Anteris obtains German clearance to recruit for PARADIGM heart‑valve trial
Anteris Technologies Global Corp. received full regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) to start patient recruitment for its pivotal PARADIGM trial of the DurAVR transcatheter heart valve. The approval allows the company to activate leading German clinical centres, expanding the trial’s European footprint. The trial plans to enrol about 1,000 patients in a 1:1 randomised comparison with existing TAVR devices. CEO Wayne Paterson said Germany’s scale and expertise will help accelerate enrollment.
Why it matters
The clearance enables Anteris to tap Europe’s largest TAVR market, potentially speeding trial enrollment and advancing the path to regulatory approval for DurAVR. The company’s stock rose 2.15% to $6.18 after the announcement, reflecting investor optimism about the trial’s progress.
Key facts
- 1Anteris received full regulatory clearance from Germany’s BfArM on Oct. 19, 2026. stocktitan.net
- 2The clearance permits patient recruitment at leading German centres for the PARADIGM trial. stocktitan.net
- 3The PARADIGM trial aims to enrol approximately 1,000 patients in an All‑Comers Randomized Cohort. stocktitan.net
- 4Patients will be randomised 1:1 to receive DurAVR or an approved commercial TAVR. stocktitan.net
- 5Wayne Paterson, Vice Chairman and CEO, said Germany’s scale and expertise create an important opportunity to advance enrollment. stocktitan.net
- 6AVR stock closed at $6.18, up 2.15%, and was up 3.40% in overnight trading. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.