Anteris gets Danish clearance to start DurAVR THV global pivotal trial

Anteris Technologies Global Corp.

Danish Medicines Agency clears Anteris to initiate DurAVR THV PARADIGM Trial for severe calcific aortic stenosis.
Patient recruitment at Danish centers expected in 4Q 2025; trial to enroll ~1000 patients, 1:1 vs. commercial TAVR.
IDE under FDA review; U.S. approval expected soon to allow U.S. sites in the trial.
Study co-chairs Dr. Michael Reardon and Prof. Stephan Windecker; CMO Chris Meduri cites potential to transform care.
Company calls approval a watershed moment, beginning commercialization planning for PMA and CE Mark.

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