2025 Full Year Highlights & Recent Developments
Initiated the global pivotal PARADIGM Trial, building on experience from successfully treating 130 patients with the DurAVR® THV, including de novo (first time) aortic stenosis cases, complex anatomies and valve-in-valve patients
Received FDA Investigational Device Exemption ("IDE") approval in the fourth quarter of 2025 to initiate the PARADIGM Trial in the United States
Reported favorable 30-day (100 patients) and 1-year (65 patients) DurAVR® THV clinical outcomes from rolling cohorts of small annuli, symptomatic severe aortic stenosis patients
Completed the first "double DurAVR®" implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions
Strengthened operational infrastructure and advanced quality management system buildout while advancing manufacturing scale-up to support clinical activities, including ISO 13485 certification for DurAVR® THV production
Appointed David Roberts and Gregory Moss to serve as two new independent directors on the Board of Directors
Received approval from the Company's stockholders for ASX Limited's grant to the Company of a waiver from ASX Listing Rule 7.1
Completed aggregate capital raises totalling $320 million in early 2026, including a strategic investment from Medtronic, plc to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV System
"2025 was a pivotal year for Anteris, advancing DurAVR® with disciplined execution, strengthening our clinical foundation, and positioning the company for long term leadership in structural heart. We converted strategy into measurable progress, reinforcing our competitive position and accelerating our path toward commercial readiness. The progress achieved in 2025 ...
