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Anteris Reports 2025 Financial Results and Provides Corporate Update
Globenewswire· 2026-02-26 23:00
Core Insights - Anteris Technologies reported significant advancements in 2025, focusing on the development of the DurAVR transcatheter heart valve (THV) and positioning itself for leadership in the structural heart market [3][4]. Financial Performance - The company's net operating cash outflows for 2025 were $77.8 million, reflecting increased clinical, regulatory, and manufacturing requirements to support the PARADIGM Trial [4]. - Research and Development (R&D) expenses totaled $69.1 million, which included costs for manufacturing upscaling, clinical trial preparations, and an increase in R&D personnel [6]. - Selling, general, and administrative expenses were reported at $26.1 million [6]. Clinical Developments - Anteris initiated the global pivotal PARADIGM Trial, building on prior experience treating 130 patients with the DurAVR THV, including complex cases [5]. - The company received FDA Investigational Device Exemption (IDE) approval in Q4 2025 to commence the PARADIGM Trial in the U.S. [5]. - The PARADIGM Trial aims to enroll approximately 1,000 patients to evaluate the safety and effectiveness of the DurAVR THV compared to existing transcatheter aortic valve replacements (TAVRs) [8]. Strategic Initiatives - Anteris completed capital raises totaling $320 million in early 2026, including a strategic investment from Medtronic to support the PARADIGM Trial and advance global commercialization of the DurAVR THV System [5]. - The company strengthened its operational infrastructure and advanced its quality management system, achieving ISO 13485 certification for DurAVR THV production [5]. Product Overview - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, aiming to replicate the performance of a healthy human aortic valve [11]. - The valve is made from Anteris' patented ADAPT tissue, which has been clinically used for over 10 years and is FDA-cleared [11].
Anteris Technologies Global Corp. Announces Postponement of Special Meeting of Stockholders
Globenewswire· 2025-09-04 05:42
Core Points - Anteris Technologies Global Corp. has postponed its Special Meeting of Stockholders to September 11, 2025, to allow more time for stockholder participation [1][2] - The Board of Directors recommends voting FOR the proposals in the definitive Proxy Statement filed with the SEC on August 18, 2025 [2] - The company’s lead product, the DurAVR Transcatheter Heart Valve, is designed to treat aortic stenosis and utilizes patented ADAPT tissue technology [8] Voting Details - Stockholders who have already voted do not need to take further action as their votes will remain counted [3] - Proxies must be submitted by 11:59 p.m. Eastern time on September 10, 2025, for Internet or telephone submissions, and by the close of business on the same date for mail submissions [4] - CDI holders must direct CDN to vote by 5:00 p.m. Central time on September 9, 2025 [5] Company Overview - Anteris Technologies is a global structural heart company focused on developing medical devices to restore heart function [7] - The company is based in Australia with a significant presence in Minneapolis, USA, and is committed to delivering solutions for structural heart disease [7]