Anteris reports Q2 2026 progress on PARADIGM Trial, adds two board members

Anteris Technologies Global Corp. reported financial and operating results for the quarter ended June 30, 2026 on August 12, 2026 (AEST). The company secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services national coverage policy, enabling reimbursement for eligible procedures at U.S. sites.¹

The company also initiated U.S. recruitment in the PARADIGM Trial, with the first U.S. patients enrolled and treated in May 2026.¹ Recruitment activity expanded, with active recruitment underway in the U.S., Denmark and the Netherlands, and secured regulatory clearance in Canada and France.¹

On governance, Anteris appointed Ms. Susan Knight and Mr. Stephen Denaro to the Board of Directors, broadening governance, financial and public company leadership as the Company advances the DurAVR® THV toward commercialization.¹

Regarding the trial design, PARADIGM is a prospective randomized controlled trial evaluating the safety and effectiveness of the DurAVR Transcatheter Heart Valve against commercially available TAVRs, enrolling approximately 1,000 patients in an All Comers Randomized Cohort with 1:1 randomization, assessing non-inferiority on a composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year.¹ The CMS coverage step matters operationally because eligible U.S. procedures are covered under the Transcatheter Aortic Valve Replacement National Coverage Determination 20.32.¹

On finances, the company reported net operating cash outflows for the three months ended June 30, 2026 of $20.8 million, primarily attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial.¹ R&D expenses of $23.4 million were driven by the scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM trial related activities, including clinical costs associated with patient enrollment and the scaling of the field-based clinical team.¹