{"id":957947,"date":"2026-05-05T06:03:44","date_gmt":"2026-05-05T10:03:44","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/"},"modified":"2026-05-05T06:03:44","modified_gmt":"2026-05-05T10:03:44","slug":"anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/","title":{"rendered":"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">MINNEAPOLIS and BRISBANE, Australia, May  05, 2026  (GLOBE NEWSWIRE) &#8212; <strong>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 that the first patients in the United States have been enrolled and successfully treated in the DurAVR<sup>\u00ae<\/sup> Transcatheter Heart Valve (\u201cTHV\u201d) global pivotal trial for patients with severe calcific aortic stenosis (the \u201cPARADIGM Trial\u201d). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States.<\/p>\n<p align=\"justify\">\u201cPerforming the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial\u00a0investigators, and our early procedural experience with the DurAVR<sup>\u00ae<\/sup> THV System has been\u00a0highly encouraging,\u201d said Dr. Latib, Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore. \u201cPARADIGM is\u00a0specifically designed to answer clinically meaningful questions and go beyond the usual safety\u00a0metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular\u00a0recovery. Initiating enrollment represents a critical step toward generating the evidence\u00a0needed to inform future patient care.\u201d<\/p>\n<p align=\"justify\">\u201cFollowing CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week. This marks a major milestone for the PARADIGM Trial as our U.S. study sites come on line and expand recruitment capability,\u201d said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.<\/p>\n<p align=\"justify\">\n        <strong>About the PARADIGM Trial<\/strong>\n      <\/p>\n<p align=\"justify\">The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR<sup>\u00ae<\/sup> THV compared to commercially available transcatheter aortic valve replacements (TAVRs).<\/p>\n<p align=\"justify\">This head-to-head study will enroll approximately 1000 patients in the \u2018All Comers Randomized Cohort\u2019\u00a0with 1:1 randomization of patients who will receive either the DurAVR<sup>\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<p align=\"justify\">For further information, please refer to ClinicalTrials.gov NCT07194265.<\/p>\n<p align=\"justify\">\n        <strong>About Anteris<\/strong>\n      <\/p>\n<p align=\"justify\">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<p align=\"justify\">Anteris\u2019 lead product, the DurAVR<sup>\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<sup>\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<sup>\u00ae <\/sup>THV is made using a single piece of molded ADAPT<sup>\u00ae<\/sup> tissue, Anteris\u2019 patented anti-calcification tissue technology. ADAPT<sup>\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<sup>\u00ae<\/sup> THV System is comprised of the DurAVR<sup>\u00ae<\/sup> valve, the ADAPT<sup>\u00ae<\/sup> tissue, and the balloon-expandable ComASUR<sup>\u00ae<\/sup> Delivery System.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">This announcement contains forward-looking statements, including the quotes contained herein. 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<p align=\"justify\">\n        <strong>For more information:<\/strong>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\n            <strong>Global Investor Relations<\/strong>\n          <\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%\">\n            <strong>Investor Relations (US)<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td>investors@anteristech.com<\/td>\n<td>mchatterjee@bplifescience.com<\/td>\n<\/tr>\n<tr>\n<td>Debbie Ormsby\u00a0<\/td>\n<td>Malini Chatterjee, Ph.D.<\/td>\n<\/tr>\n<tr>\n<td>Anteris Technologies Global Corp.<\/td>\n<td>Blueprint Life Science Group<\/td>\n<\/tr>\n<tr>\n<td>+61 1300 550 310 | +61 7 3152 3200<\/td>\n<td>+1 917 330 4269<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">\n        \n      <\/p>\n<table align=\"left\" style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:10%;width:10%;min-width:10%;text-align: left;vertical-align: middle\">Website\u00a0<\/td>\n<td style=\"max-width:90%;width:90%;min-width:90%;text-align: left;vertical-align: middle\">www.anteristech.com<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;vertical-align: middle\">X<\/td>\n<td style=\"text-align: left;vertical-align: middle\">@AnterisTech<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;vertical-align: middle\">LinkedIn<\/td>\n<td style=\"text-align: left;vertical-align: middle\">https:\/\/www.linkedin.com\/company\/anteristech<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">\n        \n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxMzE3MiM3NTgzNDQ5IzIyNjIyMTM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/YTcyOTZmNTktN2M0NS00ZTlkLWE2OWEtY2MyZGFmYmQwNGY2LTEyNzM3NjMtMjAyNi0wNS0wNS1lbg==\/tiny\/Anteris-Technologies-Pty-Ltd.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MINNEAPOLIS and BRISBANE, Australia, May 05, 2026 (GLOBE NEWSWIRE) &#8212; 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 that the first patients in the United States have been enrolled and successfully treated in the DurAVR\u00ae Transcatheter Heart Valve (\u201cTHV\u201d) global pivotal trial for patients with severe calcific aortic stenosis (the \u201cPARADIGM Trial\u201d). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States. \u201cPerforming the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial\u00a0investigators, and our early procedural experience with the DurAVR\u00ae THV System has &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial&#8221;<\/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-957947","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal 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-announces-first-u-s-patients-treated-in-global-pivotal-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 Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MINNEAPOLIS and BRISBANE, Australia, May 05, 2026 (GLOBE NEWSWIRE) &#8212; 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 that the first patients in the United States have been enrolled and successfully treated in the DurAVR\u00ae Transcatheter Heart Valve (\u201cTHV\u201d) global pivotal trial for patients with severe calcific aortic stenosis (the \u201cPARADIGM Trial\u201d). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States. \u201cPerforming the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial\u00a0investigators, and our early procedural experience with the DurAVR\u00ae THV System has &hellip; Continue reading &quot;Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-05T10:03:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxMzE3MiM3NTgzNDQ5IzIyNjIyMTM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial\",\"datePublished\":\"2026-05-05T10:03:44+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/\"},\"wordCount\":728,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTcxMzE3MiM3NTgzNDQ5IzIyNjIyMTM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\\\/\",\"name\":\"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial - 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(\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 that the first patients in the United States have been enrolled and successfully treated in the DurAVR\u00ae Transcatheter Heart Valve (\u201cTHV\u201d) global pivotal trial for patients with severe calcific aortic stenosis (the \u201cPARADIGM Trial\u201d). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States. \u201cPerforming the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial\u00a0investigators, and our early procedural experience with the DurAVR\u00ae THV System has &hellip; Continue reading \"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/","og_site_name":"Market Newsdesk","article_published_time":"2026-05-05T10:03:44+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxMzE3MiM3NTgzNDQ5IzIyNjIyMTM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial","datePublished":"2026-05-05T10:03:44+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/"},"wordCount":728,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxMzE3MiM3NTgzNDQ5IzIyNjIyMTM=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/anteris-technologies-announces-first-u-s-patients-treated-in-global-pivotal-paradigm-trial\/","name":"Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial - 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