Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial
Rhea-AI Summary
Anteris Technologies (NASDAQ: AVR) announced on May 5, 2026 that the first U.S. patients were enrolled and treated in the global pivotal PARADIGM Trial evaluating the DurAVR® Transcatheter Heart Valve for severe calcific aortic stenosis.
Procedures were performed by Dr. Azeem Latib at Montefiore Medical Center. The trial will assess safety, hemodynamics, and the impact of flow patterns on left ventricular recovery. Company leadership cited rapid U.S. site activation following CMS approval.
Positive
- First U.S. patients enrolled and treated in PARADIGM
- CMS approval enabled rapid U.S. site activation and enrollment
- Trial design includes left ventricular recovery and flow-pattern endpoints
Negative
- No patient-level efficacy or long-term safety results reported yet
- Initial reports describe early experience as encouraging without quantitative data
News Market Reaction – AVR
On the day this news was published, AVR gained 0.98%, reflecting a mild positive market reaction. This price movement added approximately $6M to the company's valuation, bringing the market cap to $639.78M at that time.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
AVR was down 3.62% while several peers also traded lower (e.g., KRMD -1.72%, MBOT -1.4%, NYXH -2.37%). Momentum scanner only flagged NYXH to the upside, and scanner data indicates this move is not a coordinated sector trend.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 28 | CMS reimbursement | Positive | +0.3% | CMS reimbursement eligibility for PARADIGM Trial procedures under TAVR policy. |
| Feb 26 | Earnings & update | Positive | +2.7% | 2025 results, PARADIGM initiation, IDE approval and favorable DurAVR outcomes. |
| Feb 23 | Investor conferences | Positive | +8.4% | CEO presentations at TD Cowen and Barclays with investor meetings and webcasts. |
| Jan 22 | Strategic investment | Positive | -1.7% | Medtronic’s $90M strategic investment within $320M capital raise for PARADIGM. |
| Jan 22 | Equity offering | Negative | -1.7% | Closing of $230M public stock offering and Medtronic private placement. |
Recent news, including funding and CMS reimbursement, has mostly seen price moves aligned with positive catalysts.
Over the last few months, Anteris has advanced the DurAVR program and its pivotal PARADIGM Trial. In January 2026, the company completed a $320M capital raise and a $90M Medtronic strategic investment to fund the trial and commercialization. Subsequent conference participation in March 2026 and 2025 financial results with trial progress updates were followed by positive price reactions. Most recently, securing CMS reimbursement eligibility for PARADIGM-supported procedures on April 28, 2026 saw a modestly positive move, framing today’s first U.S. patient treatments as the next execution milestone.
Market Pulse Summary
This announcement marks first U.S. patients treated in the global pivotal PARADIGM Trial for DurAVR, building on CMS reimbursement eligibility disclosed on April 28, 2026 and prior financing to fund the program. It highlights clinically focused endpoints, including flow patterns and left ventricular recovery. Investors may track future enrollment updates, additional clinical data, and regulatory interactions to gauge how this pivotal trial shapes the company’s structural heart strategy.
Key Terms
transcatheter heart valve medical
thv medical
severe calcific aortic stenosis medical
hemodynamics medical
left ventricular recovery medical
cms regulatory
AI-generated analysis. Not financial advice.
MINNEAPOLIS and BRISBANE, Australia, May 05, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR® Transcatheter Heart Valve (“THV”) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States.
“Performing the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial investigators, and our early procedural experience with the DurAVR® THV System has been highly encouraging,” said Dr. Latib, Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore. “PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Initiating enrollment represents a critical step toward generating the evidence needed to inform future patient care.”
“Following CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week. This marks a major milestone for the PARADIGM Trial as our U.S. study sites come on line and expand recruitment capability,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.
For further information, please refer to ClinicalTrials.gov NCT07194265.
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements, including the quotes contained herein. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
For more information:
| Global Investor Relations | Investor Relations (US) |
| investors@anteristech.com | mchatterjee@bplifescience.com |
| Debbie Ormsby | Malini Chatterjee, Ph.D. |
| Anteris Technologies Global Corp. | Blueprint Life Science Group |
| +61 1300 550 310 | +61 7 3152 3200 | +1 917 330 4269 |
| Website | www.anteristech.com |
| X | @AnterisTech |
| https://www.linkedin.com/company/anteristech |
