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 Fractyl Health, Inc.
 3 Van de Graaff Drive, Suite 200
 Burlington, MA 01803 March 13, 2025
 Via EDGAR Securities and Exchange Commission
 Division of Corporation Finance Office of Life Sciences
 100 F Street, N.E. Washington, D.C. 20549

 Re:
 Fractyl Health, Inc.
 Amendment No. 1 to Registration Statement on Form S-3
 Filed March 13, 2025
 File No. 333-285522
 To whom it may concern: Pursuant to Rule 461(a)
under the Securities Act of 1933, as amended, Fractyl Health, Inc. (the “ Company ”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form
 S-3 (File No. 333-285522) be accelerated by the Securities and Exchange Commission to 4:00 p.m., Washington D.C. time, on March 18, 2025 or as soon as
practicable thereafter. The Company requests that we be notified of such effectiveness by a telephone call to Jonathan Sarna of
Latham & Watkins LLP at (312) 876-7686 and that such effectiveness also be confirmed in writing.

 Very truly yours,

 Fractyl Health, Inc.

 By:

 /s/ Lisa A. Davidson

 Lisa A. Davidson

 Chief Financial Officer

 cc:
 Sarah Toomey, Fractyl Health, Inc.
 Nathan Ajiashvili, Latham & Watkins LLP
 Jonathan Sarna, Latham & Watkins LLP

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 March 11, 2025

Harith Rajagopalan
Chief Executive Officer
Fractyl Health, Inc.
3 Van de Graaff Drive
Suite 200
Burlington, MA 01803

 Re: Fractyl Health, Inc.
 Registration Statement on Form S-3
 Filed March 3, 2025
 File No. 333-285522
Dear Harith Rajagopalan:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Robert Augustin at 202-551-8483 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Jonathan Sarna
</TEXT>
</DOCUMENT>

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Acceleration Request

 January 30, 2024

Via EDGAR

 Division of Corporation Finance

 Office of Life Sciences

 U.S. Securities and Exchange
Commission

 100 F Street, N.E.

 Washington, DC 20549-6010

Attention:

Tyler Howes

Alan Campbell

Michael Fay

Brian Cascio

Re: 

Fractyl Health, Inc.

Registration Statement on Form S-1

Filed December 14, 2023

File No. 333-276046

 To the addressees set forth above:

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 so that it will become effective on February 1, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as
Fractyl Health, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212)
906-2916, or in his absence, Jonathan Sarna at (312) 876-7686, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.

Sincerely yours,

Fractyl Health, Inc.

By:

/s/ Harith Rajagopalan

Harith Rajagopalan, M.D., Ph.D.

Chief Executive Officer

cc:
 Nathan Ajiashvili, Esq.

Jonathan Sarna, Esq.

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Underwriter Acceleration Request

 VIA EDGAR

January 30, 2024

 United States Securities and Exchange
Commission

 Division of Corporation Finance

 Office of Life
Sciences

 100 F Street, N.E.

 Washington, D.C. 20549-6010

Attention:

Tyler Howes

Alan Campbell

Michael Fay

Brian Cascio

Re:

Fractyl Health. Inc. (the “Registrant”)

Registration Statement on Form S-1 (File No. 333-276046)

Request for Acceleration

 Ladies and Gentlemen:

 In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), BofA Securities, Inc., Morgan Stanley & Co. LLC and Evercore Group L.L.C., as representatives of the several underwriters, hereby join the
Registrant in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-276046)
(the “Registration Statement”) to become effective as of 4:00 p.m. Eastern time, on February 1, 2024, or as soon thereafter as possible.

Pursuant to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Securities Act of 1933, as amended, please be
advised that there has been distributed or will be distributed to each underwriter or dealer who is reasonably anticipated to participate in the distribution of the security as many copies of the Company’s preliminary prospectus dated
January 29, 2024, as appears to be reasonable to secure adequate distribution of the preliminary prospectus.

 We advise that we have complied and
will continue to comply, and that we have been informed by the participating underwriters that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended, to the extent applicable.

 [signature page follows]

Very truly yours,

BOFA SECURITIES, INC.

MORGAN STANLEY & CO. LLC

EVERCORE GROUP L.L.C.

As representatives of the Underwriters

BOFA SECURITIES, INC.

By:

 /s/ Michele A.H. Allong

Name: Michele A.H. Allong

Title: Authorized Signatory

MORGAN STANLEY & CO. LLC

By:

 /s/ Chris Rigoli

Name: Chris Rigoli

Title: Executive Director

EVERCORE GROUP L.L.C.

By:

 /s/ Ed Baxter

Name: Ed Baxter

Title: Senior Managing Director

 [Signature Page to Acceleration Request Letter]

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CORRESP

1271 Avenue of the Americas

New York, New York 10020-1401

Tel: +1.212.906.1200 Fax: +1.212.751.4864

www.lw.com

FIRM / AFFILIATE OFFICES

Austin

Milan

Beijing

Munich

Boston

New York

Brussels

Orange County

Century City

Paris

Chicago

Riyadh

 January 29, 2024

Dubai

San Diego

Düsseldorf

San Francisco

Frankfurt

Seoul

Hamburg

Silicon Valley

Hong Kong

Singapore

Houston

Tel Aviv

London

Tokyo

Los Angeles

Washington, D.C.

 VIA EDGAR

Madrid

 Division of Corporation Finance

Office of Life Sciences

 U.S. Securities and Exchange Commission

 100 F Street, N.E.

 Washington, DC 20549-6010

Attention:

 Tyler Howes

 Alan Campbell

Michael Fay

 Brian Cascio

 Re:  Fractyl Health, Inc.

Registration Statement on Form S-1

Filed December 14, 2023

File No. 333-276046

 To the addressees set forth above:

On behalf of our client, Fractyl Health, Inc. (the “Company”), set forth below is the Company’s response to the
comment of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) in its letter dated December 20, 2023, relating to the
Company’s registration statement on Form S-1 filed on December 14, 2023 (the “Registration Statement”).

The Company has filed today Amendment No. 1 to the Registration Statement (“Amendment
No. 1”), together with this letter, via EDGAR submission. For convenience of reference, the text of the comment in the Staff’s letter has been reproduced in bold and italics herein. The Company has
also provided its response immediately after the comment. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in Amendment No. 1.

 January 29, 2024

Page 2

 Registration Statement on Form S-1

Prospectus Summary

 Overview, page 1

1.
 Please revise to provide the source for your statement that up to
two-thirds of patients discontinue weekly GLP-1RA therapy within the first year. In your revisions, please disclose the drugs that were discontinued and the dates
covered by the study or studies showing the discontinuation.

 Response: In response to the Staff’s
comment, the Company has revised the disclosure on pages 1, 101, 122 and 130 of Amendment No. 1.

 *********

We hope that the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as
possible. Please do not hesitate to contact me at (212) 906-2916 with any questions or further comments you may have regarding this filing or if you wish to discuss the above.

 Sincerely,

 /s/ Nathan Ajiashvili

 Nathan Ajiashvili

of LATHAM & WATKINS LLP

 Enclosures

 cc: (via e-mail)

 Harith Rajagopalan, M.D., Ph.D., Chief Executive Officer, Fractyl Health, Inc.

Johan Brigham, Latham & Watkins LLP

 Evan Smith,
Latham & Watkins LLP

 Jonathan Sarna, Latham & Watkins LLP

Edwin O’Connor, Goodwin Procter LLP

 Alicia Tschirhart,
Goodwin Procter LLP

United States securities and exchange commission logo
December 20, 2023
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Registration Statement on Form S-1
Filed December 14, 2023
File No. 333-276046
Dear Harith Rajagopalan:
            We have reviewed your registration statement and have the following comment.
            Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.Please revise to provide the source for your statement that up to two-thirds of patients
discontinue weekly GLP-1RA therapy within the first year. In your revisions, please
disclose the drugs that were discontinued and the dates covered by the study or
studies showing the discontinuation.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 December 20, 2023 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
December 20, 2023
Page 2
statement.
            Please contact Michael Fay at 202-551-3812 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:       Nathan Ajiashvili, Esq.

CORRESP
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SEC Response Letter

1271 Avenue of the Americas

New York, New York 10020-1401

Tel: +1.212.906.1200  Fax: +1.212.751.4864

www.lw.com

FIRM / AFFILIATE OFFICES

Austin

Milan

Beijing

Munich

Boston

New York

Brussels

Orange County

Century City

Paris

Chicago

Riyadh

December 14, 2023

Dubai

San Diego

Düsseldorf

San Francisco

Frankfurt

Seoul

Hamburg

Silicon Valley

Hong Kong

Singapore

Houston

Tel Aviv

London

Tokyo

Los Angeles

Washington, D.C.

Madrid

 VIA EDGAR

Division of Corporation Finance

 Office of Life Sciences

U.S. Securities and Exchange Commission

 100 F Street, N.E.

Washington, DC 20549-6010

Attention:

Tyler Howes

Alan Campbell

Michael Fay

Brian Cascio

Re:

 Fractyl Health, Inc.

 Amendment
No. 6 to Draft Registration Statement on Form S-1

 Submitted September 21, 2023

CIK 0001572616

 To the addressees set forth above:

On behalf of our client, Fractyl Health, Inc. (the “Company”), set forth below is the Company’s response to the
comment of the Staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) in its letter dated October 3, 2023, relating to the
Company’s Amendment No. 6 to the draft registration statement on Form S-1 submitted on September 21, 2023.

The Company has publicly filed today the registration statement on Form S-1 (the
“Registration Statement”), together with this letter, via EDGAR submission. For convenience of reference, the text of the comment in the Staff’s letter has been reproduced in bold and italics herein. The Company has also
provided its response immediately after the comment. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in the Registration Statement.

 December 14, 2023

 Page
 2

 Amendment No. 6 to Draft Registration Statement on Form
S-1

 Prospectus Summary

Our Development Pipeline, page 2

1.
 We note your response to prior comment 2 and reissue in part. Please further clarify if both the
“CE Mark” approval arrow and “Insulin-Treated T2D” arrow are for separate indications. To the extent both of these arrows are targeting the same indication, revise the Revita section of your pipeline table so that the same
indication does not appear twice.

 Response: In response to the Staff’s comment, the Company
has revised the pipeline table on pages 3 and 123 of the Registration Statement. The Company respectfully advises the Staff that the “CE Mark” approval arrow and the “Insulin-Treated T2D” arrow are for separate indications.
As disclosed in the Registration Statement, the Company obtained a CE mark from the EU and UK in 2016 for Revita for the improvement of glycemic control in patients with inadequately controlled T2D despite oral and/or injectable glucose lowering
medications and/or long-acting insulin, as the Company has indicated in Footnote 1 of the pipeline table on pages 3 and 123 of the Registration Statement. The “Germany Real World Registry” study is evaluating Revita in an ongoing
post-approval study in real-world patients with inadequately controlled T2D on at least one ADA, and the Revitalize-1 “Insulin-Treated T2D” study is evaluating Revita in a pivotal Phase 3 clinical
study in patients with inadequately controlled T2D despite being on up to three ADAs and 20 to 100 units of insulin daily, a separate indication to the CE Mark approval.

*********

 We hope that the foregoing has been
responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (212) 906-2916 with any questions or further comments
you may have regarding this filing or if you wish to discuss the above.

Sincerely,

 /s/ Nathan Ajiashvili

 Nathan Ajiashvili

 of LATHAM & WATKINS
LLP

 Enclosures

 cc: (via e-mail)

 Harith Rajagopalan, M.D., Ph.D., Chief Executive Officer, Fractyl Health, Inc.

Johan Brigham, Latham & Watkins LLP

 Evan Smith,
Latham & Watkins LLP

 Jonathan Sarna, Latham & Watkins LLP

Edwin O’Connor, Goodwin Procter LLP

 Alicia Tschirhart,
Goodwin Procter LLP

United States securities and exchange commission logo
October 3, 2023
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Amendment No. 6 to Draft Registration Statement on Form S-1
Submitted September 21, 2023
CIK 0001572616
Dear Harith Rajagopalan:
            We have reviewed your amended draft registration statement and have the following
comment.
            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 our 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.
Amendment No. 6 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Development Pipeline, page 2
1.We note your response to prior comment 2 and reissue in part. Please further clarify if
both the "CE Mark" approval arrow and "Insulin-Treated T2D" arrow are for separate
indications. To the extent both both of these arrows are targeting the same
indication, revise the Revita section of your pipeline table so that the same indication does
not appear twice.
            Please contact Michael Fay at 202-551-3812 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other
questions.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 October 3, 2023 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
October 3, 2023
Page 2
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:       Nathan Ajiashvili, Esq.

United States securities and exchange commission logo
September 15, 2023
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Amendment No. 5 to Draft Registration Statement on Form S-1
Submitted August 22, 2023
CIK 0001572616
Dear Harith Rajagopalan:
            We have reviewed your amended draft registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
            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 our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 5 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your statements here and elsewhere regarding your expected timing to initiate a
first-in-human clinical study of Rejuva. Please remove this disclosure as it appears to be
premature given your disclosure indicates that you have yet to nominate a candidate,
complete preclinical studies and submit an IND for this program.
Our Development Pipeline, page 2
2.Please revise the Revita section of your pipeline table so that the same indication does not
appear twice. In that regard, we note that you have included arrows for both "Germany

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 September 15, 2023 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
September 15, 2023
Page 2
Real World Registry" and "Insulin-Treated T2D", which appear to be duplicative. Please
also revise your pipeline table with respect to Rejuva to show Phase 1, Phase 2 and Phase
3 columns to clearly represent what development stages must be completed prior to
commercialization of this candidate.
3.Please revise this subsection or elsewhere in the Prospectus Summary, as appropriate, to
disclose why you did not commercially launch Revita in Europe prior to the first half of
2023.
What Sets Us Apart, page 3
4.We note that your disclosure here and elsewhere indicates that your product candidates are
designed to target dysfunction with "one-time" treatments. However, your disclosure
throughout the prospectus also indicates that the Revita system is designed to enable
"repeatable" metabolic improvement. Please reconcile your disclosure.
            You may contact Michael Fay at 202-551-3812 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:       Nathan Ajiashvili, Esq.

United States securities and exchange commission logo
January 13, 2022
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted January 12, 2022
CIK 0001572616
Dear Dr. Rajagopalan:
            We have reviewed your amended draft registration statement and have the following
comment.  In our comment, we may ask you to provide us with information so we may better
understand your disclosure.
            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 our 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 comment and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Solution: Revita, page 2
1.We note your response to prior comment 1 and revised disclosure, including your
discussion of the results of the follow-up studies of the PP populations in your Revita-1
feasibility and INSPIRE pilot studies. Please revise here and throughout the prospectus, as
appropriate, to disclose (i) the number of patients who participated in the follow-up
studies and (ii) whether the findings of improvements in glucose control through 24
months in the Revita-1 follow-up and reduced need for insulin through 18 months in the
INSPIRE follow-up were statistically significant.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 January 13, 2022 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
January 13, 2022
Page 2
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Nathan Ajiashvili

United States securities and exchange commission logo
January 4, 2022
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 20, 2021
CIK 0001572616
Dear Dr. Rajagopalan:
            We have reviewed your amended draft registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
            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 our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Our Solution: Revita, page 2
1.We note your response to prior comment 5 and revised disclosures identifying certain
results as derived from "pooled, post-hoc" analysis.  Please revise the Business section to
present the complete results from all pooled and/or post-hoc analyses while discussing the
protocols followed and any material limitations to these analyses.  Please disclose
the number of patients analyzed, indicate whether certain categories of patients were not
analyzed and specify whether the findings were statistically significant.  In this regard, we
note that your disclosure on page 40 indicates that the observed reduction in HbA1c
through 24 months was in "certain patients" who underwent the Revita DMR Procedure.
Also, tell us whether you plan to include pooled, post-hoc analysis in your PMA

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 January 4, 2022 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
January 4, 2022
Page 2
application to demonstrate durability beyond 48 weeks, if required. We may have further
comment regarding this analysis, including the existing descriptions in the Prospectus
Summary, after reviewing your response.
What Sets Us Apart, page 6
2.We note your response to prior comment 10 and re-issue. Please balance your disclosure
that describes the advantages of your product candidates and approach with equally
prominent disclosure regarding challenges, adverse results or disadvantages.
A Letter From Our Co-Founder, page 117
3.We note your response to prior comment 2.  Please revise the prospectus, where
appropriate, to identify the epidemiologists who have made the $2 trillion a year
projection for 2030 and revise your disclosures to clarify whether this is a U.S. or a
worldwide projection.  Similarly revise the prospectus, where appropriate, to identify the
epidemiologists who estimate that half of the individuals with T2D in the United States
are not achieving targeted disease control.
Business, page 118
4.We note your response to prior comment 13 and re-issue in part. Please revise your
Business section to discuss your plans for prospectively studying the safety and
effectiveness of potential repeat procedures relative to your plans to file a PMA and
commercialize. To the extent that your plans do not call for studies in the near term,
please discuss whether the uncertainty cited in the risk factor could impact the scope of
your PMA approval, and explain in greater detail how it could have a material adverse
impact on clinical utility and commercial adoption.
Ongoing Revitalize-1 Pivotal Clinical Study, page 147
5.We note your response to prior comment 16 and re-issue in part. Please revise your
disclosure to discuss the rationale for establishing the pivotal trial endpoints at 24 weeks
and your basis for determining, if true, that data at 24 weeks will support a finding of
durable effectiveness.  In this regard, please revise to discuss what feedback, if any, FDA
staff has provided you with respect to the endpoints and what would be required to
support a successful PMA application for the applicable indication. To the extent that the
scope of PMA approval or commercialization is dictated or impacted by the 24-week
timeframe, please revise to discuss.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 January 4, 2022 Page 3
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
January 4, 2022
Page 3
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Nathan Ajiashvili

United States securities and exchange commission logo
December 14, 2021
Harith Rajagopalan, M.D., Ph.D.
Chief Executive Officer
Fractyl Health, Inc.
17 Hartwell Avenue
Lexington, MA 02421
Re:Fractyl Health, Inc.
Draft Registration Statement on Form S-1
Submitted November 9, 2021
CIK 0001572616
Dear Dr. Rajagopalan:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            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 our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
A Letter From Our Co-Founder, page iii
1.We refer to the letter from your co-founder. Please revise your presentation so that the
letter does not appear in the forepart of the registration statement prior to your Summary.
2.Please revise your founder letter, page 1 of the Summary and page 123 of the Business
section to clarify the source for the following three disclosures: (i) there will be 50 million
people in the United States with type 2 diabetes in 2035, (ii) more than 50% of these
patients will have poorly controlled disease and (iii) that we will be spending $2 trillion
per year combating T2D.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 December 14, 2021 Page 2
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
December 14, 2021
Page 2
Our Solution: Revita, page 2
3.We note your statements here and elsewhere in the prospectus that (i) Revita is intended to
target the organ-level root cause of T2D with an endoscopic procedure that does not
require ongoing patient adherence and (ii) Revita does not rely on perfect patient
adherence or persistence to chronic therapy, unlike diet and lifestyle interventions or
pharmacologic management. Please revise your disclosure here and elsewhere in the
prospectus to clarify that your studies of the Revita system have involved ongoing OADs
and/or a GLP-1ra as well as lifestyle counseling, including a tailored diet. Alternatively,
please advise.
4.Please tell us whether you are aware of independent, peer-reviewed studies which
characterize the dysfunctional duodenal mucosa as a root cause of T2D. To the extent that
these and similar statements throughout the prospectus, including on page 116 and page
130, where you refer to dysfunctional duodenal mucosa as a driver of insulin resistance,
are based on management's belief, please so state.
5.We note your statement highlighting that Revita, in combination with ongoing oral
antidiabetic agents, or OADs, and/or a glucagon-like peptide-1 receptor agonist, and
lifestyle counseling, has been observed to improve glucose control and reduce the need for
insulin for 18 to 24 months.  With a view to revised disclosure, please tell us your basis
for making performance claims beyond 48 weeks. Based on your disclosures on pages
141-152, it is not clear that you have conducted any human trials that assessed patients
beyond 48 weeks or that any improvement measured by anyone beyond 48 weeks is
statistically significant.
6.Please revise your disclosure to indicate whether the "prototype rendering" of the Revita
console is the console that is being used in the Revitalize-1 trial.
7.We note your discussion of the Breakthrough Device designation for Revita. Please revise
your disclosure here and throughout the prospectus where the Breakthrough Device
designation is mentioned to clarify that the process of medical device development is
inherently uncertain and that there is no guarantee that this designation will accelerate the
timeline for approval or make it more likely that Revita will be approved. Also, revise the
prospectus, where appropriate, to disclose, if known, which of the four criteria discussed
on page 161 served as the basis for Revita's designation.
Our Development Pipeline, page 5
8.Please revise your pipeline chart with respect to Rejuva to show Phase 1, Phase 2 and
Phase 3 columns.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 December 14, 2021 Page 3
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
December 14, 2021
Page 3
Our Team, page 5
9.We note that you identify certain entities as investors in your company here and on page
119. However, certain of these entities do not appear to be among your principal
stockholders as disclosed on page 203. If material, please expand your disclosure to
describe the nature of each such entity's investment in your company and explain to us
why including this information is appropriate. Please also explain in the response your
plans to update investors about any changes these entities make with respect to their
investments in your company. Alternatively, please remove these entities from your
disclosure.
What Sets Us Apart, page 6
10.Please balance your summary that describes the advantages of your product candidates
with equally prominent disclosure regarding adverse results or disadvantages.  For
instance, and without limitation, we note your disclosures elsewhere in the prospectus that
very few products utilizing gene transfer have been approved in the U.S. or Europe and no
gene therapy products that utilize an endoscopic method of administration have been
approved.
Summary Risk Factors, page 8
11.Please revise the eighth risk factor on page 8 to explain that there is uncertainty as to
whether patients will need additional procedures in the future.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Research and Development expenses, page 107
12.Please separately disclose in tabular form your R&D expenses incurred for each year
presented by product candidate or project.
Business, page 116
13.We refer to your risk factor disclosure on page 40 indicating that you have not yet studied
the ability of Revita to be used in repeated procedures.  Please revise the Business section
to discuss your plans for studying this area, including the timing of the referenced study or
studies relative to your plans to file a PMA application and commercialize.  To the extent
that your plans do not call for studies in the near term, please discuss whether the
uncertainty cited in the risk factor could impact the scope of your PMA approval, and
explain in greater detail how it could have a material adverse impact on clinical utility and
commercial adoption.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 December 14, 2021 Page 4
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
December 14, 2021
Page 4
Type 2 Diabetes Overview, page 124
14.Please revise to provide the source for the figures presented in the graphic at the top of
page 124. Please also revise to provide sources for the data that appear in the graphics on
pages 134 and 135.
Clinical Data Overview: Revita, page 141
15.Please revise your disclosure regarding the Revita-2 and the Revita First-in-Human
studies to clearly state whether (i) each study achieved its endpoints and (ii) the reported
reductions in HbA1c, MRI-PDFF, HOMA-IR and weight were statistically significant.
Ongoing Revitalize-1 Pivotal Clinical Study, page 145
16.We note that the primary efficacy endpoint for the Revitalize-1 study occurs at 24 weeks.
We note that this timeframe is shorter than for some of the completed studies referenced
in this section and for the performance claims highlighted in the Summary.  Please discuss
the rationale for establishing the pivotal trial endpoint at 24 weeks and your basis for
determining, if true, that data at 24 weeks could support a finding of durable
effectiveness.  To the extent that the scope of PMA approval or commercialization is
dictated or impacted by the 24-week timeframe, please revise to discuss.
INSPIRE Pilot Study, page 150
17.Please identify the investigators and indicate whether these results have been published.
Depending on your responses to this comment and comment 5 above, we may have
further comment.
Intellectual Property, page 155
18.Please revise this section to reflect your disclosure on page 68 indicating that you are
aware of (i) third-party patents and patent applications that may be construed to cover
your product candidates or technologies, including Revita and (ii) pending patent
applications that if they result in issued patents could be alleged to be infringed by some
of your product candidates or technologies, including Revita.
Executive and Director Compensation, page 191
19.Please revise this section to describe your employment arrangements with your named
executive officers.
General
20.Please supplementally provide us with 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,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copes of the communications.

 FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
 Comapany NameFractyl Health, Inc.
 December 14, 2021 Page 5
 FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
December 14, 2021
Page 5
            You may contact Michael Fay at 202-551-3812 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters.  Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Nathan Ajiashvili