Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced that it has 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 for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial’s European footprint.

Germany is Europe’s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial. 

“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,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

The Company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany’s inclusion strengthens the trial’s European presence and adds meaningful scale to the PARADIGM Trial.