Anteris Technologies Expands PARADIGM Trial as US Recruitment Begins

Anteris Technologies Global (ASX: AVR) broadened recruitment in its global PARADIGM Trial during the second quarter of 2026, with the first US patients enrolled and treated in May.

The company secured Medicare reimbursement eligibility for eligible procedures at participating US study sites under a Centers for Medicare & Medicaid Services national coverage policy, providing the reimbursement framework needed to support wider trial execution.

Active recruitment is now under way in the US, Denmark, and the Netherlands, while regulatory clearance has been obtained in Canada and France and selected Australian sites are progressing through start-up requirements subject to ethics committee approval.

The PARADIGM Trial is evaluating the DurAVR transcatheter heart valve (THV) against commercially available transcatheter aortic valve replacement (TAVR) devices as Anteris works towards potential commercialisation of its lead product.

Trial Recruitment Momentum

Clinical centres are moving through ethics and regulatory approvals, site initiation visits and investigator training alongside screening and enrolment, with further US sites expected to contribute as activation progresses.

The approximately 1,000-patient randomised study will allocate participants equally between the DurAVR THV and approved TAVR devices, as well as assess non-inferiority using a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalisation one year after the procedure.

Anteris also presented clinical and scientific progress at New York Valves 2026 during the quarter and appointed Susan Knight and Stephen Denaro to its board as it continued preparations for the next stages of development and commercialisation.

“Q2 marked an important period of execution for Anteris as we advanced the PARADIGM Trial across clinical, regulatory and reimbursement milestones,” chief executive officer Wayne Paterson said.

“These achievements, together with the continued strengthening of our board, support our progress toward commercialisation and our commitment to improving outcomes for patients with severe aortic stenosis,”

Spending Supports Pivotal Program

Net operating cash outflows for the three months ended 30 June were US$20.8 million, primarily reflecting clinical, regulatory, and manufacturing requirements associated with the PARADIGM Trial.

Research and development expenses reached US$23.4m as Anteris scaled manufacturing and quality capabilities, including process development and validation, increased headcount, and expanded trial activity.

R&D spending also incorporated clinical costs associated with patient enrolment and expansion of the field-based clinical team, partly offset by lower DurAVR THV product research costs.

The DurAVR THV uses a single piece of moulded ADAPT tissue and forms part of a system that includes the ComASUR Delivery System, with the valve designed to mimic the performance of a healthy human aortic valve and replicate normal aortic blood flow.

ADAPT tissue has been used clinically for more than 10 years and distributed for use in more than 55,000 patients worldwide.