Anteris Technologies Global (NASDAQ:AVR) Chief Executive Officer Wayne Paterson outlined the company’s DurAVR transcatheter aortic valve replacement (TAVR) program during a fireside chat at TD Cowen’s conference in Boston, focusing on the platform’s design rationale, early clinical experience, and the company’s pivotal study plans.
DurAVR’s origins and “biomimetic” design goal
Paterson said DurAVR was developed over roughly eight years, beginning with what he described as a “blank piece of paper” approach that started from a disease-management perspective. He contrasted this with what he characterized as a more purely engineering-led approach to valve design.
Paterson argued that as TAVR expanded into younger populations—he cited a drop in mean patient age from about 85 to 73 between 2019 and 2021—device requirements changed, while the core products in use did not. He said physicians sought “pre-disease” mean gradients in the range of 5–10 mmHg, which he said existing bioprosthetic valve designs could not reliably achieve. He described DurAVR as a new “biomimetic” class of valve intended to be more physiologically and anatomically aligned with the native aortic valve.
Clinical signals discussed: gradients, laminar flow, and LV remodeling
Paterson pointed to clinical consistency across what he described as patient 1 through patient 140, saying DurAVR has “consistently achieved” 5–10 mmHg mean gradients. He said the experience spans nine cohorts with follow-up ranging from very recent implants to a longest cohort “pushing up past four years.” He also described treatment across a range of anatomies and settings, including tricuspid and bicuspid valves, tortuous anatomies, valve-in-valve procedures, and one patient implanted with DurAVR in both aortic and mitral positions.
Beyond hemodynamics, Paterson emphasized two additional themes: restoration of laminar flow and left ventricular (LV) remodeling. He said stenotic valves create turbulent flow and asserted that standard-of-care TAVR valves also result in turbulent flow rather than restoring normal flow. That turbulence, he said, can lead to back pressure on the ventricle, LV enlargement, and progression toward heart failure. Paterson stated the company has observed a “30% reduction in the LV mass over six months,” which he framed as moving LV mass back toward normal ranges.
He also highlighted performance in small annuli, which he said represent about 40% of the market and are more common in female patients, and in valve-in-valve procedures. Paterson called valve-in-valve a “wild card” opportunity and said patients receiving DurAVR in valve-in-valve procedures have achieved better mean gradients than with their first valve.
Patient-prosthesis mismatch and comparative framing
Paterson described patient-prosthesis mismatch (PPM) as a key clinical challenge for interventionalists. He cited a 3% PPM rate for DurAVR and compared it to about 30% for “the other balloon-expandable device,” saying PPM can lead to poor outcomes, higher mortality, and impaired flow.
Imaging and measuring flow: growing role for cardiac MRI
In discussing how laminar versus turbulent flow is assessed, Paterson said 2D MRI has become more widely used and that 4D MRI is gaining prevalence. He said 4D MRI is included in Anteris’s pivotal trial as part of secondary endpoint assessments and provides clear visualization of flow patterns.
Asked whether major competitors are adopting cardiac MRI to assess post-implant flow, Paterson said he was not aware of broad initiatives and suggested there may be limited incentive based on what he said Anteris has seen when evaluating flow in other companies’ patients. He referenced the SMART study and said it showed a 40% bioprosthetic valve dysfunction (BVD) rate in the Edwards arm over 12 months, adding that flow disruption can be a leading indicator of valve degradation.
Pivotal study PARADIGM: head-to-head, global, and multi-label
Paterson called Anteris’s PARADIGM IDE protocol the best clinical trial protocol he has seen, citing a relatively small sample size for the category and a head-to-head design that he described as the first registration head-to-head for TAVR. He said secondary endpoints include hemodynamic superiority measures, laminar flow, and LV remodeling assessed using 4D MRI, and he suggested the resulting publication could influence guidelines.
He described PARADIGM as a global study spanning the U.S. and Europe and said it is designed to support four labels under the same umbrella: low, medium, high risk, and valve-in-valve. Discussing enrollment, he compared it to the SMART study, describing PARADIGM’s randomized design as approximately 1,000 patients (about 500 DurAVR and 500 standard of care) in the first part. He acknowledged a larger total number on ClinicalTrials.gov, attributing it to additional cohorts, including valve-in-valve and continued access in low-risk patients.
Paterson said major sites are “locked and loaded,” including large U.S. and European centers, and stated the company already has patients enrolled in the study. He said physicians believe enrollment could occur quickly, though he noted logistics and manufacturing capacity are factors in pacing. Paterson also said investors would continue to get updates outside the pivotal trial through ongoing presentations of the 140-patient experience at major conferences, including CRT, New York Valves, London Valves, and others, alongside quarterly company disclosures and pivotal-study updates.
Strategic interest and Medtronic investment
Paterson said multiple strategic companies have engaged with Anteris over time, including the “usual suspects” as well as Johnson & Johnson, and discussed Medtronic’s recent investment. He said Medtronic holds no special rights from the investment and characterized Medtronic as both an investor and a competitor, adding that discussions could continue around areas such as co-development, co-promotion, and co-manufacturing.
He also addressed recent disclosures around Medtronic’s Evolut platform, saying the developments did not change Anteris’s go-to-market view but could make its commercial strategy “a little bit easier,” particularly in small annuli and valve-in-valve segments where he said DurAVR has shown strong performance and where Evolut has meaningful usage.
Delivery system and IP approach
Paterson said DurAVR’s balloon-expandable delivery system is “50% of the equation” for adoption and emphasized that the company deliberately assessed existing intellectual property early in development. He described extensive physician input and iterative development in labs and cadaver work, and he cited features such as commissural alignment and differences in balloon technology and valve crimping. Paterson said the goal was to match the ease of use of market leaders while maintaining strong IP protection.
About Anteris Technologies Global (NASDAQ:AVR)
Anteris Technologies Global Corp. engages in the development and commercialization of medical devices for heart diseases. The company was founded in 1999 and is headquartered in Eagan, MN.
