• Anteris receives regulatory clearance from Danish Medicines Agency to initiate DurAVR® Transcatheter Heart Valve global pivotal trial
• Trial to evaluate safety and effectiveness of DurAVR® THV compared to commercially available TAVRs
• Planned expansion across the US, Europe and Canada

Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) announced that 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. 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 aoric valve replacements (TAVRs). The trial will enroll approximately 1000 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. 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 the United States, Europe and Canada. The Company continues to expect FDA approval for the Investigational Device Exemption (IDE) application in the near term, which will allow initiation of study sites in the PARADIGM Trial in the United States, pending Institutional Review Board (IRB) approval.

Anteris is excited to be able to allow access to an increasing pool of patients globally who will benefit from this life saving technology. The commencement of this trial reflects the commitment and tireless work of the Anteris team, as well as their Physician and Scientific Advisors.