10:24 AM EDT, 10/15/2025 (MT Newswires) -- Anteris Technologies Global ( AVR ) received approval from the Danish Medicines Agency to begin its pivotal global trial of the DurAVR transcatheter heart valve in patients with severe calcific aortic stenosis.

The trial will evaluate the safety and effectiveness of the DurAVR valve compared with existing transcatheter devices, the company said Wednesday in a statement.

Patient enrollment at Danish centers is expected to start in Q4. Additional trial centers in the US, Europe and Canada will be added pending regulatory clearance, with Denmark marking the first European approval.

Anteris said its Investigational Device Exemption application for US sites remains under review by the Food and Drug Administration.

The company's shares rose 2.8% in Wednesday trading.

Price: 4.70, Change: +0.13, Percent Change: +2.84