Anteris Advances Global PARADIGM Expansion with French Regulatory Clearance
Rhea-AI Summary
Anteris (NASDAQ: AVR, ASX: AVR) received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR Transcatheter Heart Valve (THV) global pivotal PARADIGM trial in severe calcific aortic stenosis. This clearance allows patient recruitment at leading French centers and supports the company’s broader clinical strategy, which includes ongoing site activations and patient enrollment in the United States and Europe.
Positive
- Full ANSM regulatory clearance for DurAVR THV PARADIGM global pivotal trial in France
- Authorization enables patient recruitment at leading clinical centers in France
- PARADIGM Trial targets patients with severe calcific aortic stenosis
- Global clinical strategy progressing with site activations in the United States and Europe
- Ongoing patient enrollment across U.S. and European PARADIGM Trial sites
Negative
- None.
News Market Reaction – AVR
In the Jun 8 session, AVR declined 3.11%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 13 | Board appointments | Positive | -2.5% | Added two directors to support governance and trial advancement. |
| May 12 | Q1 2026 results | Positive | -2.5% | Reported Q1 results, heavy trial investment, and $320M capital raises. |
| May 05 | First U.S. patients | Positive | +1.0% | First U.S. patients treated in PARADIGM DurAVR pivotal trial. |
| Apr 28 | CMS reimbursement | Positive | +0.3% | Secured Medicare reimbursement eligibility supporting U.S. site activation. |
| Feb 26 | 2025 results | Positive | +2.7% | Reported 2025 results, DurAVR outcomes, and capital raises. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news tied to the PARADIGM trial and DurAVR has more often seen aligned positive price reactions, while governance and some earnings-related updates have coincided with short-term pullbacks.
Over the last six months, Anteris has repeatedly advanced the DurAVR® PARADIGM pivotal trial, including CMS reimbursement support on Apr 28, first U.S. patients treated on May 5, and capital-funded trial progress in Q1 2026 results on May 12. Governance was strengthened with new board appointments on May 13. Today’s French regulatory clearance continues this sequence of geographic and regulatory expansion for the global pivotal program.
Key Terms
transcatheter heart valve medical
thv medical
severe calcific aortic stenosis medical
pivotal trial medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
MINNEAPOLIS and BRISBANE, Australia, June 08, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) announced today that it has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the “PARADIGM Trial”). This authorization marks a significant milestone in the Company’s clinical and regulatory strategy and enables patient recruitment to commence at leading centers in France.
“Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. “France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study.”
The Company continues to advance its global clinical strategy, with ongoing site activations and patient enrollment across the United States and Europe.
About the PARADIGM Trial
The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs).
This head-to-head study will enroll approximately 1,000 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 healthcare 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 statements regarding the expectation that patient recruitment will commence in France. 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. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, 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 |
