SecProbe.io

<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>