Anteris Technologies Global Corp. has received approval from the U.S. Food and Drug Administration (FDA) to initiate the PARADIGM global Investigational Device Exemption $(IDE)$ clinical trial. The trial will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and is intended to support a future premarket approval (PMA) submission. This regulatory milestone also allows Anteris to begin patient recruitment in the United States, following the successful launch and treatment of initial patients in Denmark. The PARADIGM Trial is co-chaired by leading cardiovascular experts from Houston Methodist Hospital, Texas, and Bern University Hospital, Switzerland. No grant or funding was announced for multiple organizations.