# EDGAR Filing Document

**Accession Number:** 0001794546
**File Stem:** 0000000000-25-006355
**Filing Date:** 2025-6
**Character Count:** 7100
**Document Hash:** f4dd188113ae4bfd2dd1ad1aedfa8816
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-25-006355.hdr.sgml**: 20250905

**ACCESSION NUMBER**: 0000000000-25-006355

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20250617

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CARLSMED, INC.
- **CENTRAL INDEX KEY:** 0001794546
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 831081863
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD
- **SEC FILE NUMBER:** 377-07934

**BUSINESS ADDRESS:**
- **STREET 1:** 1800 ASTON AVENUE
- **STREET 2:** SUITE 100
- **CITY:** CARLSBAD
- **STATE:** CA
- **ZIP:** 92008
- **BUSINESS PHONE:** 858-295-9290

**MAIL ADDRESS:**
- **STREET 1:** 1800 ASTON AVENUE
- **STREET 2:** SUITE 100
- **CITY:** CARLSBAD
- **STATE:** CA
- **ZIP:** 92008
**PUBLIC REFERENCE ACCESSION NUMBER**: 0000950123-25-003656

## Text-Extract

```

                                                            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

```

### Attached PDF Documents

**Attachment 1:** `filename1`

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