Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

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MINNEAPOLIS, United States and BRISBANE, Australia, Oct. 27, 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, today announced the first patients have been enrolled and successfully treated in the DurAVR^® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). The procedures were performed by Prof. Dr. Ole De Backer at, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

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“We are proud to be the first enrolling center for this important trial,“ said Prof. Dr. De Backer. “Our initial experience with the DurAVR^® THV System has been very positive, and we look forward to providing definitive comparative evidence which could transform patient care.”

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“With the first patients now randomized in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR^® THV toward commercialisation, expanding treatment options for aortic stenosis patients,” said Anteris Chief Medical Officer, Chris Meduri, M.D. “This head-to-head study will provide robust comparative evidence across all surgical risk groups, which we believe will differentiate our platform based on efficacy, safety and ease of use.”

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The PARADIGM Trial builds on Anteris’ existing clinical data set of 130 patients successfully treated with the DurAVR^® THV, including de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid aortic valve patients. Anteris aims to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement.

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About the PARADIGM Trial

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The PARADIGM Trial is a prospective randomized controlled trial* (RCT) which will evaluate the safety and effectiveness of the DurAVR^® THV compared to commercially available transcatheter aortic valve replacements (TAVRs).

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This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR^® THV or TAVR using commercially available and approved THVs. 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.

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For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies includes additional cohorts.

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*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison between treatment groups.