{"id":955173,"date":"2026-04-28T06:04:21","date_gmt":"2026-04-28T10:04:21","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-secures-cms-reimbursement-supporting-u-s-site-activation-for-paradigm-trial\/"},"modified":"2026-04-28T06:04:21","modified_gmt":"2026-04-28T10:04:21","slug":"anteris-technologies-secures-cms-reimbursement-supporting-u-s-site-activation-for-paradigm-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-secures-cms-reimbursement-supporting-u-s-site-activation-for-paradigm-trial\/","title":{"rendered":"Anteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial"},"content":{"rendered":"
\n

MINNEAPOLIS and BRISBANE, Australia, April 28, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp.<\/strong> (\u201cAnteris\u201d or the \u201cCompany\u201d) (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.<\/p>\n

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.<\/p>\n

\n About the PARADIGM Trial<\/strong>\n <\/p>\n

The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR\u00ae<\/sup> Transcatheter Heart Valve (\u201cTHV\u201d) compared to commercially available transcatheter aortic valve replacements (TAVRs).<\/p>\n

This head-to-head study will enroll approximately 1000 patients in the \u2018All Comers Randomized Cohort\u2019 with 1:1 randomization of patients who will receive either the DurAVR\u00ae<\/sup> 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.<\/p>\n

For further information, please refer to ClinicalTrials.gov NCT07194265.<\/p>\n

\n About Anteris<\/strong>\n <\/p>\n

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.<\/p>\n

Anteris\u2019 lead product, the DurAVR\u00ae<\/sup> THV, was designed in collaboration with the world\u2019s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis \u2013 a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR\u00ae<\/sup> 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. DurAVR\u00ae <\/sup>THV is made using a single piece of molded ADAPT\u00ae<\/sup> tissue, Anteris\u2019 patented anti-calcification tissue technology. ADAPT\u00ae<\/sup> tissue, which is FDA-cleared, has been used clinically for over 10\u00a0years and distributed for use in over 55,000 patients worldwide. The DurAVR\u00ae<\/sup> THV System is comprised of the DurAVR\u00ae<\/sup> valve, the ADAPT\u00ae<\/sup> tissue, and the balloon-expandable ComASUR\u00ae<\/sup> Delivery System.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

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 \u201cbelieve,\u201d \u201cproject,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cbudget,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cstrategy,\u201d \u201cplan,\u201d \u201cguidance,\u201d \u201coutlook,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cwill be,\u201d \u201cwill continue,\u201d \u201cwill likely result\u201d 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 \u201cRisk Factors\u201d in Anteris\u2019 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.<\/p>\n

\n For more information:<\/strong>\n <\/p>\n\n\n\n\n\n\n
\n Global Investor Relations<\/strong>\u00a0<\/td>\n\n Investor Relations (US)<\/strong>\n <\/td>\n<\/tr>\n
investors@anteristech.com<\/td>\nmchatterjee@bplifescience.com<\/td>\n<\/tr>\n
Debbie Ormsby\u00a0<\/td>\nMalini Chatterjee, Ph.D.\u00a0\u00a0<\/td>\n<\/tr>\n
Anteris Technologies Global Corp.<\/td>\nBlueprint Life Science Group<\/td>\n<\/tr>\n
+61 1300 550 310 | +61 7 3152 3200<\/td>\n+1 917 330 4269<\/td>\n<\/tr>\n<\/table>\n

\n \n <\/p>\n\n\n\n\n
Website\u00a0<\/td>\nwww.anteristech.com<\/td>\n<\/tr>\n
X<\/td>\n@AnterisTech<\/td>\n<\/tr>\n
LinkedIn<\/td>\nhttps:\/\/www.linkedin.com\/company\/anteristech<\/td>\n<\/tr>\n<\/table>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

MINNEAPOLIS and BRISBANE, Australia, April 28, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (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, … <\/p>\n

Continue reading “Anteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-955173","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAnteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-secures-cms-reimbursement-supporting-u-s-site-activation-for-paradigm-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MINNEAPOLIS and BRISBANE, Australia, April 28, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (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. 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