Anteris Secures French Approval for DurAVR® Valve Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 08 2026
0mins
Source: Newsfilter
- Regulatory Milestone: Anteris Technologies has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety, marking the initiation of the global pivotal trial for the DurAVR® transcatheter heart valve, which is expected to significantly enhance the company's market position in cardiac treatment.
- Trial Scale and Design: The PARADIGM Trial will enroll approximately 1,000 patients with a 1:1 randomization to compare the safety and effectiveness of the DurAVR® valve against existing transcatheter aortic valve replacements, potentially introducing new competitive dynamics in the heart valve market.
- Strategic Market Importance: France is viewed as a key market with experienced centers and investigators, and this approval not only enhances the quality and execution of the trial but also lays the groundwork for Anteris's expansion in Europe.
- Technological Innovation Advantage: The DurAVR® valve utilizes ADAPT® tissue technology, which has been used in over 55,000 patients globally, and is expected to improve patient outcomes and quality of life through its biomimetic design and clinical validation.
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Analyst Views on AVR
Wall Street analysts forecast AVR stock price to rise
3 Analyst Rating
3 Buy
0 Hold
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Strong Buy
Current: 9.500
Low
15.00
Averages
17.33
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22.00
Current: 9.500
Low
15.00
Averages
17.33
High
22.00
About AVR
Anteris Technologies Global Corp. is a structural heart company, which is engaged in providing cardiac care by science-driven and measurable advancements to restore heart valve patients to healthy function. Its lead asset, the DurAVR Transcatheter Heart Valve System (THV) consists of a single-piece, biomimetic valve made with its ADAPT tissue-enhancing technology and deployed with its ComASUR balloon-expandable delivery system. DurAVR THV is a novel transcatheter aortic valve for the treatment of aortic stenosis that is shaped to mimic the performance of a healthy human aortic valve. DurAVR THV’s single-piece design mimics the native anatomy of a human aortic valve, as compared to traditional three-piece aortic valves. The Company's ADAPT is its proprietary anti-calcification tissue shaping technology that is designed to reengineer xenograft tissue into a pure, single-piece collagen bioscaffold. Its ComASUR delivery system is a physician-developed balloon expandable delivery system.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Anteris Secures French Approval for DurAVR® Valve Trial
- Regulatory Milestone: Anteris Technologies has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety, marking the initiation of the global pivotal trial for the DurAVR® transcatheter heart valve, which is expected to significantly enhance the company's market position in cardiac treatment.
- Trial Scale and Design: The PARADIGM Trial will enroll approximately 1,000 patients with a 1:1 randomization to compare the safety and effectiveness of the DurAVR® valve against existing transcatheter aortic valve replacements, potentially introducing new competitive dynamics in the heart valve market.
- Strategic Market Importance: France is viewed as a key market with experienced centers and investigators, and this approval not only enhances the quality and execution of the trial but also lays the groundwork for Anteris's expansion in Europe.
- Technological Innovation Advantage: The DurAVR® valve utilizes ADAPT® tissue technology, which has been used in over 55,000 patients globally, and is expected to improve patient outcomes and quality of life through its biomimetic design and clinical validation.
See More
Anteris Technologies Reports Q1 Financials and Trial Progress
- Cash Flow Situation: For the first quarter ending March 31, 2026, Anteris reported net operating cash outflows of $28.7 million, primarily due to clinical, regulatory, and manufacturing needs to support the PARADIGM Trial, indicating financial pressure during the R&D phase.
- Capital Raising Achievement: In January 2026, the company successfully raised a total of $320 million, providing essential funding for the execution of the PARADIGM Trial and advancing the global commercialization of the DurAVR THV System, thereby enhancing its market competitiveness.
- Trial Progress Update: The first quarter reflects strong execution across the PARADIGM Trial, with patient enrollment ongoing in Europe and continued progress on key recruitment activities globally, demonstrating the company's proactive stance in clinical trials.
- Strategic Execution Status: With the U.S. market now online and the first patients enrolled, Anteris is firmly executing its strategy towards the commercial launch of DurAVR, showcasing the company's growth potential and confidence in the market.
See More
Anteris Technologies Reports Q1 2026 Financial Results and Updates on PARADIGM Trial
- Successful Capital Raise: Anteris raised $320 million in January 2026 to support the execution of the PARADIGM Trial and advance the global commercialization of the DurAVR®THV System, indicating strong growth potential in the cardiac medical device sector.
- Trial Recruitment Progress: Recruitment for the PARADIGM Trial is ongoing, with U.S. patient enrollment commencing post-quarter-end, which not only enhances the company's clinical trial capabilities but also lays the groundwork for future product launches.
- Financial Expenditure Analysis: For the quarter ended March 31, 2026, Anteris reported net operating cash outflows of $28.7 million, primarily driven by clinical, regulatory, and manufacturing needs for the PARADIGM Trial, reflecting ongoing investments in R&D and market expansion.
- Impact of CMS Coverage Decision: The recent coverage determination by the Centers for Medicare and Medicaid Services is expected to facilitate patient recruitment and support site adoption of new technologies, thereby accelerating the market penetration of the DurAVR®THV.
See More
Anteris Secures US Medicare Coverage for PARADIGM Trial
- Coverage Milestone: Anteris Technologies has secured US Medicare reimbursement eligibility for its global pivotal PARADIGM Trial, expected to provide treatment for approximately 1,000 patients with the DurAVR® heart valve, significantly enhancing the company's market competitiveness in cardiac care.
- Trial Design and Objectives: This prospective randomized controlled trial will compare the safety and efficacy of DurAVR® against existing TAVR devices, primarily assessing one-year all-cause mortality, stroke, and cardiovascular hospitalization rates to ensure the non-inferiority of DurAVR®.
- Accelerating Operational Momentum: By obtaining Medicare coverage, Anteris anticipates accelerating the activation of US study sites, driving operational momentum across participating centers, and further solidifying its leadership position in the structural heart disease sector.
- Technological Advantages and Market Potential: The DurAVR® heart valve utilizes Anteris' patented ADAPT® tissue technology, clinically used in over 55,000 patients worldwide, demonstrating strong clinical outcomes and poised to capture a larger share in the rapidly growing heart valve market.
See More
Anteris Treats First US Patients in DurAVR Pivotal Trial
- Trial Milestone: Anteris has successfully enrolled and treated the first US patients in the global pivotal trial of its DurAVR® Transcatheter Heart Valve, marking a significant advancement that is expected to enhance the company's market share in cardiac treatment.
- Medical Collaboration: Following CMS approval, the Anteris team worked closely with physicians to achieve rapid patient enrollment, demonstrating the company's efficient execution in clinical trials and strengthening partnerships with medical institutions.
- Trial Design: The PARADIGM trial is designed to evaluate the safety and effectiveness of the DurAVR THV, aiming to enroll approximately 1,000 patients with a 1:1 random assignment, intending to provide comparative data to support future patient care decisions.
- Medicare Coverage: Anteris has secured US Medicare reimbursement eligibility for procedures under the PARADIGM trial, utilizing a Coverage with Evidence Development model that ensures financial support for patients while generating clinical data during the trial.
See More
Anteris Technologies Begins U.S. Trials for DurAVR Heart Valve
- Trial Launch: Anteris Technologies announced that the first U.S. patients have been treated in the pivotal PARADIGM trial evaluating DurAVR, a next-generation transcatheter heart valve aimed at restoring natural valve function in patients with severe symptomatic aortic stenosis.
- Study Design: The PARADIGM study is a multicenter, prospective, single-arm pivotal trial intended to enroll patients eligible for transcatheter aortic valve replacement (TAVR), assessing safety and performance outcomes, including valve function and clinical improvement.
- Technological Innovation: DurAVR features a unique single-piece, 3D-shaped leaflet design that mimics the natural motion of a healthy aortic valve, with early clinical data indicating promising hemodynamic performance that may enhance long-term durability.
- Market Outlook: The treatment of the first U.S. patients marks a significant milestone in the global development of DurAVR, with additional enrollment expected across the U.S., Europe, and Australia through 2026, reflecting increasing clinical adoption of this technology across multiple regions.
See More
Anteris Secures French Approval for DurAVR® Valve Trial
- Regulatory Milestone: Anteris Technologies has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety, marking the initiation of the global pivotal trial for the DurAVR® transcatheter heart valve, which is expected to significantly enhance the company's market position in cardiac treatment.
- Trial Scale and Design: The PARADIGM Trial will enroll approximately 1,000 patients with a 1:1 randomization to compare the safety and effectiveness of the DurAVR® valve against existing transcatheter aortic valve replacements, potentially introducing new competitive dynamics in the heart valve market.
- Strategic Market Importance: France is viewed as a key market with experienced centers and investigators, and this approval not only enhances the quality and execution of the trial but also lays the groundwork for Anteris's expansion in Europe.
- Technological Innovation Advantage: The DurAVR® valve utilizes ADAPT® tissue technology, which has been used in over 55,000 patients globally, and is expected to improve patient outcomes and quality of life through its biomimetic design and clinical validation.
See More
Anteris Technologies Reports Q1 Financials and Trial Progress
- Cash Flow Situation: For the first quarter ending March 31, 2026, Anteris reported net operating cash outflows of $28.7 million, primarily due to clinical, regulatory, and manufacturing needs to support the PARADIGM Trial, indicating financial pressure during the R&D phase.
- Capital Raising Achievement: In January 2026, the company successfully raised a total of $320 million, providing essential funding for the execution of the PARADIGM Trial and advancing the global commercialization of the DurAVR THV System, thereby enhancing its market competitiveness.
- Trial Progress Update: The first quarter reflects strong execution across the PARADIGM Trial, with patient enrollment ongoing in Europe and continued progress on key recruitment activities globally, demonstrating the company's proactive stance in clinical trials.
- Strategic Execution Status: With the U.S. market now online and the first patients enrolled, Anteris is firmly executing its strategy towards the commercial launch of DurAVR, showcasing the company's growth potential and confidence in the market.
See More
Anteris Technologies Reports Q1 2026 Financial Results and Updates on PARADIGM Trial
- Successful Capital Raise: Anteris raised $320 million in January 2026 to support the execution of the PARADIGM Trial and advance the global commercialization of the DurAVR®THV System, indicating strong growth potential in the cardiac medical device sector.
- Trial Recruitment Progress: Recruitment for the PARADIGM Trial is ongoing, with U.S. patient enrollment commencing post-quarter-end, which not only enhances the company's clinical trial capabilities but also lays the groundwork for future product launches.
- Financial Expenditure Analysis: For the quarter ended March 31, 2026, Anteris reported net operating cash outflows of $28.7 million, primarily driven by clinical, regulatory, and manufacturing needs for the PARADIGM Trial, reflecting ongoing investments in R&D and market expansion.
- Impact of CMS Coverage Decision: The recent coverage determination by the Centers for Medicare and Medicaid Services is expected to facilitate patient recruitment and support site adoption of new technologies, thereby accelerating the market penetration of the DurAVR®THV.
See More
Anteris Secures US Medicare Coverage for PARADIGM Trial
- Coverage Milestone: Anteris Technologies has secured US Medicare reimbursement eligibility for its global pivotal PARADIGM Trial, expected to provide treatment for approximately 1,000 patients with the DurAVR® heart valve, significantly enhancing the company's market competitiveness in cardiac care.
- Trial Design and Objectives: This prospective randomized controlled trial will compare the safety and efficacy of DurAVR® against existing TAVR devices, primarily assessing one-year all-cause mortality, stroke, and cardiovascular hospitalization rates to ensure the non-inferiority of DurAVR®.
- Accelerating Operational Momentum: By obtaining Medicare coverage, Anteris anticipates accelerating the activation of US study sites, driving operational momentum across participating centers, and further solidifying its leadership position in the structural heart disease sector.
- Technological Advantages and Market Potential: The DurAVR® heart valve utilizes Anteris' patented ADAPT® tissue technology, clinically used in over 55,000 patients worldwide, demonstrating strong clinical outcomes and poised to capture a larger share in the rapidly growing heart valve market.
See More
Anteris Treats First US Patients in DurAVR Pivotal Trial
- Trial Milestone: Anteris has successfully enrolled and treated the first US patients in the global pivotal trial of its DurAVR® Transcatheter Heart Valve, marking a significant advancement that is expected to enhance the company's market share in cardiac treatment.
- Medical Collaboration: Following CMS approval, the Anteris team worked closely with physicians to achieve rapid patient enrollment, demonstrating the company's efficient execution in clinical trials and strengthening partnerships with medical institutions.
- Trial Design: The PARADIGM trial is designed to evaluate the safety and effectiveness of the DurAVR THV, aiming to enroll approximately 1,000 patients with a 1:1 random assignment, intending to provide comparative data to support future patient care decisions.
- Medicare Coverage: Anteris has secured US Medicare reimbursement eligibility for procedures under the PARADIGM trial, utilizing a Coverage with Evidence Development model that ensures financial support for patients while generating clinical data during the trial.
See More
Anteris Technologies Begins U.S. Trials for DurAVR Heart Valve
- Trial Launch: Anteris Technologies announced that the first U.S. patients have been treated in the pivotal PARADIGM trial evaluating DurAVR, a next-generation transcatheter heart valve aimed at restoring natural valve function in patients with severe symptomatic aortic stenosis.
- Study Design: The PARADIGM study is a multicenter, prospective, single-arm pivotal trial intended to enroll patients eligible for transcatheter aortic valve replacement (TAVR), assessing safety and performance outcomes, including valve function and clinical improvement.
- Technological Innovation: DurAVR features a unique single-piece, 3D-shaped leaflet design that mimics the natural motion of a healthy aortic valve, with early clinical data indicating promising hemodynamic performance that may enhance long-term durability.
- Market Outlook: The treatment of the first U.S. patients marks a significant milestone in the global development of DurAVR, with additional enrollment expected across the U.S., Europe, and Australia through 2026, reflecting increasing clinical adoption of this technology across multiple regions.
See More
