Anteris Technologies advances toward PARADIGM trial after key regulatory and clinical milestones

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15h ago 5:39

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Anteris Technologies Global Corp. CEO Wayne Paterson joined Steve Darling from Proactive to provide an update on the company’s progress during the first quarter of 2025, highlighting significant regulatory, clinical, and operational milestones following its successful $80 million initial public offering. A core focus of the quarter was the continued development of the company’s DurAVR® transcatheter heart valve (THV), a first-in-class device designed for patients with severe aortic stenosis. Approximately $20.8 million of the IPO proceeds have been allocated to advancing DurAVR®, including funding for the pivotal PARADIGM clinical trial and related manufacturing and regulatory initiatives. Paterson emphasized that the company successfully submitted its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration during the quarter—marking a significant regulatory milestone that clears the path for Anteris to initiate its U.S.-based clinical trial program. “Reaching over 100 patients treated with DurAVR® is a critical clinical milestone,” Paterson noted. “We are bringing a new class of valve technology to a space that hasn’t seen true innovation in decades.” To support this expansion, Anteris has scaled its clinical field team, manufacturing, and quality operations, tripling its operational capacity in 2024. These enhancements position the company to manage increased clinical activity and meet regulatory demands as the PARADIGM Trial ramps up. Pending FDA approval of its IDE application, Anteris expects to commence the PARADIGM Trial in Q3 2025—a pivotal step toward broader commercial adoption of DurAVR®. #proactiveinvestors #anteristechnologiesglobalcorp #asx #avr #nasdaq #avr #DurAVR #TAVR #MedicalDevices #CardiologyInnovation #ClinicalTrials #StructuralHeart #FDAApproval #HeartValve #MedTechUpdates

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