• First US patients enrolled and successfully treated in the global pivotal PARADIGM trial for the DurAVR® Transcatheter Heart Valve
• Trial designed to evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs)
• Milestone achievement for trial investigators and early procedural experience with the DurAVR® THV System highly encouraging

Anteris Technologies Global Corp. announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR® Transcatheter Heart Valve ('THV') global pivotal trial for patients with severe calcific aortic stenosis (the 'PARADIGM Trial'). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States. Dr. Latib, the Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore, stated that the early procedural experience with the DurAVR® THV System has been highly encouraging and that the PARADIGM trial is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris, said that following CMS approval, the Anteris team and their physician partners worked closely together to achieve first patient enrolments within the week, marking a major milestone for the PARADIGM Trial as the US study sites come online and expand recruitment capability.

The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1000 patients in the 'All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.