UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 8-K


CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 23, 2025


Anteris Technologies Global Corp.
(Exact name of registrant as specified in its charter)


Delaware
001-42437
99-1407174
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

Toowong Tower, Level 3, Suite 302
9 Sherwood Road
Toowong, QLD
Australia
4066
(Address of Principal Executive Offices)
(Zip Code)

Registrant’s telephone number, including area code: +61 7 3152 3200

Not Applicable
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Common Stock, par value $0.0001 per share
  
AVR
  
The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 3.02.
Unregistered Sales of Equity Securities.
 
On or about October 23, 2025 (October 24, 2025 AEST), Anteris Technologies Global Corp. (the “Company”) entered into (i) subscription agreements  (the “Subscription Agreements”) with certain investors, pursuant to which we agreed to sell 2,244,896 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and accompanying five-year warrants (the “Common Stock Warrants”) to purchase 2,244,896 shares of Common Stock at a price of US$4.90 per share of Common Stock and accompanying Common Stock Warrant (the “Common Stock Offering”), and (ii) confirmation letters (the “Confirmation Letters”) with certain investors, pursuant to which we agreed to sell 2,788,064 CHESS Depositary Interests (“CDIs”) and accompanying five-year warrants (the “CDI Warrants”) to purchase 2,788,064 CDIs at a price of A$7.50 per CDI and accompanying CDI Warrant (the “CDI Offering”, and together with the Common Stock Offering, the “Offering”). The Common Stock Offering is expected to close on or around October 27, 2025, subject to customary closing conditions.  The CDI Offering is expected to settle on or around October 30, 2025, subject to customary closing conditions. The Offering is expected to result in aggregate gross proceeds of approximately US$25 million. Evolution Capital Pty Ltd acted as lead manager for the CDI Offering, and will be issued 250,000 CDI Warrants.
 
Each of the Common Stock Warrants and the CDI Warrants are exercisable commencing six months following the date of issuance. The exercise price of the Common Stock Warrants is $7.50 per share, and the exercise price of the CDI Warrants is A$11.50 per CDI.
 
As part of the Subscription Agreements and the Confirmation Letters, the Company is required to prepare and file a registration statement (the “Registration Statement”) with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), covering the resale of the Shares, the shares of Common Stock issuable upon exercise of the Common Stock Warrants, the shares of common stock underlying the CDIs issued in the CDI Offering, and the shares of Common Stock underlying the CDIs issuable upon exercise of the CDI Warrants.
 
The securities to be sold in the Offering will be issued and sold without registration under the Securities Act, in reliance on the exemption provided by Section 4(a)(2) of the Securities Act, including under Rule 506 of Regulation D promulgated thereunder, with respect to the Shares and accompanying Common Stock Warrants in the Common Stock Offering, and Regulation S with respect to the CDIs and accompanying CDI Warrants in the CDI Offering.
 
Item 7.01.
Regulation FD Disclosure.
 
Attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference is a form of corporate presentation used by the Company in discussions with certain of its securityholders and other persons.
 
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or incorporated by reference into any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
 
Forward Looking Statements
 
This Current Report on Form 8-K contains forward-looking statements, including statements regarding the expected closing dates of the offering, the expected gross proceeds from the offering and the expected cash of the Company following the Offering. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

Item 9.01.
Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are filed with this Current Report on Form 8-K:

Exhibit
No.
  
Description
     
 
Corporate Presentation, dated October 2025
     
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES
 
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Anteris Technologies Global Corp.



 Date: October 24, 2025
By:
 /s/ Wayne Paterson


Name: Wayne Paterson


Title: Vice Chairman and Chief Executive Officer


Exhibit 99.1

 October 2025  NASDAQ: AVR | ASX: AVR 
 
 Disclaimer  This presentation has been prepared by Anteris Technologies Global Corp. (“Anteris,” the “Company,” “we” or “us” or "our"). This presentation, and its contents and the accompanying discussion with management are confidential and may not be further copied, distributed or passed on, directly or indirectly, to any other person or published or reproduced directly or indirectly, in whole or in part, by any medium or in any form for any purpose without the Company’s prior written consent. The recipient should not construe the contents of this presentation as legal, tax, accounting, investment advice or recommendation or business, financial or related advice. The recipient should consult its own counsel and tax and financial advisors as to legal and related matters concerning the matters described in this presentation. This presentation does not purport to be all-inclusive or to contain all of the information that the recipient may require. To the maximum extent permitted by law, none of the Company, its representatives, nor any other person accepts any liability, including, without limitation, any liability arising out of fault or negligence for any loss arising from the use of the information contained in this presentation.   Forward-Looking Statements  This presentation (including oral commentary that accompanies this presentation) contains forward-looking statements, including statements related to our business, products and the PARADIGM Trial. Any statements about our expectations, beliefs, plans, predictions, forecasts, objectives, assumptions, or future events or performance are not historical facts and may be forward-looking. In some cases, you can identify forward-looking statements through the use of words such as “believes,” “expects,” “may,” “will,” “should,” “would,” “seeks,” “intends,” “plans,” “pro forma,” “estimates,” “contemplates,” “aims,” “continues,” “anticipates” and similar expressions. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements are not guarantees of future performance and involve risks and uncertainties which are subject to change based on various important factors, some of which are beyond our control. Among the factors that could cause actual results to differ materially from those suggested by forward-looking statements are: our current and future research and development activities, including clinical testing and manufacturing and related costs and timing; sufficiency of our capital resources; our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products in our markets; our ability to commercialize products and generate product revenues; our ability to raise additional funding when needed; any statements concerning anticipated regulatory activities, including our ability to obtain regulatory clearances; our research and development expenses; and risks facing our operations and intellectual property; and the other risks described in our Annual Report on Form 10-K for the year ended December 31, 2024 and the other filings we make with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual future results, performance and events and circumstances may differ in material respects from the performance projected in these forward-looking statements. The forward-looking statements included in this presentation are made only as of the date hereof. The Company does not undertake any obligation to update any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in the Company’s expectations, except as may be required by law. Accordingly, the Company cautions you not to place any undue reliance on any forward-looking statements.  Industry Data  This presentation also includes data, forecasts and information obtained from industry publications and other information available to us. Some data is also based on our good faith estimates, which are derived from management’s knowledge of the industry and independent sources. We have not independently verified any of the data from third-party sources, nor have we ascertained the underlying assumptions relied upon therein. While we are not aware of any misstatements regarding the industry data presented herein, estimates and forecasts involve uncertainties and risks and are subject to change based on various factors.  Milestones  This presentation contains various milestones. These milestones are not projections and instead are forward-looking goals that are subject to significant business, economic, regulatory and competitive uncertainties and contingencies, many of which are beyond the control of the Company and its management and are based upon assumptions with respect to future decisions, which are subject to change. Actual results will vary, and those variations may be material. Nothing in this presentation should be regarded as a representation by any person that these milestones will be achieved and the Company undertakes no duty to update these milestones.  No Offer or Solicitation  This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful. Before you invest, you should read the documents we file with the SEC for more complete information about us. You can obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov.   2 
 
 3 
 
 Anteris Technologies – Executing on strategy   4  Building commercial readiness for a new class of TAVR that mimics a healthy aortic valve   Successfully priced U.S. IPO and listed on Nasdaq in December 2024 - Enhancing liquidity and visibility in the world’s largest healthcare investment market  1  Total of 130 DurAVR® THV patients, 49 patients treated YTD- Building momentum, 38% of all patients enrolled in 6 months (Jan-Jun 2025)  2  Data showcased by global KOLs at leading cardiovascular conferences- CRT (Mar), Sydney Valves (Mar), Euro PCR (May), CSI Frankfurt (Jun), New York Valves (Jun)   3  First-in-human DUAL valve-in-valve success with DurAVR® THV- DurAVR® successfully implanted in both aortic (Mar) and mitral ViV procedures (May)   4  Hosted global investigator meeting to launch pivotal PARADIGM Trial- Setting the foundation for accelerated site activation and patient enrollment (Jun)  5 
 
 Investment Highlights  5  The only biomimetic balloon expandable TAVR with 130 treated patients  Path to Commercialization  Poised to disrupt a high value, growth market  DurAVR® THV is the only balloon expandable aortic valve to deliver curative, pre-disease hemodynamics1,2.  Forecasted US$9.9bn by 2028  (US12.5bn with Valve-in-Valve)3.  Underpenetrated with 80-85% of severe aortic stenosis patients untreated4.  130 patients. Strong performance at 30 days & 1 year.  PARADIGM Pivotal trial targeted 4Q25*, 50% DurAVR® vs. 50% SAPIEN or Evolut.   Potential pathway to FDA & CE Mark approval. Scaled manufacturing, engaged global KOLs, early adopter site identification.  Compact market allows a capital-efficient launch with lean, scalable field force. Established TAVR reimbursement pathways.  Proprietary, First-in-Class TAVR  Multi-billion-dollar global TAVR market   Clinical Validation  Commercial Readiness   Commercial Launch  Garg, P., Markl, M., Sathananthan, J. et al. Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention. Nat Rev Cardiol 21, 264–273 (2024). https://doi.org/10.1038/s41569-023-00943-6.   Garg, P. DurAVR® TAVI: biomimetic design restores flow and leads to significant LV mass regression. MRI study. Oral presentation at PCR London Valves; Nov 2024; London, England.   Future Market Insights. Transcatheter Heart Valve Replacement (TAVR) Market: Global Industry Analysis 2016 – 2023 and Opportunity Assessment 2024 – 2034. Future Market Insights; 2024. Available from: https://www.futuremarketinsights.com/reports/transcatheter-heart-valve-replacement-tavi-market   Gahl B, Çelik M, Head SJ, et al. Natural History of Asymptomatic Severe Aortic Stenosis and the Association of Early Intervention With Outcomes: A Systematic Review and Meta-analysis. JAMA Cardiol. 2020;5(10):1102–1112. doi:10.1001/jamacardio.2020.2497.  *Subject to regulatory approval 
 
 Highly Experienced Leadership – Clinical, Operational, Commercial  6  Mr. McDonnell has served as CFO since November 2018. Prior to his appointment he worked at KPMG for over 24 years, where Mr. McDonnell held several senior positions including 10 years as a partner. He has experience in restructurings, acquisitions, divestments, privatizations and other significant financial transactions.  Matthew McDonnell  Chief financial officer  Dr. Meduri has served as Anteris’ CMO since August 2021. Dr. Meduri is a practicing Interventional Cardiologist at Stern Cardiovascular Foundation, Memphis, TN and a recognized global leader in the field of valvular heart disease with over 3,500 career structural heart procedures and over 300 annually. He has served as global head of many TAVR, mitral and tricuspid trials.  Dr. Chris Meduri  Chief medical officer  Mr. Paterson has served as CEO since March 2017 and was appointed Vice Chairman in March 2025. He held global positions in big pharma incl. Merck KGaA (“Merck”) from 2005-2013, and Roche (1995-2005). His roles included Global Head of CV Medicine, President of Europe, Israel, Canada & Australia, President of Emerging Markets incl. Russia & LATAM, CEO of Japan, Head of Commercial Operations in China, Head of Korea, and Product Manager. He also sat on a NASDAQ board (CHPD) and led a $5B sale of that business. He has launched global healthcare products 36 times totaling billions in revenue and driven dozens of acquisitions, in-licensing and out-licensing deals globally.  Wayne Paterson  VICE CHAIRMAN & CEO  Mr. St Denis has served as COO since July 2017 and was appointed President and Director in March 2025. From 2008-2017 he held senior positions at Merck including Head of Commercial Operations for Europe and Canada, and Head of Operations for Emerging Markets. From 1996-2006, he held senior roles at Millennium Pharmaceuticals Inc.   David St Denis  President & Director 
 
 Board of Directors  7  John Seaberg  Chairman  Mr. Seaberg has been Chairman since March 2017 and a director since October 2014. He has served as Board Chair of Preceptis Medical Inc since 2016 and Phraxis Medical Inc since 2009. He was Executive VP at Cedar Point Capital from 2015-2023. He was Chair of Synovis Inc., a manufacturer of medical devices and tissue products from 2008-2012.  Mr. Paterson has served as CEO since March 2017 and was appointed Vice Chairman in March 2025. He held global positions in big pharma incl. Merck KGaA (“Merck”) from 2005-2013, and Roche (1995-2005). His roles included Global Head of CV Medicine, President of Europe, Israel, Canada & Australia, President of Emerging markets incl. Russia & LATAM, CEO of Japan, Head of Commercial Ops in China. He sat on a NASDAQ board (CHPD) and led a $5B sale of that business. He has launched 36 global healthcare products totaling billions in revenue.  Wayne Paterson  VICE CHAIRMAN & CEO  DIRECTOR & Company secretary  Mr. St Denis has served as COO since July 2017 and was appointed President and Director in March 2025. From 2008-2017 he held senior positions at Merck including Head of Commercial Operations for Europe and Canada, and Head of Operations for Emerging Markets. From 1996-2006, he held senior roles at Millennium Pharmaceuticals Inc.   David St Denis  President & Director  Greg Moss  Non-Executive Director  Mr. Moss serves as Chief Business and Legal Officer, as well as Corporate Secretary and Chief Compliance Officer of Evommune, Inc. Prior to Evommune, he served as Executive Vice President, General Counsel, and Corporate Secretary, Chief Compliance Officer at Kadmon, culminating in Kadmon’s $1.9 billion acquisition in 2021.   Dave Roberts  Non-Executive Director  Mr. Roberts joined LeMaitre Vascular (NASDAQ: LMAT) in 1997 as its twelfth employee and has served as a Board Director since 2001 and as President since 2007. Mr. Roberts has also served as a Board Director of Lexington Medical since 2023 and of Parasole Restaurant Holdings since 2013.  Stephen Denaro  Mr. Denaro has been a director and Company Secretary since October 2018. Mr. Denaro serves as director and sole shareholder of Trio Business Intermediaries Pty Ltd. He has over 25 years of experience in mergers and acquisitions, business valuations, accountancy services, and income tax compliance. 
 
 Global Manufacturing Footprint   8  Purpose-built infrastructure designed for efficient scale-up and commercial readiness 
 
 TAVR market opportunity expected to reach US$9.9bn in 2028  9  Currently 3 industry trials in progress, anticipated to be completed in 2025   Potential for further significant growth  Edwards Lifesciences: SAPIEN 3 platform FDA approved for asymptomatic severe AS patients based on EARLY TAVR Trial (May 2025)  Medtronic: to explore the treatment of moderate AS with early TAV implantation (TAVI) before AS becomes severe  Edwards Lifesciences: will examine the TAVR procedure in patients who are > 65 years, have moderate AS, and have at least one additional risk factor   Gahl B, Çelik M, Head SJ, et al. Natural History of Asymptomatic Severe Aortic Stenosis and the Association of Early Intervention With Outcomes: A Systematic Review and Meta-analysis. JAMA Cardiol. 2020;5(10):1102–1112. doi:10.1001/jamacardio.2020.2497.  Future Market Insights. Transcatheter Heart Valve Replacement (TAVR) Market: Global Industry Analysis 2016 – 2023 and Opportunity Assessment 2024 – 2034. Future Market Insights; 2024. Available from: https://www.futuremarketinsights.com/reports/transcatheter-heart-valve-replacement-tavi-market.  Underpenetrated patient population with only 15-20%1 of severe aortic stenosis cases treated today 
 
 A New Class of TAVR 
 
 Aortic Stenosis (AS) - Current Treatment Options   11  A life-threatening condition caused by narrowing of the aortic valvePatients with severe AS have a 50% risk of dying within 2 Years1  Leon MB, Smith CR, Mack M, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med. 2010;363(17):1597-1607. doi:10.1056/NEJMoa1008232.  SAVR: Surgical aortic valve replacement, TAVR: Transcatheter aortic valve replacement  SAVR – Invasive, open-heart surgery  TAVR - Minimally invasive procedure  
 
 12  Yesterday’s TAVRs were not developed for today’s patients  DurAVR® was deliberately designed for younger and more active patients  STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol (2020);76:2492-2516.    N Engl J Med 2019; 380:1695-1705.  Patients need a safer alternative to open heart surgery  Patients need a valve that restores an active lifestyle for the rest of their life  First & second generation TAVRs  ~85 yrs  Third generation TAVRs  ~73 yrs  2011-2013 average patient age was 841  2016-2017 average patient age is 73 & declining2 
 
 Anteris set out to address the needs in TAVR by asking different questions  13  Our expert panel of physicians advised the Company what they wanted in a next generation valve:  Balloon-expandable deliveryDrives clinical adoption - Controlled expansion, predictable placement, commissure alignment   Clinically better For younger and more active patients  Curative, pre-disease hemodynamics, laminar flow  How can we mimic a native valve?  How does a healthy aortic valve perform?  How do we deliver the valve?  How can we put that valve in a frame? 
 
 Single-piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve.  DurAVR®: A New Class of TAVR  14 
 
 DurAVR® Sustained hemodynamic performance to 1 year  15  Puri, R. DurAVR®: A Novel First-in-Class Biomimetic Transcatheter Aortic Valve 1-Year Performance. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.  MPG  (Mean Pressure Gradient mmHg)  DVI  (Doppler Velocity Index)  2.1  EOA  (Effective Orifice Area cm2)  8.6  0.58  Mean Annular Diameter: 22.4 mm  Mean Pressure Gradient (MPG)  The average pressure across the aortic valve between the left ventricle and aorta  ​  Patients with severe AS have MPG ≥ 40 mmHg​  Effective Orifice Area (EOA)  The cross–sectional area of the aortic valve opening that is available for blood flow​  Patients with severe AS have an EOA of ≤ 1cm2   Doppler Velocity Index (DVI)  An index that expresses EOA as a proportion of valve area   DVI represents the physical ratio of a patient’s aortic valve area to the left ventricular outflow tract area 
 
 16  “  A balloon expandable valve with self-expanding hemodynamics is like the holy grail.  Dr Michael ReardonProfessor of Cardiothoracic Surgery, Allison Family Distinguished Chair of Cardiovascular Research Methodist DeBakey Heart & Vascular Center  “  Clinician panel discussion, PCR London Valves 2023.    
 
 Restores flow dynamics, significantly reducing left ventricular (LV) mass  17  SEVERE AORTIC STENOSIS  EOA 2.2cm2  MPG 7.5 mmHg  IMPAIRED FLOW  NORMAL LAMINAR FLOW  Waggoner T. DurAVR® Biomimetic Transcatheter Heart Valve: Early Feasibility Study (EFS) Update. Oral Presentation at: CRT Conference, March 2024; Washington, USA.  Cavalcante J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression: update from First-in-Human (FIH) Study with novel DurAVR® Transcatheter Heart Valve​. Oral Presentation at: New York Valves; June 2024; New York, New York, USA.  A narrowed aortic valve creates increased pressure in the left ventricle.  Narrowed EOA(Effective Orifice Area)  High MPG(Mean Pressure Gradient)  EnlargedLeft Ventricular Thickness  NormalLeft Ventricular Thickness  Increased LV mass is an adaptive response to the increased workload caused by the narrowed aortic valve. Untreated it may progress to heart failure.  EFS Data1  29%  Reduction in LV Mass Index2 
 
 Normal Aortic Flow  DurAVR® is the first aortic valve to restore normal aortic flow  18  Post DurAVR® THV implant  Healthy Aortic Valve   FD = 14%   FRR = 4%  (n=5)   FD = 46% FRR = 23%  When compared to a healthy aortic valve, DurAVR® THV showed no significant difference in flow (p>0.05)  Severe AS  Sapien 3  CEP Magna Ease  Evolut R  FD = 10%  FRR = 1%  (n=5)  FD = 48% FRR = 35%  FD = 27% FRR = 30%  FD = 25% FRR = 4 %  FD = Flow Displacement | FRR = Flow Reversal Ratio  Garg, P. DurAVR® TAVI novel leaflet design restores ascending aortic flow haemodynamics on cardiac MRI: First-in-human study. Oral presentation at PCR London Valves; November 2022; London, England.  Garg, P. DurAVR® TAVI: biomimetic design restores flow and leads to significant LV mass regression. MRI study. Oral presentation at PCR London Valves; November 2024; London, England.  Cavalcante, J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression: update from First-in-Human (FIH) Study with novel DurAVRTM Transcatheter Heart Valve. Oral presentation at New York Valves; June 2024; New York, New York, USA.  Controls with no known aortic valve disease assessed and age-height-weight matched to reduce bias. Limitations: Small sample size. Control n=5, DurAVR® n=5, Other TAVRs n=4, SAVR n=8.  Impaired Aortic Flow  Normal Valve (n=5) vs: TAVR (n=4) p<0.05 | SAVR (n=8) p<0.01 
 
 Existing bioprosthetic valves fail and patients need retreatment  ViV ChallengesPreserving coronary access, providing good hemodynamic result  Solution – DurAVR® THVShort-frame valve, paradigm-shifting hemodynamic performance and large open cell geometry to maintain coronary access  Case Study (Valve-in-Valve-in-Valve)77-year-old patient, too high risk for repeat surgery with failure of his valve-in-valveCompassionate use approved by Swedish Regulatory Authority  Valve in Valve (ViV) expanding TAVR market – US$2.5bn by 2028  19  Date  Vmax aom/s  MPG mmHg   DVI  2011 Surgical Valve  3.1  23  0.4  2018 Evolut in Surgical Valve  3.7  31  0.34  2024 Max stress  4.0  41  0.15  Post DurAVR®  3.0  20  0.33–0.40  Failed Evolut  Surgical Valve  Settergren, M. DurAVR® THV ViViV case: How to achieve optimal gradients in limited space. Oral Presentation at: PCR London Valves; November 2024; London, England.  Vmax ao: The maximum velocity of blood flow across the aortic valve during systole. In healthy individuals, the Vmax ao is typically 1.0 m/s. As AS progresses, the valve narrows, and the blood flows through the smaller opening at a higher velocity.  
 
 Path to Commercialization 
 
 130 DurAVR® patients – support pivotal trial launch (PARADIGM Trial)   21  2021  2022  2023  2024  2025  First-in-human (“Embark”) Study  Early Feasibility Study (“EFS”) - DurAVR®  Valve-in-Valve  Compassionate use  *Subject to regulatory approval  Patient recruitment targeted 4Q 2025*  FDA submission  FDA approval  Ongoing monitoring   FPI Nov 2021  FPI: First patient in Embark Study  49 patients treated YTD (2025) 
 
 
 Study Co-Chairs: Dr. Michael J. Reardon, Professor Stephan Windecker  The first all-risk, head-to-head TAVR registration trial  “All Comers” Randomized Cohort  1-year data used to support PMA Submission  Enrollment I  Allocation I  Follow-Up I  Analysis I  Assessment for Eligibility  1:1 Randomization(All surgical risk strata)  All surgical risk  Control ArmAll surgical risk  10-YearFollow-Up  10-YearFollow-Up  Primary Endpoint Analysis at 1-Year  (Composite of all-cause mortality, all stroke, and cardiovascular rehospitalization according to VARC-3)  23  Clinical Trial Snapshot  Sample size ~1,000 patients, all surgical risk groups  Sites Up to 85 centers in the U.S., Europe & Canada  Primary end pointNon-inferiority at 1-year (DurAVR® THV vs. SAPIEN or Evolut series THV)  Regulatory & Commercial Pathway  PMA Submission 1-year clinical data potentially supports U.S. FDA Premarket Approval   CE Mark European regulatory submission anticipated to progress in parallel  Commercialization Launch to commence following PMA or CE Mark approval  Premarket Approval (PMA) is required for commercialization of the DurAVR® THV in the United StatesCE Mark approval is required for commercialization of the DurAVR® THV in the European Economic Area (EEA) 
 
 PARADIGM Trial – Planned enrollment and revenue*  24  Category B Medicare coverage of US$25k per device*  ENROLLMENT  Patients screened for eligibility. If selected, they are randomized and treated.  FOLLOW UP  Patients followed up at 1 month, and 1 year (primary study endpoint for PMA). Follow up then continues annually for 10 years.  REVIEW  The 1-year data is included in a PMA application. The FDA reviews the application and determines whether to grant market approval.  *US Medicare coverage. An approval for a Category B (Nonexperimental/investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial. Medicare Coverage Related to Investigational Device Exemption (IDE) Studies | CMS - coverage is subject to FDA IDE approval  ** Anteris will seek FDA approval for continued access 
 
 Supplementary studies not expected to be required for all-risk TAVR approval*  “Low Risk” Randomized Continued Access  Commences when ‘all-risk’ PMA study recruitment concludes  Enrollment II  Allocation II  Follow-Up II  Analysis II  Assessment for Eligibility  1:1 Randomization(Low surgical risk)  Low surgical risk  Control ArmLow surgical risk  10-YearFollow-Up  10-YearFollow-Up  Primary Endpoint Analysis at 2-Year (Bayesian)  Including all subjects at low surgical risk from the “All Comers” Cohort and from the “Low Risk” Cohort(Composite of all-cause mortality, all stroke, and cardiovascular rehospitalization according to VARC-3)  Valve-in-Valve Cohort  Standalone parallel registry  Enrollment  Allocation  Follow-Up  Analysis   Assessment for Eligibility:Subjects with failed surgical bioprosthesis at high surgical risk  Subjects implanted with DurAVR® only  5-YearFollow-Up  Primary Endpoint Analysis at 1-Year(Composite of all-cause mortality, all stroke, and cardiovascular rehospitalization according to VARC-3)  25  Low-risk data are not required to support the regulatory submission, whether PMA or CE Mark, for an all-risk TAVR indication for severe aortic stenosis   ViV registry is a separate registry conducted in parallel and is not required to support the regulatory submission for an all-risk TAVR indication for severe aortic stenosis   *Subject to FDA determination 
 
 Anticipated Milestones  26  US IPO & NASDAQ LISTING  TCT presentation: Flow   EU ViV Study  PCR LV presentationFlow & ViViV case report   Q4 2024 (completed)  PARADIGM - EU Investigator Meeting  PCR – Innovation session  PARADIGM – Global Investigator Meeting  CSI – recorded case  NY Valves – recorded case   Q2 2025 (completed)  DurAVR® IDE Submission for PARADIGM Trial  Sydney Valves – 1 year data  Milestone: 100 DurAVR® THV patients treated   Q1 2025 (completed)  ESC presentation   Q3 2025 (completed)  Targeted DurAVR® IDE approval for PARADIGM Trial*  Targeted PARADIGM Trial FPI: signifies launch of pivotal registration study**   Danish regulatory clearance receivedfor PARADIGM Trial  TCT presentation, EACTS live case, PCR LV presentation   Q4 2025  DurAVR® CE Mark Submission  PCR presentation  Q2 2026  CRT presentation  THT presentation  ACC presentation   Q1 2026   Q3 2026  PARADIGM Trial LPI: Patient recruitment completed for all-risk patientcohort      Q4 2026  PARADIGM – EU Investigator Meeting  *Following our IDE submission in the first quarter of 2025, the FDA provided us with requests for additional information, which we are working to address. As of the date of this presentation, the FDA has not approved the IDE. We cannot predict whether or to what extent the FDA will have further requests for information or guarantee that the IDE will be approved at all or on any particular timeline. In particular, if prolonged government shutdown or disruption occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions. To the extent the PARADIGM Trial is commenced in a non-U.S. jurisdiction prior to obtaining FDA approval of the IDE, there is a risk that the results of such trial may not be permitted to be used to support a future marketing approval or clearance of the device by the FDA to the extent that the FDA-approved IDE version differs from the version tested in such non-U.S. jurisdiction. **Subject to regulatory approval, as described in the preceding footnote.  
 
 Key Takeaways  27  1  DurAVR® THV - Proprietary, new class of TAVR for aortic stenosis - Easy, predictable balloon expandable deployment with the function of a healthy, native aortic valve  Building commercial readiness for a new class of TAVR that mimics a healthy aortic valve   Future Market Insights. Transcatheter Heart Valve Replacement (TAVR) Market: Global Industry Analysis 2016 – 2023 and Opportunity Assessment 2024 – 2034. Future Market Insights; 2024. Available from: https://www.futuremarketinsights.com/reports/transcatheter-heart-valve-replacement-tavi-market.  *Subject to regulatory approval  US$9.9bn global TAVR market forecasted by 20281 with many untreated patients- DurAVR® was designed to offer advantages over two TAVR market leaders  2  Clinically validated with 130 patients- 30 day and 1 year data supports strong DurAVR® safety profile and hemodynamics   3  PARADIGM Trial targeted start 4Q 2025* potentially supporting FDA & CE Mark filings- High quality global KOL adoption expected to drive rapid trial enrollment  4  Commercial ready - capital efficient go to market plan- Highly experienced clinical & commercial leadership plus infrastructure in place  5 
 
 Appendices 
 
 Anteris is guided by a global team of well-regarded cardiovascular Physician advisors  29  Medical Advisory Board  North America  Europe  Australia 
 
 Technical Success (VARC 3): 94%Device Success (VARC 3): 92.3%n = 65   Procedural Success Endpoints Across Various Anatomies  30  1 patient required 2 valves; 3 patients had vascular access site complications  Severe annular calcium  Extreme leaflet calcium  Type 1 bicuspid  Extreme LVOT calcium  BAV = Balloon Aortic Valvuloplasty  MDCT = Multidetector Computed Tomography  Predictable BE Placement  Challenging anatomies treated (Baseline MDCT)  Puri R. DurAVR®: A Novel First-in-Class Biomimetic Transcatheter Aortic Valve 1-Year Performance. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia. 
 
 DurAVR® Data Spotlight  31  Zero Prosthesis Patient Mismatch (PPM) in Small Annuli  Low Paravalvular Leak  Measured at 1-year, n=37  No moderate or severe PVL  Puri R. DurAVR®: A Novel First-in-Class Biomimetic Transcatheter Aortic Valve 1-Year Performance. Oral Presentation at: Sydney Valves; March 2025; Sydney, Australia.