Anteris Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Anteris Technologies Global Corp. (AVR)
Company Research
Source: GlobeNewswire
MINNEAPOLIS and BRISBANE, Australia, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the “PARADIGM Trial”). Patient recruitment at Danish centers is expected to begin in 4Q 2025. PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices With the first regulatory clearance secured, Anteris is positioned to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across
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News
- Anteris Technologies Global (NASDAQ:AVR) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Anteris Technologies Presents Data from 100 DurAVR® THV Patients at PCR London ValvesGlobeNewswire
- Anteris Announces Results for the Third Quarter of 2025GlobeNewswire
- FDA Approves Anteris’s DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)GlobeNewswire
- Anteris Technologies Global (NASDAQ:AVR) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
AVR
Sec Filings
- 12/4/25 - Form 8-K
- 12/1/25 - Form 8-K
- 11/26/25 - Form S-1
- AVR's page on the SEC website