Anteris Technologies Celebrates Major Milestone with DurAVR®

Anteris Technologies Achieves Clinical Milestone

MINNEAPOLIS and BRISBANE, Australia — Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR), a leader in the structural heart space, is thrilled to announce a groundbreaking achievement in its mission to enhance the lives of heart valve patients. The company has reached a significant marker, successfully treating over 100 patients worldwide with its innovative biomimetic DurAVR® Transcatheter Heart Valve (THV). This milestone highlights Anteris’ commitment to redefining cardiac care for individuals suffering from severe aortic stenosis.

Key Achievements in Patient Treatment

The outstanding results encompass a diverse patient population, showcasing the versatility of the DurAVR® THV in various cases. Notably:

• Over 100 patients have been treated with the DurAVR® THV, which includes first-time aortic stenosis cases, valve-in-valve (ViV) patients, and those with complex conditions like bicuspid aortic valves.
• 65 patients have completed essential safety and efficacy measures, confirming significant hemodynamic benefits just 30 days post-implant.
• Long-term efficacy data from 37 aortic stenosis patients indicates impressive hemodynamic performance, highlighted by sustained large effective orifice areas (EOAs) and minimal mean pressure gradients (MPGs).
• An exceptional safety profile has been established, with no reported valve-related mortalities or cardiovascular complications at one year.
• A broad range of valve sizes has been utilized, ensuring compatibility with a diverse patient demographic.

Expert Insights on DurAVR® THV's Impact

Chris Meduri, M.D., Chief Medical Officer at Anteris, reflected on this significant achievement, stating, “We take immense pride in reaching this milestone, underpinned by years of dedication and collaboration with leading physicians. The impressive hemodynamic results we’re observing underscore DurAVR®’s potential to restore natural heart valve function, ultimately setting a new standard for success in aortic stenosis treatment.”

Furthermore, Dr. Michael Reardon, a prominent figure in cardiovascular research and the Study Chair of the DurAVR® THV Pivotal Trial, emphasized the company's commitment to thorough scientific evaluation. He expressed confidence in building upon a robust foundation of clinical evidence as they move forward towards the pivotal registration trial for DurAVR® THV.

Anticipating Future Trials and Developments

Vice Chairman and CEO Wayne Paterson shared his perspective on this clinical milestone, emphasizing that this achievement will not only benefit the company but also investors. "Crossing this threshold of treating over 100 patients stands as a testament to our clinically relevant results, significantly distinguishing us from current therapies. DurAVR® is the first innovative product in this space in many years, and these results further affirm its value for both physicians and patients as we prepare for our upcoming registration trial.”

Anteris is diligently preparing to commence the DurAVR® THV Pivotal Trial in the third quarter of 2025, with anticipation of securing approval from regulatory bodies.

About Anteris Technologies

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is committed to advancing the field of structural heart solutions through the design and commercialization of leading-edge medical devices. With its roots in Australia and a growing presence in Minneapolis, Anteris operates as a science-driven organization, guided by a team of experienced professionals dedicated to delivering innovative treatments for patients with structural heart diseases.

The company’s flagship product, the DurAVR® Transcatheter Heart Valve (THV), aims to address aortic stenosis—a serious condition resulting from narrowing of the aortic valve. The unique design of the DurAVR® THV, created in collaboration with world-class interventional cardiologists and cardiac surgeons, mimics the function of a healthy aortic valve, promoting optimal blood flow. Constructed from ADAPT® tissue, Anteris’ proprietary anti-calcification technology, the DurAVR® THV has been successfully utilized in clinical settings for over a decade, benefiting over 55,000 patients globally.

Frequently Asked Questions

What milestone has Anteris Technologies recently achieved?

Anteris Technologies has successfully treated over 100 patients with its DurAVR® Transcatheter Heart Valve (THV).

What are the key benefits of the DurAVR® THV?

The DurAVR® THV offers impressive hemodynamic performance, a wide range of sizes for varied patient needs, and a strong safety profile with no valve-related mortalities reported at one year.

Who were key contributors to the development of DurAVR® THV?

Leading interventional cardiologists and cardiac surgeons collaborated with Anteris in creating the DurAVR® THV to ensure its effectiveness in treating aortic stenosis.

When will Anteris start the pivotal trial for DurAVR® THV?

The pivotal trial for the DurAVR® THV is set to commence in the third quarter of 2025, pending the necessary approvals.

How does Anteris seek to redefine cardiac care?

Anteris aims to redefine cardiac care through innovative solutions that restore normal heart function, leveraging advanced technology and clinical expertise to meet patient needs.

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