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Anteris Technologies Global Corp.
Response Received
1 company response(s)
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Anteris Technologies Global Corp.
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Anteris Technologies Global Corp.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2024-11-19
Anteris Technologies Global Corp.
Filing - SEC Comment Letter to Anteris Technologies Global Corp.
UPLOAD · 2024-11-19
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Company responded
2024-11-22
Anteris Technologies Global Corp.
Filing - Correspondence from Anteris Technologies Global Corp.
CORRESP · 2024-11-22
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Company responded
2024-12-10
Anteris Technologies Global Corp.
Filing - Correspondence from Anteris Technologies Global Corp.
CORRESP · 2024-12-10
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Anteris Technologies Global Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-10-28
Anteris Technologies Global Corp.
Filing - SEC Comment Letter to Anteris Technologies Global Corp.
UPLOAD · 2024-10-28
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Anteris Technologies Global Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-08-26
Anteris Technologies Global Corp.
Filing - SEC Comment Letter to Anteris Technologies Global Corp.
UPLOAD · 2024-08-26
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Anteris Technologies Global Corp.
Awaiting Response
0 company response(s)
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SEC wrote to company
2024-06-10
Anteris Technologies Global Corp.
Filing - SEC Comment Letter to Anteris Technologies Global Corp.
UPLOAD · 2024-06-10
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-06 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2026-01-06 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 333-292565 | Read Filing View |
| 2025-12-09 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-12-10 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-12-10 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-11-22 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-11-19 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-10-28 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-06-10 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-06 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 333-292565 | Read Filing View |
| 2024-11-19 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-10-28 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| 2024-06-10 | SEC Comment Letter | Anteris Technologies Global Corp. | DE | 377-07104 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-06 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2025-12-09 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-12-10 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-12-10 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
| 2024-11-22 | Company Response | Anteris Technologies Global Corp. | DE | N/A | Read Filing View |
2026-01-06 - CORRESP - Anteris Technologies Global Corp.
CORRESP 1 filename1.htm ANTERIS TECHNOLOGIES GLOBAL CORP. Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD 4066 Australia January 6, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Anteris Technologies Global Corp. Registration Statement on Form S-3 File No. 333-292565 Ladies and Gentlemen: Anteris Technologies Global Corp. (the “ Company ”) respectfully requests under Rule 461 promulgated under the Securities Act of 1933, as amended, that the effective date of the above-referenced Registration Statement on Form S-3 (the “ Registration Statement ”) be accelerated to 4:00 p.m. Eastern time on January 8, 2026, or as soon thereafter as practicable, or at such later time as the Company or our legal counsel, Jones Day, may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. Once the Registration Statement has been declared effective, the Company respectfully requests that you confirm that event with Jeremy Cleveland of Jones Day by a telephone call to (650) 687-4173. Please contact Jeremy Cleveland, of Jones Day, if you have any questions concerning the foregoing. Thank you for your attention to this matter. Very truly yours, ANTERIS TECHNOLOGIES GLOBAL CORP. By: /s/ Wayne Paterson Name: Wayne Paterson Title: Chief Executive Officer
2026-01-06 - UPLOAD - Anteris Technologies Global Corp. File: 333-292565
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 6, 2026 Wayne Paterson Chief Executive Officer Anteris Technologies Global Corp. 860 Blue Gentian Road Suite 340 Eagan, MN 55121 Re: Anteris Technologies Global Corp. Registration Statement on Form S-3 Filed January 2, 2026 File No. 333-292565 Dear Wayne Paterson: 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 Nicholas O'Leary at 202-551-4451 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Jeremy W. Cleveland, Esq. </TEXT> </DOCUMENT>
2025-12-09 - CORRESP - Anteris Technologies Global Corp.
CORRESP 1 filename1.htm ANTERIS TECHNOLOGIES GLOBAL CORP. Toowong Tower, Level 3, Suite 302 9 Sherwood Road Toowong, QLD 4066 Australia December 9, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Anteris Technologies Global Corp. Registration Statement on Form S-1 File No. 333-291821 Ladies and Gentlemen: Anteris Technologies Global Corp. (the “ Company ”) respectfully requests under Rule 461 promulgated under the Securities Act of 1933, as amended, that the effective date of the above-referenced Registration Statement on Form S-1 (the “ Registration Statement ”) be accelerated to 4:00 p.m. Eastern time on December 11, 2025, or as soon thereafter as practicable, or at such later time as the Company or our legal counsel, Jones Day, may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. Once the Registration Statement has been declared effective, the Company respectfully requests that you confirm that event with Jeremy Cleveland of Jones Day by a telephone call to (650) 687-4173. Please contact Jeremy Cleveland, of Jones Day, if you have any questions concerning the foregoing. Thank you for your attention to this matter. Very truly yours, ANTERIS TECHNOLOGIES GLOBAL CORP. By: /s/ Matthew McDonnell Name: Matthew McDonnell Title: Chief Financial Officer
2024-12-10 - CORRESP - Anteris Technologies Global Corp.
CORRESP
1
filename1.htm
ANTERIS TECHNOLOGIES GLOBAL CORP.
Toowong Tower, Level 3, Suite 302
9 Sherwood Road
Toowong, QLD 4066
Australia
December 10, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Anteris
Technologies Global Corp.
Registration
Statement on Form S-1
File
No. 333-283414
Ladies and Gentlemen:
Anteris Technologies Global Corp. (the “Company”)
respectfully requests under Rule 461 promulgated under the Securities Act of 1933, as amended, that the effective date of the above-referenced
Registration Statement on Form S-1 (as amended, the “Registration Statement”) be accelerated to 4:00 p.m. Eastern
time on December 12, 2024, or as soon thereafter as practicable, or at such later time as the Company or our legal counsel, Jones
Day, may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission.
Once the Registration Statement has been declared
effective, the Company respectfully requests that you confirm that event with Jeremy Cleveland of Jones Day by a telephone call to (650)
687-4173.
Please contact Jeremy Cleveland, of Jones Day,
if you have any questions concerning the foregoing. Thank you for your attention to this matter.
Very truly yours,
ANTERIS TECHNOLOGIES GLOBAL CORP.
By:
/s/ Wayne Paterson
Name:
Wayne Paterson
Title:
Chief Executive Officer
2024-12-10 - CORRESP - Anteris Technologies Global Corp.
CORRESP 1 filename1.htm TD Securities (USA) LLC 1 Vanderbilt Avenue New York, New York 10017 Barclays Capital Inc. 745 Seventh Avenue New York, NY 10019 Cantor Fitzgerald & Co. 110 East 59th Street, 6th Floor New York, NY 10022 December 10, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Re: Anteris Technologies Global Corp. Registration Statement on Form S-1, as amended File No. 333-283414 Request for Acceleration of Effective Date Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Anteris Technologies Global Corp. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1 so that it becomes effective as of 4:00 p.m. Eastern time on December 12, 2024, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Jones Day, orally request that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there 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 proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of Page Intentionally Left Blank; Signature Page Follows] Very truly yours, TD SECURITIES (USA) LLC BARCLAYS CAPITAL INC. CANTOR FITZGERALD & CO. For themselves and on behalf of the several Underwriters listed in Schedule A of the Underwriting Agreement TD SECURITIES (USA) LLC By: /s/ Michael Campbell Name: Michael Campbell Title: Managing Director BARCLAYS CAPITAL INC. By: /s/ Dan Cocks Name: Dan Cocks Title: Managing Director CANTOR FITZGERALD & CO. By: /s/ Jason Fenton Name: Jason Fenton Title: Global Co-Head of ECM
2024-11-22 - CORRESP - Anteris Technologies Global Corp.
CORRESP
1
filename1.htm
November 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, D.C. 20549
Attn:
Kristin Lochhead
Michael Fay
Benjamin Richie
Jane Park
Re:
Anteris Technologies Global Corp.
Amendment No. 4 to
Draft Registration Statement on Form S-1
Submitted November 4, 2024
CIK No. 0002011514
On November 19, 2024,
we received the following comments from the staff (the “Staff”) of the Division of Corporation Finance of the
United States Securities and Exchange Commission on the Amendment No. 4 to the Draft Registration Statement on Form S-1 filed
by Anteris Technologies Global Corp., a Delaware corporation (the “Company”), on November 4, 2024. The
Company is concurrently publicly submitting its Registration Statement on Form S-1 (the “Registration Statement”).
For your convenience, the
bolded numbered responses set forth below correspond with the comments received from the Staff. Page references in the text of this
response letter correspond to page numbers in the Registration Statement unless otherwise noted. Capitalized terms used in this letter
but otherwise not defined herein shall have the meaning ascribed to such terms in the Registration Statement.
Amendment No. 4 to Draft Registration Statement on Form S-1
submitted November 4, 2024
Risk Factors, page 12
1. We note your disclosure relating to the convertible note facility with Obsidian Global Partners. Please revise your disclosure,
where appropriate, to discuss the impact that the convertible note facility may have upon dilution and the adjusted net tangible book
value.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised its disclosure on pages 46, 47, 54 and 55 of the Registration Statement.
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
November 22, 2024
Page 2
Business, page 56
2. We note your disclosure that the follow-up for the last patient in the FIH clinical study is expected in Q4 of 2024, the sixth
patient cohort in your FIH study was implanted with DurAVR THV in September 2024 and that the 30-day clinical data for this cohort
is not yet available, and the 12-month data from your EFS study is scheduled to be available late 2024. Please revise to update your disclosure
in regard to these recent developments accordingly.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised its disclosure on pages 58, 68 and 69 of the Registration Statement.
Anticipated Milestones, page 68
3. We refer to the graphic on page 69 relating to your anticipated near-term milestones, which includes references to presentations
and trials that are not otherwise included in the prospectus. Please revise your disclosure to provide further detail related to your
near-term milestones and clarify that there can be no assurance that the submission of an IDE will result in your ability to commence
clinical trials. We refer to your disclosure on page 82.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised its disclosure on pages 70-71 of the Registration Statement.
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
Results of Operations, Comparison of Nine Months Ended September 30,
2024 and September 30, 2023, page 97
4. We reference the significant increase in selling, general and administrative expense during the nine months ended September 30,
2024. Please revise to provide quantitative disclosure related to the amount of the increase related to the expansion of the work related
to the Company’s plans to re-domicile, list on the NASDAQ and conduct its initial public offering, the grant of additional stock
options and increase in headcount. In addition, if material, disclose the nature of the employment positions added during the period.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised its disclosure on page 100 of the Registration Statement. The Company notes that while it does
not consider the nature of the employment positions added during the period to be material, it has included disclosure on the departmental
areas of headcount increase.
***
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
November 22, 2024
Page 3
We hope that the foregoing has been responsive
to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please direct any questions
or comments regarding the foregoing to me at (650) 687-4173 or jcleveland@jonesday.com or to Brad Brasser at (612) 217-8886 or bbrasser@jonesday.com.
Very truly yours,
/s/ Jeremy Cleveland
Jeremy Cleveland
Partner, Jones Day
cc:
Wayne Paterson (Anteris Technologies Global Corp.)
Matthew McDonnell (Anteris Technologies Ltd.)
Bradley C. Brasser (Jones Day)
2024-11-19 - UPLOAD - Anteris Technologies Global Corp. File: 377-07104
November 19, 2024
Wayne Paterson
Chief Executive Officer
Anteris Technologies Global Corp.
860 Blue Gentian Road
Suite 340
Eagan, MN 55121
Re:Anteris Technologies Global Corp.
Amendment No. 4 to
Draft Registration Statement on Form S-1
Submitted November 4, 2024
CIK No. 0002011514
Dear Wayne Paterson:
We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in
our October 25, 2024 letter.
Amendment No. 4 to Draft Registration Statement on Form S-1 submitted November 4, 2024
Risk Factors, page 12
1.We note your disclosure relating to the convertible note facility with Obsidian Global
Partners. Please revise your disclosure, where appropriate, to discuss the impact that
the convertible note facility may have upon dilution and the adjusted net tangible
book value.
November 19, 2024
Page 2
Business, page 56
2.We note your disclosure that the follow-up for the last patient in the FIH clinical study
is expected in Q4 of 2024, the sixth patient cohort in your FIH study was implanted
with DurAVR THV in September 2024 and that the 30-day clinical data for this
cohort is not yet available, and the 12-month data from your EFS study is scheduled to
be available late 2024. Please revise to update your disclosure in regard to these recent
developments accordingly.
Anticipated Milestones, page 68
3.We refer to the graphic on page 69 relating to your anticipated near-term milestones,
which includes references to presentations and trials that are not otherwise included in
the prospectus. Please revise your disclosure to provide further detail related to your
near-term milestones and clarify that there can be no assurance that the submission of
an IDE will result in your ability to commence clinical trials. We refer to your
disclosure on page 82.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, Comparison of Nine Months Ended September 30, 2024 and
September 30, 2023, page 97
4.We reference the significant increase in selling, general and administrative expense
during the nine months ended September 30, 2024. Please revise to provide
quantitative disclosure related to the amount of the increase related to the expansion
of the work related to the Company’s plans to re-domicile, list on the NASDAQ and
conduct its initial public offering, the grant of additional stock options and increase in
headcount. In addition, if material, disclose the nature of the employment positions
added during the period.
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 Benjamin Richie at 202-551-7857 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.
2024-10-28 - UPLOAD - Anteris Technologies Global Corp. File: 377-07104
October 25, 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. 3 to
Draft Registration Statement on Form S-1
Submitted October 11, 2024
CIK No. 0002011514
Dear Paterson Wayne:
We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in
our August 23, 2024 letter.
Amendment No. 3 to Draft Registration Statement on Form S-1 submitted October 11, 2024
Prospectus Summary, page 1
We note your revised disclosure in response to prior comment 1. You also disclose on
page 2 and elsewhere in the prospectus that you are “currently planning to submit the
DurAVR THV system pivotal IDE study to the FDA by Q1 of 2025,” and that if you
obtain approval from the FDA, you intend to begin enrollment for your study in the
third quarter of 2025. Please revise to clarify whether the pivotal IDE study is
differentiated from your planned Pivotal Trial, and if so, please disclose when you 1.
October 25, 2024
Page 2
expect to complete your submission of the Pivotal Trial to the FDA.
2.We note your revised disclosure in response to prior comment 2 that Future Market
Insights, Inc. provided the estimated total global market opportunity of $9.9 billion for
TAVR. Please expand your disclosure to discuss the basis and assumptions underlying
such projected global market figure and revise to disclose the addressable market for
TAVR in the United States.
Collaborations, page 68
3.We note your revised disclosure in response to prior comment 10. Please further
revise your discussion to specify the referenced key development milestones and the
five stages of the v2v Agreements.
Single Source Suppliers, page 69
4.We note your revised disclosure in response to prior comment 3. Please revise your
disclosure on page 70 to disclose the termination provisions of and the date on which
you first entered into the Service Agreements with QMED.
Other Agreements, page 70
5.We note your revised disclosure in response to prior comment 7. Please revise your
disclosure relating to your Master Services Agreement with IQVIA on page 71 to
disclose the termination provision.
Intellectual Property, page 71
6.We note your response to prior comment 12, which we reissue in part. Please revise
your disclosure to more clearly differentiate between and describe the unique patents
that are held by the Company. In this regard, we note that many of the patents are
presented with the same title, even among those patents held within the same
jurisdiction.
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 Benjamin Richie at 202-551-7857 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.
2024-08-26 - UPLOAD - Anteris Technologies Global Corp. File: 377-07104
August 23, 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. 2 to
Draft Registration Statement on Form S-1
Submitted August 9, 2024
CIK No. 0002011514
Dear Paterson Wayne:
We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our
June 9, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1 submitted August 9, 2024
Prospectus Summary, page 1
1.We note your revised disclosure in response to prior comment 1 and reissue in part. Please
provide further detail, where appropriate, regarding the Company's design and scope of
the planned pivotal clinical trial. Please note that the Summary should not include a
lengthy description of your clinical trials and results. We note that this detailed
information is better suited for the body of the prospectus and that your Business
discussion already contains substantially the same presentation.
August 23, 2024
Page 2
2.We note your revised disclosure in response to prior comment 2 and reissue the comment.
Please provide details supporting management's expectation that the total global market
opportunity will reach $10 billion in 2028. Please also provide the Company's potential
addressable market.
Risk Factors, page 10
3.We note your revised disclosure in response to prior comment 6 and reissue in part. Please
disclose whether you have entered into any agreements with the named third parties on
page 21. If so, please further revise your disclosure, here or elsewhere as
appropriate, to discuss the material terms of any such agreements. If material, please file
these agreements as exhibits to the registration statement or provide your analysis as to
why it would not be required under Item 601(b)(10) of Regulation S-K.
We rely on third parties for the supply of materials and for the design and manufacture of our
products..., page 21
4.We note your revised disclosure on page 21 that you currently rely on a limited number of
suppliers to supply raw materials and other components. Please clarify whether you rely
on any single-source suppliers for any raw materials used in your products. Please expand
your disclosure under an appropriate heading in the Business section to identify any such
suppliers on which you rely and the material terms of your agreements with such parties.
Refer to Item 101(h)(4)(v) of Regulation S-K.
Clinical Results and Trials, page 60
5.We refer to your revised disclosure in the Summary and elsewhere in the registration
statement that your trial results suggest the “favorable performance of [y]our DurAVR
THV” compared with the published results of the Sapien 3 THV system developed by
your competitor, Edwards Lifesciences Corporation, although your “DurAVR THV
system has not been tested head-to-head against existing approved systems.” Please note
that your clinical trial results or your product candidate’s performance in such trials
should not be compared to other products or alternative trials unless head-to-head trials
were conducted. Please revise to remove references to this comparison throughout your
registration statement accordingly.
6.We note your revised disclosure in response to prior comment 15, which we reissue in
part. Please revise your disclosure under an appropriate heading in the Business section to
discuss the data and the significance of and differences between the EOA, MPG, and
DVT metrics rather than drawing conclusions from the results.
7.We note your revised disclosure discussing your agreements with IQVIA Inc, Yale
University, and the Yale Cardiovascular Research Group in response to prior comment
16. Please revise your disclosure to disclose the material terms of such agreements,
including but not limited to, when you entered into such agreements and the aggregate
amounts paid or received to date under these agreements, as applicable. If material,
please file such agreements as exhibits to your registration statement or explain to us why
you believe you are not required to do so. Refer to Item 601(b)(10) of Regulation S-K.
August 23, 2024
Page 3
License Agreements, page 64
8.We note your disclosure that the sale of the distribution and manufacturing rights for
CardioCel and VascuCel to LeMaitre Vascular included an exclusive intellectual property
license to use your proprietary ADAPT tissue limited to the cardiovascular patch field of
use. Please revise to clarify whether you entered into a license agreement with LeMaitre
and if so, please disclose the material terms of such agreement, including the duration of
the agreement, aggregate amounts paid or received to date under the agreement (including
any up-front or execution fees), aggregate future potential milestone payments to be paid
or received, royalty rates, and termination provisions, as applicable. Please also file the
license agreement as an exhibit to your registration statement, if applicable, 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.
9.We note your revised disclosure in response to prior comment 19 and reissue in part.
Please revise your disclosure to specify the aggregate amounts paid or received to date
(including any upfront or execution fees) under each of your supply and license
agreement with 4C and material development agreement with ESIA.
10.We note your revised disclosure in response to prior comment 20, which we reissue in
part. We refer to your disclosure that you contributed $0.2 million concurrently with the
purchase of 30% of the equity capital stock of v2vmedtech pursuant to the stock purchase
agreement. Please revise to disclose the aggregate amounts paid to date under the v2v
Agreements. You also disclose that the v2v Agreements will expire one year after
completion of first use of the products in an early feasibility study or any human clinical
trial. Please revise to disclose the current stage of development of the products subject to
the v2v Agreements and when you expect to complete an early feasibility study.
11.We note your reference to a source provided by Clarivate DRG relating to the expected
global market for leaky valve devices in 2028. Please revise to specify the source and the
citation that support your statement, including any reports or publications.
Intellectual Property, page 67
12.Please revise your disclosure within this section to clarify the type of patent protection
(such as composition of matter, use or process) for each patent and patent application.
Please also identify the specific products or technologies to which each such patent and
patent application relates. For example, we note that multiple patents and patent
applications are listed in the tables with the same titles.
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 91
We have reviewed your responses to comments 25 and 26 and note that you do not track
research and development expenses related to the previously identified components. We
note, however, a significant increase in research and development expense primarily due
to preparatory activities related to EFS, increased clinical costs related to the enrollment
of additional patients, and increased headcount related to the upscaling of manufacturing
capabilities and expansion of medical affairs activities. Please revise your discussion to
provide additional quantitative information and amounts related to these identified items 13.
August 23, 2024
Page 4
and the year-over-year increase. Refer to Item 303 of Regulation S-K.
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 Benjamin Richie at 202-551-7857 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.
2024-06-10 - UPLOAD - Anteris Technologies Global Corp. File: 377-07104
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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Page 2
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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Anteris Technologies Global Corp.
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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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June 9, 2024 Page 4
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June 9, 2024
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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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June 9, 2024 Page 5
FirstName LastName
Paterson Wayne
Anteris Technologies Global Corp.
June 9, 2024
Page 5
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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June 9, 2024 Page 6
FirstName LastName
Paterson Wayne
Anteris Technologies Global Corp.
June 9, 2024
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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
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