Q1 2026 Highlights
Completed aggregate capital raises totalling $320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV System
Advanced PARADIGM Trial recruitment, supported by ongoing regulatory and operational work to activate additional countries and sites, post quarter-end, U.S. enrollment commenced
Presented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026, supporting ongoing scientific engagement and exchange with the clinical community
"Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrollment ongoing in Europe and continued progress on key recruitment activities globally. With the U.S. now on line and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®," said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
Business & Operations
Following initiation of our global pivotal trial in Q4 2025, we are seeing continued progress across Europe, and the United States where patient enrollment has recently commenced.
Clinical centers are advancing through key start up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside active patient screening and enrollment at activated sites.
In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment by supporting reimbursement and facilitating site-level adoption. Eligible procedures performed at ...
