Core Points - Anteris has received FDA approval to initiate the PARADIGM clinical trial for the DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis [1][2] - The trial will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [4][5] - The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada [5] Company Overview - Anteris Technologies Global Corp. is a global structural heart company focused on designing and commercializing advanced medical devices for heart function restoration [8] - The DurAVR THV is the first biomimetic valve designed to replicate the performance of a healthy human aortic valve, utilizing Anteris' patented ADAPT tissue technology [9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial (RCT) assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [5][6] - The trial is co-chaired by prominent cardiology experts, Dr. Michael J. Reardon and Professor Stephan Windecker [3] - The trial aims to provide robust clinical evidence to support a future Premarket Approval (PMA) application to the FDA [6][7]