our business in jurisdictions outside of the United States, we face significant risks if we fail to comply with the FCPA and other laws that prohibit improper payments, offers or promises of payment to foreign governments and their officials and political parties by us and other business entities for the purpose of obtaining or retaining business or other advantages. In many foreign countries, particularly in countries with developing economies, it may be a local custom that businesses operating in such countries engage in business practices

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that are prohibited by the FCPA or other laws and regulations. Although we have implemented a company policy requiring our employees and consultants to comply with the FCPA and similar laws, such policy may not prevent all potential FCPA or other violations. Although our agreements with our international distributors clearly state our expectations for our distributors’ compliance with applicable laws, including the FCPA and other anti-bribery and anti-corruption laws, and provide us with various remedies upon any non-compliance, including the ability to terminate the agreement, we also cannot guarantee our distributors’ compliance with these laws, including the FCPA. Therefore, there can be no assurance that our employees and agents, or those companies to which we outsource certain of our business operations, have not and will not take actions that violate our policies or applicable laws, for which we may be ultimately held responsible. Any violation of the FCPA or other anti-bribery and anti-corruption laws could result in substantial penalties, including fines, enforcement actions, civil and/or criminal sanctions, which could adversely affect our business, results of operations and financial condition.

Most European countries and/ or government hospitals and clinics have laws/ rules limiting interactions between the medical device industry and HCPs, HCOs and patient organizations. In some countries our interactions with these persons are also subject to prior authorization or notification requirements and/ or to requirements to publish information detailing these interactions together with the value of support or payments provided. Failure to meet these requirements can lead to criminal and civil sanctions being imposed as well as potential exclusion from EU tendering opportunities.

Furthermore, we are subject to U.S. and foreign export controls, trade sanctions and economic embargoes, and import laws and regulations, including, but not limited to, the U.S. Export Administration Regulations administered by the Department of Commerce, and U.S. trade sanctions administered by the Office of Foreign Assets Control within the Department of the Treasury. Governmental regulation of the import or export of our products, or our failure to obtain any required import or export authorization for our products, when applicable, could harm our international or domestic sales and adversely affect our revenue. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions limit our ability to market, sell, distribute or otherwise transfer our products or technology to prohibited countries or persons. A determination that we have failed to comply, whether knowingly or inadvertently, may result in substantial penalties, including fines, enforcement actions, civil and/or criminal sanctions, the disgorgement of profits, the imposition of a court-appointed monitor, as well as the denial of export privileges, and may adversely affect our business, results of operations and financial condition.

Risks Related to Intellectual Property Matters

Protection of our intellectual property rights may be difficult and costly, and our inability to protect our intellectual property could adversely affect our competitive position.

Our overall success depends, in part, on our ability to protect our proprietary rights to the technologies and inventions used in, or embodied by, our products, as well as our ability to operate without infringing, misappropriating, or otherwise violating the proprietary rights of others. To protect our proprietary technologies and products, we may rely on a combination of patent, copyright, trade secret and trademark protections, as well as nondisclosure, confidentiality and other contractual restrictions in our consulting and employment agreements and similar agreements. These legal means afford only limited protection, however, and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Our success depends in part on our ability to obtain, maintain, expand, enforce, and defend the scope, ownership or control, validity and enforceability of our intellectual property rights in the United States and other countries with respect to our products and proprietary technologies. We generally seek, and may in the future seek, to protect our proprietary position, in part, by filing patent applications in the United States and abroad relating to our products and technologies. We may also seek to protect our proprietary position in the future by acquiring or in-licensing relevant issued patents or pending patent applications from third parties. If we are unable to obtain, maintain, expand, enforce and defend the scope, ownership or control, validity and enforceability of our intellectual property rights, our business, financial condition, results of operations and prospects could be materially harmed. Our existing or future confidentiality and/or invention assignment agreements with employees, contractors, and others who participate in IP development activities could be

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breached, or we may not enter into sufficient and adequate agreements with those individuals in the first instance, and we may not have adequate remedies for such breaches. Furthermore, we may be subject to, and forced to defend against, third-party claims of ownership to our intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or rights to use, valuable intellectual property. Such an outcome could adversely affect our business, results of operations and financial condition. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

The process of applying for patent protection is complex, time-consuming and expensive and we cannot assure you that all of our patent applications will issue as patents or that, if issued, they will issue in a form that will be advantageous to us. The rights granted to us under our patents, including prospective rights sought in our pending patent applications, may not be meaningful or provide us with any commercial advantage, and they could be opposed, contested, narrowed, or circumvented by our competitors or declared invalid or unenforceable in judicial or administrative proceedings. We may not be able to file, prosecute, maintain, and enforce all necessary or desirable patent applications or maintain and enforce patents that may issue based on our patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. As a result, some of our products may not currently be, and in the future may not be, protected by patents. We generally apply for patents in those countries where we intend to make, have made, use, offer for sale, or sell products and where we assess the risk of infringement to justify the cost of seeking patent protection. However, we do not seek protection in all countries where we sell products and we may not accurately predict all the countries where patent protection would ultimately be desirable. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may use our technologies and innovations in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories in which we have patent protection but where such protection may not be sufficient to enjoin infringing activities.

We own numerous issued patents and pending patent applications relating to our technologies and products. The rights granted to us under these patents, including prospective rights sought in our pending patent applications, could be opposed, contested or circumvented by our competitors or declared invalid or unenforceable in judicial or administrative proceedings. If any of our patents are challenged, invalidated or legally circumvented by third parties, and if we do not own other enforceable patents protecting our products, competitors could market products and use processes that are substantially similar to, or superior to, those of ours, and our business will suffer. In addition, the patents we own may not be of sufficient scope or strength to provide us with any meaningful protection or commercial advantage, and competitors may be able to design around our patents or develop products that provide outcomes comparable to those of ours without infringing on our intellectual property rights.

Even if our patents are determined by the U.S. Patent and Trademark Office, or USPTO, foreign patent office, or a court to be valid and enforceable, they may not be drafted or interpreted sufficiently broadly to prevent others from marketing products and services similar to ours or designing around our patents. For example, third parties may be able to develop products that are similar to ours but that are not covered by the claims of our patents. Third parties may assert that we were not the first to make the inventions covered by our issued patents or pending patent applications. The claims of our issued patents or patent applications when issued may not cover our commercial technologies or the future products and services that we develop. We may not have freedom to operate unimpeded by the patent rights of others. Third parties may have dominating, blocking or other patents relevant to our technologies of which we are not aware. In addition, because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after the filing of certain priority documents (or, in some cases, are not published until they issue as patents) and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for our technologies or our contemplated technology. Any such patent applications may have priority over our patent applications or issued patents, which could require us to obtain rights from third parties to issued patents or pending patent applications covering such technologies to allow us to commercialize our technologies. If another party has filed a U.S. patent application on inventions similar to ours, depending on when the timing of the filing date falls under certain patent laws, we may have to participate in a priority contest (such as an interference proceeding) declared by the USPTO to determine

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priority of invention in the United States. There may be prior public disclosures of which we are not aware that could invalidate our patents or a portion of the claims of our patents. Further, we may not develop additional proprietary technologies and, even if we do, they may not be patentable.

We may rely on our trademarks as one means to distinguish our products from the products of our competitors, and have registered or applied to register certain of these trademarks. However, we may not be able to successfully secure trademark registrations for all such applications. Third parties may oppose our trademark applications, or otherwise challenge our use of both registered and unregistered trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks, then we may not be able to compete effectively and our business, results of operations and financial condition may be adversely affected.

We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, vendors, former employees or current employees, despite the existence generally of confidentiality agreements and other contractual restrictions. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective.

We have not secured copyright registrations for our works of authorship such as our websites, marketing materials, and training materials, and registration would be necessary if we would elect to bring a lawsuit for copyright infringement in the United States. Moreover, certain statutory damages may be unavailable based upon the date of the third party infringement because any application for registration may not be filed before any potential copyright infringement.

Changes in patent laws or their interpretation could diminish the value of patents in general, thereby imposing our ability to protect our products.

Changes in either the patent laws or interpretation of the patent laws in the United States or in other lead to additional uncertainties and increased costs surrounding the prosecution of our patent applications or enforcement and defense of our issued patents. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the America Invents Act) enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before us or our future licensors could therefore be awarded a patent covering an invention of ours or our future licensors even if we or our future licensors had made the invention before it was made by such third party. This requires us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our future licensors are the first to either (i) file any patent application related to our products and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our patents or patent applications.

The America Invents Act also included a number of significant changes that affect the way patent applications filed after March 2013 are prosecuted and also affect patent litigation. These include allowing third party protests and submission of prior art to the USPTO during patent prosecution and creating additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our owned patent claims or any patent claims we may license in the future that would not have been

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invalidated if first challenged by the third party as a defendant in a district court action. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third- parties to commercialize our technologies or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.

In addition, depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have or may obtain or license in the future.

For example, on June 1, 2023, the European Union Patent Package (EU Patent Package) regulations were implemented with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (UPC) for litigation involving European patents. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC, unless otherwise opted out. It is uncertain how the UPC will impact granted European patents in the medical device industries. Our current and future European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technologies and our products due to increased competition and, resultantly, on our business, financial condition, results of operations and prospects. The UPC and Unitary Patent are significant changes in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation in the UPC.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and patent applications often must be paid to the USPTO and various foreign patent agencies over the lifetime of the patent and patent applications. While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our products or technologies, we may not be able to stop a competitor from marketing products that are the same as or similar to our products, which would adversely affect our business, results of operations and financial condition.

Further, the USPTO and various foreign government agencies require compliance with certain foreign filing requirements during the patent application process. For example, in some countries, including the United States, China and some European countries, a foreign filing license is required before certain patent applications are filed. The foreign filing license requirements vary by country and depend on various factors, including where the inventive activity occurred, citizenship status of the inventors, the residency of the inventors and the invention owner, the place of business for the invention owner and the nature of the subject matter to be disclosed (e.g., items related to national security or national defense). In some, but not all cases,

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for example in China, a foreign filing license cannot be obtained retroactively in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment of a pending patent application or can be grounds for revoking or invalidating an issued patent, resulting in the loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the relevant markets with similar or identical products or technologies, which could have a material adverse effect on our business, financial condition, results of operations and prospects. We may also in the future be dependent on our licensors to take the necessary actions to comply with these requirements with respect to our future licensed intellectual property.

We may not be able to protect our intellectual property and proprietary rights throughout the world.

Filing, prosecuting and defending patents on our products in all countries throughout the world would be prohibitively expensive. Prosecution of foreign patent applications is often a longer process and patents may grant at a later date, and with a shorter term, than in the United States. The requirements for patentability may differ in certain jurisdictions and countries, particularly developing countries, and the breadth of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries may not protect our intellectual property rights to the same extent as laws in the United States, or from selling or importing products made using our intellectual property in and into the United States or other jurisdictions. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories in which we have patent protection that may not be sufficient to terminate infringing activities. These products may compete with our products, and our current or future owned or licensed patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Due to differences between foreign and U.S. patent laws, our patented intellectual property rights may not receive the same degree of protection in every jurisdiction in which we obtain patents. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to medical device products, which could make it difficult for us to stop the infringement of our owned patents or any patents we may license in the future or marketing of competing products in violation of our intellectual property and proprietary rights generally. In addition, some jurisdictions, such as Europe, Japan and China, may have a heightened standard for patentability than in the United States, including, for example, the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing. Under those heightened patentability requirements, we may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in the United States and other jurisdictions. Furthermore, we do not have patent rights in certain foreign countries in which a market may exist in the future. We may need to expend additional resources to protect or defend our intellectual property rights in these countries, and the inability to protect or defend the same could impair our brand or adversely affect the growth of our business internationally. For example, we may not be able to stop a competitor from marketing and selling in foreign countries products that are the same as or similar to our products.

Proceedings to enforce our intellectual property and proprietary rights in the United States or other jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our owned and any patents we may license in the future at risk of being invalidated or interpreted narrowly, could put our patent applications and any patent applications we may license in the future at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties, including governmental agencies. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we are forced to grant a

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license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.

Patent terms may be inadequate to protect the competitive position of our products for an adequate amount of time.

Patents have a limited lifespan, and the protection patents affords is limited. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional or international patent application filing date. The actual protection afforded by a patent varies from country to country, and depends on many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent. Although various extensions may be available, the term of a patent, and the protection it affords, is limited. We may also be required to disclaim a portion of a patent term in order to overcome double patenting rejections from the patent office, thus potentially shortening our exclusivity period. Even if patents covering our products are obtained, once the patent life has expired for patents covering a product, we may be vulnerable to competition from competitive products and services. In addition, although upon issuance in the United States a patent’s term can be extended based on certain delays caused by the USPTO, this extension can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. A patent term extension based on regulatory delay may be available in the United States for medical devices. However, only a single patent can be extended for each marketing approval, and any patent can be extended only once for a single product. Moreover, the scope of protection during the period of the patent term extension does not extend to the full scope of the claim, but instead only to the scope of the product as approved. Laws governing analogous patent term extensions in foreign jurisdictions vary widely, as do laws governing the ability to obtain multiple patents from a single patent family. Additionally, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Given the amount of time required for the development, testing and regulatory review of our products, the remaining patent term of our regulatory-approved products may be limited. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Certain of our patents that cover our commercial motion preservation products are expected to expire in the next couple of years. Accordingly, as and when these different patents expire, our commercial motion preservation products could become subject to increased competition. If we do not have sufficient patent life to protect our products, our business, financial condition, results of operations and prospects will be adversely affected.

We may need to obtain licenses from third parties to advance our research or allow commercialization of our products and technologies.

We may need to obtain licenses from third parties to advance our research or allow commercialization of our products and technologies. We may fail to obtain any of these licenses on commercially reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In the event that we are not able to acquire a license, we may be required to expend significant time and resources to develop or license replacement technology, which may entail additional costs and commercialization delays. If we are unable to do so, we may be unable to develop or commercialize the affected products and technologies, which could materially harm our business. In addition, the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties or other forms of compensation and damages.

The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies that may be more established or have greater resources than we do may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our products. More established companies may have a competitive advantage over us due to their size, resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. There can be no assurance that we will be able to successfully complete these types of negotiations and ultimately acquire the rights to the intellectual property related to the products that we may seek to develop or market. If we are

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unable to successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, our business, results of operations and financial condition could suffer.

Licensing of intellectual property involves complex legal, business and scientific issues.

Disputes may arise between us and our future licensors regarding intellectual property that is subject to a license agreement, including:

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the scope of rights granted under the license agreement and other interpretation-related issues;

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whether and the extent to which our technologies and products infringe on intellectual property of the licensor that is not subject to the license agreement;

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our right to sublicense patent and other rights to third parties under future license arrangements or collaborative development relationships;

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our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our products and technologies, and what activities satisfy those diligence obligations; and

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the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.

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If disputes over intellectual property that we may license prevent or impair our ability to maintain our future licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize such affected products and technologies.

Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technologies.

Certain provisions in our intellectual property agreements may be susceptible to multiple interpretations. Further, any agreements we may enter into in the future under which we license intellectual property or technology from third parties could be complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could affect the scope of our rights to the relevant intellectual property or technology, or affect financial or other obligations under the relevant agreement, either of which could adversely affect our business, results of operations and financial condition.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact conceives or develops intellectual property that we regard as our own. Our assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, results of operations and financial condition.

We may in the future be a party to patent and other intellectual property litigation and administrative proceedings that could be costly and could interfere with our ability to successfully market our products.

The medical device industry has been characterized by frequent and extensive intellectual property litigation and is highly competitive. Companies in the medical device industry have used intellectual property litigation to gain a competitive advantage. Our commercial success depends in part upon our ability and that of our contract manufacturers and suppliers to manufacture, market, and sell our products, and to use our technologies without infringing, misappropriating or otherwise violating the proprietary rights or intellectual property of third parties. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our products and any future products and technologies, whether or not we are actually infringing, misappropriating or otherwise violating the rights of third parties. While we take reasonable steps to ensure that we do not infringe upon, misappropriate, or otherwise violate the intellectual property rights of others, there may be pertinent intellectual property rights of others which we or our suppliers are presently unaware. Our competitors or other patent holders may assert

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that our products and/or the methods employed in our products are covered by their patents or that we are infringing, misappropriating, or misusing their trademark, copyright, trade secret, and/or other proprietary rights.

Patent litigation is costly to defend and can result in significant damage awards, including treble damages and attorneys’ fees under certain circumstances, and injunctions that could prevent the manufacture and sale of affected products or force us to make significant royalty payments in order to continue selling the affected products. In the event that we become involved in such a dispute, we may incur significant costs and expenses and may need to devote resources to resolving any claims, which would reduce the cash we have available for operations and may be distracting to management and other employees, including those involved in the development of intellectual property. We may not have sufficient funds to enforce or defend our patents in litigation which could have a material adverse effect on our business. A successful claim of patent or other intellectual property infringement against us could have a material adverse effect on our business, results of operations, financial condition and cash flows.

We do not know whether our competitors or potential competitors have applied for, will apply for, or will obtain patents that will prevent, limit or interfere with our ability to make, use, sell, import or export our products. Because patent applications can take many years to issue, third parties may have currently pending patent applications which may later result in issued patents that our products and technologies may infringe, or which such third parties claim are infringed by the use of our products or technologies. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that we infringe. There is no guarantee that patents will not issue in the future from currently pending applications that may be infringed by our technologies or products. In addition, identification of third-party patent rights that may be relevant to our technologies is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, and difficulty in assessing the meaning of patent claims. We cannot guarantee that any of our or future licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are or will be complete or thorough, nor can we be certain that we or our future licensors have identified or will identify each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our current and future products in any jurisdiction. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect and it is also possible that patents owned by third parties of which we are aware, but which we do not believe we infringe or that we believe we have valid defenses to any claims of patent infringement, could be found to be infringed by us. Moreover, as the medical device industry expands and more patents are issued in this area, the risk increases that we may be subject to claims of infringement of the patent rights of third parties. We cannot assure you that we will prevail in such actions, or that other actions alleging misappropriation or misuse by us of third-party trade secrets or infringement by us of third-party patents, copyrights, trademarks or other rights or challenging the validity of our patents, copyrights, trademarks or other rights will not be asserted against us. In a patent infringement claim against us, we may assert, as a defense, that we do not infringe the relevant patent claims, that the patent is invalid or both. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. However, we could be unsuccessful in advancing non-infringement and/or invalidity arguments in our defense. In the United States, issued patents enjoy a presumption of validity, and the party challenging the validity of a patent claim must present clear and convincing evidence of invalidity, which is a high burden of proof. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof. Competing products may also be sold in other countries in which our patent coverage might not exist or be as strong. If we lose a foreign patent or other intellectual property lawsuit alleging our infringement of a competitor’s patents or other intellectual property, we could be prevented from marketing our products in one or more foreign countries.

Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe or violate the intellectual property rights of others. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced

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to pay damages, we may be temporarily or permanently prohibited from commercializing any of our product candidates that are held to be infringing. We might, if possible, also be forced to redesign products or services so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

We may also initiate litigation against third parties to enforce our patent and proprietary rights or to determine the scope, enforceability or validity of the proprietary rights of others. Our patents have not been tested in litigation. If we initiate litigation to protect our patent rights, we run the risk of provoking perceived infringers to assert counterclaims or file administrative actions against us alleging that we infringe their patents and having our patents and other proprietary rights invalidated, canceled, held unenforceable, in whole or in part, or narrowed, which could undermine our competitive position. Further, if the scope of protection provided by our patents or patent applications or other proprietary rights is threatened or reduced as a result of litigation, it could discourage third parties from entering into collaborations with us that are important to the commercialization of our products. We may elect to enter into license agreements in order to settle patent infringement claims or to resolve disputes before litigation, and any such license agreements may require us to pay royalties and other fees that could be significant.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract management and our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Class A Common Stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

In addition, third parties may assert infringement claims against our customers. These claims may require us to initiate or defend protracted and costly litigation on behalf of our customers or indemnify our customers for any costs associated with their own initiation or defense of infringement claims, regardless of the merits of these claims. If any of these claims succeed or settle, we may be forced to pay damages or settlement payments on behalf of our customers or may be required to obtain licenses for the products they use. If we cannot obtain all necessary licenses on commercially reasonable terms, our customers may be forced to stop using our products.

We may be subject to ownership disputes relating to intellectual property, including disputes arising from conflicting obligations of consultants or others who are involved in developing our products. Furthermore, if we enter into licensing agreements in the future and if a license to necessary technology is terminated, the licensor may initiate litigation claiming that our processes, products or activities infringe or misappropriate its patent or other intellectual property rights and/or that we breached our obligations under such license agreement, and we and our collaborators would need to defend against such proceedings.

These lawsuits and proceedings, regardless of merit, are time-consuming and expensive to initiate, maintain, defend or settle, and could divert the time and attention of managerial and technical personnel, which could materially adversely affect our business, results of operations and financial condition. Any such claim could also force us to do one or more of the following:

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incur substantial monetary liability for infringement or other violations of intellectual property rights, which we may have to pay if a court decides that the product, service, or technology at issue infringes or violates the third-party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the third-party’s attorneys’ fees;

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pay substantial damages to our customers or end users to discontinue use or replace infringing technology with non-infringing technology;

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stop manufacturing, offering for sale, selling, using, importing, exporting or licensing the product or technology incorporating the allegedly infringing technology or stop incorporating the allegedly infringing technology into such product, service, or technology;

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obtain from the owner of the infringed intellectual property right a license, which may require us to pay substantial upfront fees and/or royalties to sell or use the relevant technology and which may not be available on commercially reasonable terms, or at all;

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redesign our products, services, and technology so they do not infringe or violate the third-party’s intellectual property rights, which may not be possible or may require substantial monetary expenditures and time;

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enter into cross-licenses with our competitors, which could weaken our overall intellectual property position;

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lose the opportunity to license our technologies to others or to collect royalty payments based upon successful protection and assertion of our intellectual property against others;

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find alternative suppliers for non-infringing products and technologies, which could be costly and create significant delay; or

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relinquish rights associated with one or more of our patent claims, if our claims are held invalid or otherwise unenforceable.

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Some of our competitors may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources, and many of our competitors, who have made significant investments in competing technologies, may seek, or may already have sought or obtained, patents that will limit, interfere with or eliminate our ability to make, use and sell our products. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays, divert the time, attention and resources of management, or prohibit us from manufacturing, marketing or otherwise commercializing our products and technologies. Any uncertainties resulting from the initiation and continuation of any litigation could adversely affect our ability to raise additional funds or otherwise adversely affect our business, results of operations and financial condition.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If these results are perceived to be negative, the price of our Class A Common Stock could be adversely affected.

In addition, certain of our agreements with suppliers, distributors, customers and other entities with whom we do business may require us to defend or indemnify these parties to the extent they become involved in infringement claims relating to our technologies or products, or rights licensed to them by us. We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships. If we are required or agree to defend or indemnify any of these third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, results of operation and financial condition.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our business. Any of the foregoing may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of management from our core business, and harm our reputation.

We may be subject to damages resulting from claims that we or our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of our competitors or their current or former employers or are in breach of non-competition or non-solicitation agreements with our competitors or their current or former employers.

We could in the future be subject to claims that we or our employees, consultants, or advisors have inadvertently or otherwise used or disclosed alleged trade secrets or other proprietary information of such

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individual’s current or former employers or competitors. In addition, we may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction to management. If our defense to those claims fails, in addition to paying monetary damages, a court could prohibit us from using technologies or features that are essential to our products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the competitors or such individual’s current or former employers. An inability to incorporate technologies or features that are important or essential to our products could adversely affect our business, results of operations and financial condition, and may prevent us from selling our products. In addition, we may lose valuable intellectual property rights or personnel. Any litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, which could adversely affect our business, results of operations and financial condition.

In addition, while it is our policy to require our employees, contractors, advisors and other individuals who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, results of operations and financial condition.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patent protection for our products and technologies, we may rely on trade secret protection and confidentiality agreements to protect our unpatented know-how, technologies, and other proprietary information and to maintain our competitive position. We seek to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, consultants, vendors, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees, contractors and advisors.

Trade secrets and know-how can be difficult to protect. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, vendors, former employees or current employees, despite the existence generally of confidentiality agreements and other contractual restrictions. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective.

Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. For example, the FDA, as part of its Transparency Initiative, is currently considering whether to make additional information publicly available on a routine basis, including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change in the future, if at all. Our competitors could use any of the information we may be required to disclose by the FDA to develop independently technology similar to those of ours.

If we were to enforce a claim that a third-party had illegally obtained, misappropriated or was using our trade secrets or know-how, it would be expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. If any of the technologies or information that we protect as trade secrets or know-how were to be independently developed by a competitor, we would have no right to prevent them from using that technology or information to compete with us.

Misappropriation or unauthorized disclosure of our trade secrets or know-how could impair our competitive position and may adversely affect our business, results of operations and financial condition. Additionally, if

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the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret or know-how.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

We may rely on our trademarks as one means to distinguish our products from the products of our competitors, and have registered or applied to register certain of these trademarks. However, our registered or unregistered trademarks or trade names may be challenged, infringed, diluted, circumvented or determined to be infringing, misappropriating or violating other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in the markets of interest. During trademark registration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions. Although we will be given an opportunity to respond to such rejections, we may be unable to overcome them. If our trademarks are successfully challenged or determined to be infringing, misappropriating or violating other marks, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote resources to advertising and marketing new brands. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, which may not survive such proceedings. Moreover, any name we may propose to use with our products in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. Similar requirements exist in Europe. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA or an equivalent administrative body in a foreign jurisdiction objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe, misappropriate or otherwise violate the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

We may not be able to obtain, protect or enforce our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement, misappropriation, dilution or other claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to obtain, enforce or protect our proprietary rights related to trademarks, trade names, domain name, or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.

We generally apply for trademark registrations in those countries where we intend to sell products and where we assess the risk of infringement to justify the cost of seeking trademark protection. However, we do not seek protection in all countries where we advertise and sell products and we may not accurately predict all the countries where trademark registrations would ultimately be desirable. We also have not secured trademark registrations for each mark used in connection with our products and services. Filing, prosecuting and enforcing trademarks for our products and services in all countries throughout the world would be prohibitively expensive. Consequently, we may not be able to successfully prevent third parties from using our trademarks in all countries.

Intellectual property rights do not necessarily address all potential threats to our business.

Once granted, patents may remain open to invalidity challenges including opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices or similar proceedings for a given period after allowance or grant, during which time third parties can

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raise objections against such grant. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to limit the scope of the allowed or granted claims thus attacked, or may lose the allowed or granted claims altogether.

In addition, the degree of future protection afforded by our intellectual property rights is uncertain because even granted intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors or permit us to maintain our competitive advantage. Moreover, if a third-party has intellectual property rights that cover the practice of our technologies, we may not be able to fully exercise or extract value from our intellectual property rights. The following examples are illustrative:

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others may be able to develop and/or practice technology that is similar to our technologies or aspects of our technologies, but that are not covered by the claims of the patents that we own or control, assuming such patents have issued or do issue;

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we or any future strategic partners might not have been the first to conceive or reduce to practice the inventions covered by the issued patents or pending patent applications that we own;

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we or any future strategic partners might not have been the first to file patent applications covering certain of our or their inventions;

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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

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our pending or future patent applications that we own or may license may not lead to issued patents;

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issued patents that we own or may license in the future may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors or other third parties;

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if we enter into licensing agreement with strategic partners in the future, others may have access to the same intellectual property rights licensed to us in the future on a non-exclusive basis;

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our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

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third parties performing manufacturing or testing for us using our products or technologies could use the intellectual property of others without obtaining a proper license;

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parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property;

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we may not develop or in-license additional proprietary technologies that are patentable;

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we may fail to identify potential patentable subject matter and/or may fail to file on it;

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we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; and

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the patents of others may adversely affect our business.

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Should any of these events occur, they could adversely affect our business, results of operations and financial condition.

Risks Related to Our Organizational Structure

Our principal asset after the completion of this offering will be our direct or indirect interest in Centinel LLC, and, as a result, we will depend on distributions from Centinel LLC to pay our taxes and expenses (including payments under the Tax Receivable Agreement) and pay dividends (if any). Centinel LLC’s ability to make such distributions may be subject to various limitations and restrictions.

Upon the consummation of this offering and the Organizational Transactions, we will be a holding company and will have no material assets other than our ownership of Series A Common Units. As such, we will have

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no independent means of generating revenue or cash flow, and our ability to pay our taxes and operating expenses or declare and pay dividends in the future, if any, will be dependent upon the financial results and cash flows of Centinel LLC and distributions we receive from Centinel LLC. There can be no assurance Centinel LLC will generate sufficient cash flow to distribute funds to us or that applicable state law and contractual restrictions, including negative covenants in any applicable debt instruments, will permit such distributions. Centinel LLC is currently subject to debt instruments or other agreements that restrict its ability to make distributions to us, which may in turn affect Centinel LLC’s ability to pay distributions to us and thereby adversely affect our cash flows.

Although no assurances can be provided, we anticipate that Centinel LLC will continue to be treated as a partnership for U.S. federal income tax purposes (and not as a “publicly traded partnership” taxable as a corporation for U.S. federal income tax purposes) and, as such, generally will not be subject to any entity-level U.S. federal income tax. Instead, any taxable income of Centinel LLC will be allocated to holders of LLC Units, including us. Accordingly, we will incur income taxes on our allocable share of any net taxable income of Centinel LLC. However, Centinel LLC may, absent an election to the contrary (which we may not make), be subject to material liabilities pursuant to the partnership audit rules enacted pursuant to the Bipartisan Budget Act of 2015 and related guidance if, for example, its calculations of taxable income are incorrect. Pursuant to these rules, Centinel LLC may be liable for underpayments of taxes attributable to the equity interests of the Continuing Equity Owners, or historic equityholders of Centinel LLC from periods before this offering, in which case we may indirectly economically bear a portion of such taxes (including any applicable penalties and interest) even though we did not economically benefit from the income giving rise to such taxes. Further, we will be responsible for the unpaid tax liabilities of the Blocker Companies we acquire as part of the Organizational Transactions, including for the taxable year (or portion thereof) of such entities ending on the date of this offering. To the extent that we need funds and Centinel LLC is restricted from making such distributions under applicable law or regulations, or as a result of covenants in the debt agreements of Centinel LLC, we may not be able to obtain such funds on terms acceptable to us or at all which as a result could have a material adverse effect on our business, financial condition and results of operations.

Under the terms of the Amended and Restated Centinel LLC Agreement, Centinel LLC will be obligated to make tax distributions to holders of LLC Units, including us. In addition to tax expenses, we will also incur expenses related to our operations, including payments under the Tax Receivable Agreement, which we expect will be significant. See “Certain Relationships and Related Party Transactions—Tax Receivable Agreement.” We intend, as its managing member, to cause Centinel LLC to make cash distributions to the holders of LLC Units (including us) in an amount sufficient to (i) fund all or part of their tax obligations in respect of taxable income allocated to them and (ii) cover our operating expenses, including payments under the Tax Receivable Agreement. However, Centinel LLC’s ability to make such distributions may be subject to various limitations and restrictions, such as restrictions on distributions that would either violate any contract or agreement to which Centinel LLC is then a party, including debt agreements, or any applicable law, or that would have the effect of rendering Centinel LLC insolvent.

If we do not have sufficient funds to pay taxes or other liabilities, or to fund our operations (including, if applicable, because of an acceleration of our obligations under the Tax Receivable Agreement), we may have to borrow funds, which could materially and adversely affect our liquidity and financial condition, and subject us to various restrictions imposed by any lenders of such funds. To the extent we are unable to make timely payments under the Tax Receivable Agreement for any reason, such payments generally will be deferred and will accrue interest until paid; provided, however, that nonpayment for a specified period may constitute a material breach of a material obligation under the Tax Receivable Agreement resulting in the acceleration of payments due under the Tax Receivable Agreement. See “Certain Relationships and Related Party Transactions—Tax Receivable Agreement.” In addition, if Centinel LLC does not have sufficient funds to make distributions, our ability to declare and pay cash dividends (if any) will also be restricted or impaired, although we do not anticipate declaring or paying any cash dividends on our Class A Common Stock in the foreseeable future. See “Risk Factors—Risks Related to This Offering and Ownership of Our Class A Common Stock” and “Dividend Policy.”

As a result of (i) potential differences in the amount of net taxable income allocable to us and to the other holders of LLC Units, (ii) the lower tax rate applicable to corporations as opposed to individuals, and (iii) certain tax benefits covered by, and payments under, the Tax Receivable Agreement, tax distributions

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from Centinel LLC may be in amounts that exceed our tax liabilities. Our board of directors will determine the appropriate uses for any excess cash so accumulated, which may include, among other uses, the payment of obligations under the Tax Receivable Agreement and the payment of other expenses. We will have no obligation to distribute such cash (or other available cash) to our stockholders. No adjustments to the exchange ratio of the LLC Units for shares of Class A Common Stock will be made as a result of any cash dividend or distribution by us or any retention of cash by us. As a result, the holders of Series B Common Units may benefit from value, if any, attributable to such cash balances if they acquire shares of Class A Common Stock in exchange for their Series B Common Units, notwithstanding that such holders may have participated previously as holders of Series B Common Units in distributions that resulted in such excess cash balances to us. To the extent we do not distribute such excess cash as dividends on our Class A Common Stock, we may take other actions with respect to such excess cash (for example, holding such excess cash, or lending or contributing it (or a portion thereof) to Centinel LLC) which may result in shares of our Class A Common Stock increasing in value relative to the value of LLC Units.

Conflicts of interest could arise between certain of our stockholders and the Continuing Equity Owners, which may impede business decisions that could benefit our stockholders.

The Continuing Equity Owners, who will be the only holders of LLC Units other than us upon consummation of this offering, have the right to consent to certain amendments to the Amended and Restated Centinel LLC Agreement, as well as to certain other matters. The Continuing Equity Owners will have significant rights and interests that may not align with those of our stockholders, including the right to receive substantial payments under the Tax Receivable Agreement (together with our Blocker Stockholders), the ability to cause Centinel LLC to make tax distributions that may exceed their actual tax liabilities and the right to exchange Series B Common Units and shares of Class B Common Stock for shares of Class A Common Stock (or cash, at our election), potentially resulting in dilution to our stockholders. In addition, the Continuing Equity Owners, through their ownership of Class B Common Stock, will have significant voting power and influence over our corporate governance and major transactions. The Continuing Equity Owners may exercise these voting rights in a manner that conflicts with the interests of our stockholders. Circumstances may arise in the future when the interests of the Continuing Equity Owners conflict with the interests of our stockholders. As we control Centinel LLC as its managing member, we have certain obligations to the Continuing Equity Owners that may conflict with fiduciary duties our officers and directors owe to our stockholders. These conflicts may result in decisions that are not in the best interests of stockholders.

The Tax Receivable Agreement requires us to make cash payments to the Continuing Equity Owners and the Blocker Stockholders in respect of certain tax benefits to which we may become entitled, and we expect that such payments will be substantial.

In connection with the consummation of this offering, we will enter into a Tax Receivable Agreement with Centinel LLC and the TRA Parties that provides for the payment by us to such Continuing Equity Owners and Blocker Stockholders of 85% of certain tax benefits, if any, that we actually realize, or are deemed to realize (calculated using certain assumptions), as a result of (i) our allocable share of existing tax basis in Centinel LLC’s assets acquired in this offering, (ii) increases in our allocable share of existing tax basis and tax basis adjustments to the tangible and intangible assets of Centinel LLC as a result of sales or exchanges of LLC Units in connection with or after this offering, (iii) our utilization of certain tax attributes (including any existing tax basis) of the Blocker Companies, which Centinel Holdco acquires in connection with this offering, and (iv) certain other tax benefits related to our entering into the Tax Receivable Agreement, including tax benefits attributable to payments under the Tax Receivable Agreement (collectively, “Tax Benefits”). We will be required to make such payments to the Continuing Equity Owners and the Blocker Stockholders even if all of the Continuing Equity Owners were to exchange or redeem their remaining Series B Common Units.

The payment obligations under the Tax Receivable Agreement are an obligation of Centinel Holdco and not of Centinel LLC. We expect that the amount of the cash payments we will be required to make under the Tax Receivable Agreement will be substantial. Any payments made by us to the TRA Parties under the Tax Receivable Agreement will not be available for reinvestment in our business and will generally reduce the amount of overall cash flow that might have otherwise been available to us. To the extent that we are unable to make timely payments under the Tax Receivable Agreement for any reason, the unpaid amounts will be deferred and will accrue interest until paid by us; provided, however, that nonpayment for a specified period

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may constitute a material breach of a material obligation under the Tax Receivable Agreement resulting in the acceleration of payments due under the Tax Receivable Agreement. See “Certain Relationships and Related Party Transactions—Tax Receivable Agreement.” Payments under the Tax Receivable Agreement are not conditioned upon continued ownership of Centinel LLC by the exchanging TRA Parties. Furthermore, if we experience a change of control (as defined under the Tax Receivable Agreement), which includes certain mergers, asset sales, and other forms of business combinations, we would be obligated to make an immediate payment, and such payment may be significantly in advance of, and may materially exceed, the actual realization, if any, of the future Tax Benefits to which the payment relates. This payment obligation could (i) make us a less attractive target for an acquisition, particularly in the case of an acquirer that cannot use some or all of the Tax Benefits that are the subject of the Tax Receivable Agreement and (ii) result in holders of our Class A Common Stock receiving substantially less consideration in connection with a change of control transaction than they would receive in the absence of such obligation. Accordingly, the TRA Parties’ interests may conflict with those of the holders of our Class A Common Stock.

The actual Tax Benefit and the actual utilization of any Tax Benefits, as well as the amount and timing of any payments under the Tax Receivable Agreement, will vary depending upon a number of factors including: the timing of exchanges; the price of shares of our Class A Common Stock at the time of the exchange; the extent to which such exchanges are taxable; the amount of gain recognized by the parties to the Tax Receivable Agreement; the amount and timing of the taxable income allocated to us or otherwise generated by us in the future; the portion of our payments under the Tax Receivable Agreement constituting imputed interest; and the federal and state tax rates then applicable.

In certain cases, payments under the Tax Receivable Agreement may be accelerated or significantly exceed any actual benefits we realize in respect of the tax attributes subject to the Tax Receivable Agreement.

The Tax Receivable Agreement will generally apply to each of our taxable years, beginning with the first taxable year ending after the consummation of the Organizational Transactions. There is no maximum term for the Tax Receivable Agreement. However, the Tax Receivable Agreement will provide that if (i) we materially breach any of our material obligations under the Tax Receivable Agreement, (ii) certain mergers, asset sales, other forms of business combinations or other changes of control occur after the consummation of this offering, or (iii) we elect an early termination of the Tax Receivable Agreement, then our obligations, or our successor’s obligations, under the Tax Receivable Agreement to make payments will be determined based on certain assumptions, including an assumption that we will have sufficient taxable income to fully utilize all potential future Tax Benefits that are subject to the Tax Receivable Agreement.

As a result of the foregoing, we would be required to make an immediate cash payment equal to the present value of the anticipated future Tax Benefits that are the subject of the Tax Receivable Agreement, based on certain assumptions (including that we (or our successor) would have sufficient taxable income to fully utilize the benefits arising from the increased tax deductions and tax basis and other benefits covered by the Tax Receivable Agreement), which payment may be made significantly in advance of the actual realization, if any, of such future Tax Benefits. Such cash payment could be greater than the specified percentage of any actual benefits we ultimately realize in respect of the Tax Benefits that are subject to the Tax Receivable Agreement. In these situations, our obligations under the Tax Receivable Agreement could have a substantial negative impact on our liquidity and could have the effect of delaying, deferring, or preventing certain mergers, asset sales, other forms of business combinations or other changes of control or negatively impact the value received by owners of our Class A Common Stock in a change of control transaction. For example, should we elect to terminate the Tax Receivable Agreement immediately following this offering, assuming no material changes in the relevant tax laws or tax rates and that we earn sufficient taxable income to realize all tax potential benefits that are subject to the Tax Receivable Agreement, we estimate that the aggregate of termination payments would be approximately $      million based on the assumed initial public offering price of $      per share of our Class A Common Stock, which is the midpoint of the range set forth on the cover page of this prospectus, and assuming SOFR (as defined in the Tax Receivable Agreement) were to be    %. There can be no assurance that we will be able to fund or finance our obligations under the Tax Receivable Agreement. We may need to incur debt to finance payments under the Tax Receivable Agreement to the extent our cash resources are insufficient to meet our obligations under the Tax Receivable Agreement as a result of timing discrepancies or otherwise.

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We will not be reimbursed for any payments made under the Tax Receivable Agreement in the event that any Tax Benefits are disallowed.

Payments under the Tax Receivable Agreement will be based on the tax reporting positions that we determine, and the Internal Revenue Service (“IRS”), or another tax authority, may challenge all or part of the basis adjustments or other Tax Benefits we claim or utilize, as well as other related tax positions we take, and a court could sustain such challenge. If the outcome of any such challenge would reasonably be expected to materially and adversely affect the rights and obligations of the TRA Parties under the Tax Receivable Agreement, then we will not be permitted to settle such challenge without the consent (not to be unreasonably withheld or delayed) of the TRA Parties. The interests of the TRA Parties in any such challenge may differ from or conflict with our interests and your interests, and the TRA Parties may exercise their consent rights relating to any such challenge in a manner adverse to our interests and your interests. We will not be reimbursed for any cash payments previously made to the TRA Parties under the Tax Receivable Agreement in the event that any Tax Benefits initially claimed by us and for which payment has been made to a TRA Party are subsequently challenged by a taxing authority and are ultimately disallowed. Instead, any excess cash payments made by us to a TRA Party will be netted against future cash payments, if any, that we might otherwise be required to make to such TRA Party, under the terms of the Tax Receivable Agreement. However, we might not determine that we have effectively made an excess cash payment to a TRA Party for a number of years following the initial time of such payment. Moreover, the excess cash payments we made previously under the Tax Receivable Agreement could be greater than the amount of future cash payments against which we would otherwise be permitted to net such excess. The applicable U.S. federal income tax rules for determining applicable Tax Benefits we may claim or utilize are complex and factual in nature, and there can be no assurance that the IRS or a court will agree with our tax reporting positions. As a result, payments could be made under the Tax Receivable Agreement significantly in excess of any actual cash tax savings that we realize in respect of the Tax Benefits with respect to a TRA Party that are the subject of the Tax Receivable Agreement.

If Centinel LLC were to be treated as a “publicly traded partnership” taxable as a corporation for U.S. federal or state income tax purposes, we might be subject to significant tax inefficiencies, and we would not be able to recover payments previously made by us under the Tax Receivable Agreement, even if the corresponding Tax Benefits were subsequently determined to have been unavailable due to such status.

We intend to operate Centinel LLC such that it does not become a “publicly traded partnership” taxable as a corporation for U.S. federal income tax purposes. A “publicly traded partnership” is a partnership the interests of which are traded on an established securities market or are readily tradable on a secondary market or the substantial equivalent thereof. An entity that would otherwise be classified as a partnership for U.S. federal income tax purposes (such as Centinel LLC) may nonetheless be treated as, and taxable as, a corporation if it is a “publicly traded partnership” unless 90% or more of such partnership’s gross income consists of certain passive-type qualifying income, such as interest, dividends and real property rents. Under certain circumstances, transfers of LLC Units (including pursuant to the Exchange Agreement) could cause Centinel LLC to be treated as a “publicly traded partnership.” Applicable U.S. Treasury regulations provide for certain safe harbors from treatment as a “publicly traded partnership,” and we intend to operate such that exchanges or other transfers of LLC Units qualify for one or more of such safe harbors. Accordingly, while such position is not free from doubt, Centinel LLC is expected to be operated such that it is not treated as a “publicly traded partnership” taxable as a corporation for U.S. federal income tax purposes and we intend to take the position that Centinel LLC is not so treated as a result of exchanges of its interests pursuant to the Exchange Agreement. If Centinel LLC were to become a “publicly traded partnership” taxable as a corporation for U.S. federal income tax purposes, significant tax inefficiencies might result for us and for Centinel LLC. Centinel LLC would be taxable on its income at the U.S. federal income tax rates applicable to corporations and distributions by Centinel LLC to its members (including us) may be taxable as dividends to such members to the extent of the current or accumulated earnings and profits of Centinel LLC, as determined under U.S. federal income tax principles, if we are unable to file a consolidated U.S. federal income tax return with Centinel LLC. In addition, we may not be able to realize the Tax Benefits covered under the Tax Receivable Agreement, including that we would no longer have the benefit of increases in the tax basis of Centinel LLC’s assets as a result of exchanges of LLC Units, and would not be able to recover any payments previously made by us under the Tax Receivable Agreement related to such tax benefits, even if they were subsequently determined to have been unavailable.

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We may be subject to withholding obligations in connection with exchanges of Series B Common Units by holders who are non-U.S. persons, which could create administrative burdens and potential liability for us.

Any holder of Series B Common Units who is a non-U.S. person (as defined under the Code) that exchanges its Series B Common Units for shares of Class A Common Stock (or cash, at our election) may be subject to U.S. federal income tax withholding on such exchange. Because the exchange of Series B Common Units for shares of Class A Common Stock is expected to be treated as a taxable sale of a partnership interest, we (or Centinel LLC) may be required to withhold tax on the amount realized by the exchanging non-U.S. holder (despite the fact that it is a “cashless” exchange). If we do not properly withhold on such exchange, we could be held liable for any failure to properly withhold and remit such amounts to the IRS. Compliance with such withholding obligations may create significant administrative burdens for us, including the obligation to determine which exchanging holders are non-U.S. persons and to collect applicable tax certifications, as well as sourcing the cash that will be used to satisfy such withholding obligations. Any failure to withhold the required amounts may subject us to penalties and interest, which could adversely affect our financial condition.

Certain aspects of the Organizational Transactions involve uncertain tax treatment, and the IRS could challenge our tax positions, which could result in adverse tax consequences to us.

The Organizational Transactions involve a series of complex steps, including the recapitalization of Centinel LLC’s equity, the mergers of the Blocker Companies with and into us, and the conversion of certain convertible debt and warrant instruments. Certain of these steps involve areas of tax law that are uncertain or for which there is limited direct authority. Any adverse determination by the IRS or a court with respect to the tax treatment of any step of the Organizational Transactions could result in unexpected tax liabilities for us and could adversely affect the Tax Benefits that are the subject of the Tax Receivable Agreement.

If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), as a result of our ownership of Centinel LLC, applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business.

Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes of the 1940 Act if it (i) is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities, or (ii) is engaged, or proposes to engage, in the business of investing, reinvesting, owning, holding, or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis. We do not believe that we are an “investment company,” as such term is defined in either of those sections of the 1940 Act.

We and Centinel LLC intend to conduct our operations so that we will not be deemed an investment company. As the sole managing member of Centinel LLC, we will control and operate Centinel LLC. On that basis, we believe that our interest in Centinel LLC is not an “investment security” as that term is used in the 1940 Act. However, if we were to cease participation in the management of Centinel LLC, or if Centinel LLC itself becomes an investment company, our interest in Centinel LLC could be deemed an “investment security” for purposes of the 1940 Act.

If it were established that we were an unregistered investment company, there would be a risk that we would be subject to monetary penalties and injunctive relief in an action brought by the SEC, that we would be unable to enforce contracts with third parties and that third parties could seek to obtain rescission of transactions undertaken during the period it was established that we were an unregistered investment company. If we were deemed an investment company, restrictions imposed by the 1940 Act, including limitations on our capital structure and our ability to transact with affiliates, could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business.

Risks Related to This Offering and Ownership of Our Class A Common Stock

There may not be an active trading market for our Class A Common Stock, which may cause shares of our Class A Common Stock to trade at a discount from the initial public offering price and make it difficult to sell the shares of Class A Common Stock you purchase.

Prior to this offering, there has been no public market for our Class A Common Stock. It is possible that after this offering, an active trading market will not develop or, if developed, that any market will not be sustained,

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which would make it difficult for you to sell your shares of Common Stock at an attractive price or at all. The lack of an active market may impair the value of your shares or your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The initial public offering price per share of Class A Common Stock will be determined by agreement among us and the representatives of the underwriters and may not be indicative of the price at which shares of our Class A Common Stock will trade in the public market, if any, after this offering. The market value of our Class A Common Stock may decrease from the initial public offering price. Furthermore, an inactive market may also impair our ability to raise capital in the future by selling shares of our Class A Common Stock.

We are an “emerging growth company” and a “smaller reporting company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our Class A Common Stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. We will remain an “emerging growth company” until the earliest to occur of:

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the last day of the fiscal year during which our total annual revenue equals or exceeds $1.235 billion (subject to adjustment for inflation);

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the last day of the fiscal year following the fifth anniversary of this offering;

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the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt; or

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the date on which we are deemed to be a “large accelerated filer” under the Exchange Act.

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As a result of our “emerging growth company” status, we may take advantage of exemptions from various reporting requirements that would otherwise be applicable to public companies including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We also are a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this offering is less than $250.0 million. We may continue to be a smaller reporting company after this offering if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our annual report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Investors may find our Class A Common Stock less attractive because we may rely on these exemptions. If some investors find our Class A Common Stock less attractive as a result, there may be a less active trading market for our Class A Common Stock and the market price of our Class A Common Stock may be adversely affected and more volatile.

We will incur increased costs and become subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business.

As a public company, we will incur significant legal, accounting, and other expenses that we have not incurred as a private company, including costs associated with public company reporting requirements. We have also incurred and will continue to incur costs associated with the Sarbanes-Oxley Act and related rules implemented by the SEC and the exchange on which our securities are listed. The expenses generally incurred by public companies for reporting and corporate governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. These laws and regulations also could make it more difficult or costly for us to obtain certain types of

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insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on our board committees or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of our Class A Common Stock, fines, sanctions, other regulatory action, and potentially civil litigation.

If we are unable to design, implement, and maintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Class A Common Stock may decline.

As a public company, we will be required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls. In addition, beginning with our second annual report on Form 10-K, we will be required to furnish a report by management on the effectiveness of our internal control over financial reporting, pursuant to the rules and regulations of the SEC regarding compliance with Section 404 of the Sarbanes-Oxley Act. The process of designing, implementing and testing the internal control over financial reporting required to comply with this obligation is time consuming, costly and complicated. While we have not identified material weaknesses in the past, we may identify material weaknesses in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations, or cash flows. Further, if we identify one or more material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we or, if required, our auditors, are unable to assert that our internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Class A Common Stock could decline, and we could also become subject to investigations by the stock exchange on which our Class A Common Stock is listed, the SEC or other regulatory authorities, which could require additional financial and management resources. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

We do not intend to pay dividends in the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our Class A Common Stock.

We do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and expansion of our business. Any future determination related to dividend policy will be made at the discretion of our board of directors, subject to applicable laws, and will depend upon, among other factors, our results of operations, prospects, financial condition, contractual restrictions and capital requirements. In addition, our ability to pay cash dividends on our capital stock is limited by the terms of the Loan Agreement and the Credit Agreement, and may be limited by the terms of any future debt or preferred securities we issue or any future credit facilities we enter into. Accordingly, investors must for the foreseeable future rely on sales of their Class A Common Stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments.

The market price of our Class A Common Stock may be volatile, which could result in substantial losses for investors purchasing shares in this offering.

Even if an active trading market develops, the market price of our Class A Common Stock may be highly volatile and could be subject to wide fluctuations. The initial public offering price for our Class A Common Stock will be determined through negotiations with the underwriters. This initial public offering price may differ from the market price of our Class A Common Stock after the offering. As a result, you may not be able to sell your Class A Common Stock at or above the initial public offering price. Some of the factors that may cause the market price of our Class A Common Stock to fluctuate include:

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delays or setbacks in the ongoing commercialization of our products and procedures;

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the success of existing or new competitive products or technologies;

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regulatory or legal developments in the United States and other countries that we pursue expansion in;

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developments or disputes concerning patent applications, issued patents or other proprietary rights;

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the recruitment or departure of key personnel;

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the commencement of litigation;

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actual or anticipated changes in estimates as to financial condition and results of operations;

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announcement or expectation of additional financing efforts;

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announcements by us or our competitors of significant business developments, acquisitions, new offerings, licenses, strategic partnerships, joint ventures or capital commitments;

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the impact of pandemics epidemics, endemics and other public health emergencies on the performance of procedures;

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the impact of political instability, natural disasters, events of terrorism or war;

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sales of our Class A Common Stock by us, our insiders or other stockholders, or the anticipation of such sales, including if existing stockholders sell shares into the market when applicable “lock-up” periods end;

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expiration of market standoff or lock-up agreements;

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variations between our actual operating results, or those of companies that are perceived to be similar to us, and the expectations of securities analysts, investors and the financial community;

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any forward-looking financial or operating information we may provide to the public or securities analysts, any changes in this information or our failure to meet expectations based on this information;

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changes in estimates or recommendations by securities analysts, if any, that cover our stock;

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various macroeconomic events, including changes in inflation, interest rates and overall economic conditions and uncertainties;

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changes in the structure of health care payment systems;

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market conditions in the medical device sector;

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changes in the anticipated future size and growth rate of our market;

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the seasonality of our business;

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an increase in the rate of returns of our products;

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general economic, industry and market conditions, including economic recessions or slowdowns; and

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the other factors described in this “Risk Factors” section.

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In recent years, the stock market in general, and the market for medical device companies in particular, has experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose stock is experiencing those price and volume fluctuations. Further, the stock market in general has been highly volatile due to various macroeconomic events. Broad market and industry factors may seriously affect the market price of our Class A Common Stock, regardless of our actual operating performance. These fluctuations may be even more pronounced in the trading market for our stock shortly following this offering. Following periods of such volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. Because of the potential volatility of our stock price, we may become the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from our business.

If our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of our Class A Common Stock may decline.

We may, but are not obligated to, provide public guidance on our expected operating and financial results for future periods. Any such guidance will be comprised of forward-looking statements subject to the risks and

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uncertainties described in this prospectus and in our other public filings and public statements. Our actual results may not always be in line with or exceed any guidance we have provided, especially in times of economic uncertainty. If actual circumstances differ from those in our assumptions, our operating and financial results could fall below our publicly announced guidance or the expectations of investors. If, in the future, our operating or financial results for a particular period do not meet any guidance we provide or the expectations of investment analysts or investors generally, or if we reduce our guidance for future periods, the market price of our Class A Common Stock may decline. Even if we do issue public guidance, there can be no assurance that we will continue to do so in the future.

We will have broad discretion in the use of net proceeds to us from this offering and may not use them effectively.

We will have broad discretion in the application of the net proceeds to us from this offering, including for any of the purposes described in “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. If we do not use the net proceeds that we receive in this offering effectively, our business, financial condition, results of operations, and prospects could be harmed, and the market price of our Class A Common Stock could decline. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities such as money market accounts, certificates of deposit, commercial paper, and guaranteed obligations of the U.S. government that may not generate a high yield for our stockholders. These investments may not yield a favorable return to our investors.

Investors in this offering will experience immediate and substantial dilution in the net tangible book value of the shares of Class A Common Stock purchased in this offering.

The initial public offering price of our Class A Common Stock is expected to be substantially higher than the pro forma as adjusted net tangible book value per share of our Class A Common Stock. Therefore, if you purchase shares of our Class A Common Stock in this offering, you will pay a price per share that substantially exceeds our pro forma as adjusted net tangible book value per share after this offering. Based on the assumed initial public offering price of $      per share, the midpoint of the price range set forth on the cover page of this prospectus, you will experience immediate dilution of $      per share, representing the difference between our pro forma as adjusted net tangible book value per share at           , 2026 after giving effect to this offering and the initial public offering price. In addition, purchasers of Class A Common Stock in this offering will have contributed 100% of the aggregate price paid by all purchasers of our Class A Common Stock but will own only approximately    % of our Class A Common Stock outstanding after this offering and    % of total equity outstanding after this offering. Furthermore, if the underwriters exercise their over-allotment option, or outstanding options and warrants (if any) are exercised, you could experience further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section titled “Dilution.”

Additional stock issuances (including in connection with exchanges of Series B Common Units held by our Continuing Equity Owners) could result in significant dilution to our stockholders and cause the trading price of our Class A Common Stock to decline.

We may issue our capital stock or securities convertible into our capital stock from time to time in connection with financing our business operations or growth, to repay debt, or for acquisitions, investments or otherwise (including in connection with exchanges of Series B Common Units held by our Continuing Equity Owners). Additional issuances of our Class A Common Stock or securities convertible into Class A Common Stock will result in dilution to existing holders of our Class A Common Stock. Any such issuances could result in substantial dilution to our existing stockholders and cause the trading price of our Class A Common Stock to decline. In particular, following the issuance of shares of Class A Common Stock in connection with the exchanges of Series B Common Units held by our Continuing Equity Owners and the related cancellation of shares of our Class B Common Stock, such shares of Class A Common Stock will have the same economic rights as other shares of Class A Common Stock.

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Sales of a substantial number of shares of our Class A Common Stock in the public market could cause our stock price to fall.

Sales of a substantial number of shares of our Class A Common Stock in the public market could occur at any time. These sales, upon the expiration of the market standoff and lock-up agreements, the early release of these agreements or the perception in the market that the holders of a large number of shares of our Class A Common Stock intend to sell shares, could reduce the market price of our Class A Common Stock. After this offering, we expect that we will have           shares of our Common Stock outstanding (assuming no exercise of the underwriters’ over-allotment option). Of these shares,           shares we are selling in this offering may be resold in the public market immediately, unless purchased by our affiliates. The remaining shares, or approximately           of our outstanding shares after this offering, are currently prohibited or otherwise restricted under securities laws, or lock-up agreements entered into by our directors, officers and substantially all of our stockholders with the underwriters. However, subject to applicable securities law restrictions, prohibitions and restrictions on the sale of these shares in the public market will be lifted beginning 180 days after the date of this prospectus. Morgan Stanley & Co. LLC, Goldman Sachs & Co. LLC and Piper Sandler & Co. may release all or some portion of the shares subject to lock-up agreements at any time and for any reason.

All of the shares of Class A Common Stock sold in this offering will be freely tradable without restriction or further registration under the Securities Act of 1933, as amended (the “Securities Act”), except that any shares held by our affiliates, as that term is defined under Rule 144 of the Securities Act (“Rule 144”), may be sold only in compliance with the limitations described in “Shares Eligible for Future Sale-Affiliate Resales of Restricted Securities.”

In addition, shares issued upon the exercise of stock options outstanding under our equity incentive plans, or pursuant to future awards granted under those plans, will become available for sale in the public market to the extent permitted by the provisions of applicable vesting schedules, any applicable market standoff and lock-up agreements, and Rule 144 and Rule 701 under the Securities Act (“Rule 701”). See the section titled “Shares Eligible for Future Sale” for additional information.

In connection with this offering, we intend to file a registration statement on Form S-8 providing for the registration of all shares of our Class A Common Stock that we may issue under our equity compensation plan. Once we register these shares, they can be freely sold in the public market upon issuance and once vested, subject to volume limitations applicable to affiliates and the lock-up agreements described in the section titled “Underwriting.” If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our Class A Common Stock could decline.

Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

After this offering, our directors, officers, holders of more than 5% of our outstanding stock and their respective affiliates will beneficially own        shares, in the aggregate, representing approximately    % of our outstanding shares of Common Stock (or approximately     % if the underwriters’ over-allotment option is exercised in full). As a result, these stockholders, if they act together, will be able to influence our management and affairs and all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control of our company and might affect the market price of our Class A Common Stock.

Certain of our directors are affiliates of other entities operating in the medical device industry that may overlap with our business.

The medical device industry is highly competitive, subject to change and significantly affected by new product introductions and market activities of industry participants. Two of our directors, Anthony Viscogliosi and Marc Viscogliosi, are also principals of Viscogliosi Brothers, LLC (“VB”), a single-family office founded by Anthony, John, and Marc Viscogliosi, with extensive experience in the neuro-musculoskeletal industry. VB’s portfolio companies (“VB Entities”), of which we are one, also include other companies in the medical device industry, such as VB Spine, LLC, a medical technology company that acquired Stryker’s U.S. spine implant

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business (“VB Spine”), and Companion Spine, a provider of posterior spine non-fusion solutions. Anthony Viscogliosi and Marc Viscogliosi also serve as officers and/or directors of certain of the VB Entities. See the sections titled “Management” and “Certain Relationships and Related Party Transactions” for additional information about Anthony Viscogliosi, Marc Viscogliosi and the VB Entities.

There may be an overlap of our business strategies with those of one or more VB Entities, and the interests of our company and those of one or more VB Entities may be opposed to the interests of one another. This overlap could create conflicts of interest. For example, this overlap could create conflicts in determining, to which entity a particular investment opportunity should be presented. Acquisitions or other opportunities that may be of interest to us may come to, and may be pursued by, one of the VB Entities instead of us. These conflicts may not be resolved in our favor, and a potential target business that Anthony Viscogliosi and/or Marc Viscogliosi become aware of may be presented to a VB Entity prior to being presented to us. In addition, in the ordinary course of business, we will be sharing with Anthony Viscogliosi and Marc Viscogliosi, as directors serving on our board, confidential non-public information about our business, strategy and prospects. Such confidential non-public information may include information that would be useful in connection with the operations of one or more of the VB Entities (even if the VB Entities are not directly competing with our business). Anthony Viscogliosi’s position and/or Marc Viscogliosi’s position with one or more of the VB Entities may create a conflict between the advice provided to such entities and the fiduciary responsibilities owed to us. There can be no assurance that such conflicts will be resolved in our favor, which could adversely impact our business or prospects.

Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.

Our amended and restated certificate of incorporation and amended and restated bylaws that will be in effect immediately prior to the consummation of this offering will contain provisions that could delay or prevent changes in control or changes in our management without the consent of our board of directors. These provisions will include the following:

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a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

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no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

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subject to the rights of holders of any series of preferred stock, the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;

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subject to the rights of holders of any series of preferred stock, the Board or any individual director may be removed from office at any time, but only for cause and only by the affirmative vote of the holders of at least 66-2/3% of all of the outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class;

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the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

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the ability of our board of directors to alter our amended and restated bylaws without obtaining stockholder approval;

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the required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal our amended and restated bylaws (however if the amended and restated bylaws amendment was recommended to the stockholders by Board, only a majority vote of all stockholders is required);

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the required approval of at least 66-2/3% of the shares entitled to vote to adopt, amend or repeal certain provisions of our amended and restated certificate of incorporation, including those regarding the rights and limitations of our preferred stock and common stock and the election and removal of directors;

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a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

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an exclusive forum provision providing that the Court of Chancery of the State of Delaware will be the exclusive forum for certain actions and proceedings;

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the requirement that a special meeting of stockholders may be called only by our board of directors, the Chair of our board of directors, our Chief Executive Officer or our President, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and

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advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of us.

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These anti-takeover provisions could discourage, delay, or prevent a transaction involving a change in control of our company, including actions that our stockholders may deem advantageous, or negatively affect the trading price of our Class A common stock. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and to cause us to take other corporate actions you desire. For further discussion of these and other such anti-takeover provisions, see the section titled “Description of Capital Stock.”

Claims for indemnification by our directors, officers, and other employees or agents may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our amended and restated certificate of incorporation will provide that we will indemnify our directors and officers to the fullest extent permitted by Delaware law. In addition, as permitted by Section 145 of the Delaware General Corporation Law, our amended and restated certificate of incorporation to be effective immediately prior to the completion of this offering and our indemnification agreements that we have entered into with our directors, officers and certain other employees will provide that:

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We will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.

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We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.

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We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.

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We will not be obligated pursuant to our amended and restated certificate of incorporation to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees.

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The rights conferred in our amended and restated certificate of incorporation are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees, and agents and to obtain insurance to indemnify such persons.

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We may not retroactively amend our amended and restated certificate of incorporation provisions to reduce our indemnification obligations to directors, officers, employees, and agents.

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Our amended and restated certificate of incorporation will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees or the underwriters or any offering giving rise to such claim.

Our amended and restated certificate of incorporation that will be in effect immediately after the closing of this offering will provide, that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a breach of fiduciary duty, any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided, that, this provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Furthermore, our amended and restated certificate of incorporation will also provide that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. These choice of forum provisions may result in increased costs to stockholders to bring a claim, limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, and may generally have the effect of discouraging lawsuits against us and our directors, officers and other employees. By agreeing to this provision, however, stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable or unenforceable. If a court were to find the choice of forum provisions in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

General Risk Factors

We are subject to risks from legal and arbitration proceedings that may prevent us from pursuing our business activities or require us to incur additional costs in defending against claims or paying damages.

We may become subject to legal disputes and regulatory proceedings in connection with our business activities involving, among other things, product liability, product defects, intellectual property infringement, employment matters, and/or alleged violations of other applicable laws in various jurisdictions. We may not be insured against all potential damages that may arise out of any claims to which we may be party in the ordinary course of our business. A negative outcome of these proceedings may prevent us from pursuing certain activities and/or require us to incur additional costs in order to do so and pay damages. In addition, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, financial condition, results of operations and prospects. Additionally, the significant increase in the cost of directors’ and officers’ liability insurance may cause us to opt for lower overall policy limits or to forgo insurance that we may otherwise rely on to cover significant defense costs, settlements, and damages awarded to plaintiffs.

The outcome of pending or potential future legal and arbitration proceedings is difficult to predict with certainty. In the event of a negative outcome of any material legal or arbitration proceeding, whether based on a judgment or a settlement agreement, we could be obligated to make substantial payments, which could have a material adverse effect on our business, financial condition, results of operations, and prospects. In addition, the costs related to litigation and arbitration proceedings may be significant, and any legal or arbitration proceedings could have a material adverse effect on our business, financial condition, results of operations, and prospects.

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The requirements of being a public company may divert our management’s attention from our growth strategies and other business concerns.

As a public company, we will be subject to the reporting requirements of the Exchange Act and will be required to comply with the applicable requirements of the Sarbanes-Oxley Act and the Dodd- Frank Wall Street Reform and Consumer Protection Act of 2010 (the “Dodd-Frank Act”), the listing requirements of the New York Stock Exchange and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time consuming or costly and increase demand on our systems and resources. Among other things, the Exchange Act requires that we file annual, quarterly and current reports with respect to our business and results of operations and maintain effective disclosure controls and procedures and internal controls over financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal controls over financial reporting to meet this standard, significant resources and management oversight may be required. As a result, management’s attention may be diverted from executing our growth strategies and managing other business concerns and, which could have a material adverse effect on our business, financial condition and results of operations. We may need to hire additional employees to comply with these requirements, which will increase our costs and expenses. Additionally, as a public company, it will be more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.

We will incur significant costs as a result of operating as a public company and our executive management team expects to devote substantial time to public company compliance programs.

As a public company, we will incur significant legal, accounting and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act, as well as rules implemented by the SEC and NYSE. Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business. Our executive management team and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act, and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.

The trading market for our Class A Common Stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If no or few securities or industry analysts commence coverage of us, the market price for our stock would be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our results of operations fail to meet the expectations of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Upon the completion of this offering, we will become subject to the periodic reporting requirements of the Exchange Act. We must design our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to

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management, and recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement, causing us to fail to make a required related party transaction disclosure. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

The increasing use of social media platforms presents new risks and challenges.

Social media is increasingly being used to communicate about our products and technologies, and we utilize appropriate social media in connection with the commercialization of our implants. Social media practices in the medical device industry continue to evolve and regulations and regulatory guidance relating to such use are evolving and not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business, resulting in potential regulatory actions against us, along with the potential for litigation. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or our systems on any social networking website. If any of these events were to occur or we otherwise fail to comply with any applicable regulations, we could incur liability, face restrictive regulatory actions, or incur other harm to our business such as reputational damage.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

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the expected growth of our business and our organization and our ability to continue to expand geographically;

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the continued and future acceptance of our existing portfolio of products and any new products by physicians, patients, third-party payors and others in the medical community;

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our estimates of our market opportunity and the factors we believe drive demand for our products and our ability to sustain or increase such demand;

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our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize;

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availability of additional funds in the future on acceptable terms or at all;

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our ability to comply with financial or other covenants in our financing agreements;

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the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals;

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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for, or ability to obtain, additional financing;

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our reliance on a limited number of suppliers, which may impact the availability of our products;

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our compliance with, and the cost of, federal, state, and foreign regulatory requirements;

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our ability to retain and recruit key personnel, including the continued development of our sales and marketing infrastructure;

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our ability to maintain intellectual property protection for our products;

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developments and projections relating to our competitors and our industry;

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our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act;

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our expected use of our existing cash and cash equivalents and the proceeds from this offering.

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the amount and timing of payments under the Tax Receivable Agreement;

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the tax benefits we expect to realize as a result of the Up-C organizational structure and the related Tax Receivable Agreement;

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the impact of our organizational structure, including the Tax Receivable Agreement, on our financial condition and results of operations, and the potential for payments under the Tax Receivable Agreement to exceed our actual cash tax savings;

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anticipated trends and challenges in our business and the markets in which we operate;

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our ability to obtain and maintain the listing of the Class A Common Stock on the NYSE in connection with and following this offering;

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other events or factors, including those resulting from pandemics, war or incidents of terrorism; and

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other risks and uncertainties, including those listed under the caption “Risk Factors.”

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We caution you that the foregoing list does not contain all of the forward-looking statements made in this prospectus.

Forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this prospectus may turn out to be inaccurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Factors that may cause actual results to differ materially from current expectations include, among other things, those described in the section titled “Risk Factors” and elsewhere in this prospectus. Potential investors are urged to consider these factors carefully in evaluating these forward-looking statements.

Forward-looking statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this prospectus, and while we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements.

You should not place undue reliance on our forward-looking statements. We qualify all of the forward-looking statements in this prospectus by these cautionary statements.

These forward-looking statements speak only as of the date of this prospectus. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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USE OF PROCEEDS

We estimate the net proceeds from this initial public offering of           shares of Class A Common Stock will be approximately $      million, or $      million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $      per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $      per share, the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our net proceeds by approximately $      million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1,000,000 shares in the number of shares offered by us would increase (decrease) our net proceeds by approximately $      million, assuming that the assumed initial public offering price remains the same, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

We intend to use such net proceeds to purchase           newly-issued Series A Common Units of Centinel LLC. The Series A Common Units will be purchased by us at a purchase price per unit equal to the initial public offering price per share of Class A Common Stock in this offering, less underwriting discounts and commissions. See “Organizational Structure—Organizational Transactions.”

In turn, Centinel LLC intends to use the proceeds received from us in respect of the newly-issued Series A Common Units, as follows:

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approximately $      million to $      million to pay expenses incurred in connection with this offering and the Organizational Transactions;

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approximately $      million to $      million to repay the term notes maturing on September 30, 2030 issued under the 2023 Credit Agreement, together with accrued and unpaid interest at 10% per annum and the Make-Whole Amount;

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approximately $      million to $      million to repay a portion of the Term Loan maturing on March 1, 2030 outstanding under the Loan Agreement, together with accrued and unpaid interest at a floating interest rate per annum equal to the Term SOFR plus 5.30%;

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approximately $      million to $      million to fund sales and marketing, including expanding the sales infrastructure, patient awareness platform and our medical education programs;

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approximately $      million to $      million to fund our research and development expenses, including our clinical expenses to pursue two level indication for prodisc C, as well as cervical hybrid indication for prodisc C, prodisc Vivo, prodisc SK and prodisc Nova, estimated to achieve the FDA approval, provided, however, that the FDA approval for these indications is not guaranteed;

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approximately $      million to $      million to fund capital expenditures, including more instrument sets and implant inventory; and

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the remainder for general corporate purposes, including working capital and operating expenses.

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See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Debt Obligations” for information related to the terms of our indebtedness under the Loan Agreement, the 2025 Credit Agreement, and the 2023 Credit Agreement, including, but not limited to, the Make-Whole Amount.

Centinel LLC may also use a portion of our net proceeds to acquire or invest in complementary products, technologies, or businesses; however, we currently have no agreements or commitments to complete any such transactions.

We believe, based on our current operating plan, that our current capital resources, along with the net proceeds from this offering, will be sufficient for us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. However, our expected use of the net proceeds from this offering described

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above represents our intentions based upon our current plans and business conditions. We cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual expenditures will depend on numerous factors, including the time and cost necessary to conduct our planned commercialization activities, the results of our planned clinical studies and other factors described in the section titled “Risk Factors” in this prospectus, as well as the amount of cash used in our operations and any unforeseen cash needs. Therefore, our actual expenditures may differ materially from the estimates described above. We may find it necessary or advisable to use the net proceeds for other purposes, and we will have broad discretion over the allocation of the net proceeds from this offering.

Pending use of the net proceeds from this offering described above, we may invest the net proceeds from this offering in short- and intermediate-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States government.

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DIVIDEND POLICY

We do not anticipate declaring or paying any cash dividends to holders of our Class A Common Stock in the foreseeable future. We currently intend to retain all available funds and future earnings, if any, to finance the growth of our business. However, we may, in the future, decide to pay dividends on our Class A Common Stock. Any declaration and payment of cash dividends in the future, if any, will be at the discretion of our board of directors and will depend upon such factors as earnings levels, cash flows, capital requirements, levels of indebtedness, restrictions imposed by applicable law, applicable credit or financing agreements, our overall financial condition, restrictions in our debt financing agreements, and any other factors deemed relevant by our board of directors.

Immediately following this offering, we will be a holding company, and our sole asset will be the direct or indirect ownership of Series A Common Units we purchase from Centinel LLC. If we decide to pay a dividend in the future, we would need to cause Centinel LLC to make distributions to us in an amount sufficient to cover such dividend. If Centinel LLC makes such distributions to us, the Continuing Equity Owners will be entitled to receive pro rata distributions. See “Risk Factors—Risks Related to Our Organizational Structure.”

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ORGANIZATIONAL STRUCTURE

Centinel Holdco, a Delaware corporation, was formed on April 24, 2026 and is the issuer of the shares of Class A Common Stock offered by this prospectus. Prior to this offering and the Organizational Transactions, all of our business operations have been conducted through Centinel LLC and its direct and indirect subsidiaries. Centinel Holdco has not engaged in any business or other activities other than in connection with our formation and this offering. We will consummate the Organizational Transactions, excluding this offering, substantially concurrently with or prior to the consummation of this offering. Upon consummation of this offering and the application of the net proceeds therefrom, we will be a holding company and the sole managing member of Centinel LLC, and upon consummation of the Organizational Transactions, our principal asset will consist of Series A Common Units and we will operate and control all of the business and affairs and consolidate the financial results of Centinel LLC.

Existing Organization

Centinel LLC is treated as a partnership for U.S. federal income tax purposes and, as such, is generally not subject to any U.S. federal entity-level income taxes. Taxable income or loss of Centinel LLC is included in the U.S. federal income tax returns of Centinel LLC’s members.

The diagram below depicts our historical organizational structure prior to the completion of the Organizational Transactions. This diagram is provided for illustrative purposes only and does not purport to represent all legal entities owned or controlled by us, or owning a beneficial interest in us.

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Reorganization Transactions

The following reorganization transactions will each be completed prior to or in connection with the completion of this offering:

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We will issue Class B Preferred Units of Centinel LLC to the Convertible Debt Holders of Centinel LLC’s outstanding 6% Convertible Note upon the conversion of the outstanding principal amount (plus accrued interest, if any) of the 6% Convertible Note at a conversion price of $1.39435 per unit;

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We will issue Class B Preferred Units of Centinel LLC to the Convertible Debt Holders of Centinel LLC’s outstanding 4.42% Convertible Notes upon the conversion of the outstanding principal amount (plus accrued interest) of the 4.42% Convertible Notes at a conversion price of $1.39435 per unit, if and to the extent such Convertible Debt Holders convert their 4.42% Convertible Notes;

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We will issue Class A Preferred Units of Centinel LLC to the Class A Warrant Holders, if and to the extent such Class A Warrant Holders exercise their Class A Warrants on a cashless basis;

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We will issue Class B Preferred Units of Centinel LLC to the Class B Warrant Holders, if and to the extent such Class B Warrant Holders exercise their Class B Warrants on a cashless basis;

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All outstanding Class A Preferred Units and Class B Preferred Units, including those that are issued upon conversion or exercise, as applicable, of the Convertible Notes, Class A Warrants and Class B Warrants will be converted into common units of Centinel LLC;

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We will amend and restate the existing Centinel LLC Agreement, effective immediately prior to the consummation of this offering, to, among other things, (i) modify the capital structure of Centinel LLC by replacing the then current common units with two new series of common membership interests consisting of the Series A Common Units and the Series B Common Units and (ii) appoint Centinel Holdco as the sole managing member of Centinel LLC. See “—Amended and Restated Operating Agreement of Centinel LLC.”

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In accordance with the terms of the Class A Warrants and Class B Warrants, Centinel LLC will issue replacement warrants to purchase Series B Common Units to the Class A Warrant Holders and Class B Warrant Holders that did not exercise their Class A Warrants and Class B Warrants, and the Class A Warrants and Class B Warrants will be terminated. The replacement warrants issued to each such Class A Warrant Holder will be exercisable into an equivalent number of Series B Common Units of Centinel LLC on a           -to-           basis (i.e., for each Class A Preferred Unit into which a Class A Warrant was exercisable, the replacement warrant shall be exercisable into           Series B Common Units). The replacement warrants issued to each such Class B Warrant Holder will be exercisable into an equivalent number of Series B Common Units of Centinel LLC on a         -to-           basis (i.e., for each Class B Preferred Unit into which a Class B Warrant was exercisable, the replacement warrant shall be exercisable into           Series B Common Units). In addition, upon the exercise of either replacement Class A Warrant or replacement Class B Warrant, the holder will also receive shares of Class B Common Stock, which will be equal to the number of Series B Common Units received upon such exercise.

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We will amend and restate the certificate of incorporation of Centinel Holdco to, among other things, provide (i) for Class A Common Stock, with each share of our Class A Common Stock entitling its holder to one vote per share on all matters presented to our stockholders generally, (ii) for Class B Common Stock, with each share of our Class B Common Stock entitling its holder to one vote per share on all matters presented to our stockholders generally, and (iii) for undesignated preferred stock, the rights, preferences and privileges of which may be designated from time to time by our Board, and which can be issued by our Board from time to time in one or more series without stockholder approval;

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Centinel Holdco will acquire, by means of a series of sequential two-step mergers, the Blocker Companies as follows: (i) Centinel Holdco will form two new corporations: “CSH Merger Sub 1, Inc.” and “DS Merger Sub 2, Inc.,” and also form two limited liability companies: “CSH Legacy Blocker I, LLC” and “DS Legacy Blocker II, LLC”; (ii) CSH Merger Sub 1, Inc. will merge with and into Centinel Spine Holdings, Inc., with Centinel Spine Holdings, Inc. surviving, and each stockholder of Centinel Spine Holdings, Inc. exchanging its shares in Centinel Spine Holdings, Inc. for shares of Class A Common Stock in Centinel Holdco and the right to receive payments under the Tax Receivable

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Agreement. The surviving corporation would then merge into CSH Legacy Blocker I, LLC, with CSH Legacy Blocker I, LLC surviving. The Series B Common Units owned by CSH Legacy Blocker I, LLC through the mergers will be automatically cancelled and an equivalent number of Series A Common Units will be issued to CSH Legacy Blocker I, LLC. This process will be repeated for Delac Spine, Inc. with DS Merger Sub 2, Inc. and DS Legacy Blocker II, LLC.

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We will issue           shares of our Class B Common Stock to the Continuing Equity Owners, which will be equal to the number of Series B Common Units held by such Continuing Equity Owners, for nominal consideration;

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We will assume all           outstanding Centinel LLC Options issued pursuant to, and granted under, the Centinel LLC Incentive Plan, which Centinel LLC Options will become exercisable for shares of Class A Common Stock on a           -for-           basis;

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We will sell and issue           shares of our Class A Common Stock to the investors in this offering (or           shares if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock) in exchange for net proceeds of approximately $      million (or approximately $      million if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock) based upon an assumed initial public offering price of $      per share (the midpoint of the estimated price range set forth on the cover page of this prospectus), less the estimated underwriting discounts and commissions and estimated offering expenses payable by us;

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We will use the net proceeds from this offering to purchase           newly-issued Series A Common Units directly from Centinel LLC for approximately $      million, at a purchase price per Series A Common Unit equal to the initial public offering price per share of Class A Common Stock in this offering, less the underwriting discounts and commissions;

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In accordance with the terms of the 4.42% Convertible Notes, the 4.42% Convertible Notes that did not convert into Class B Preferred Units of Centinel LLC as described above will be automatically converted into newly issued shares of Class A Common Stock (with the unpaid principal being converted at a conversion price equal to a 30% discount to the initial public offering price per share of Class A Common Stock);

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Centinel LLC will issue to us a number of Series A Common Units equal to the number of shares of Class A Common Stock into which the 4.42% Convertible Notes were automatically converted as described in the previous paragraph;

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Centinel Holdco will enter into (i) the Exchange Agreement with Centinel LLC and the Continuing Equity Owners, and (ii) the Tax Receivable Agreement with Centinel LLC, the Continuing Equity Owners and the Blocker Stockholders. For a description of the terms of the Exchange Agreement and the Tax Receivable Agreement, see “Certain Relationships and Related Party Transactions.”

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Organizational Structure Following the Organizational Transactions

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Centinel Holdco will be a holding company and our principal asset will consist of Series A Common Units;

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Centinel Holdco will be the sole managing member of Centinel LLC and will control the business and affairs of Centinel LLC;

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Centinel Holdco will own, directly or indirectly,           Series A Common Units, representing approximately     % of the economic interest in Centinel LLC (or approximately     % of the economic interest in Centinel LLC if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock);

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The Continuing Equity Owners will own (i)           Series B Common Units, representing approximately     % of the economic interest in Centinel LLC (or approximately     % of the economic interest in Centinel LLC if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock), and (ii)           shares of Class B Common Stock, representing approximately    % of the combined voting power of all of Centinel Holdco’s Common Stock (or           shares of Class B Common Stock, representing approximately    % of the

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combined voting power of all of Centinel Holdco’s Common Stock if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock);

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The Blocker Stockholders will own (i)           shares of Class A Common Stock, representing approximately    % of the combined voting power of all of Centinel Holdco’s Common Stock and approximately    % of the economic interest in Centinel Holdco (or approximately    % of the combined voting power and approximately    % of the economic interest if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock), and (ii) through Centinel Holdco’s ownership of Series A Common Units, indirectly will hold approximately    % of the economic interest in Centinel LLC (or approximately    % of the economic interest in Centinel LLC if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock); and

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The investors in this offering will own (i)           shares of Class A Common Stock (or        shares of Class A Common Stock if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock), representing approximately    % of the combined voting power of all of Centinel Holdco’s Common Stock and approximately    % of the economic interest in Centinel Holdco (or approximately    % of the combined voting power and approximately    % of the economic interest if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock), and (ii) through Centinel Holdco’s ownership of Series A Common Units, indirectly will hold approximately    % of the economic interest in Centinel LLC (or approximately    % of the economic interest in Centinel LLC if the underwriters exercise in full their option to purchase additional shares of Class A Common Stock).

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Our corporate structure following this offering, as described below, is commonly referred to as an umbrella partnership-C corporation (“Up-C”) structure, which is often used by partnerships and limited liability companies when they undertake an initial public offering of their business. The Up-C structure will allow the Continuing Equity Owners to retain their equity ownership in Centinel LLC and to continue to realize tax benefits associated with owning interests in an entity that is treated as a partnership, or “flow-through” entity, for U.S. federal income tax purposes following the offering. Investors in this offering will, by contrast, hold their equity ownership in Centinel Holdco, a Delaware corporation that is a domestic corporation for U.S. federal income tax purposes, in the form of shares of Class A Common Stock.

We believe that the Continuing Equity Owners generally will find it advantageous to hold their equity interests in an entity that is not taxable as a corporation for United States federal income tax purposes. The Continuing Equity Owners will be allocated their proportionate share of any taxable income of Centinel LLC. The Continuing Equity Owners will also hold shares of our Class B Common Stock. When the Continuing Equity Owners exchange Series B Common Units for, at our election, shares of our Class A Common Stock or cash, pursuant to the Exchange Agreement described below, they will also be required to deliver an equivalent number of shares of Class B Common Stock. Any Series B Common Units and shares of Class B Common Stock so delivered will be cancelled, and Centinel LLC will issue us a number of Series A Common Units equal to the number of cancelled Series B Common Units.

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The diagram below depicts our expected organizational structure immediately following completion of the Organizational Transactions. This diagram is provided for illustrative purposes only and does not purport to represent all legal entities owned or controlled by us, or owning a beneficial interest in us.

Centinel Holdco

Centinel Holdco was incorporated in Delaware on April 24, 2026, and has not engaged in any business or other activities except in connection with its formation and this offering. Our certificate of incorporation will be amended and restated immediately prior to the consummation of this offering. Our amended and restated certificate of incorporation will authorize two classes of Common Stock, Class A Common Stock and Class B Common Stock, each having the terms described in the section titled “Description of Capital Stock.” In addition, our amended and restated certificate of incorporation will authorize shares of undesignated preferred stock, the rights, preferences and privileges of which may be designated from time to time by our Board, and which can be issued by our Board from time to time in one or more series without stockholder approval.

Shares of our Class B Common Stock, which provide no economic rights, will be issued to the Continuing Equity Owners in connection with this offering. Each share of our Class B Common Stock entitles its holder to one vote on all matters to be voted on by our stockholders generally. See the section titled “Description of Capital Stock-Class B Common Stock.” Holders of our Class A Common Stock and Class B Common Stock vote together as a single class on all matters presented to our stockholders for their vote or approval, except as otherwise required by applicable law.

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Sole Managing Member

In connection with this offering, we will become a member and the sole managing member of Centinel LLC. As the sole managing member, we will be able to control all of the day-to-day business affairs and decision-making of Centinel LLC without the approval of any other member, unless otherwise stated in the Amended and Restated Centinel LLC Agreement. As such, through our officers and directors, we will be responsible for all operational and administrative decisions of Centinel LLC and the day-to-day management of Centinel LLC’s business. Pursuant to the Amended and Restated Centinel LLC Agreement, we cannot be removed, under any circumstances, as the sole managing member of Centinel LLC, except by our election.

Compensation

We will not be entitled to compensation for our services as managing member. We will be entitled to reimbursement by Centinel LLC for fees and expenses incurred on behalf of Centinel LLC, including all expenses associated with the Organizational Transactions, including this offering, and maintaining our corporate existence.