Anteris Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Anteris (NASDAQ: AVR) received regulatory clearance from the Danish Medicines Agency to start the global pivotal PARADIGM Trial of the DurAVR® transcatheter heart valve for severe calcific aortic stenosis, announced on October 15, 2025.
Patient recruitment at Danish centers is expected to begin in 4Q 2025, with planned expansion across the United States, Europe and Canada. An IDE remains under review by the U.S. FDA, and U.S. sites will begin once IDE and IRB approvals are obtained. Management cites trial design aimed to support future PMA and CE Mark approvals.
Anteris (NASDAQ: AVR) ha ricevuto l'autorizzazione regolamentare dalla Danish Medicines Agency per avviare lo studio globale pivotale PARADIGM Trial della valvola cardiaca transcatetere DurAVR® per la stenosi aortica severa calcifica, annunciato il 15 ottobre 2025.
Il reclutamento dei pazienti presso i centri danesi dovrebbe iniziare nel 4Q 2025, con un'espansione pianificata negli Stati Uniti, Europa e Canada. Un IDE è in fase di valutazione da parte della FDA statunitense, e i siti negli Stati Uniti inizieranno non appena saranno ottenuti l'IDE e l'approvazioni IRB. Il management cita che il disegno dello studio è volto a supportare future approvazioni PMA e CE Mark.
Anteris (NASDAQ: AVR) recibió la aprobación regulatoria de la Agencia Danesa de Medicamentos para iniciar el ensayo global pivotal PARADIGM Trial de la válvula cardíaca transcatéter DurAVR® para la estenosis aórtica calcífica grave, anunciada el 15 de octubre de 2025.
Se espera que el reclutamiento de pacientes en los centros daneses comience en el 4T 2025, con la expansión prevista a través de los Estados Unidos, Europa y Canadá. Un IDE permanece en revisión por la FDA estadounidense, y los sitios en EE. UU. comenzarán una vez obtenidos el IDE y las aprobaciones del IRB. La dirección señala que el diseño del ensayo tiene como objetivo apoyar futuras aprobaciones de PMA y CE Mark.
Anteris (NASDAQ: AVR)은 중등도 이상 석회화 대동맥 협착증에 대한 DurAVR® 경유심혈관 판막의 글로벌 핵심 연구인 PARADIGM Trial의 시작을 위해 덴마크 의약품국으로부터 규제 승인을 받았습니다, 2025년 10월 15일에 발표되었습니다.
덴마크 centers에서의 환자 모집은 2025년 4분기에 시작될 것으로 예상되며, 미국, 유럽 및 캐나다 전역으로의 확장이 계획되어 있습니다. 미국 FDA의 IDE는 아직 심사 중이며, IDE 및 IRB 승인이 얻어진 후 미국 sites가 시작될 것입니다. 경영진은 이 임상시험 디자인이 향후 PMA 및 CE 마크 승인을 지원하도록 설계되었다고 밝힙니다.
Anteris (NASDAQ: AVR) a reçu l'autorisation réglementaire de la Agence danoise des médicaments pour lancer l'essai pivot global PARADIGM Trial de la valve cardio-vasculaire transcatheter DurAVR® pour la sténose aortique calcifique sévère, annoncé le 15 octobre 2025.
Le recrutement des patients dans les centres danois doit débuter au 4e trimestre 2025, avec une expansion prévue à travers les États-Unis, l'Europe et le Canada. Un IDE est toujours en cours d'examen par la FDA américaine, et les sites américains commenceront une fois l'IDE et les approbations IRB obtenus. La direction indique que la conception de l'essai vise à soutenir de futures approbations PMA et CE Mark.
Anteris (NASDAQ: AVR) erhielt die regulatorische Zulassung von der Danish Medicines Agency, um die globale pivotal PARADIGM Trial der DurAVR®-Transkatheter-Herzklappe bei schwerer calcifizierender Aortenstenose zu starten, bekannt gegeben am 15. Oktober 2025.
Die Patienteneinschreibung in dänischen Zentren soll im 4. Quartal 2025 beginnen, mit geplanter Ausweitung in den USA, Europa und Kanada. Eine IDE befindet sich weiterhin in Prüfung durch die US-amerikanische FDA, und US-Standorte werden beginnen, sobald IDE und IRB-Genehmigungen vorliegen. Das Management gibt an, dass das Studiendesign darauf abzielt, zukünftige PMA- und CE-Marken-Zulassungen zu unterstützen.
Anteris (NASDAQ: AVR) تلقّت الموافقات التنظيمية من هيئة الدواء الدنماركية لبدء التجربة العالمية المحورية PARADIGM Trial ل صمام القلب بالتدخل عن طريق القسطرة DurAVR® لاضطرابات تضيق الأبهر التكلسية الشديدة، كما أُعلن في 15 أكتوبر 2025.
من المتوقع أن يبدأ تسجيل المرضى في المراكز الدنماركية في الربع الرابع من 2025، مع توسع مخطط عبر الولايات المتحدة وأوروبا وكندا. لا يزال IDE قيد المراجعة من إدارة الغذاء والدواء الأمريكية، وسوف تبدأ المواقع الأمريكية عند الحصول على IDE وموافقات IRB. وتذكر الإدارة أن تصميم التجربة يهدف إلى دعم الموافقات المستقبلية PMA و CE Mark.
Anteris (NASDAQ: AVR) 已获得 丹麦药品管理局的监管批准，启动全球关键性研究 PARADIGM Trial，针对严重钙化性主动脉瓣狭窄的 DurAVR® 经导管心脏瓣膜，宣布日期为 2025年10月15日。
丹麦中心的患者招募预计将于 2025年第四季度开始，计划扩展至 美国、欧洲和加拿大。美国的 IDE 正在由 美国食品药品监督管理局（FDA）审查中，一旦 IDE 与 IRB 批准，美国站点将开始。管理层表示，该试验设计旨在为未来的 PMA 与 CE 标志 批准提供支持。
- Danish Medicines Agency clearance to initiate PARADIGM Trial (Oct 15, 2025)
- Patient recruitment in Danish centers expected to begin in 4Q 2025
- Planned near‑term expansion to United States, Europe and Canada
- Trial designed to generate data to support PMA and CE Mark approvals
- U.S. IDE remains under FDA review; U.S. sites pending IDE and IRB approval
Insights
Initial European clearance enables start of the global pivotal PARADIGM trial; enrollment in Denmark expected in
DurAVR moves from feasibility toward a randomized pivotal study testing safety and effectiveness versus commercial TAVR devices, which is the required pathway to generate the evidence base for regulatory approvals and broader clinical adoption.
Key dependencies include timely site activation, investigator engagement, and enrollment pace; the release states Danish recruitment begins in
Watch for early enrollment milestones in Denmark and subsequent approvals to open sites in the United States, Europe and Canada, plus any disclosed primary endpoint definitions and event rates that will determine how quickly results can read out.
Receiving Danish regulatory clearance is a formal regulatory milestone that permits initiation of the global PARADIGM pivotal trial and supports later PMA and CE Mark pathways.
The announcement confirms an active regulatory route: Danish clearance to start the trial and an IDE application under review by the FDA; the company states it "continues to expect FDA approval in the near term," which is a company expectation, not a confirmed regulatory decision.
Primary near-term monitors are the start of patient recruitment in Denmark in
MINNEAPOLIS and BRISBANE, Australia, Oct. 15, 2025 (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, announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the “PARADIGM Trial”). Patient recruitment at Danish centers is expected to begin in 4Q 2025.
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices
With the first regulatory clearance secured, Anteris is positioned to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement.
“Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial. This groundbreaking study has been designed with world-leading experts and is attracting significant interest from clinicians globally, reflecting the potential for DurAVR® to transform care for patients with aortic stenosis,” said Anteris Chief Medical Officer, Chris Meduri, M.D.
“The PARADIGM Trial enables us to bring promising new technology to patients across all surgical risk groups, building on the growing body of evidence supporting the DurAVR® THV’s favorable hemodynamic performance. We look forward to contributing meaningful data which could support both PMA* and CE Mark approvals,” said Dr. Michael Reardon and Professor Stephan Windecker, Study Co-Chairs of the global PARADIGM Trial.
“The PARADIGM trial is a multi center global study which, if successful, will result in multiple approvals and labels for the DurAVR® THV. This is a watershed moment in the company’s life cycle and marks the beginning of the commercialization planning phase as we march towards global approvals. Anteris is excited to be able to allow access to an increasing pool of patients globally who will benefit from this life saving technology. The commencement of this trial reflects the commitment and tireless work of our talented Anteris team, as well as our Physician and Scientific Advisors. The company would like to express its gratitude to the physicians, patients and shareholders who have been fundamental in developing this important new therapy,” said Vice Chairman and CEO, Wayne Paterson.
In parallel, an Investigational Device Exemption (IDE) application remains under review by the U.S. Food and Drug Administation (FDA). Anteris continues to expect FDA approval in the near term, which will allow initiation of study sites in the PARADIGM Trial in the United States, pending Institutional Review Board (IRB) approval.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aoric 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 (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies includes additional cohorts.
*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups.
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® Transcatheter Heart Valve (THV), was designed in partnership 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. DurAVR® THV 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 planned expansion of the PARADIGM Trial, the results of the PARADIGM Trial, the contours of the PARADIGM Trial, and the timing of the IDE approval. 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, 2024 that was filed with the SEC 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:
| Investor Relations | Investor Relations (US) | |
| investor@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 |
FAQ
What did Anteris (AVR) announce on October 15, 2025 about the PARADIGM Trial?
When will patient recruitment for AVR's PARADIGM Trial begin in Denmark?
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How might the Danish clearance affect Anteris's (AVR) commercialization timeline?
