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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
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
FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
support a successful PMA application for the applicable indication. To
the extent that the
Comapany
scopeNameFractyl Health,orInc.
of PMA approval commercialization is dictated or impacted
by the 24-week
timeframe, please
January 4, 2022 Page 2 revise to discuss.
FirstName LastName
Harith Rajagopalan, M.D., Ph.D.
FirstName LastNameHarith Rajagopalan, M.D., Ph.D.
Fractyl Health, Inc.
Comapany
January NameFractyl Health, Inc.
4, 2022
January
Page 3 4, 2022 Page 3
FirstName LastName
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