Anteris Technologies Ltd. announced 12-month results from the DurAVRTM First-in- Human Study designed to evaluate the safety and efficacy of the DurAVRTM THV in patients with symptomatic severe aortic stenosis. DurAVRTM THV is a new class of aortic valve replacement device that utilises the patented ADAPT anti-calcification process and innovative tissue-shaping technology in single-piece transcatheter heart valve. DurAVRTM THV's unique, first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve.

This First-in-Human Study shows DurAVRTM THV restored normal, pre-disease blood flow, producing large effective orifice areas, enabling the valve to open widely with low mean pressure gradients. Fewer sutures preserve tissue integrity and reduce leaflet stresses with longer coaptation - all crucial precursors for valve durability, improved patient outcomes and survival. The first five patients implanted with DurAVRTM THV continue to show stable, improved valve function with excellent safety at 12-month follow-up.

Study results demonstrate: Increased average Effective Orifice Area by 294% from baseline, as observed at 30 days and 12 months - an indicator paramount for increased long-term survival and exercise capacity. Reduced mean pressure gradient across the valve by 85% from baseline, which remains consistent to 12 months. Increased blood flow velocity through the valve with stable hemodynamics from baseline, as observed at 30 days and 12 months.

No mortality (all causes), disabling stroke, life-threatening bleeding or myocardial infarction was reported at 12 months. No device-related complications. The 6-minute walk test distance (6MWTD) measuring patient exercise capacity after aortic valve replacement improved by 32% from baseline, with a 17% improvement from the 30-day result at 12 months.