Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)
Anteris Technologies (NASDAQ: AVR) announced on October 27, 2025 that the first patients were enrolled and successfully treated in the global pivotal PARADIGM Trial evaluating the DurAVR® Transcatheter Heart Valve (THV) for severe calcific aortic stenosis.
The initial procedures were performed at Rigshospitalet, Copenhagen by Prof. Dr. Ole De Backer. The head-to-head study will randomize patients across surgical risk groups and builds on an existing clinical dataset of 130 patients previously treated with DurAVR® (including de novo, valve-in-valve, and bicuspid anatomies). Anteris plans near-term expansion of PARADIGM into the United States, Europe and Canada to accelerate enrollment and evidence generation toward commercialization.
Anteris Technologies (NASDAQ: AVR) ha annunciato il 27 ottobre 2025 che i primi pazienti sono stati arruolati e trattati con successo nello studio globale pivotale PARADIGM Trial che valuta la DurAVR® Transcatheter Heart Valve (THV) per la stenosi aortica calcifica severa.
Le procedure iniziali sono state eseguite al Rigshospitalet, Copenaghen, dal Prof. Dott. Ole De Backer. Lo studio head-to-head randomizzerà pazienti tra gruppi di rischio chirurgico e si basa su un dataset clinico esistente di 130 pazienti precedentemente trattati con DurAVR® (inclusi casi de novo, valve-in-valve e anatomie bicuspidi). Anteris prevede una prossima espansione di PARADIGM negli Stati Uniti, in Europa e in Canada per accelerare l'iscrizione e la generazione di evidenze verso la commercializzazione.
Anteris Technologies (NASDAQ: AVR) anunció el 27 de octubre de 2025 que los primeros pacientes fueron inscritos y tratados con éxito en el ensayo global pivotal PARADIGM Trial que evalúa la DurAVR® Transcatheter Heart Valve (THV) para la estenosis aórtica calcificada severa.
Los procedimientos iniciales se realizaron en Rigshospitalet, Copenhague, por el Prof. Dr. Ole De Backer. El estudio comparativo aleatorizará a pacientes entre grupos de riesgo quirúrgico y se apoyará en un conjunto de datos clínicos existente de 130 pacientes previamente tratados con DurAVR® (incluyendo de novo, valve-in-valve y anatomías bicúspides). Anteris planea una expansión a corto plazo de PARADIGM a Estados Unidos, Europa y Canadá para acelerar la inscripción y la generación de evidencia hacia la comercialización.
Anteris Technologies (NASDAQ: AVR)는 2025년 10월 27일에 전 세계 주요 PARADIGM 임상시험에서 DurAVR® Transcatheter Heart Valve (THV)가 중등도 이상 석회화된 대동맥판 협착증에 대해 평가되며 첫 환자들이 등록 및 성공적으로 치료되었다고 발표했습니다.
초기 시술은 코펜하겐의 Rigshospitalet에서 Ole De Backer 교수에 의해 수행되었습니다. 이 비교 연구는 수술 위험군 간의 환자를 무작위로 배정하고 DurAVR®로 이전에 치료를 받은 130명의 기존 임상 데이터 세트를 기반으로 합니다(신발, 밸브 인 밸브 및 양대판 해부학 포함). Anteris는 PARADIGM을 미국, 유럽 및 캐나다로 조기에 확장하여 등록을 가속화하고 상용화를 위한 증거 생성을 추진할 계획입니다.
Anteris Technologies (NASDAQ: AVR) a annoncé le 27 octobre 2025 que les premiers patients ont été recrutés et traités avec succès dans l'essai pivot mondial PARADIGM Trial évaluant le DurAVR® Transcatheter Heart Valve (THV) pour une sténose aortique calcifiée sévère.
Les procédures initiales ont été réalisées au Rigshospitalet, Copenhague, par le Prof. Dr. Ole De Backer. L'étude en tête-à-tête randomisera des patients dans différents niveaux de risque chirurgical et s'appuie sur un ensemble de données cliniques existant de 130 patients précédemment traités avec DurAVR® (y compris de novo, valve-in-valve et anatomies bicuspides). Anteris prévoit une expansion à court terme de PARADIGM aux États-Unis, en Europe et au Canada pour accélérer l'inscription et la génération de preuves en vue de la commercialisation.
Anteris Technologies (NASDAQ: AVR) gab am 27. Oktober 2025 bekannt, dass die ersten Patienten rekrutiert und erfolgreich im globalen pivotalen PARADIGM Trial behandelt wurden, der DurAVR® Transcatheter Heart Valve (THV) für schwere calcifizierende Aortenklappenstenose bewertet.
Die anfänglichen Eingriffe wurden am Rigshospitalet in Kopenhagen von Prof. Dr. Ole De Backer durchgeführt. Die Head-to-Head-Studie wird Patienten über verschiedene chirurgische Risikogruppen randomisieren und baut auf einen bestehenden klinischen Datensatz von 130 Patienten auf, die zuvor mit DurAVR® behandelt wurden (einschließlich de novo, Valve-in-Valve und bicuspiden Anatomien). Anteris plant eine kurzfristige Ausweitung von PARADIGM in die USA, Europa und Kanada, um die Rekrutierung zu beschleunigen und Evidenz für die Kommerzialisierung zu schaffen.
Anteris Technologies (NASDAQ: AVR) أعلنت في 27 أكتوبر 2025 أن المرضى الأوائل قد تم تسجيلهم ومعالجتهم بنجاح في تجربة PARADIGM المحورية العالمية PARADIGM Trial التي تقيم صمام DurAVR® القابل للفتح عبر القسطرة (THV) لاضطراب تضيق الأبهر الحاد المتكلس.
تمت الإجراءات الأولية في Rigshospitalet، كوبنهاجن، بواسطة الأستاذ الدكتور أولي دي باكر. ستُوزَّع الدراسة المقارنة بين مخاطر جراحية مختلفة بشكل عشوائي وتستند إلى مجموعة بيانات سريرية موجودة من 130 مريضاً عولجوا سابقاً بـ DurAVR® (بما في ذلك de novo، valve-in-valve، وتشريح ثنائي الشرف). تخطط Anteris لتوسيع PARADIGM قريباً إلى الولايات المتحدة وأوروبا وكندا لتسريع التسجيل وتوليد الأدلة نحو التسويق.
Anteris Technologies (NASDAQ: AVR) 在 2025年10月27日 宣布，全球关键性研究 PARADIGM 试验中，首批患者已入组并成功接受 DurAVR® 经导管主动脉瓣膜（THV）的治疗，用于严重钙化性主动脉瓣狭窄。
初始手术在哥本哈根的Rigshospitalet由 Ole De Backer 教授完成。这项对比研究将在外科风险等级之间对患者进行随机分配，并基于已有的 DurAVR® 临床数据集（包括新发、置换-置换、双瓣膜解剖等情况）共 130 例患者的治疗记录。Anteris 计划在近期将 PARADIGM 扩展到美国、欧洲和加拿大，以加速入组和为商业化生成证据。
- First patients enrolled and treated in global pivotal PARADIGM Trial (Oct 27, 2025)
- Existing clinical dataset of 130 patients treated with DurAVR THV
- Planned geographic expansion to United States, Europe, and Canada to accelerate enrollment
- No pivotal-trial efficacy or safety results have been reported yet
- Commercialization timeline and regulatory milestones were not specified
Insights
First randomized patients treated in the global pivotal PARADIGM Trial marks a clear clinical development milestone for Anteris.
The enrollment and successful treatment of the first patients on Anteris’s DurAVR® THV in the PARADIGM Trial establishes operational trial start and initial site performance as of
Key dependencies include sustained site expansion and recruitment across the planned regions, data quality from randomized comparisons, and consistent procedural outcomes. The company cites prior experience with 130 treated patients, which supports feasibility, but the pivotal study must replicate favorable safety and efficacy in a randomized setting to be meaningful.
Watch for enrollment cadence and additional site activations in the United States, Europe and Canada in the near term, interim safety reviews and randomized comparison endpoints as they mature over the next 12–36 months. Those milestones will materially affect the evidentiary value of this program and its path toward commercialization.
MINNEAPOLIS, United States and BRISBANE, Australia, Oct. 27, 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, today announced the first patients have been enrolled and successfully treated in the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). The procedures were performed by Prof. Dr. Ole De Backer at, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
“We are proud to be the first enrolling center for this important trial,“ said Prof. Dr. De Backer. “Our initial experience with the DurAVR® THV System has been very positive, and we look forward to providing definitive comparative evidence which could transform patient care.”
“With the first patients now randomized in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR® THV toward commercialisation, expanding treatment options for aortic stenosis patients,” said Anteris Chief Medical Officer, Chris Meduri, M.D. “This head-to-head study will provide robust comparative evidence across all surgical risk groups, which we believe will differentiate our platform based on efficacy, safety and ease of use.”
The PARADIGM Trial builds on Anteris’ existing clinical data set of 130 patients successfully treated with the DurAVR® THV, including de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid aortic valve patients. Anteris aims 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.
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 aortic valve replacements (TAVRs).
This head-to-head study will enroll approximately 1,000 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 mimimize 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 quotes from Prof. Dr. De Backer and Chris Meduri, M.D., the contours of the PARADIGM Trial, and the expansion of the PARADIGM trial to other countries and cohorts. 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 | ||
| LinkedIn https://www.linkedin.com/company/anteristech |
FAQ
What did Anteris (AVR) announce on October 27, 2025?
How many patients had Anteris treated with DurAVR® before the PARADIGM Trial?
Where were the first PARADIGM Trial procedures performed for AVR?
What patient populations does the PARADIGM Trial (AVR) include?
Will Anteris expand PARADIGM Trial enrollment for AVR beyond Denmark?
Does the PARADIGM Trial announcement include clinical results for the DurAVR® THV?
