Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) made progress on its pivotal PARADIGM Trial during the June quarter, enrolling and treating its first US patients after securing Medicare reimbursement eligibility for qualifying procedures.
The company also expanded recruitment across international sites, with patients now being recruited in the US, Denmark and the Netherlands, while regulatory clearance was secured in Canada and France.
Anteris is developing its DurAVR® Transcatheter Heart Valve (THV) as a treatment for aortic stenosis, with the PARADIGM study representing the pivotal clinical program supporting its path toward potential commercialisation.
June quarter highlights
A key milestone was securing reimbursement eligibility for the PARADIGM Trial under a US Centers for Medicare & Medicaid Services (CMS) national coverage policy.
Eligible procedures carried out at participating US study sites are now covered under the Transcatheter Aortic Valve Replacement National Coverage Determination, providing the reimbursement framework required to support patient enrolment and broader site participation.
US recruitment commenced during the quarter, with the first patients enrolled and treated in May 2026.
Clinical centres are progressing through start-up activities including ethics and regulatory approvals, site initiation visits and investigator training, as well as screening and enrolment at activated sites.
Selected Australian centres are also completing initial start-up documentation ahead of activation and recruitment, subject to ethics committee approval.
Anteris also presented clinical and scientific progress with DurAVR at the New York Valves 2026 conference and appointed Susan Knight and Stephen Denaro to its board during the period.
PARADIGM Trial targets around 1,000 patients
The PARADIGM Trial is a prospective randomised controlled study comparing the safety and effectiveness of DurAVR THV against commercially available transcatheter aortic valve replacements.
Around 1,000 patients are expected to participate in the trial's All Comers Randomized Cohort, with patients assigned on a 1:1 basis to either DurAVR or an approved commercially available THV.
The trial will assess non-inferiority using a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at 1 year following the procedure.
Trial investment drives quarterly expenditure
Anteris recorded net operating cash outflows of US$20.8 million for the 3 months to June 30, primarily related to clinical, regulatory and manufacturing requirements for PARADIGM.
Research and development expenses totalled US$23.4 million, reflecting increased manufacturing and quality capabilities, process development and validation work, additional headcount and costs associated with patient enrolment and expansion of its field-based clinical team.
These expenses were partly offset by lower DurAVR product research costs.
Next steps
Anteris expects US site activation and patient recruitment to continue progressing as additional centres join the PARADIGM Trial.
Australian sites are also expected to move toward activation and patient recruitment once individual ethics committee approvals are secured.
About Anteris Technologies
Anteris Technologies is a global healthcare company developing medical devices for structural heart disease.
Its lead product, DurAVR THV, is a balloon-expandable transcatheter heart valve designed to treat aortic stenosis. The valve is shaped to mimic the function of a healthy human aortic valve and uses Anteris' ADAPT® anti-calcification tissue technology.
The DurAVR system comprises the valve, ADAPT tissue and the balloon-expandable ComASUR® Delivery System.