Anteris Secures Medicare Reimbursement to Boost US PARADIGM Trial Activation
Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.
- CMS national coverage policy enables Medicare reimbursement
- Supports U.S. site activation for PARADIGM Trial
- Randomized study comparing DurAVR to existing TAVRs
- Enrollment target of approximately 1000 patients
- DurAVR uses patented biomimetic ADAPT tissue technology
Medicare Coverage Unlocks US Trial Momentum
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX:AVR) has secured a significant regulatory milestone with the U.S. Centers for Medicare & Medicaid Services (CMS) granting Medicare reimbursement eligibility for procedures performed in its global PARADIGM Trial. This coverage falls under the CMS Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32, operating via a Coverage with Evidence Development (CED) model that supports reimbursement while clinical evidence is gathered.
This development is expected to accelerate activation of U.S. clinical sites participating in the PARADIGM Trial, providing financial support that could ease operational challenges and hasten patient enrolment. The trial compares Anteris’ DurAVR® Transcatheter Heart Valve (THV) against commercially available TAVR devices in a head-to-head randomized controlled study targeting around 1000 patients.
PARADIGM Trial Design and Clinical Objectives
The PARADIGM Trial is designed to assess the safety and effectiveness of the DurAVR THV by randomizing patients 1:1 to receive either DurAVR or a commercially approved TAVR. The primary endpoint is a composite of all-cause mortality, all stroke, and cardiovascular hospitalisation at one year post-procedure, aiming to demonstrate non-inferiority.
The DurAVR valve is notable for its biomimetic design, mimicking natural aortic valve function, and is constructed from Anteris’ patented ADAPT® tissue technology. This single-piece, balloon-expandable valve integrates the ComASUR® Delivery System and leverages over a decade of clinical use of ADAPT tissue in more than 55,000 patients worldwide.
Financial and Strategic Backing Supports Trial Progress
This reimbursement milestone builds on Anteris’ recent capital raises, including a combined $320 million funding round involving a public offering and a strategic $90 million private placement from Medtronic, which has been instrumental in advancing the DurAVR pivotal trial and manufacturing scale-up. Earlier in 2026, the company reported a $94.2 million loss for 2025 amid a revenue decline but highlighted progress in the PARADIGM Trial and secured financing to support ongoing development and commercialisation efforts.
Medtronic’s backing aligns with the strategic goal of bringing innovative TAVR technology to market, and the CMS reimbursement eligibility is a critical step in facilitating U.S. site participation and data collection under real-world clinical conditions. The company’s operational momentum in the U.S. trial sites will be closely watched as enrolment progresses.
Bottom Line?
CMS reimbursement eligibility removes a key barrier for U.S. trial activation, but patient enrolment pace and trial outcomes remain critical to watch.
Questions in the middle?
- How quickly will U.S. sites activate and begin enrolling patients following CMS coverage?
- Will the DurAVR valve demonstrate non-inferiority or potential advantages over existing TAVRs?
- How might CMS reimbursement influence commercial adoption post-trial if results are positive?
