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Anteris Technologies Ltd (ASX:AVR)

ALERT: Price-sensitive ASX Announcement for AVR
Current share price for AVR : $11.560 4.49 (63.51%)+
Announcement
Release
3 Nov 2025 9:08AM
Price at Release
$7.070
Full Release
download
Summary
Anteris Technologies Ltd has received FDA approval to commence the PARADIGM Trial, a global Investigational Device Exemption (IDE) clinical trial designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) for patients suffering from severe calcific aortic stenosis. The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada, comparing the safety and effectiveness of the DurAVR® THV to commercially available TAVR devices. This trial is a major step toward obtaining Premarket Approval (PMA) from the FDA and CE Mark approval, supporting Anteris' mission to provide life-saving technology for aortic stenosis patients.
Key Points
  • FDA approved the PARADIGM Trial for DurAVR® THV.
  • Trial aims to evaluate DurAVR® THV for severe calcific aortic stenosis.
  • PARADIGM Trial involves 1000 patients across the US, Europe, and Canada.
  • The trial compares DurAVR® THV with existing TAVR devices.
  • It seeks to support FDA Premarket Approval and CE Mark.
  • DurAVR® THV is a biomimetic valve for aortic stenosis.
  • Anteris uses ADAPT® tissue technology in DurAVR® THV.
  • The trial is a critical step in Anteris' global expansion strategy.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.