Anteris Secures Medicare Reimbursement, Expands PARADIGM Trial
Event summary
- Anteris secured U.S. Medicare reimbursement for PARADIGM Trial procedures under CMS national coverage policy.
- U.S. recruitment in the PARADIGM Trial began with first patients enrolled and treated in May 2026.
- Trial expanded to Denmark, Netherlands, Canada, and France with active recruitment underway.
- Appointed Susan Knight and Stephen Denaro to Board of Directors to strengthen governance.
- Reported $20.8 million net operating cash outflows for Q2 2026, primarily due to clinical and regulatory expenses.
The big picture
Anteris' strategic focus on securing reimbursement and expanding its pivotal trial positions it to challenge established players in the transcatheter aortic valve replacement (TAVR) market. The company's biomimetic valve technology, if proven effective, could disrupt the $6 billion global TAVR market by offering a potentially superior alternative to current treatments for severe aortic stenosis.
What we're watching
- Regulatory Momentum
- The pace at which Anteris secures additional regulatory clearances for the PARADIGM Trial will determine its global expansion capabilities.
- Reimbursement Impact
- Whether Medicare reimbursement eligibility accelerates U.S. site activation and patient recruitment in the PARADIGM Trial.
- Clinical Data
- How early clinical results from the DurAVR® THV compare against existing TAVR technologies in the head-to-head study.