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CapsoVision, Inc
CIK: 0001378325  ·  File(s): 333-287148  ·  Started: 2025-06-30  ·  Last active: 2025-06-30
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2025-06-30
CapsoVision, Inc
Offering / Registration Process
File Nos in letter: 333-287148
CapsoVision, Inc
CIK: 0001378325  ·  File(s): 333-287148  ·  Started: 2025-06-30  ·  Last active: 2025-06-30
Orphan - no UPLOAD in window 1 company response(s) Low - unmatched response
CR Company responded 2025-06-30
CapsoVision, Inc
Offering / Registration Process
File Nos in letter: 333-287148
CapsoVision, Inc
CIK: 0001378325  ·  File(s): 377-07713  ·  Started: 2025-03-28  ·  Last active: 2025-05-09
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2025-03-28
CapsoVision, Inc
CR Company responded 2025-05-09
CapsoVision, Inc
Regulatory Compliance Financial Reporting Business Model Clarity
References: March 28, 2025
CapsoVision, Inc
CIK: 0001378325  ·  File(s): 377-07713  ·  Started: 2025-03-10  ·  Last active: 2025-03-10
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-03-10
CapsoVision, Inc
DateTypeCompanyLocationFile NoLink
2025-06-30 Company Response CapsoVision, Inc DE N/A
Offering / Registration Process
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2025-06-30 Company Response CapsoVision, Inc DE N/A
Offering / Registration Process
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2025-05-09 Company Response CapsoVision, Inc DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2025-03-28 SEC Comment Letter CapsoVision, Inc DE 377-07713 Read Filing View
2025-03-10 SEC Comment Letter CapsoVision, Inc DE 377-07713 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-03-28 SEC Comment Letter CapsoVision, Inc DE 377-07713 Read Filing View
2025-03-10 SEC Comment Letter CapsoVision, Inc DE 377-07713 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-06-30 Company Response CapsoVision, Inc DE N/A
Offering / Registration Process
Read Filing View
2025-06-30 Company Response CapsoVision, Inc DE N/A
Offering / Registration Process
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2025-05-09 Company Response CapsoVision, Inc DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2025-06-30 - CORRESP - CapsoVision, Inc
CORRESP
 1
 filename1.htm

 CORRESP

 CAPSOVISION, INC.
 18805 Cox Avenue, Suite 250
 Saratoga, CA 95070 June 30, 2025
 Via EDGAR U.S. Securities and Exchange Commission
 Division of Corporation Finance 100 F Street, N.E.
 Washington, D.C. 20549 Attn: Mr. Robert Augustin,
Ms. Jane Park, Ms. Kristin Lochhead, Mr. Michael Fay

 Re:

 CapsoVision, Inc. Registration Statement on Form S-1 (Registration No. 333-287148)
 Dear Mr. Augustin, Ms. Park, Ms. Lochhead and Mr. Fay:
 In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the
acceleration of the effective date of the above-referenced Registration Statement, as amended, so that it will become effective on July 1, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as
CapsoVision, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Ms. Portia Ku of
O’Melveny & Myers LLP, counsel to the Company, at 702-964-0094, or in her absence, Mr. Kurt Berney at 415-984-8989, to provide notice of
effectiveness, or if you have any other questions or concerns regarding this matter.

 Sincerely,

 CapsoVision, Inc.

 By:

 /s/ Kang-Huai (Johnny) Wang

 Kang-Huai (Johnny) Wang

 President and Chief Executive Officer

 cc:
 Portia Ku

  
 Kurt Berney
2025-06-30 - CORRESP - CapsoVision, Inc
CORRESP
 1
 filename1.htm

 CORRESP

 June 30, 2025
 VIA EDGAR United States Securities and Exchange
Commission 100 F. Street, NE Washington, DC 20549

 Attn:
 Mr. Robert Augustin
 Ms. Jane Park
 Ms. Kristin Lochhead
 Mr. Michael Fay

 Re:
 CapsoVision, Inc.
 Registration Statement on Form S-1
 File No. 333-287148
 Ladies and Gentlemen: As representative of the
several underwriters of the proposed offering of shares of common stock of CapsoVision, Inc. (the “ Company ”), we hereby join the Company’s request for acceleration of the above-referenced Registration Statement,
requesting effectiveness at 5:00 p.m., Eastern Time, on Tuesday, July 1, 2025, or as soon thereafter as possible, or at such later time as the Company or its counsel may request via telephone call to the staff.
 The undersigned advise that they have complied and will continue to comply with Rule 15c2-8 under the
Securities Exchange Act of 1934, as amended. [ Signature Page Follows ]

 Sincerely,

 The Benchmark Company, LLC

 By:

 /s/ Michael Jacobs

 Name: Michael Jacobs

 Title: Managing Director
 [ Signature Page to Acceleration Request ]
2025-05-09 - CORRESP - CapsoVision, Inc
Read Filing Source Filing Referenced dates: March 28, 2025
CORRESP
 1
 filename1.htm

 CORRESP

 O’Melveny & Myers LLP JC Plaza,
12 th Floor 1225 Nanjing Road West
 Shanghai 200040

 T: +1 86 21 2307 7091 F: +1 86 21 2307 7300
 omm.com

 File Number: 0134980-00002

 May 9, 2025
 VIA EDGAR

 Portia Ku D: +1 86 21 2307 7091
 pku@omm.com
 United States Securities and Exchange Commission
 Division of Corporation Finance Office of Industrial
Applications and Services 100 F Street, N.E. Washington,
D.C. 20549

 Attention:

 Robert Augustin Jane Park
 Kristin Lochhead Michael Fay

   

 Re:

 CAPSOVISION, INC. Draft Registration
Statement on Form S-1 Submitted March 14, 2025
 CIK No. 0001378325
 To the addressees set forth above:
 On behalf of our client, CapsoVision, Inc, a Delaware corporation (the “ Company ”), we hereby submit to the staff (the
“ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) this letter setting forth the Company’s responses to the comments contained in the Staff’s letter dated March 28, 2025, regarding
the above-referenced Draft Registration Statement on Form S-1, as confidentially submitted via EDGAR to the Commission on March 14, 2025 (the “ Draft Registration Statement ”).
 Concurrently with the submission of this letter, the Company is filing its revised registration statement on Form S-1
(the “ Revised Registration Statement ”) via EDGAR to the Commission for review. For the Staff’s convenience, we have reproduced
below the comments from the Staff in bold italics, in each case followed by the Company’s corresponding response. Where applicable, we have included references to pages in the Revised Registration Statement where the language addressing a
particular comment appears. Capitalized terms used in this letter and not otherwise defined herein have the meanings ascribed to them in the Revised Registration Statement.

 Austin • Century City • Dallas • Houston • Los Angeles • Newport Beach • New York • San Francisco •
Silicon Valley • Washington, DC Beijing • Brussels • Hong Kong • London • Seoul • Shanghai • Singapore
• Tokyo

 Draft Registration Statement on Form S-1 submitted March 14,
2025 Manufacturing and Supply, page 107

 1.
 We refer to your revised disclosure in response to prior comment 13, which we reissue in part. Please
expand your disclosure relating to the minimum purchase requirements in the Toshiba Agreement. Response:
 In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure in the
“Manufacturing and Supply” subsection of the Business section of the Revised Registration Statement on page 112. In particular, the Company has revised the disclosure to clarify that the Toshiba Agreement does not contain a minimum
purchase commitment but rather, a provision that allows Toshiba to discontinue the supply of CMOS image sensors to the Company if the Company does not place purchase orders totaling more than a specified number of units in any consecutive 12 months.
 Intellectual Property, page 110

 2.
 We note your response to prior comment 14, which we reissue. For each
 non-U.S. patent listed, please revise to disclose the expected expiration and the type of patent protection for each of the granted patents.
 Response: In response to
the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure in the “Intellectual Property” section of the Revised Registration Statement on pages 119 to 122.
 *    *    *
 We appreciate the Staff’s comments and request that the Staff contact the undersigned at +86 21 2307 7091 or pku@omm.com with any questions or
comments regarding this letter and/or the Revised Registration Statement.

 Sincerely,

 /s/ Portia Ku

 Portia Ku of O’Melveny & Myers
LLP

 cc:

 Kang-Huai (Johnny) Wang, President and Chief Executive Officer, CapsoVision, Inc.
 Kevin Lundquist, Chief Financial Officer, CapsoVision, Inc. Kurt
Berney, O’Melveny & Myers LLP Richard I. Anslow, Ellenoff Grossman & Schole LLP
 Jonathan Deblinger, Ellenoff Grossman & Schole LLP
 Joseph A. Smith, Ellenoff Grossman & Schole LLP
2025-03-28 - UPLOAD - CapsoVision, Inc File: 377-07713
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 March 28, 2025

Kang-Huai Wang
Chief Executive Officer
CapsoVision, Inc.
18805 Cox Avenue, Suite 250
Saratoga, CA 95070

 Re: CapsoVision, Inc.
 Amendment No. 1
 Draft Registration Statement on Form S-1
 Submitted March 14, 2025
 CIK No. 0001378325
Dear Kang-Huai Wang:

 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 March 7, 2025 letter.

Draft Registration Statement on Form S-1 submitted March 14, 2025
Manufacturing and Supply, page 107

1. We refer to your revised disclosure in response to prior comment 13,
which we
 reissue in part. Please expand your disclosure relating to the minimum
purchase
 requirements in the Toshiba Agreement.
Intellectual Property, page 110

2. We note your response to prior comment 14, which we reissue. For each
non-U.S.
 patent listed, please revise to disclose the expected expiration and the
type of patent
 March 28, 2025
Page 2

 protection for each of the granted patents.
 Please contact Kristin Lochhead at 202-551-3664 or Michael Fay at
202-551-3812 if
you have questions regarding comments on the financial statements and related
matters. Please contact Robert Augustin at 202-551-8483 or Jane Park at
202-551-7439 with
any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Portia Ku, Esq.
</TEXT>
</DOCUMENT>
2025-03-10 - UPLOAD - CapsoVision, Inc File: 377-07713
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 March 7, 2025

Kang-Huai Wang
Chief Executive Officer
CapsoVision, Inc.
18805 Cox Avenue, Suite 250
Saratoga, CA 95070

 Re: CapsoVision, Inc.
 Draft Registration Statement on Form S-1
 Submitted February 7, 2025
 CIK No. 0001378325
Dear Kang-Huai Wang:

 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 February 7, 2025
Prospectus Summary, page 1

1. Please balance your disclosure in the Prospectus Summary with equally
prominent
 disclosure of the limitations you face in implementing your business
strategy and
 gaining market acceptance, including, but not limited to the competition
from
 companies in the capsule endoscopy market that are developing or have
already
 established a market presence with FDA-cleared devices; your history of
operating
 losses; and the going concern opinion provided by the company's auditors
in relation
 to your audited financial statements for the year ended December 31,
2023.
2. We note your disclosure on page 113 that your CapsoCam Plus product is
currently
 classified as a Class II device and has received FDA marketing
authorization through
 the 510(k) clearance process. Please revise to include disclosure of the
Class II
 March 7, 2025
Page 2

 classification in the Summary as well. Please also disclose the FDA
classification for
 your CapsoCam Colon product.
Market Overview
Overview and Challenges of Detecting Colon Polyps, page 2

3. Here, and throughout your filing, including your description of business
and the
 market in which you intend to operate, when referring to a statistic
that is not common
 knowledge, a research article, or clinical trial, please cite the source
and, at first
 instance, provide a summary of the material findings. For example only,
you disclose
 that "[e]ach year in the U.S., there are approximately 153,000 new cases
of CRC and
 approximately 53,000 deaths." Please provide appropriate sources for
these and other,
 relevant statements throughout the filing, or characterize the same as
management's
 opinions or beliefs, where appropriate.
Our Growth Strategies, page 4

4. We note your disclosure that your goal is to obtain 510(k) clearance for
your updated
 CapsoCam Plus product from the FDA in late 2025. When discussing FDA or
other
 regulatory approvals, please revise to include a statement acknowledging
that FDA or
 other regulatory agency, foreign or domestic, approval is not guaranteed
and may take
 longer than planned. Further, when discussing trials, please revise to
state that there is
 no guarantee that the trials will produce positive results or that the
results will support
 the company's claims. Please make conforming changes throughout your
filing.
Government Regulation, page 12

5. We refer to your disclosure throughout the registration statement that
you began
 commercial sales of your small bowel CapsoCam capsule system in Europe
in 2012.
 Please revise your disclosure in this section to discuss any regulatory
requirements
 you may be subject to in Europe.
Our amended and restated certificate of incorporation will provide that...,
page 55

6. We note your disclosure that the choice of forum provision in your
amended and
 restated certificate of incorporation may limit a shareholder s
ability to bring a claim
 in a judicial forum that it finds favorable for disputes with you and
may discourage
 such lawsuits. Please revise this risk factor and your disclosure in the
Business section
 to disclose that there is also a risk that your choice of forum
selection provision may
 result in increased costs for investors to bring a claim.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 68

7. Where you describe two or more business reasons that contributed to a
material
 change in a financial statement line item between periods, please
quantify, where
 possible, the extent to which each factor contributed to the overall
change in that line
 item, including any offsetting factors. For your discussion of revenue
fluctuations,
 explain the context around the generic reference to "acceptance of
CapsoCam
 Plus" and "growth in the small-bowel capsule endoscopy" and quantify the
impact of
 domestic versus international sales fluctuations during the periods
presented. In
 March 7, 2025
Page 3

 addition, where you identify intermediate causes of changes in your
operating results,
 also describe the reasons underlying the intermediate causes. Please
ensure that you
 explain in sufficient detail the reasons driving the changes in your
results of
 operations and that your overall revised disclosures assist in
satisfying the
 requirements of Item 303(a)-(b) of Regulation S-K and the three
principal objectives
 of MD&A:

 to provide a narrative explanation of a company s financial
statements that
 enables investors to see the company through the eyes of management;
 to enhance the overall financial disclosure and provide the
context within which
 financial information should be analyzed; and
 to provide information about the quality of, and potential
variability of, a
 company s earnings and cash flow, so that investors can ascertain
the likelihood
 that past performance is indicative of future performance.
Business, page 78

8. We refer to your disclosure on page 83 and elsewhere in the registration
statement that
 prior studies have demonstrated the CapsoCam s superior detection
of the normal
 papilla relative to non-panoramic systems. Please clarify whether you
have
 conducted a head-to-head clinical trial comparing CapsoCam with other
competing
 endoscopy devices, and if so, please revise to include a discussion of
the scope, size
 and design of the head-to-head study in this section. If you have not
conducted a head-
 to-head clinical trial, please expand your disclosure of these prior
studies and discuss
 any known differences in trial protocols, conditions and patient
populations that could
 materially impact the comparability of the trial data presented.
9. We note your disclosure of your plans to submit to the FDA the clinical
results of the
 first arm of our CapsoCam Colon pivotal study in a 510(k) submission and
to seek
 FDA 510(k) clearance for the use of AI in CapsoCam Plus in the first
half of 2025.
 You also state that you plan to commence clinical investigation of
CapsoCam s
 accuracy in detecting abnormalities indicative of pancreatic neoplasia
and screening
 esophageal varices in cirrhotic patients. Please revise to provide
greater detail of the
 current status and expected timeline of your studies and clinical
investigations.
Our Program, page 81

10. We note your disclosure that you have completed the feasibility and
pilot studies for
 your CapsoCam Colon capsule endoscopy system. Please revise to specify
when you
 completed these studies.
Pivotal Study, page 98

11. We refer to your disclosure of the pivotal study for your CapsoCam Colon
that was
 completed in 2021. Please revise to clarify whether the pivotal study
was powered for
 statistical significance, and if so, please expand your discussion of
the statistical
 significance and p-values and revise your characterizations of the study
to discuss the
 data, rather than drawing conclusions from the results.
 March 7, 2025
Page 4

Exclusive Distribution Agreements, page 102

12. We note your disclosure that you have had approximately 50 exclusive
distributors
 covering multiple non-U.S. countries or regions, including Europe and
Africa, and
 one exclusive distributor for sales of your CapsoCam capsule for the
veterinary
 market worldwide. Please revise your disclosure to specify the
jurisdictions in which
 these regional distributors operate and clearly state whether you have
entered into any
 distribution agreements or other types of firm commitment arrangements
with these
 regional distributors. If you have entered into distribution agreements,
please expand
 your disclosure to provide a brief description of the material terms of
such agreement
 and file the agreement as an exhibit to your registration as required by
Item
 601(b)(10) of Regulation S-K, or tell us why you believe you are not
required to do
 so.
Manufacturing and Supply, page 104

13. We note your disclosure on page 104 that you have entered into a
development
 agreement with Toshiba Corporation and a development and manufacturing
 agreement with Moai Electronics Corporation. Please expand your
disclosure to
 ensure all material terms of these agreements are described, including,
without
 limitation, any minimum purchase commitments and the termination
provisions.
Intellectual Property, page 106

14. We refer to your disclosure of your patent portfolio. Please revise your
disclosure to
 identify the type of patent protection (such as composition matter, use,
or process) for
 each patent and pending patent application.
Facilities, page 112

15. We note your disclosure here that you lease two office facilities in
Taiwan, one of
 which expired on February 14, 2025. Please revise to disclose whether
you renewed
 your expired lease in Taiwan.
State Corporate Practice of Medicine and Fee-Splitting Laws, page 119

16. We note your disclosure that you have entered into arrangements with
contracted
 telemedicine providers. Please revise to briefly describe the material
terms of these
 agreements are described, including, without limitation, the term of the
agreement and
 the termination provisions. Please also file the agreement as an exhibit
to the
 registration statement or explain to us why you are not required to do
so. Refer to Item
 601(b)(10) of Regulation S-K.
Employment Agreements, page 128

17. We note your disclosure that "[you] have entered into offer letter with
each of the
 NEOs..." Please revise to describe the material terms of these
agreements, including
 but not limited to any termination provisions, and file the actual
agreements rather
 than the form of employment agreement as exhibits to your registration
statement.
 Refer to Item 601(b)(10) of Regulation S-K.
 March 7, 2025
Page 5

Transactions with VeriSilicon, page 134

18. We refer to your disclosure on page 134 that you entered into the ASIC
Design,
 Manufacturing and Product Sales Agreement with VerSilicon, Inc. in May
2022.
 Please revise to briefly describe the material terms of the VerSilicon
agreement and
 file the agreement as an exhibit to your registration statement or
explain to us why
 you believe you are not required to do so. Refer to Item 601(b)(10) of
Regulation S-
 K.
Financial Statements
Revenue Recognition, page F-11

19. We note that your contracts with customers contain both fixed and
variable
 consideration. Please expand your disclosures for variable consideration
to identify
 each type of variable consideration you estimate and to provide the
disclosures
 required by ASC 606-10-50-1(b), 50-17 and 50-20.
20. Please describe in further detail the payment terms you offer your
customers, the
 rights of return you offer your customers, and any warranties you offer
them.
 Separately provide the information for group purchasing organizations if
the
 information differs between your different categories of customers.
Refer to ASC 606-
 10-50-12.
6. Revenue and Deferred Revenue, page F-20

21. Please separately disclose revenues attributable any individual foreign
country,
 if material. Refer to ASC 280-10-50-41(a).
General

22. 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 Kristin Lochhead at 202-551-3664 or Michael Fay at
202-551-3812 if
you have questions regarding comments on the financial statements and related
matters. Please contact Robert Augustin at 202-551-8483 or Jane Park at
202-551-7439 with
any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Portia Ku, Esq.
</TEXT>
</DOCUMENT>