MINNEAPOLIS and BRISBANE, Australia, April 28, 2026 (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 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.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve ("THV") compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study 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.
For further information, please refer to ClinicalTrials.gov NCT07194265.
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
Anteris' lead product, the DurAVR THV, was designed in collaboration with the world's leading interventional cardiologists and cardiac surgeons to treat aortic stenosis - a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVRTHV is made using a single piece of molded ADAPT tissue, Anteris' patented anti-calcification tissue technology. ADAPT tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding the expectation that achievement of the milestone will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "budget," "target," "aim," "strategy," "plan," "guidance," "outlook," "may," "should," "could," "will," "would," "will be," "will continue," "will likely result" and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under "Risk Factors" in Anteris' Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
For more information:
| Global Investor Relations | Investor Relations (US) |
| investors@anteristech.com | mchatterjee@bplifescience.com |
| Debbie Ormsby | Malini Chatterjee, Ph.D. |
| Anteris Technologies Global Corp. | Blueprint Life Science Group |
| +61 1300 550 310 | +61 7 3152 3200 | +1 917 330 4269 |
| Website | www.anteristech.com |
| X | @AnterisTech |
| https://www.linkedin.com/company/anteristech |
