Anteris Technologies [ASX:AVR]
Ushering in a New Era in Aortic Stenosis Treatment

Anteris Technologies [ASX:AVR] has achieved a groundbreaking milestone in the field of aortic valve stenosis treatment. Through pioneering efforts, the Anteris team has developed a novel transcatheter aortic valve replacement (TAVR) product, DurAVR™ Transcatheter Heart Valve (THV) with a biomimetic design.

Numerous clinical studies have shown the product’s exceptional functionality to empower patients in regaining their heart health and quality of life. By restoring aortic blood flow to its pre-disease condition, DurAVR™ THV signifies an extraordinary technology leap forward, providing a solution once deemed unattainable.

“Our attention gravitated toward TAVR as catheter-based approaches are known for their minimally invasive benefits.

But our collective analysis of current TAVR modalities found many deficiencies, with a notable shortcoming to fully resolving the disease state. It almost always leaves patients with a milder form of aortic stenosis, which still presents symptoms and side effects,” says Wayne Paterson, Managing Director and CEO of Anteris Technologies.

Determined to solve this problem, Anteris Technologies embarked on an incredible journey to create its own TAVR— an innovative departure from the predominantly stagnant landscape of heart valve design that persisted for the last two decades. While the majority of available TAVR modalities fell into the bioprosthetic category, the firm forged ahead to create a first-of-its-kind biomimetic TAVR valve - creating a new class of TAVR devices.

Addressing Unmet Patient Care Needs

DurAVR™ THV arrives at a critical juncture, as the prevalence of aortic stenosis continues to escalate. With global aging and extended life expectancy, the incidence of this cardiovascular condition has reached alarming levels affecting approximately nine million people worldwide according to a recent NCBI report. It is present in about 5 percent of the population at age 65, with increasing prevalence with advancing age. This highlights the urgent need for more effective interventions, a need Anteris Technologies is uniquely equipped to fulfill.

DurAVR™ THV is designed as an alternative for patients considered too “high-risk” or unsuitable candidates for traditional open-heart valve surgery. By offering a less invasive option, Anteris Technologies empowers patients with a new choice, offering faster recovery to those who would otherwise face limited treatment choices when dealing with aortic stenosis.

In response to the evolving patient demographics, Anteris Technologies’ proactive approach also reimagines the existing TAVR products to better serve a diverse range of patients today. To date, TAVR technologies have been focused on providing therapy to older, high-risk surgical patients, typically aged 85 and above, with limited life expectancy. While providing modest extensions to their lives, the primary objective was to enhance their end-of-life experience rather than achieve long-term curative outcomes.

However, since 2019, relatively younger patients with an average age of 73 have begun undergoing these procedures—a demographic not initially anticipated during the development of existing TAVR products. This shift presents a new set of challenges. Unlike older patients, these individuals have longer life expectancies, and their active lifestyles and higher cardiovascular functions require solutions that can sustain their health and performance in the long term.

DurAVR™ THV is well-suited to meet this need as its unique design greatly enhances the functionality of the heart valve, aiming to bring patients out of the disease and restore their cardiovascular well-being.

Under the Hood of DurAVR

DurAVR™ THV system comprises three distinct components; the DurAVR™ THV valve, the ADAPT® tissue treatment, and the ComASUR™ transfemoral delivery system.

DurAVR™ THV—made up of a single piece of tissue to mimic the natural performance of a healthy human aortic valve—offers excellent hemodynamic performance and outcomes. Its multi-dimensional leaflet design produces remarkable hemodynamic performance as longer leaflet coaptation produces near-perfect laminar blood flow and results in “pre-disease-like blood flow through the valve”. Large open cells in the stent frame improve coronary access. The innovation does not stop at that.

Through pioneering efforts, the Anteris team has developed a novel transcatheter aortic valve replacement (TAVR) product, DurAVR™ THV, with a biomimetic design that impeccably replicates the performance of a healthy aortic valve

ADAPT® tissue has already delivered significant clinical benefits to over 50,000 heart patients worldwide. This is a truly unique technology, as no other competitor has perfected tissue science or achieved such strong results in peer-reviewed publications before. ADAPT^(R) tissue effectively eliminates primary inflammatory precursors responsible for calcification, a key concern with bioprosthetic heart valve failures.

Existing bioprosthetic valves possess limitations in their opening capacity, so when patients receive these valves, their gradient across the valve usually remains elevated, categorizing them as still having a mild disease. But Anteris Technologies’ optimized design and functionality succeeds in achieving mean gradients on an average of only 8.66 mmHg (millimeters of mercury) immediately, bringing patients into a healthy range. In one instance, a patient had a dire prognosis, with severe mean gradient of over 90 mmHg, and following implant, DurAVR™ THV resulted in a mean gradient of only 9 mmHg within 48 hours.

Anteris Technologies’ first-in-human DurAVR™ THV study has also demonstrated remarkable, sustained hemodynamic performance at one-year.

This clinically significant improvement is beyond what has been demonstrated by current TAVR platforms and supports the ongoing thesis that DurAVR™ THV will be an important treatment option for patients in the future.

In addition to such outcomes, DurAVR™ THV contains significantly fewer sutures and seams in its construction compared with conventional valves. This preserves tissue integrity and further reduces calcification risk, contributing to extended valve durability.

Unlike conventional approaches where engineers often drive design, DurAVR™ THV is designed in partnership with the world’s pre-eminent and experienced TAVR physicians. This ‘physician-led innovation’ has also resulted in the ComASUR™ Transfemoral Delivery System - a unique balloon-expandable system with a unique ability to rotate the valve before deployment to enable predictable and precise alignment with the heart’s native commissures.There is a growing body of evidence to support the role effective commissural alignment plays in patient outcomes and effective lifetime management.

Clinical Success Rooted in its Talented Team

Anteris Technologies has assembled an exceptional team, combining expertise from the medical technology and pharmaceutical industries. The team has forged collaborative partnerships with renowned physicians from esteemed institutions such as Abbott Northwestern, Cleveland Clinic, Columbia University Medical Center. This unique composition enables the company to tackle challenges and scientific complexities with a fresh and innovative approach.

Forging a Promising Path Ahead

Anteris continues its innovation in biocompatible materials, exploring new technologies leading to potential cost reductions, improved consistency, and even better patient outcomes.

Developing a biocompatible material that fulfills all necessary requirements is a complex task, but the team is determined to bring forth a second-generation product to provide patients and their physicians with yet more innovative solutions.

The firm has also announced its partnership with a Columbia University-affiliated company for a new mitral valve repair technology. This project has attracted the involvement of some of the world’s leading mitral surgeons. Anteris Technologies is taking its highly physician-centric approach, leveraging its expertise and insights to develop solutions that will further serve patient needs in new market segments.

“Our unwavering focus remains on continuing to drive innovation and making a tangible difference in tackling different diseases, and I believe we have been achieving that objective admirably,” concludes Paterson.