Anteris Technologies secures Danish clearance for global PARADIGM trial of DurAVR® Valve

Proactive - Interviews for investors

Anteris Technologies CEO Wayne Paterson joined Steve Darling from Proactive to share a major milestone in the company’s development of DurAVR®, its groundbreaking aortic valve replacement technology designed to transform treatment for patients suffering from aortic stenosis — a fatal heart disease for which no pharmacotherapy options exist. Paterson explained that DurAVR® was designed from the ground up following extensive collaboration with leading cardiologists and cardiac surgeons. The result is a biomimetic, balloon-expandable valve engineered to replicate natural valve anatomy and physiology — a radical advancement over traditional bioprosthetic devices. “We developed one that is physiologically and anatomically correct. It gives you pre-disease mean gradients — that’s been established across 130 patients now,” Paterson said, underscoring the valve’s ability to restore near-normal cardiac function. The company recently secured its first regulatory clearance in Europe, paving the way for broader international approvals in the near term. This clearance allows Anteris to initiate its global PARADIGM pivotal trial, which will evaluate DurAVR® across low-, medium-, and high-risk patient groups. The study will also feature a valve-in-valve registry and target a non-inferiority primary endpoint, aligning with global regulatory pathways for approval. Paterson highlighted that medical device trials carry far less risk than pharmaceutical studies, with Anteris already demonstrating highly consistent patient outcomes. The company has also laid significant groundwork for clinical expansion, including site preparation and an upcoming investigator meeting at the TCT conference in San Francisco. Built on Anteris’ proprietary ADAPT® tissue platform, DurAVR® has shown 20–30% clinical superiority in objective performance metrics. Paterson noted that the company has achieved what physicians have long demanded: clinical superiority combined with balloon-expandable delivery. “This milestone moves us closer to our goal of redefining valve replacement therapy,” Paterson said. “DurAVR® represents the future of aortic valve technology — designed by physicians, built for patients, and proven by data.”