{"id":114713,"date":"2026-10-20T02:28:07","date_gmt":"2026-10-20T02:28:07","guid":{"rendered":"https:\/\/pakistaninewspaperlist.com\/news\/anteris-advances-global-paradigm-trial-expansion-with-german-regulatory-clearance\/"},"modified":"2026-10-20T02:28:07","modified_gmt":"2026-10-20T02:28:07","slug":"anteris-advances-global-paradigm-trial-expansion-with-german-regulatory-clearance","status":"publish","type":"post","link":"https:\/\/pakistaninewspaperlist.com\/news\/anteris-advances-global-paradigm-trial-expansion-with-german-regulatory-clearance\/","title":{"rendered":"Anteris Advances Global PARADIGM Trial Expansion with German Regulatory Clearance"},"content":{"rendered":"
\n

MINNEAPOLIS and BRISBANE, Australia, Oct. 19, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp.<\/strong> (\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR\u00ae<\/sup>\u00a0Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the \u201cPARADIGM Trial\u201d). This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial\u2019s European footprint.<\/p>\n

Germany is Europe\u2019s largest and most established transcatheter aortic valve replacement (TAVR) market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial.\u00a0<\/p>\n

\u201cGermany\u2019s scale, clinical expertise and established TAVR infrastructure create an important opportunity to advance enrollment and extend PARADIGM\u2019s reach across leading international TAVR markets,\u201d said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.<\/p>\n

The Company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany\u2019s inclusion strengthens the trial\u2019s European presence and adds meaningful scale to the PARADIGM Trial.<\/p>\n

ENDS<\/strong><\/p>\n

About the PARADIGM Trial<\/strong><\/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 compared to commercially available transcatheter aortic valve replacements (TAVRs).<\/p>\n

This head-to-head study will enrol approximately 1,000 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

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

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare 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

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

This announcement contains forward-looking statements, including statements regarding the expectation that this regulatory clearance enables patient recruitment in Germany. 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\n\n\n
For more information:<\/strong><\/td>\n\u00a0<\/td>\n<\/tr>\n
Global Investor Relations
<\/strong>investors@anteristech.com
Debbie Ormsby
Anteris Technologies Global Corp.
+61 1300 550 310 | +61 7 3152 3200
<\/strong><\/td>\n		Investor Relations (US)
<\/strong>mchatterjee@bplifescience.com
Malini Chatterjee, Ph.D. \u00a0 \u00a0 \u00a0
Blueprint Life Science Group
+1 917 330 4269 \u00a0 \u00a0
<\/strong><\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

Website \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0www.anteristech.com
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LinkedIn \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0https:\/\/www.linkedin.com\/company\/anteristech<\/p>\n

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

MINNEAPOLIS and BRISBANE, Australia, Oct. 19, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (\u201cAnteris\u201d or the \u201cCompany\u201d) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for the DurAVR\u00ae\u00a0Transcatheter Heart Valve (THV) global pivotal trial for patients with severe […]<\/p>\n","protected":false},"author":2,"featured_media":114714,"comment_status":"","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"fifu_image_url":"https:\/\/ml.globenewswire.com\/Resource\/Download\/90a5ae8d-7cf0-4a3d-b38c-f4ad7e3fbf0e","fifu_image_alt":"","footnotes":""},"categories":[208],"tags":[],"class_list":["post-114713","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t