Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) is making steady progress towards the next phase of clinical testing for its biomimetic heart valve, DurAVR, as the company continues to strengthen its financial and operational position. The Brisbane- and Minneapolis-based med-tech this week reported encouraging one-year results from its early studies and secured new funding to support the upcoming PARADIGM pivotal trial.
The company on Tuesday raised A$38.5 million through a placement to institutional investors including L1 Capital, Sio Capital and Rhenman & Partners Asset Management. The funds will be used to advance patient recruitment for the global trial, expand manufacturing capacity, and maintain development of its ADAPT tissue platform.
With these milestones, Anteris is entering a critical phase — one that will test both the scientific promise of its technology and its ability to navigate a highly competitive global device market.
Designed to replicate natural valve performance
DurAVR is a transcatheter heart valve (THV) designed to replicate the function and flow characteristics of a healthy aortic valve. It uses Anteris’ ADAPT® anti-calcification tissue — a single-piece material that has been used clinically for more than a decade — to support durability and reduce the risk of calcification.
Recent clinical data presented at cardiology meetings show the device achieved sustained one-year hemodynamic performance and left ventricular mass regression in treated patients. In small annuli, there were no moderate or severe paravalvular leaks reported.
According to Dr Michael Reardon, a cardiothoracic surgeon at Houston Methodist and co-chair of the PARADIGM study, “a balloon-expandable valve with self-expanding hemodynamics is like the holy grail”.
Advancing the PARADIGM trial
Anteris has begun enrolling patients in the PARADIGM trial, a head-to-head global study comparing DurAVR with established market leaders such as Edwards Lifesciences’ SAPIEN and Medtronic’s Evolut systems. On Tuesday, it announced the successful treatment of the first patients in the trial, with the procedures performed at The Heart Centre at Rigshospitalet Copenhagen University in Denmark.
The 1,000-patient trial will include participants across all surgical risk categories and is expected to run at up to 85 sites across the United States, Europe and Canada. Regulatory approval for study initiation in the US is pending following Anteris’ submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration earlier this year.
The trial’s one-year data will form the basis for a potential Premarket Approval (PMA) submission in the United States and a CE Mark application in Europe.
Under US Medicare provisions, the company may also receive coverage of up to US$25,000 per device during the study period, providing partial cost recovery for clinical activity.
A growing but under-treated market
The global market for transcatheter aortic valve replacement (TAVR) continues to expand, supported by longer life expectancy and a gradual shift towards treating lower-risk, more active patients. Yet industry data suggest as many as 85% of patients with severe aortic stenosis remain untreated, highlighting the scale of unmet need.
Within this environment, DurAVR is positioned as a next-generation device intended to improve blood flow and long-term outcomes. The company’s manufacturing and regulatory expansion — including new tissue sourcing channels in Australia and the US — forms part of its strategy to prepare for potential commercialisation.
Incremental progress, broader visibility
Anteris’ listing on Nasdaq in late 2024 increased its visibility with international investors and helped align the company with larger peers in the structural heart space. The latest capital raise reflects continuing institutional interest as Anteris transitions from feasibility studies to pivotal testing.
While challenges remain — including the complexity of large-scale clinical recruitment and regulatory review — the company’s progress through 2025 marks a key stage in a longer development pathway. For investors tracking advanced medical device innovation, Anteris’ next updates will hinge on the timing of US trial approvals and early enrolment data from PARADIGM.