United States securities and exchange commission logo





                              June 9, 2024

       Paterson Wayne
       Chief Executive Officer
       Anteris Technologies Global Corp.
       860 Blue Gentian Road
       Suite 340
       Eagan, Minnesota 55121

                                                        Re: Anteris
Technologies Global Corp.
                                                            Amendment No. 1 to
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted May 13,
2024
                                                            CIK No. 0002011514

       Dear Paterson Wayne:

                                                        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.

       Amendment No. 1 to Draft Registration Statement on Form S-1 submitted
May 13, 2024

       Prospectus Summary, page 1

   1.                                                   We note your prominent
disclosure of your pivotal clinical trial for the DurAVR THV
                                                        system in the Summary
and in the pipeline table on page 58 and that you "are aiming to
                                                        secure approval from
the FDA to undertake" this trial. Please expand your disclosure here
                                                        and elsewhere in the
registration statement relating to the design and scope of your pivotal
                                                        clinical trial and
specify when you expect to secure the FDA's approval. Please also revise
                                                        to disclose the date
the FDA determined under the IDE that you met the regulatory
                                                        requirements for
manufacturing the DurAVR valve at your facility.
   2.                                                   We note your disclosure
on page 2 that "[t]he total market opportunity for TAVR is
                                                        expected to reach $10
billion in 2028." You also disclose on page 54 that you estimate the
 Paterson Wayne
FirstName  LastNamePaterson  Wayne
Anteris Technologies Global Corp.
Comapany
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         total addressable market of TAVR to be $35 million. Please revise to
discuss how you
         calculated the estimates of the total market opportunity and
addressable market, and
         specify the relevant jurisdiction(s) for your estimates.
3.       We note your disclosure that "[c]ontinuous introduction of new
products and
         improvements of existing products is required for us to maintain
market leadership in a
         market subject to accelerated technological innovations." For all
statements here and
         throughout the registration statement regarding industry leadership,
please substantiate
         your claims or remove such statements.
4.       We note your disclosure on page 64 that your DurAVR THV system is
classified as a
         Class III medical device. Please revise your disclosure in the Summary
to briefly discuss
         the FDA   s regulation and classification of medical devices and
include disclosure of your
         DurAVR THV system   s Class III classification as well.
5.       We note your disclosure in the Summary of your    significant growth
potential in a large,
         underpenetrated and growing market    and the advantages of your
DurAVR THV system
         compared to the limitations of current standard-of-care TAVRs. Please
balance your
         disclosure with equally prominent disclosure that you are a
development stage company
         and to highlight that you have incurred net losses in each year since
your inception and the
         challenges you face in implementing your business strategy and gaining
market
         acceptance.
Risk Factors, page 9

6.       We note your disclosure on page 19 that you "work with leading global
physicians who
         provide considerable knowledge and experience." We also note your
disclosure on pages
         19 and 23 that you are "dependent on third parties to conduct [y]our
clinical trials and
         preclinical studies for [y]our DurAVR    THV system", that you "rely
on, and will
         continue to rely on, medical institutions, clinical investigators, lab
service providers, and
         consultants to conduct clinical trials and preclinical studies", and
that "historically [you]
         also entered into collaborative arrangements and strategic alliances
to provide [you]
         access to new technologies". Finally, we note your disclosure on pages
20 and 21 that you
         "rely on third parties for a broad range of materials and other items
in the design and
         manufacture of certain of [y]our products" and that you "currently
rely on a limited
         number of suppliers of components for [y]our devices". Please revise
to identify the
         partners, third parties, manufacturers and/or suppliers that you rely
on and discuss the
         terms of any material contracts or relationships with such parties.
Please also file such
         material contracts as exhibits to your registration statement or
provide your analysis as to
         why each is not material. Refer to Item 601(b)(10) of Regulation S-K.
Our operations are subject to environmental, health, and safety regulations
that could result in
substantial costs., page 27

7.       We note your disclosure that you "have incurred and may incur in the
future expenditures
         in connection with environmental, health and safety laws, and
regulations." Please revise
 Paterson Wayne
FirstName  LastNamePaterson  Wayne
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         to discuss these past expenditures.
Certain of our directors reside outside of the United States and it may be
difficult to bring or
enforce judgments..., page 33

8.       Please revise to disclose which of your directors and executive
officers reside outside of
         the United States.
We may be unable to achieve some or all of the benefits that we expect to
achieve from the
Reorganization, which could materially..., page 33

9.       We note your disclosure that "[t]he ATL board of directors believes
that the
         Reorganization is in the best interests of ATL   s shareholders and
optionholders because it
         has the potential to improve the attractiveness of [y]our company as a
potential target for
         change of control transaction". Please revise, either in this risk
factor or elsewhere, as
         applicable, to further discuss the motivations behind the
reorganization. In particular,
         please elaborate on what you mean by "change of control transaction".
Our Amended and Restated Bylaws will designate the Court of Chancery of the
State of
Delaware as the sole and exclusive forum..., page 40

10.      Please revise to also note that the choice-of-forum provisions may
result in increased costs
         for stockholders seeking to bring a claim against the company and/or
its directors,
         officers, employees or agents.
Use of Proceeds, page 45

11.      Please revise to disclose the approximate amount of proceeds that you
plan to allocate for
         each of the following: (a) for the preparation of the FDA pivotal
trial of DurAVR    THV;
         (b) for continued ViV trials; and (c) for working capital and other
general corporate
         purposes. Please also disclose how far the proceeds from the offering
will allow you to
         proceed with the continued development of each of your products and
trials. Refer to
         Instruction 3 to Item 504 of Regulation S-K.
Business, page 52

12.      We note your disclosures throughout the business section regarding the
efficacy of your
         products. In particular, we note the following disclosures:

                Page 54: "In addition, our DurAVR THV system has been developed
to last longer
              than traditional three-piece aortic valves biomechanically, and
aims to provide a
              better quality of life compared to the current standard of care."
                Page 55: "ADAPT tissue has been clinically proven to be
calcium-free for up to
              10 years and distributed for use in over 55,000 patients
globally."
                Page 55: "ADAPT has been observed to offer potentially
significant improvements
              compared with other widely available commercial processes adopted
by healthcare
 Paterson Wayne
Anteris Technologies Global Corp.
June 9, 2024
Page 4
              providers, including with respect to bio-compatibility,
durability, strength, pliability,
              functionality and controlled remodeling."
                Page 56: "Within the ComASUR delivery system, we have
rotational control of the
              DurAVR valve with the native commissures. This allows for
commissure alignment
              which is superior to a number of others in the market."

         Please revise your disclosures to provide support for the above
statements.
13.      Please clarify the meaning of scientific or technical terms the first
time they are used in
         the Business section or in close proximity thereto in order to ensure
that lay readers will
         understand the disclosure. For example, please briefly explain what
you mean by
         xenograft, bio scaffold, commissures, laminar flow, hemodynamics,
coaption, and
         acellularized.
14.      We note your disclosure on page 60 that CardioCel was approved by the
FDA in 2014 for
         use in human medical device applications. Please expand your
disclosure here and
         throughout your registration statement relating to each of your
products, including
         CardioCel, VascuCel, ADAPT and the ComASURE system, to discuss the FDA
  s
         classification for each such product and clarify whether you have
applied for or received
         regulatory approvals for such products.
Clinical Results and Trials, page 57

15.      We note your disclosure here and in the Summary relating to your FIH
study. Please
         expand your disclosure of the scope and design of the study, including
the primary
         endpoint, the age range of the participants, the criteria used for the
enrollment of
         participants, whether the study was powered for statistical
significance, and discuss the p-
         values and statistical significance. Please revise your
characterizations of the study to
         discuss the data and results, including a brief discussion of the EOA,
MPG and DVT
         metrics.
16.      We refer to your disclosure on page 60 that you have partnered with
IQVIA Inc., the
         Cardiovascular Research Foundation, Yale University and the Yale
Cardiovascular
         Research Group in connection with your Early Feasibility Study. Please
expand your
         disclosure to clarify the scope and duration of these partnerships and
whether you have
         entered into any agreements with these parties, and if so, please
provide a brief description
         of the material terms of such arrangements.
17.    We note your disclosure on page 60 that your DurAVR THV system was used
in a ViV
       procedure as part of Health Canada   s Special Access Program (   SAP
). Please expand
FirstName LastNamePaterson Wayne
       your disclosure relating to your participation in Health Canada   s SAP,
including the
Comapany   NameAnteris
       duration           Technologies
                of the participation and Global Corp.entered into any agreement
with Health
                                         if you have
June 9,Canada.
        2024 Page 4
FirstName LastName
 Paterson Wayne
FirstName  LastNamePaterson  Wayne
Anteris Technologies Global Corp.
Comapany
June 9, 2024NameAnteris Technologies Global Corp.
June 9,
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FirstName LastName
License Agreements, page 60

18.      We note your disclosure on pages 60 and 61 that "[o]n October 11,
2019, [you] sold the
         distribution rights and exclusive intellectual property licenses for
CardioCel and
         VascuCel to LeMaitre Vascular Inc., along with certain other related
assets, in order to
         focus [y]our business on the development of [y]our proprietary ADAPT
tissue for the
         DurAVR THV system." We also note your disclosure that "[c]oncurrent
with such sale,
         [you] entered into a distribution agreement with LeMaitre Vascular
pursuant to which
         [you] manufacture and sell CardioCel and VascuCel products to LeMaitre
Vascular in
         exchange for a fixed unit fee." Please revise to address the following
issues:

                Please revise to discuss the consideration that you received
for the sale of
              the distribution rights and exclusive intellectual property
licenses. Please also
              disclose the fixed unit fee in connection with the distribution
agreement, and specify
              the jurisdictions where CardioCel and VascuCel are currently sold
and the status of
              EMDDR's review and approval of these products; and
                Please expand your disclosure relating to the material terms of
the distribution
              agreement, including the termination provisions, minimum purchase
commitments,
              and aggregate amounts received to date under such agreement, as
applicable. Please
              also file this agreement as an exhibit to the registration
statement as required by Item
              601(b)(10) of Regulation S-K or explain to us why you believe you
are not required
              to do so.
19.      Please revise your disclosures regarding your license and
collaboration agreements as
         follows:

                We note your disclosure on page 61 that on August 30, 2017, you
entered into a
              supply and license agreement with 4C Medical Technologies, Inc.
Please revise to
              discuss the consideration received for your entry into the supply
and license
              agreement, when the last-to-expire patent is scheduled to expire,
the royalty term, the
              termination provisions, minimum purchase commitments, royalty
rates, and the
              aggregate amounts received to date under such agreements, as
applicable; and
                We note your disclosure on page 61 that on December 5, 2022,
you entered into a
              material development agreement with the Ear Science Institute
pursuant to which you
              have the right to use ESI   s ClearDrum technology. Please revise
to discuss the
              consideration received for your entry into the development
agreement, and any
              applicable termination provisions. Please also file the material
development
              agreement as an exhibit to your registration statement or provide
your analysis as to
              why the agreement does not need to be filed pursuant to Item
601(b)(10) of
              Regulation S-K.
20.      We also note your disclosure on page 61 that on April 18, 2023, you
purchased 30% of the
         equity capital stock of v2vmedtech pursuant to a contribution and
stock purchase
         agreement, and concurrently entered into a series of development
agreements with
 Paterson Wayne
Anteris Technologies Global Corp.
June 9, 2024
Page 6
         v2vmedtech, which included a perpetual and exclusive license to
v2vmedtech   s
         technology and data developed pursuant to such agreements. Please
revise to address the
         following issues:

                Please revise to discuss the nature and scope of the
intellectual property transferred,
              the aggregate amounts paid to date under these agreements
(including any up-front or
              execution payments), aggregate future potential milestone
payments to be paid or
              received, royalty rates, and termination provisions, as
applicable. We also note your
              disclosure that the v2v development agreements will expire one
year after the    final
              development stage    of the agreement. Please expand your
disclosure relating to the
              various development stages of the agreement, including any
specified milestones;
                You disclose that the license to v2vmedtech   s developed
technology and data
              excludes    certain applications within v2vmedtech's field of
use." Please provide
              additional detail relating to these applications; and
                Please also revise to provide support for your claim that the
mitral and tricuspid valve
              repair space is expected to reach $2.8 billion in 2028 and
specify the relevant
              jurisdiction(s) for this estimate.
Competition, page 62

21.      We note your disclosure that your primary competitors include Edwards
Lifesciences
         Corporation and Medtronic plc. Please revise to discuss whether any of
your competitors
         are developing similar TAVR products consisting of single-piece heart
valves, and
         whether such products are available commercially.
Intellectual Property, page 62

22.      We note your disclosure that you rely on a combination of patent,
copyright, trademark
         and trade secret laws and confidentiality and invention assignment
agreements to protect
         your intellectual property rights in the United States and other
markets. Please revise your
         disclosure to address the following:

             We note your disclosure relating to your rights to 42 issued
patents and 57 pending
           patent applications. Please expand your disclosure relating to your
patent portfolio
           and identify for each material patent and patent application, as
applicable, the scope
           and technology of each such patent or patent application, the type
of patent
           protection, jurisdiction, and expiration dates. Consider adding
tabular disclosure in
           addition to the narrative for ease of use; and
           Please revise to specify when you obtained your trademarks and
whether your
FirstName LastNamePaterson
           intellectual propertyWayne
                                  includes federal or state trademarks. If they
are state trademarks,
Comapany please
           NameAnteris    Technologies   Global
                   discuss the differences       Corp.
                                           between   the benefits and rights of
a federal and state
           trademark.
June 9, 2024 Page 6
FirstName LastName
 Paterson Wayne
FirstName  LastNamePaterson  Wayne
Anteris Technologies Global Corp.
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Manufacturing and Supply, page 63

23.      We note your disclosure that you invested $30.9 million in research
and development in
         2023. Please revise to further discuss how this investment was
allocated.
Facilities, page 74

24.      We refer to your disclosure relating to your leased properties in
Australia and Minnesota.
         Please revise to file each material lease agreement as exhibits or
tell us why you believe
         each of the leases is not material. Refer to Item 102 and Item
601(b)(10)(ii)(D) of
         Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, Comparison of Years Ended December 31, 2023 and December
31, 2022
Research and Development Expense, page 80

25.      We note from page 79 that your research and development expenses have
been for the
         early design and development of the DurAVR    THV system, the ComASUR
  delivery
         system, a disposable crimper, and an expandable access sheath. Please
disclose the costs
         incurred during each period presented for each of your
         key research and development product candidates. If you do not track
         your research and development costs by project, disclose that fact and
explain why you do
         not maintain and evaluate research and development costs by project.
26.      As a related matter, please revise your disclosure to quantify each
item identified as a
         reason for the increase in research and development expense from 2022
to 2023.
Executive Compensation, page 93

27.      Please revise your summary compensation table to disclose the
compensation paid to the
         NEOs during the last two completed fiscal years. Refer to Item 402(n)
of Regulation S-K.
Principal Stockholders, page 100

28.      Please revise your footnotes to your table to identify the natural
persons who are the
         beneficial owners of the shares held by L1 Capital Pty Ltd, Perceptive
Advisors LLC, and
         Sio Capital Management, LLC.
Certain Material U.S. Federal Income Tax Consequences To Non-U.S. Holders, page
106

29.      Please revise your heading and the introductory paragraph to clarify
that the discussion is
         of material tax considerations, not merely "certain" tax consequences.
Refer to Section
         III.C.1 of Staff Legal Bulletin 19.
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Anteris Technologies Ltd Consolidated Financial Statements for the year ended
December 31,
2023
Note 2. Summary of Significant Accounting Policies
(d) Revenue and Other income, page F-9

30.      We note that you offer warranties on your tissue and valves that they
conform to the
         specifications, fit for their intended purpose, and do not have
material defects. Please
         disclose how you account for product warranties. Refer to ASC
460-10-25-5 through 25-
         7.
Note 20. Acquisition of Subsidiary, page F-45

31.      We reference the statement that you used a third-party valuation
specialist to determine
         the fair value of the IPR&D asset and the fair value of the
anti-dilution rights. Please tell
         us the nature and extent of the specialist   s involvement and whether
you believe the
         specialist was acting as an expert as defined under Section 11(a) of
the Securities Act of
         1933 and Section 436(b) of Regulation C, such that you must disclose
the name of the
         specialist in the Form S-1 along with a consent from the specialist.
If you conclude the
         specialist is not considered an expert under the Securities Act,
please revise your
         disclosures to clarify.
32.      Please revise your balance sheet to comply with ASC 810-10-45-25 and
provide the
         disclosures required by ASC 810-10-50-2AA(b) and (d).
Note 24. Segment Reporting, page F-48

33.      Please tell us how you assessed ASC 280-10-50 in determining that the
sales of
         regenerative tissue products is not a separate operating segment.
General

34.      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 those
         communications.
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FirstName  LastNamePaterson  Wayne
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       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 Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other
questions.



                                                         Sincerely,

                                                         Division of
Corporation Finance
                                                         Office of Industrial
Applications and
                                                         Services
cc:      Jeremy W. Cleveland, Esq.