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CARLSMED, INC.
Response Received
5 company response(s)
Medium - date proximity
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CARLSMED, INC.
Awaiting Response
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-18 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-18 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-07 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-06-26 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-06-17 | SEC Comment Letter | CARLSMED, INC. | DE | 377-07934 | Read Filing View |
| 2025-05-21 | SEC Comment Letter | CARLSMED, INC. | DE | 377-07934 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-17 | SEC Comment Letter | CARLSMED, INC. | DE | 377-07934 | Read Filing View |
| 2025-05-21 | SEC Comment Letter | CARLSMED, INC. | DE | 377-07934 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-18 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-18 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-15 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-07-07 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
| 2025-06-26 | Company Response | CARLSMED, INC. | DE | N/A | Read Filing View |
2025-07-18 - CORRESP - CARLSMED, INC.
CORRESP 1 filename1.htm CORRESP BofA Securities, Inc. One Bryant Park New York, NY 10036 Goldman Sachs & Co. LLC 200 West Street New York, New York 10282 Piper Sandler & Co. 1251 Avenue of the Americas 39th Floor New York, New York 10020 July 18, 2025 VIA EDGAR Office of Industrial Applications and Services Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Robert Augustin, Katherine Bagley, Tayyaba Shafique and Terence O’Brien Re: Carlsmed, Inc. Registration Statement on Form S-1, as amended Filed July 15, 2025 File No. 333‑288339 Acceleration Request Requested Date: July 22, 2025 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), we, as the representatives of the several underwriters (the “Representatives”), hereby join in the request of Carlsmed, Inc., a Delaware corporation (the “Company”), that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time, on July 22, 2025, or as soon thereafter as practicable, or at such other time thereafter as the Company or its outside counsel, Morrison & Foerster LLP, may request by telephone to the staff of the Securities and Exchange Commission. Pursuant to Rule 460 under the Securities Act, we, as the Representatives, wish to advise you that we will take reasonable steps to secure adequate distribution of the preliminary prospectus to underwriters, dealers, institutions and others prior to the requested effective time of the Registration Statement. We, the undersigned Representatives, hereby represent that we are in compliance and will comply, and we have been informed by the other participating underwriters that they are in compliance and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, in connection with the offering pursuant to the above-referenced Registration Statement and Preliminary Prospectus. [ Signature Page Follows ] Very truly yours, BofA Securities, Inc. Goldman Sachs & Co. LLC Piper Sandler & Co. As Representatives of the several Underwriters BOFA SECURITIES, INC. By: /s/ Milton Hsu Name: Milton Hsu Title: Managing Director Goldman Sachs & Co. LLC By: /s/ Lyla Bibi Name: Lyla Bibi Title: Partner, Global Head of Healthcare ECM PIPER SANDLER & CO. By: /s/ Neil Riley Name: Neil Riley Title: Managing Director [ Signature Page to Underwriters’ Acceleration Request Letter ]
2025-07-18 - CORRESP - CARLSMED, INC.
CORRESP 1 filename1.htm CORRESP CARLSMED, INC. 1800 Aston Avenue, Suite 100 Carlsbad, CA 92008 July 18, 2025 VIA EDGAR Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Robert Augustin, Katherine Bagley, Tayyaba Shafique, Terence O’Brien Re: Carlsmed, Inc. Registration Statement on Form S-1 File No. 333-288339 Ladies and Gentlemen, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Carlsmed, Inc. (the “Company”) hereby requests that the effective date of the above-referenced Registration Statement be accelerated so that the Registration Statement, as then amended, will become effective under the Securities Act at 4:00 p.m. (New York City time) on July 22, 2025 or as soon thereafter as practicable or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. In this regard, the Company is aware of its obligations under the Securities Act. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Morrison & Foerster LLP, by calling John Hensley at (512) 617-0661 or H. Thomas Felix at (858) 314-7530. The Company hereby authorizes Mr. Hensley and Mr. Felix to orally modify or withdraw this request for acceleration. Very truly yours, Carlsmed, Inc. By: /s/ Michael Cordonnier Name: Michael Cordonnier Title: Chief Executive Officer and President
2025-07-15 - CORRESP - CARLSMED, INC.
CORRESP 1 filename1.htm CORRESP 12531 High Bluff Drive Suite 200 San Diego California 92130-2040 TELEPHONE: 858.720.5100 FACSIMILE: 858.720.5125 www.mofo.com morrison & foerster llp amsterdam, austin, berlin, boston, brussels, denver, hong kong, london, los angeles, miami, new york, palo alto, san diego, san francisco, shanghai, singapore, tokyo, washington, d.c. July 15, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Robert Augustin Katherine Bagley Tayyaba Shafique Terence O’Brien Re: Carlsmed, Inc. Registration Statement on Form S-1 Submitted on June 26, 2025 File No. 333-288339 Ladies and Gentlemen, On behalf of our client, Carlsmed, Inc. (the “ Company ”), we submit this letter in response to the oral comments from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) received on July 8, 2025, with respect to the Company’s Registration Statement on Form S-1 filed by the Company with the Commission on June 26, 2025 (the “ Registration Statement ”). Concurrently with the submission of this response letter, the Company is filing Amendment No. 1 to the Registration Statement (“ Amendment No. 1 ”) in response to the Staff’s oral comments, as well as certain other changes. Set forth below are the Company’s responses to the Staff’s oral comments. We have reproduced below in bold the Staff’s comments and have provided the Company’s responses immediately following each comment. Page references in the text of this response letter correspond to the page numbers of Amendment No. 1. Capitalized terms used in this response letter but not otherwise defined herein have the meanings set forth in Amendment No. 1. July 15, 2025 Page Two Oral Comments 1. Please advise if you commissioned the 2024 Spine Fusion US Market Report (i.e. the SmartTRAK report). If so, please revise your disclosure accordingly to note that you commissioned the report and file the consent required under Rule 436 under the Securities Act. Response : The Company acknowledges the Staff’s comment and informs the Staff that it did not commission the SmartTRAK report for use in connection with the Registration Statement. The SmartTRAK report was published independently, without the Company’s involvement, and such report is available to the public for a subscription fee. 2. Please revise your disclosure to add a summary of the terms of the lock-up agreement described elsewhere in the prospectus to the Offering Summary. Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosure on page 13 of Amendment No. 1. Please do not hesitate to contact me by telephone at (858) 314-7530 with any questions or comments regarding this correspondence. Sincerely, /s/ H. Thomas Felix H. Thomas Felix of MORRISON & FOERSTER LLP c.c.: (via email) Michael Cordonnier, Chief Executive Officer, President and Chairman, Carlsmed, Inc. Leonard Greenstein, Chief Financial Officer, Carlsmed, Inc. R. John Hensley, Morrison & Foerster LLP James M. Krenn, Morrison & Foerster LLP B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP
2025-07-07 - CORRESP - CARLSMED, INC.
CORRESP
1
filename1.htm
CORRESP
12531 High Bluff Drive Suite 200 San Diego California 92130-3588 TELEPHONE: 858.720.5100 FACSIMILE: 858.720.5125 www.mofo.com
morrison & foerster llp amsterdam, austin, berlin, boston, brussels, denver, hong kong, london, los angeles, miami, new york, palo alto, san diego, san francisco, shanghai, singapore, tokyo, washington, d.c.
July 7, 2025
Via EDGAR
FOIA Confidential Treatment Request Under 17 C.F.R §200.83
U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Robert Augustin Katherine Bagley Tayyaba Shafique Terence O’Brien Re: Carlsmed, Inc. Registration Statement on Form S-1 (File No. 333-288339) Ladies and Gentlemen: On behalf of Carlsmed, Inc. (the “Company”), we submit this supplemental letter in response to comment 15 from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in a letter dated May 21, 2025 (the “Initial Comment Letter”), relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on April 23, 2025, resubmitted to the Commission on May 30 , 2025, and filed with the Commission on June 26, 2025 (the “Registration Statement”). Capitalized terms used herein and not otherwise defined shall have the meanings set forth in the Registration Statement.
July 7, 2025 Page Two On behalf of the Company, we are respectfully requesting confidential treatment for specified portions of this letter pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.83. This letter is accompanied by such request for confidential treatment because of the commercially sensitive nature of the information discussed in this letter. A redacted version of this letter will be filed with the Commission on EDGAR, omitting the confidential information. The Company respectfully requests that the Commission provide timely notice to the undersigned before it permits any disclosure of the bracketed and highlighted information contained in this letter. Estimated IPO Price Range The Company confirms to the Staff that no price range has yet been provided in the preliminary prospectus included in the Registration Statement. However, the Company has authorized us to inform the Staff supplementally that, based on consultations with the lead underwriters, if the marketing of the proposed initial public offering (“IPO”) were to commence today, the Company’s present view is that the estimated offering range would be $[***] to $[***] per share (the “Preliminary IPO Price Range”) (not taking into an account a reverse stock split that the Company intends to implement prior to the filing of, and that will be reflected in, an amendment to the Registration Statement to be made prior to the commencement of the roadshow for the IPO). The Company advises the Staff that the Preliminary IPO Price Range represents the Company’s current belief of what the indicative price range in the preliminary prospectus may be. Given the volatility in the public trading markets and uncertainty of the timing of the IPO, the final price range to be included in a pre-effective amendment to the Registration Statement remains under discussion between the Company and the lead underwriters and will be subject to then-current market conditions and developments impacting the Company. However, the Company does not believe that the Preliminary IPO Price Range will change significantly. We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the IPO, the Company will file a pre-effective amendment to the Registration Statement that will include all information, other than information that may be excluded in reliance upon Rule 430A under the Securities Act of 1933, as amended. Such preeffective amendment to the Registration Statement will include a post-split bona fide estimated public offering price range. We further confirm on behalf of the Company that the bona fide offering price range included in the preliminary prospectus will not be greater than $2.00 if the maximum price is $10.00 per share or less, or 20% of the top end of the range, if the maximum price is greater than $10.00 per share, unless otherwise approved by the Staff.
[***] Certain information contained in this letter, marked by brackets, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. §200.83. CONFIDENTIAL TREATMENT REQUESTED BY CARLSMED, INC.
July 7, 2025 Page Three To assist the Staff in its evaluation of the Company’s stock-based compensation, the Company has provided the analysis as set forth below. Summary of Equity Awards in the Preceding 12 Months The Company periodically grants stock options and restricted share unit (“RSU”) awards to certain of its employees, directors and consultants. The following table summarizes by month of grant date the number of shares of common stock underlying stock options or RSUs granted during the previous 12 months, as well as the associated option exercise price per share and the estimated fair value per share of the Company’s common stock on the grant date.
Grant Date
Type of Award
Number of Shares Underlying Award
Option Exercise Price per Share
Estimated Fair Value per Share at Grant Date
August 28, 2024
Stock options
281,000
$0.38
$0.75 1, 3
November 13, 2024
Stock options
1,735,660
$0.40
$0.75 2, 3
February 19, 2025
Stock options
4,447,833
$0.78
$0.78
March 5, 2025
Restricted stock units
627,630
N/A
$1.06
April 10, 2025
Stock options
399,158
$1.06
$1.06
May 21, 2025
Stock options
66,000
$1.17
$1.17
1. At the time of these option grants, the Board determined the fair value of the Company’s common stock to be $0.38, in part, after taking into account the Company’s most recently available third-party valuation of its common stock, as well as the other objective and subjective criteria identified on pages 97-98 of the Registration Statement. See “March 2024 Valuation and August 2024 Awards” below for more information. 2. At the time of these option grants, the Board determined the fair value of the Company’s common stock to be $0.40, in part, after taking into account the Company’s most recently available third-party valuation of its common stock, as well as the other objective and subjective criteria identified on pages 97-98 of the Registration Statement. See “September 2024 Valuation and November 2024 Awards” below for more information. 3. In connection with the preparation of the Company’s financial statements as of and for the year ended December 31, 2024, and the confidential submission of the Company’s draft registration statement on Form S-1, the Company reassessed the fair value of the underlying common stock used to calculate the related stock-based compensation solely for financial reporting purposes. The fair value reassessment is discussed in more detail below under “August and November Fair Value Reassessment.”
[***] Certain information contained in this letter, marked by brackets, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. §200.83. CONFIDENTIAL TREATMENT REQUESTED BY CARLSMED, INC.
July 7, 2025 Page Four Determination of Fair Value of Common Stock Overview As described in the Registration Statement, as there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock historically has been determined by the board of directors of the Company (the “Board”), with input from management, considering the Company’s most recently available third-party valuations of its common stock as well as the Board’s assessment of additional objective and subjective factors that the Board believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the equity award. Independent Third-Party Valuations. The Board’s determination of the fair value at the time of each grant above was based, in part, on the results of a third-party valuation of the Company’s common stock. These third-party valuations were prepared in accordance with the American Institute of Certified Public Accountants Accounting and Valuation Guide: Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”), which prescribes several valuation approaches for determining the value of an enterprise, such as the income approach, market approach and asset/cost approach, and various methodologies for allocating the value of an enterprise to its capital structure and specifically its common stock. These include: • Option Pricing Method (“OPM”). The OPM allocates value for each class of equity by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The values of the preferred and common stock are inferred by analyzing these options.
[***] Certain information contained in this letter, marked by brackets, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. §200.83. CONFIDENTIAL TREATMENT REQUESTED BY CARLSMED, INC.
July 7, 2025 Page Five • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering a number of discrete possible outcomes of the business, as well as the economic and control rights of each share class. • Hybrid Method (“Hybrid Method”). The Hybrid Method is a weighted-average method that combines both the OPM and PWERM. Weighting allocations are assigned to the OPM and PWERM methods factoring in possible future liquidity events. Additional Factors. In addition to the most recent independent third-party valuations, the Board considered various objective and subjective factors to determine the fair value of the Company’s common stock as of each award date, including: 1. the Company’s stage of development and business strategy, including the status of research and development efforts of the Company’s products, and the material risks related to the Company’s business and industry; 2. the Company’s results of operations and financial position, including the Company’s levels of available capital resources; 3. the valuation of publicly traded companies in the life sciences and medical device sectors, as well as recently completed mergers and acquisitions of peer companies; 4. the lack of marketability of the Company’s common stock as a private company; 5. the prices of the Company’s convertible preferred stock sold to investors in arm’s-length transactions and the rights, preferences, and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock; 6. the likelihood of achieving a liquidity event for the holders of the Company’s common stock, such as an initial public offering or a sale of the Company’s company, given prevailing market conditions;
[***] Certain information contained in this letter, marked by brackets, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. §200.83. CONFIDENTIAL TREATMENT REQUESTED BY CARLSMED, INC.
July 7, 2025 Page Six 7. the hiring of key personnel and the experience of management; 8. trends and developments in the Company’s industry; and 9. external market conditions affecting the life sciences and medical device industry sectors. Valuations and Awards Over the Previous 12 Months March 2024 Valuation and August 2024 Awards The Company obtained an independent third-party valuation report of the Company’s common stock as of March 14, 2024 (the “March 2024 Valuation”). The March 2024 Valuation used the OPM method due to the expected term to liquidity and the lack of precise information regarding the timing and likelihood of potential exit events. Under the OPM, the Company applied the subject company transaction method, which calculates the implied enterprise value by accounting for all share class rights and preferences as of the date of the latest financing. In order to determine the value of the Company’s common shares, the Company’s recently closed round of financing was used, where the Company sold shares of Series C Preferred Stock for $1.92 per share on March 12, 2024. The total value implied by this transaction was then applied in the OPM context to determine the value of each class of shares. Within the OPM, the March 2024 Valuation used a risk-free interest rate of [***]%, volatility of [***]% and a weighted time to exit of [***] years. The valuation also applied a [***]% discount for lack of marketability. Based on this analysis, the March 2024 Valuation determined that the equity value of the Company was $[***] million, which resulted in an estimated fair value per share of common stock of $0.38. At the time of the equity grants on August 28, 2024, the Board considered the results of the March 2024 Valuation, as well as the other objective and subjective criteria discussed above, and determined that the fair value of the Company’s common stock was $0.38 per share. For the period from the date of the March 2024 Valuation to August 28, 2024, the Board determined there were no internal or external developments since the date of such valuation that warranted a change in the estimated fair value of the common stock.
[***] Certain information contained in this letter, marked by brackets, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. §200.83. CONFIDENTIAL TREATMENT REQUESTED BY CARLSMED, INC.
July 7, 2025 Page Seven September 2024 Valuation and November 2024 Awards The Company obtained an independent third-party valuation report of the Company’s common stock as of September 30, 2024 (the “September 2024 Valuation”). The September 2024 Valuation used the OPM method due to the expected term to liquidity and the lack of precise information regarding the timing and likelihood of potential exit events. Under the OPM, the company applied the subject company transaction method, which calculates the implied enterprise value by accounting for all share class rights and preferences as of the date of the latest financing. In order to determine the value of the Company’s common shares, the Company’s recently closed round of financing was used, where the Company sold shares of Series C Preferred Stock for $1.92 per share on September 20, 2024. The Company indicated that this transaction remained an indication of value. The valuation also applied a market adjustment to account for changes in key financial metrics between the starting date and the valuation date. The resulting enterprise value was then applied in the OPM context to determine the value of each class of shares. Within the OPM, the September 2024 Valuation used a risk-free interest rate of [***]%, volatility of [***]% and a weighted time to exit of [**] years. The valuation also applied a [***]% discount for lack of marketability. Based on this analysis, the September 2024 Valuation determined that the equity value of the Company was $[***] million, which resulted in an estimated fair value per share of common stock of $0.38. At the time of the equity grants on November 13, 2024, the Board considered the results of the September 2024 Valuation, as well as the other objective and subjective criteria discussed above, and determined that the fair value of the Company’s common stock was $0.40 per share. For the period from the date of the September 2024 Valuation to November 13, 2024, the Board determined there were no internal or external developments since the date of such valuation that warranted a change in the estimated fair value of the comm
2025-06-26 - CORRESP - CARLSMED, INC.
CORRESP 1 filename1.htm CORRESP 12531 High Bluff Drive Suite 200 San Diego California 92130-3588 TELEPHONE: 858.720.5100 FACSIMILE: 858.720.5125 www.mofo.com morrison & foerster llp amsterdam, austin, berlin, boston, brussels, denver, hong kong, london, los angeles, miami, new york, palo alto, san diego, san francisco, shanghai, singapore, tokyo, washington, d.c. June 26, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-3720 Attention: Robert Augustin Katherine Bagley Tayyaba Shafique Terence O’Brien Re: Carlsmed, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted on May 30, 2025 CIK No. 0001794546 Ladies and Gentlemen, On behalf of our client, Carlsmed, Inc. (the “ Company ”), we submit this letter in response to the comments received from the staff (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) by letter dated June 17, 2025 (the “ Comment Letter ”) with respect to the Amendment No. 1 to the Company’s Draft Registration Statement on Form S-1 submitted confidentially by the Company to the Commission on May 30, 2025 (the “ DRS Amendment No. 1 ”). Concurrently with the submission of this response letter, the Company is filing a Registration Statement on Form S-1 (the “ Registration Statement ”), which has been revised to reflect the Company’s responses to the Comment Letter, as well as certain other changes. Set forth below are the Company’s responses to the Staff’s comments. We have reproduced below in bold the Staff’s comments and have provided the Company’s responses immediately following each comment. The numbering of the paragraphs below corresponds to the numbering of the comments in the Comment Letter, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Registration Statement. Capitalized terms used in this response letter but not otherwise defined herein have the meanings set forth in the Registration Statement. June 26, 2025 Page Two Basis of Presentation Market, Industry, and Other Data, page i 1. We note your revised disclosure that “certain market data is based on data from BioMedGPS, provider of SmartTRAK Business Intelligence Solutions.” In your response, please provide additional detail describing the BioMedGPS and SmartTRAK Business Intelligence Solutions sources, including the source(s) of the data provided by this resource, if known. In addition, where you disclose estimates that are based on data provided by SmartTRAK, please revise to briefly describe the data underlying these estimates. For example, where you disclose that, “[a]ccording to market data provided by SmartTRAK, there will be approximately 445,200 lumbar fusion surgeries and approximately 372,600 cervical fusion surgeries performed in the United States in 2025,” please briefly describe the market data supporting these estimates. Make conforming changes throughout your filing. Response : The Company acknowledges the Staff’s comment and has revised its disclosure on pages i, 1, 2, 5, 25, 101, 103, 105, 106, and 113 of the Registration Statement. The Company advises the Staff that although BioMedGPS, provider of SmartTRAK Business Intelligence Solutions, discloses the principal sources used for its market research, it does not include the underlying data in its industry reports. Prospectus Summary Market Overview Our Addressable Market Opportunity, page 5 2. We note your revised disclosure in response to comment 6, including that your total addressable market is based on data from SmartTRAK, the current average selling price of your aprevo Technology platform, and internal and third-party estimates and assumptions. Please revise to describe the data and assumptions underlying your estimates and identify the relevant third part(ies). Please also disclose, as you do on page 112, that your total addressable market is the total overall revenue opportunity available for the aprevo Technology Platform if 100% market share is achieved for lumbar fusion surgeries, and is not a representation that you will achieve such market share. Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosures on pages i, 1, 2, 5, 25, 101, 103, 105, 106, and 113 of the Registration Statement. June 26, 2025 Page Three Key Benefits of the aprevo Technology Platform, page 7 3. We note your revised disclosure in response to comment 16, but your revision here is not completely responsive to our comment. Please revise to disclose, as you do on page 121 that “results may not be directly comparable as they are not from a single head-to-head trial.” Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosures on pages 7, 102, and 116 of the Registration Statement. Risk Factors We rely on a limited number of CMOs . . ., page 18 4. We note your response to comment 7, including that “the Company has substantive relationships with alternative CMOs,” and “the Company implemented the DPS that primarily relies on a single vertically-integrated CMO in order to shorten the lead time on delivery of its products.” We also note your disclosure that your CMOs generally are not under long-term contracts with you. Please revise your disclosure to briefly describe the material terms of your agreement(s), if any, with CMOs, including your single vertically-integrated CMO. If you do not have agreements with CMOs, please revise to disclose the risks related to not having agreements in place. Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosure on pages 18 and 137 of the Registration Statement, where the Company discloses its lack of long-term contracts with its CMOs and associated risks. Our 510(k) Submissions, page 116 5. We note your response to comment 2 and your revised disclosure on page 112, including a table describing your products and relevant regulatory submissions and approvals. For your products that are “in process,” please revise to clarify where in the regulatory process these products stand; for example, whether you've submitted applications, are conducting studies, etc. Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosure on page 118 of the Registration Statement. Key Publications, page 120 6. We note your revisions to pages 121 through 126, including disclosure discussing certain complications. Please tell us whether there were any adverse events or serious adverse events reported in your studies and revise your disclosure accordingly. June 26, 2025 Page Four Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosure on pages 123, 124, and 127 of the Registration Statement. The Company advises the Staff that there were no other adverse events or serious adverse events reported in these studies. Business Intellectual Property, page 122 7. We note your revised disclosure in response comment 18, including that, as set forth in your table, your patent portfolio contains 33 total issued patents. However, your table currently includes 31 patents. Please revise or advise. In addition, revise your table to include the type of patent protection for each patent listed. Response : The Company acknowledges the Staff’s comment and has accordingly revised its disclosures on pages 139 to 141 of the Registration Statement. Please do not hesitate to contact me by telephone at (858) 314-7530 with any questions or comments regarding this correspondence. Sincerely, /s/ H. Thomas Felix H. Thomas Felix of MORRISON & FOERSTER LLP c.c.: (via email) Michael Cordonnier, Chief Executive Officer, President and Chairman, Carlsmed, Inc. Leonard Greenstein, Chief Financial Officer, Carlsmed, Inc. R. John Hensley, Morrison & Foerster LLP James M. Krenn, Morrison & Foerster LLP B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP
2025-06-17 - UPLOAD - CARLSMED, INC. File: 377-07934
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 17, 2025 Michael Cordonnier Chief Executive Officer and President Carlsmed, Inc. 1800 Aston Ave, Suite 100 Carlsbad, CA 92008 Re: Carlsmed, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted May 30, 2025 CIK 0001794546 Dear Michael Cordonnier: We have reviewed your amended draft registration statement and have the following comments. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our May 21, 2025 letter. Amendment No. 1 to Draft Registration Statement on Form S-1 Basis of Presentation Market, Industry, and Other Data, page i 1. We note your revised disclosure that "certain market data is based on data from BioMedGPS, provider of SmartTRAK Business Intelligence Solutions." In your response, please provide additional detail describing the BioMedGPS and SmartTRAK Business Intelligence Solutions sources, including the source(s) of the data provided by this resource, if known. In addition, where you disclose estimates that are based on data provided by SmartTRAK, please revise to briefly describe the June 17, 2025 Page 2 data underlying these estimates. For example, where you disclose that, "[a]ccording to market data provided by SmartTRAK, there will be approximately 445,200 lumbar fusion surgeries and approximately 372,600 cervical fusion surgeries performed in the United States in 2025," please briefly describe the market data supporting these estimates. Make conforming changes throughout your filing. Prospectus Summary Market Overview Our Addressable Market Opportunity, page 5 2. We note your revised disclosure in response to comment 6, including that your total addressable market is based on data from SmartTRAK, the current average selling price of your aprevo Technology platform, and internal and third-party estimates and assumptions. Please revise to describe the data and assumptions underlying your estimates and identify the relevant third part(ies). Please also disclose, as you do on page 112, that your total addressable market is the total overall revenue opportunity available for the aprevo Technology Platform if 100% market share is achieved for lumbar fusion surgeries, and is not a representation that you will achieve such market share. Key Benefits of the aprevo Technology Platform, page 7 3. We note your revised disclosure in response to comment 16, but your revision here is not completely responsive to our comment. Please revise to disclose, as you do on page 121 that "results may not be directly comparable as they are not from a single head-to-head trial." Risk Factors We rely on a limited number of CMOs . . ., page 18 4. We note your response to comment 7, including that "the Company has substantive relationships with alternative CMOs," and "the Company implemented the DPS that primarily relies on a single vertically-integrated CMO in order to shorten the lead time on delivery of its products." We also note your disclosure that your CMOs generally are not under long-term contracts with you. Please revise your disclosure to briefly describe the material terms of your agreement(s), if any, with CMOs, including your single vertically-integrated CMO. If you do not have agreements with CMOs, please revise to disclose the risks related to not having agreements in place. Our 510(k) Submissions, page 116 5. We note your response to comment 2 and your revised disclosure on page 112, including a table describing your products and relevant regulatory submissions and approvals. For your products that are "in process," please revise to clarify where in the regulatory process these products stand; for example, whether you've submitted applications, are conducting studies, etc. Key Publications, page 120 6. We note your revisions to pages 121 through 126, including disclosure discussing certain complications. Please tell us whether there were any adverse events or serious June 17, 2025 Page 3 adverse events reported in your studies and revise your disclosure accordingly. Business Intellectual Property, page 122 7. We note your revised disclosure in response comment 18, including that, as set forth in your table, your patent portfolio contains 33 total issued patents. However, your table currently includes 31 patents. Please revise or advise. In addition, revise your table to include the type of patent protection for each patent listed. Please contact Tayyaba Shafique at 202-551-2110 or Terence O'Brien at 202-551- 3355 if you have questions regarding comments on the financial statements and related matters. Please contact Robert Augustin at 202-551-8483 or Katherine Bagley at 202-551- 2545 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: John Hensley </TEXT> </DOCUMENT>
2025-05-21 - UPLOAD - CARLSMED, INC. File: 377-07934
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 21, 2025 Michael Cordonnier Chief Executive Officer and President Carlsmed, Inc. 1800 Aston Ave, Suite 100 Carlsbad, CA 92008 Re: Carlsmed, Inc. Draft Registration Statement on Form S-1 Submitted April 24, 2025 CIK 0001794546 Dear Michael Cordonnier: We have reviewed your draft registration statement and have the following comments. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form S-1 submitted April 24, 2025 Prospectus Summary Overview, page 1 1. Throughout your prospectus summary where you refer to a statistic that is not common knowledge, a research article, recent publication or study, industry source, or clinical trial, please cite the source at first instance, and provide a brief summary of, or cross reference to, a discussion of the material findings. Make conforming changes throughout your filing, including to your description of business. 2. We note your disclosure on page 123 that the "majority of the products that [you] currently market are classified as Class II devices and have received FDA marketing authorization through the 510(k) clearance process." Please revise to clearly disclose May 21, 2025 Page 2 all of your material, approved products and the relevant FDA Class I, II, or III classification of these products. Please also revise to identify your current products under development, and disclose the relevant regulatory approvals required for these products, provide the anticipated FDA Class I, II, or III classification for these products, if applicable, and the timeline for when you intend to submit these products for regulatory review. To the extent you have obtained or intend to obtain separate regulatory approval for your implants and related software or platform services, please ensure that this is clearly disclosed. 3. We note your disclosure that you are developing your aprevo Technology Platform for use in cervical spine fusion surgeries and that, in November of 2024, you received FDA 510(k) clearance for your aprevo interbody implants for cervical interbody fusion surgeries. We also note your disclosure that you are pursuing additional clearances for your cervical software platform and plating solutions prior to commercializing the aprevo Technology Platform for surgical fusion surgery, and that, "[a]ssuming [you] get the necessary additional clearances, [you] expect to commercialize the aprevo Technology Platform for cervical fusion surgery in 2026." Please revise to disclose the regulatory clearances you are pursuing and the status of these clearances, including steps you have taken to obtain regulatory approval and whether you will be required to complete additional trials or studies. Please also revise to disclose that there is no guarantee your software platform and plating solutions will obtain FDA approval on the expected timeline or at all. 4. Throughout your filing, you reference "independent sales agents" that are separate from your direct sales team. In an appropriate place in your filing, including MD&A and your description of business, please discuss any contractual agreements with these independent sales agents, including material terms. Market Overview Burdensome Inventory Management, page 4 5. Please provide support for your disclosure that direct and indirect costs of a revision surgery frequently exceed $100,000. Our Addressable Market Opportunity, page 4 6. Please address the following related to your annual addressable market: We note your disclosure that your annual addressable market is based on your current average selling price and "the approximately 445,200 lumbar fusion surgeries that will be performed in the United States in 2025." Please revise to disclose the source for this statistic and disclose any material assumptions underlying your addressable market estimate. Please also clarify why 152 surgeon users completing one or more procedures using the aprevo Technology Platform "suggests ample opportunity to grow [y]our surgeon user base." You disclose that you are "also developing the aprevo Technology Platform to expand its use into cervical fusion procedures," and "Industry sources estimate that there will be approximately 372,600 cervical fusion procedures performed in May 21, 2025 Page 3 the United States in 2025." Please revise to cite the specific industry sources, and clarify that you will need to obtain, and may never obtain, regulatory approval prior to expanding the aprevo Technology Platform into cervical fusion procedures. Where you discuss your expansion into international markets, please disclose the status of any expansion plans, your intended timing for these plans, and any relevant regulatory approvals required for this expansion. Please also provide support for your disclosure that "a significant market opportunity also exists for the aprevo Technology Platform in international markets," including any material assumptions and relevant sources. You disclose that "[w]hile spine surgery remains our current focus, we believe that our platform technology may also benefit other musculoskeletal applications beyond the spine, unlocking greater market potential." Please revise to disclose whether these other musculoskeletal applications are currently under development and your intended timeline for obtaining regulatory approval for and commercializing these applications. Risk Factors We rely on a limited number of CMOs . . ., page 17 7. We note your disclosure that you rely on a limited number of CMOs for the manufacture, treatment, sterilization, packaging, and distribution of your products, and that your CMOs are critical to you with relatively few alternative sources of supply. Please identify the CMOs upon which you rely, or tell us why you do not believe you are required to do so. See Item 101(h)(4)(v) of Regulation S-K. If the third parties on which we rely . . ., page 18 8. We note your disclosure here that you often must rely on third parties to assist in conducting your pre-market development activities for your product candidates, and that these third parties have certain contractual duties they are obligated to perform. We also note your disclosure on page 34 that you rely on third-party researchers and clinical sites to ensure the proper and timely conduct of your clinical studies or trials. In an appropriate place in your filing, please identify the third-parties, if any, you are substantially dependent on, describe the terms of any material agreements you have with these third parties, and file these agreements as exhibits to your registration statement. See Item 601(b)(10) of regulation S-K. Our principal stockholders and management . . . , page 62 9. We note your disclosure that, after this offering, your executive officers, directors, owners of 5% of your capital stock, and their respective affiliates will have the ability to influence you through their ownership position, including that they may be able to determine all matters requiring stockholder approval, such as elections of directors, amendments to your organizational documents, or approval of certain transactions. Please revise your cover page to include substantially similar disclosure. May 21, 2025 Page 4 Our amended and restated certificate of incorporation . . ., page 65 10. We note your disclosure that the choice of forum provision in your amended and restated certificate of incorporation may limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable. Please revise to also disclose that this provision may result in increased costs for investors to bring a claim. Use of Proceeds, page 72 11. We note your disclosure that you will use certain portion of your proceeds for research and development. Please revise to specify which product(s) you plan to develop using the proceeds from this offering. Management's Discussion and Analysis of Financial Condition and Results of Operations Overview, page 79 12. We note your disclosures that "[i]n April 2025, CMS issued the IPPS 2025 Proposed Rule that includes a NTAP to provide supplemental reimbursement to hospitals for each qualifying cervical procedure using the aprevo Technology Platform" and on page 81 that "[you] believe that CMS will adopt similar codes for use of [y]our aprevo Technology Platform in cervical spine procedures," and "[i]n March 2025, CMS announced proposed X-codes for the use of customer-made anatomically designed fusion devices for cervical spine fusion surgeries." When discussing proposed rules and regulations, please revise to disclose that there is no guarantee the proposed rules or regulations will be passed in their current form. Key Components of Our Results of Operations Market Adoption, page 80 13. You disclose that, as of December 31, 2024, 152 surgeons have completed one or more procedures using the aprevo Technology Platform. To provide context for investors regarding the significance of this statistic to your business, please disclose the number of surgeons that completed one or more procedures using your platform for a comparable historical period. As a related matter, we note your disclosure that, over time, you expect to not only grow the base of surgeons actively using the aprevo Technology Platform but to also increase the number of procedures using the aprevo Technology Platform that are performed by existing surgeons, and your disclosure on page 83 that your increase in revenue was driven by sales and marketing efforts for new surgeon adoption of your platform and deepened penetration with your existing surgeons. You also disclose on page 113 that you have "an exceptional track record of surgeon retention." To provide context for your disclosures regarding your recent growth and increase in revenue, please disclose whether and to what extent your recent growth is attributable to the acquisition of new surgeons compared to retained surgeons. Please also clarify how you determine whether a surgeon is "actively" using your platform, including any relevant measurement period, and disclose your surgeon retention rate for the financial periods presented in the filing. Stock-Based Compensation, page 91 14. Please tell us how you arrived at the expected stock price volatility assumptions of May 21, 2025 Page 5 45.4% and 62.0% for the years ending December 31, 2024 and 2023, given comparable companies and company-specific factors, such as your stage of life-cycle. Common Stock Valuation, page 92 15. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock and conversion prices of preferred stock on issuances leading up to the initial public offering and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation. Please discuss with the staff how to submit your response. Business Overview Improved alignment and decreased risk of revision spine surgery, page 96 16. We note your disclosure here, in your prospectus summary, and on page 109 that "[c]linical data has demonstrated that the aprevo Technology Platform improves post- operative alignment, including compared to traditional spine fusion surgery, in both degenerative and deformity cases." Please revise your disclosure throughout the filing to disclose, as you do on page 114, that you are not aware of any direct head-to-head trials between aprevo interbody implants and stock implants, and that results may not be directly comparable as they are not from a single head-to-head trial. Key Publications, page 113 17. We note your disclosure that "[s]everal of the [key peer reviewed] studies were conducted with small sample sizes and were not powered for statistical significance, did not control for other clinical variables, or have other design limitations." We also note that your summaries of the findings of certain of these studies reference statistical significance. Please revise to clearly identify the studies that were not powered for statistical significance. Where a study references statistical significance, please revise to include the relevant p-value. Intellectual Property, page 122 18. We note your disclosure that "[a]s of March 31, 2025, [y]our patent portfolio contains 33 total issued patents." We also note your disclosure that "[a]s set forth in tabular form below, of the 28 total issued U.S. patents in our patent estate, 16 contain one or more claims that cover the currently commercial aprevo Technology Platform, all of which are fully owned by us." Please clarify whether any of the 33 patents in your portfolio, including those not reflected in the table, are licensed from a third party. In this regard, we note your disclosure in the risk factor on page 54. Please also revise your table to include all 33 patents, including any licensed patents and patents issued in jurisdictions outside of the U.S., and revise to disclose the scope and technology of each patent, the type of patent protection, and jurisdiction. May 21, 2025 Page 6 Note 2. Summary of Significant Accounting Policies Revenue Recognition, page F-13 19. You disclose revenue is recognized on a gross basis. It also appears you recognize supplemental reimbursements and that there is potential for premium reimbursement rates in the future, as disclosed on page 79. Please tell us if there are any effects of variable considerations on determining the transaction price, including adjusting for any price concessions or rebates expected to be given to different payors. If variable consideration does exist, please tell us what method is used for estimating variable consideration, and if the variable consideration is constrained. Refer to ASC 606-10- 32-5 through 32-9 and ASC 606-10-32-11 through 32-14 for guidance. General 20. Please provide us with supplemental copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, have presented or expect to present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not you retained, or intend to retain, copies of the communications. Please contact Tayyaba Shafique at 202-551-2110 or Terence O'Brien at 202-551- 3355 if you have questions regarding comments on the financial statements and related matters. Please contact Robert Augustin at 202-551-8483 or Katherine Bagley at 202-551- 2545 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: John Hensley </TEXT> </DOCUMENT>