Anteris Technologies Ltd. announced that the United States Food and Drug Administration has determined Anteris has met the regulatory requirements for manufacturing DurAVRTM THV at the Company's newly expanded production facility in Maple Grove, Minnesota USA. The FDA's determination will allow for expanded in-house production capabilities that will lead to significant cost savings for the Company, and increased production efficiency as prepare to build DurAVRTM Transcatheter Heart Valves (THV) in anticipation of upcoming clinical studies. DurAVRTM THV's produced at the Maple Grove facility will be made available to leading interventional cardiologists treating patients with severe aortic stenosis as part of the DurAVRTM THV Early Feasibility Study (EFS) and Global Pivotal Studies.

The expanded Maple Grove facility complements existing tissue engineering capabilities in Malaga, Perth, where the company's patented ADAPT® anti-calcification technology is manufactured, whilst expanding overall production capacity.