Anteris Wins German BfArM Clearance for PARADIGM DurAVR Trial; AVR Shares Rise

Anteris Technologies Global Corp. (AVR) said it received full regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to launch the global PARADIGM pivotal trial of its DurAVR transcatheter heart valve (THV) in patients with severe calcific aortic stenosis. The stock closed Monday's trade at $6.18, up 2.15%, and rose 3.40% to $6.39 in overnight trading. The clearance allows Anteris to begin patient recruitment at German sites and expand the trial's European footprint. Germany is Europe's largest TAVR market. PARADIGM is a prospective randomized controlled trial expected to enroll approximately 1,000 patients, assigned 1:1 to receive DurAVR or an approved transcatheter heart valve. The primary endpoint is a composite of all-cause mortality, stroke, and cardiovascular hospitalization at one year. AVR has traded between $3.30 and $11.06 over the past year.