SEC Comment Letter 0000000000-24-006605 to Anteris Technologies Global Corp. (AVR) (CIK 0002011514) (AVR)
Anteris Technologies Global Corp. (AVR) (CIK 0002011514)
Date: June 10, 2024 · CIK: 0002011514 · Accession: 0000000000-24-006605
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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
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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
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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
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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
your disclosure relating to your participation in Health Canada’s SAP, including the
duration of the participation and if you have entered into any agreement with Health
Canada.
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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
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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 p