Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has reported strong operational progress for the March 2026 quarter as the company advanced recruitment for its global PARADIGM pivotal trial and strengthened its balance sheet with US$320 million in capital raises.
The structural heart company said the funding completed in January would support execution of the PARADIGM Trial and accelerate the path toward global commercialisation of its DurAVR® transcatheter heart valve (THV) system.
Quarter highlights included ongoing patient enrolment across Europe, with US recruitment commencing after quarter-end, marking a key milestone for the company’s pivotal clinical program.
Vice chairman and chief executive officer Wayne Paterson said the company was continuing to build momentum toward launch.
“Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrolment ongoing in Europe and continued progress on key recruitment activities globally,” he said.
“With the US now online and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®.”
Trial momentum builds across Europe and US
Anteris said clinical centres involved in the PARADIGM Trial continued progressing through ethics approvals, regulatory clearances, site initiation visits and investigator training during the quarter.
The company is also screening and enrolling patients at activated sites as additional centres come online.
In the United States, the company said a recent coverage determination from the Centers for Medicare and Medicaid Services (CMS) was expected to support recruitment by enabling reimbursement for eligible procedures performed at participating trial sites under the TAVR National Coverage Determination framework.
Anteris also continued scientific engagement with the clinical community during the quarter, presenting clinical data from its EMBARK Study and US Early Feasibility Study at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026.
R&D spending rises with pivotal trial execution
Financially, Anteris reported net operating cash outflows of US$28.7 million for the three months to March 31, reflecting increased clinical, regulatory and manufacturing activity tied to the PARADIGM Trial.
Research and development expenses totalled US$17.5 million during the quarter, driven by manufacturing scale-up, process validation activities, expanded quality capabilities and increased headcount.
Costs also reflected higher clinical spending associated with enrolling additional patients and expanding its field-based clinical team.
These increases were partly offset by lower DurAVR® THV product research costs.