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Anteris Technologies Ltd (ASX:AVR)

ALERT: Price-sensitive ASX Announcement for AVR
Current share price for AVR : $11.370 3.04 (36.49%)+
Announcement
Release
6 May 2026 9:04AM
Price at Release
$8.330
Full Release
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Summary
Anteris Technologies Ltd has announced that the first U.S. patients have been enrolled and treated in the global pivotal PARADIGM Trial, evaluating the DurAVR® Transcatheter Heart Valve (THV) for severe calcific aortic stenosis. This trial is a significant achievement for Anteris, comparing their biomimetic valve, designed to replicate normal aortic blood flow, against commercially available TAVRs. The trial will enroll approximately 1000 patients and assess safety and effectiveness on primary endpoints including all-cause mortality, stroke, and cardiovascular hospitalization one year post-procedure. The first procedures were conducted at Montefiore Medical Center in New York, marking a major milestone for Anteris as U.S. sites begin expanding recruitment.
Key Points
  • Anteris Technologies has announced the first U.S. patients treated in the PARADIGM Trial.
  • The PARADIGM Trial is evaluating the safety and effectiveness of DurAVR® Transcatheter Heart Valve (THV).
  • The trial is prospective, randomized, and controlled, comparing DurAVR® THV against existing transcatheter aortic valve replacements (TAVRs).
  • The trial aims to enroll approximately 1000 patients in the 'All Comers Randomized Cohort'.
  • The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure.
  • The first U.S. procedures were performed by Dr. Azeem Latib at Montefiore Medical Center, New York.
  • The DurAVR® THV is the first biomimetic valve designed to mimic the performance of a healthy human aortic valve.
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.