United States securities and exchange commission logo





                             August 3, 2023

       Lori Bisson
       Chief Executive Officer
       Autonomix Medical, Inc.
       21 Waterway Avenue, Suite 300
       The Woodlands, TX 77380

                                                        Re: Autonomix Medical,
Inc.
                                                            Offering Statement
on Form 1-A
                                                            Filed July 7, 2023
                                                            File No. 024-12296

       Dear Lori Bisson:

              We have reviewed your offering 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 amending your offering statement
and providing the
       requested information. 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 any amendment to your offering statement and
the information you
       provide in response to these comments, we may have additional comments.

       Offering Statement on Form 1-A filed July 7, 2023

       Cover Page

   1.                                                   We note your disclosure
that "We will pay a cash commission of 7.0% to Digital Offering
                                                        on sales of the shares
of common stock from investors introduced to us by Digital
                                                        Offering and issue a
warrant to Digital Offering to purchase that number of shares of
                                                        Common Stock equal to
7.0% of the total number of shares sold in this offering,
                                                        exercisable for five
years at $6.25 per share." Please amend your cover page, including
                                                        your table, to include
the warrants and underlying common shares in the total volume of
                                                        securities you are
seeking to qualify in this offering, and the total dollar amount of
                                                        securities you are
seeking to qualify on this offering statement. In this regard, we note
                                                        your disclosure that
your filing "also registers the issuance of the shares of our common
                                                        stock issuable upon
exercise of such Selling Agent   s warrants," but it does not appear that
                                                        these additional shares
or the warrants are included in the total volume of securities on
                                                        your cover page.
 Lori Bisson
FirstName
AutonomixLastNameLori
            Medical, Inc. Bisson
Comapany
August      NameAutonomix Medical, Inc.
        3, 2023
August
Page 2 3, 2023 Page 2
FirstName LastName
Summary, page 4

2.       We note certain statements eluding to or stating efficacy
determinations throughout your
         offering circular. For example, you state that your "technology
platform includes a
         catheter-based microchip-enabled sensing array that can detect and
differentiate neural
         signals with up to 1,000 times greater sensitivity than currently
available transvascular
         technologies," your sensing catheter is able to "demonstrate efficacy
in animal models,"
         and that "there was a statistically significant reduction in tumor
progression" in your Pilot
         Mouse Study. Please revise, throughout the offering circular,
disclosure that states or
         implies that your device in development is effective, as these
determinations are solely
         within the authority of the FDA and comparable regulatory bodies. We
do not object to
         the presentation of objective data resulting from your trials without
conclusions related to
         efficacy. Make conforming changes throughout your filing, including
the description of
         your business.
3.       Please amend your summary to disclose, as you do on page 10, that as
of March 31, 2023,
         you had an accumulated deficit of $23,543,465, negative cash flows
from operating
         activities of $1,854,398 and working capital of $644,028, which raises
substantial doubt
         about your ability to continue as a going concern.
4.       As a related matter, please amend your disclosure in this section to
clearly disclose, if
         true, that you have not yet assembled or tested your device. In this
regard, we note your
         risk factor disclosure on page 15 that "[w]e have no experience in
assembling and testing
         our planned device, and no experience in doing so on a commercial
scale." Alternatively,
         please revise your disclosure in the risk factor section for
consistency, or advise.
Risk Factors
Concentration of ownership of our common stock . . ., page 23

5.       We note your disclosure that "[yo]ur executive officers and directors,
and their affiliates,
         in the aggregate, beneficially own approximately 55.0% of [y]our
outstanding common
         stock as of the date hereof." Please tell us whether you will be
deemed a
         "controlled company" as defined by the market on which you intend to
list your securities
         and, if so, whether you intend to rely on any exemptions as a
controlled company. If
         applicable, please disclose on the prospectus cover page and in the
prospectus summary
         that you are a controlled company, and include a risk factor that
discusses the effect, risks
         and uncertainties of being designated a controlled company.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development, page 37

6.       We note the significant increase in your research and development
expenses in fiscal
         2023. Please revise future filings to provide more details about your
research and
         development expenses for each period presented, including but not
limited to by
         product/program as well as by the nature of the expenses. To the
extent that you do not
 Lori Bisson
FirstName
AutonomixLastNameLori
            Medical, Inc. Bisson
Comapany
August      NameAutonomix Medical, Inc.
        3, 2023
August
Page 3 3, 2023 Page 3
FirstName LastName
         track expenses by product candidate, please disclose as such.
Liquidity and Capital Resources, page 38

7.       We note your disclosure in Results of Operations that "[t]he change in
[general and
         administrative expense] is attributable primarily to the warrant
expense of $12,866,911
         incurred during the year ended March 31, 2022 related to our SAFE
instrument." We also
         note your disclosure in the notes to the financial statements
describing the "SAFE
         Financing." In your "Liquidity and Capital Resources" section, please
provide additional
         detail describing the SAFE financing, including what the SAFE
instrument is, the date of
         issuance, and any relevant, material terms of the issuance and the
instrument.
Business, page 39

8.       Please provide support for the following disclosure, or characterize
the statements as
         management's opinions or beliefs:

                "very few tools currently exist for the sensing and targeting
of individual nerve fibers
              within the peripheral nervous system;"

                "Although this vascular superhighway has long been utilized for
certain catheter-
              based evaluation and intervention, its use throughout the body
has been limited by the
              lack of adequate sophistication of catheter systems;"

                "This is a relatively quick, very common and safe method of
access that should
              significantly reduce the potential for complications as compared
with NCPB. With
              the benefit of our sensing technology, we have the potential to
identify and target the
              nerves that are responsible for the pain signal and with the
ability to focus the
              ablative energy on that target, we should have a much greater
degree of accuracy,
              control and reliability as compared with NCPB;"

                "When comparing to the use of opioids, the potential benefits
are even more
              obvious;" and

                the pain management market is a "$70 billion" market, and the
hypertension market
              is a "$20 billion" market.

         In addition, we note your statement that "All told, we believe the
Autonomix platform has
         the potential to address more than $100 billion in market
opportunities." Please clarify
         how you calculated that the potential addressable market for the
Autonomix platform is
         $100 billion.
The Sensing Problem, page 40

9.       Where you make a claim that is supported by industry literature or
state the findings of
         such literature, please provide a citation to and, at each source's
first instance, include
 Lori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 4
         language summarizing the material conclusions of such literature. This
includes, but is
         not limited to, the the American Cancer Society's "Key Statistics for
Pancreatic Cancer"
         and "[a] market analysis published by Precedence Research" on page 44.
As a related
         matter, please provide a citation to the "published survey" you
reference in the section
         "Significant Unmet Need," and the "[s]tudies in animals" referenced on
page 44.
The Autonomix Solution, page 41

10.      We note that you analogize the equipment used in a catheter lab to a
"mountain" and show
         an image of a "typical catheter room." However, we also note that the
object your
         microchip replaces, based on the disclosure's description and the
graphic's circle
         designating the replacement, does not appear to take up a large
percentage of the room.
         Please revise to balance your disclosure and ensure that your
description of your device
         and its ability remains objective, and clearly disclose, as
appropriate throughout, that your
         device and its abilities are still in development. In addition, please
clarify whether the
         "proprietary chipset" shown in your diagram has been developed, or is
a rendering of your
         intended device. In this regard, we note your disclosure elsewhere
that your device has
         yet to be assembled or tested.
Beneficial Clinical Trial Dynamics/Expedited Regulatory Process, page 43

11.      We note that you "believe regulatory authorities are willing to
consider lower preclinical
         hurdles and smaller and simpler trial designs to help encourage trial
sponsors to seek
         improved treatment options." Please revise your disclosure to state
that these decisions
         are under the exclusive control of regulatory authorities and there is
no guarantee that
         certain trial designs will be approved. Further, when discussing
trials, such as the
         reference to a "pivotal clinical trial" on pages 4 and 39, please
revise to state that there is
         no guarantee that the results of the trials will produce positive
results or that the results
         will support the Company's claims.
Regulatory Pathway, page 46

12.      Here and throughout your offering circular, such as on page 48, when
         discussing regulatory approvals and projected timelines, please revise
to state that any
         such approvals or time frames are not guaranteed. Please also describe
the logistics
         related to establishing a Proof of Concept in Europe with the
intention to focus your
         approval process on the United States.
Technology Development, page 47

13.    We note that you plan to use an existing "off label" RF system in a PoC
trial attempting to
FirstName LastNameLori Bisson
       demonstrate that transvascular ablation of certain nerves will reduce
pain. Please provide
Comapany
       moreNameAutonomix      Medical,
             detail regarding this        Inc.material steps necessary to
complete prior to initiation
                                   trial and
Augustof3,this
           2023trial.
                  Page 4
FirstName LastName
 Lori Bisson
FirstName
AutonomixLastNameLori
            Medical, Inc. Bisson
Comapany
August      NameAutonomix Medical, Inc.
        3, 2023
August
Page 5 3, 2023 Page 5
FirstName LastName
Intellectual Property, page 49

14.      Please revise to identify, for each material patent and provisional
patent application, the
         identification number, type of patent protection, jurisdiction in
which the protection is
         held, and expiration dates. Please also update your discussion to
include the timeline of
         your specific trademarks, whether they are currently in active use,
and whether they must
         be in continued use or will be maintained until a third-party
challenge. In this regard, a
         tabular format may be useful.
15.      We note your disclosure that "[i]n December 2021, we granted a company
affiliated with
         certain early investors in the Company a license to our technology for
use in the field of
         cardiology. The license provides the Company with an option to
terminate in exchange for
         a termination fee of $14 million, which amount is payable in shares of
common stock of
         the Company following Offering and which option the Company intends to
exercise."
         Please amend your disclosure to provide additional detail regarding
this license
         agreement, including any fees paid by the licensee to the company and
any revenue
         generated under this agreement to date. Also, disclose the number of
shares of common
         stock the company may issue in lieu of the termination fee, and amend
your risk factors to
         disclose any risks related to dilution from the issuance of these
shares.
Exclusive Forum Provision, page 63

16.      Please revise this section to disclose the risks that the exclusive
forum provision may
         result in increased costs for investors to bring a claim. Please make
conforming changes
         to your risk factor at the top of page 27. As a related matter, please
amend your risk factor
         disclosure to include the risks to investors related to the forum
selection provision in your
         subscription agreement described on page 75.
Exhibits

17.      Please include all material exhibits in future filings. This includes,
but may not be limited
         to, the employment agreement with Lori Bisson and your 2023 Stock
Plan.
        We will consider qualifying your offering statement at your request. If
a participant in
your offering is required to clear its compensation arrangements with FINRA,
please have
FINRA advise us that it has no objections to the compensation arrangements
prior to
qualification.

        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. We also remind you that, following qualification of your
Form 1-A, Rule 257
of Regulation A requires you to file periodic and current reports, including a
Form 1-K which
will be due within 120 calendar days after the end of the fiscal year covered
by the report.
 Lori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 6

       You may contact Christie Wong at 202-551-3684 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Benjamin Richie at 202-551-7857 or Katherine Bagley at 202-551-2545
with any other
questions.



                                                          Sincerely,

FirstName LastNameLori Bisson                             Division of
Corporation Finance
                                                          Office of Industrial
Applications and
Comapany NameAutonomix Medical, Inc.
                                                          Services
August 3, 2023 Page 6
cc:       Cavas S. Pavri
FirstName LastName