Anteris is like the Tesla of TAVR valves, aiming to revolutionize heart valve replacement with a next-generation, single-piece, biomimetic design offering superior durability and hemodynamics.

Anteris is like the Apple of TAVR valves, developing a premium, single-piece, biomimetic heart valve system designed for superior durability, natural blood flow, and a better quality of life for patients.

Anteris Technologies Global (AVR) has the following major products:

• DurAVR® THV system: A single-piece, biomimetic transcatheter heart valve system designed for the treatment of aortic stenosis.
• ADAPT® tissue-enhancing technology: A proprietary anti-calcification tissue shaping technology used in the DurAVR® THV system and distributed for use in other medical indications.

Anteris Technologies Global (AVR) is currently a development-stage company focused on discovering, developing, and commercializing innovative medical devices. According to the provided background information, the company:

• Is a "development stage company" and has incurred "net losses in each year since inception."
• "currently generate small amounts of revenue and and income which are insufficient to cover our investment in research, development and operational activities resulting in recurring net operating losses, incurred since inception."
• Is planning to submit an Investigational Device Exemption (IDE) for its Pivotal Trial by Q1 2025, with anticipated enrollment to begin in Q3 2025. This trial is designed to provide the primary clinical evidence for Pre-Market Approval and future commercialization in the United States.

Given this information, Anteris Technologies Global does not currently have major commercial customers. The company is still in the clinical trial phase for its lead product, the DurAVR® transcatheter heart valve (THV) system, and is not yet commercially selling its devices in significant volumes.

Upon future commercialization, the company's customers would primarily be healthcare institutions that perform Transcatheter Aortic Valve Replacement (TAVR) procedures. These typically include:

• Hospitals: Large medical centers and hospitals with cardiac surgery departments and interventional cardiology labs.
• Cardiac Centers: Specialized clinics and centers dedicated to treating heart conditions.

The company sells its medical devices to these healthcare providers, rather than directly to individual patients, who are the end-beneficiaries of the treatment administered by medical professionals within these institutions.

Wayne Paterson, Vice Chairman & CEO

Wayne Paterson has served as the Chief Executive Officer of Anteris Technologies since March 2017 and was appointed Vice Chairman in March 2025. He joined Anteris in October 2014 as a Non-Executive Director. Prior to joining Anteris, Mr. Paterson held senior positions at multinational science and technology companies, including Merck KGaA (2005-2013), where he served as President of Europe, Canada and Australia, President of Emerging Markets, President of Japan, and President of Cardiovascular Medicine. From 1999 to 2005, he held several senior roles at Roche Pharmaceuticals, including Head of Pharmaceuticals in South Korea and Head of Commercial Operations for Roche China. Mr. Paterson also commenced as Chair of v2vmedtech, inc. from April 2023, a company in which Anteris made an investment and entered a development agreement.

Brent Moen, Chief Financial Officer

Brent Moen was appointed as Chief Financial Officer of Anteris Technologies Global Corp. effective September 11, 2026. He is an experienced financial executive with over 25 years of leadership experience, including Chief Financial Officer roles at both public and private companies. Mr. Moen possesses extensive expertise in capital markets, investor relations, mergers and acquisitions, and scaling growth-oriented organizations, including medical technology companies. His prior CFO positions include LifeLens Technologies (September 2023 to March 2026), Tactile Systems Technology (September 2018 to April 2023), and Entellus Medical (May 2016 to March 2018).

David St Denis, President & Director

David St Denis serves as the President and a Director of Anteris Technologies Global Corp.

Dr. Chris Meduri, Chief Medical Officer

Dr. Chris Meduri holds the position of Chief Medical Officer at Anteris Technologies.

The key risks for Anteris Technologies Global (AVR) primarily revolve around its stage of development, the highly regulated nature of its industry, and the competitive landscape.

1. Regulatory Approval and Commercialization

   Anteris Technologies Global's core business success is contingent upon obtaining Pre-Market Approval from the U.S. Food and Drug Administration (FDA) for its DurAVR® THV system, following a planned global pivotal study. The company anticipates submitting an Investigational Device Exemption (IDE) for this Pivotal Trial by Q1 2025, with subject enrollment expected to begin in Q3 2025. The lengthy, complex, and uncertain nature of clinical trials and regulatory approval processes poses a significant risk. Failure to secure FDA approval would prevent the commercialization of its lead product in the crucial U.S. market, thereby jeopardizing the company's future revenue generation and overall viability.

2. Financial Sustainability and Development Stage

   As a development-stage company, Anteris Technologies Global has consistently incurred net losses since its inception, with current revenues insufficient to cover investments in research, development, and operational activities. This ongoing financial challenge, coupled with limited resources and a smaller capital base, creates a risk regarding the company's ability to sustain operations, fund the extensive pivotal trial, and bring its product to market without further capital raises.

3. Market Competition and Adoption

   The medical device market, particularly for structural heart products, is highly competitive. Anteris Technologies Global faces competitors with substantial market share, significantly greater capital resources, and established relationships within the structural heart community, which could create barriers to the adoption of its DurAVR® THV system. The company's success will depend on its ability to effectively educate the market about the benefits of its disruptive technology and capture market share post-commercialization, a challenging endeavor against entrenched players.

The addressable markets for Anteris Technologies Global's main products and services are as follows:

• For severe aortic stenosis, the global market opportunity is expected to reach $9.9 billion in 2028.
• For severe aortic stenosis, the North American market opportunity is forecast to reach $5.5 billion in 2028.
• For severe aortic stenosis, the European market opportunity is forecast to reach $3.7 billion in 2028.
• For valve-in-valve (ViV) procedures, the global market opportunity is expected to reach $2.5 billion in 2028.
• For valve-in-valve (ViV) procedures, the North American market opportunity is forecast to reach $1.5 billion in 2028.
• For valve-in-valve (ViV) procedures, the European market opportunity is forecast to reach $0.8 billion in 2028.

Here are 3-5 expected drivers of future revenue growth for Anteris Technologies Global (AVR) over the next 2-3 years:

1. Advancement and Completion of the DurAVR® THV System Pivotal Trial: The company anticipates submitting an Investigational Device Exemption (IDE) for its global Pivotal Trial to the FDA by Q1 2025, with subject enrollment expected to begin in Q3 2025. This randomized, controlled multicenter study is designed to provide the primary clinical evidence required for FDA Pre-Market Approval (PMA) and subsequent commercialization of the DurAVR® THV system in the United States. Successful progress through and completion of this trial within the next 2-3 years are critical milestones that will directly lead to the ability to generate significant commercial revenue.
2. Attainment of Regulatory Approvals for the DurAVR® THV System in Key Markets: While the Pivotal Trial aims for US FDA approval, Anteris Technologies Global is a global company, and its DurAVR® THV system has already treated patients across the United States, Canada, and Europe. The design of the Pivotal Trial is also described as a "multicenter, international study." Obtaining regulatory approvals in significant target markets like North America and Europe, potentially preceding or concurrently with US PMA, will enable market entry and the commencement of product sales, driving future revenue growth.
3. Market Acceptance and Adoption of DurAVR® THV System's Differentiated Features: The DurAVR® THV system is designed to address unmet clinical needs by offering a single-piece, biomimetic valve with proprietary ADAPT® tissue technology for increased durability and improved hemodynamics, aiming to replicate the normal blood flow of a healthy human aortic valve. The company believes these features can provide a better quality of life for patients, including younger individuals being diagnosed with aortic stenosis. Educating the market about these disruptive benefits and demonstrating superior outcomes in clinical trials will be crucial for capturing market share post-commercialization, thereby driving future revenue growth.
4. Expansion within the Growing Global Transcatheter Aortic Valve Replacement (TAVR) Market: The TAVR market is experiencing substantial growth, with the total global market opportunity for severe aortic stenosis and valve-in-valve (ViV) procedures projected to reach $9.9 billion and $2.5 billion, respectively, by 2028. North America and Europe, Anteris' primary target markets, are forecast to achieve significant growth in this period. This expanding market, driven by an aging population, earlier diagnoses, and a desire for more active lifestyles, provides a large and increasing patient pool for Anteris' DurAVR® THV system once it achieves commercial availability, thereby contributing to robust future revenue growth.

Outbound Investments

• In April 2023, Anteris Technologies Global invested in, and entered a development agreement with, v2vmedtech, Inc., which develops an innovative heart valve repair device for the minimally invasive treatment of mitral and tricuspid valve regurgitation.