Anteris receives German regulatory clearance for PARADIGM Trial
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) announced on 20 October 2026 that it received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in severe calcific aortic stenosis (the “PARADIGM Trial”).
The clearance enables the company to initiate patient recruitment at leading German centres. Anteris described it as an important step in expanding the PARADIGM Trial’s European footprint.
Wayne Paterson, Vice Chairman and Chief Executive Officer
“Germany’s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment and extend PARADIGM’s reach across leading international TAVR markets.”
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Why Germany matters
According to the company, Germany is Europe’s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centres and investigators.
Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrolment in the PARADIGM Trial. For investors, enrolment pace is a key factor in how a trial progresses, although the announcement does not disclose timelines, site numbers or enrolment targets for Germany.
Anteris said it continues to execute its global clinical strategy through coordinated site activation and patient enrolment across the United States and Europe.
The first US patients were treated within one week of Medicare approval, which gives a useful benchmark for how quickly Anteris has converted regulatory and reimbursement clearances into actual enrolment.
DurAVR® THV and PARADIGM Trial explained
Aortic stenosis is a potentially life-threatening condition resulting from the narrowing of the aortic valve. TAVR is a catheter-based approach to replacing that valve.
A pivotal trial is the key study designed to evaluate a device’s safety and effectiveness, and it is typically central to regulatory and commercial prospects. The PARADIGM Trial is a head-to-head study comparing the DurAVR® THV with commercially available TAVRs.
| Feature | Detail |
|---|---|
| Design | Prospective randomized controlled trial |
| Cohort | ‘All Comers Randomized Cohort’, approximately 1,000 patients |
| Randomization | 1:1, DurAVR® THV or TAVR using commercially available and approved THVs |
| Primary endpoint | Non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure |
| Registry | ClinicalTrials.gov NCT07194265 |
What sets DurAVR® THV apart
Anteris describes the balloon-expandable DurAVR® THV in the following terms:
- It is the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve and aiming to replicate normal aortic blood flow.
- It is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology.
- ADAPT® tissue is FDA-cleared, has been used clinically for over 10 years and has been distributed for use in over 55,000 patients worldwide.
- The DurAVR® THV System comprises the DurAVR® valve, the ADAPT® tissue and the balloon-expandable ComASUR® Delivery System.
What the expansion means for investors
Anteris said Germany’s inclusion strengthens the trial’s European presence and adds meaningful scale to the PARADIGM Trial. This forms part of the company’s stated global clinical strategy alongside activity in the United States.
French regulatory clearance from ANSM earlier in 2026 already opened another major European market to PARADIGM recruitment, so Germany adds to an expanding multi-country footprint rather than standing alone.
The next step is the initiation of patient recruitment at German centres. The announcement does not disclose dates, site numbers or cost impacts, so the outlook remains qualitative.
Anteris is a global healthcare company founded in Australia, with a significant presence in Minneapolis, USA. It is listed on both NASDAQ and the ASX under the ticker AVR.
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