CMS Reimbursement Secured for PARADIGM Trial

• Anteris secures U.S. Medicare reimbursement eligibility for PARADIGM Trial
• CMS framework enables reimbursement with clinical evidence generation
• Milestone expected to facilitate U.S. site activation and accelerate operational momentum

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR), a global structural heart company, has announced that it has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbursement with clinical evidence generation in the PARADIGM Trial. This milestone is expected to facilitate U.S. site activation, accelerating operational momentum across participating centers. The PARADIGM Trial is a prospective randomized controlled trial that will evaluate the safety and effectiveness of Anteris' DurAVR® Transcatheter Heart Valve (THV) compared to commercially available transcatheter aortic 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 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 achievement of this milestone is expected to facilitate U.S. site activation and accelerate operational momentum across participating centers for the PARADIGM Trial.