Anteris Technologies Receives Danish Regulatory Clearance for Transcatheter Heart Valve Trial; Shares Up 5%
MT Newswires Live
Oct 16, 2025
Anteris Technologies (ASX:AVR) secured regulatory clearance from the Danish Medicines Agency to initiate the DurAVR transcatheter heart valve global pivotal trial in patients with severe calcific aortic stenosis, according to a Thursday filing with the Australian bourse.
Calcific aortic stenosis is a progressive heart condition where calcium deposits on the aortic valve, causing it to thicken and narrow, obstructing blood flow.
The recruitment of patients at Danish centers is anticipated to begin in the fourth quarter of the year, the filing said.
Additionally, an investigational device exemption application is under review by the US Food and Drug Administration, per the filing.
Shares rose 5% in afternoon trade on Thursday.
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