Anteris Technologies (AVR) TD Cowen 46th Annual Health Care Conference summary

Platform innovation and clinical results

• Developed a biomimetic valve platform, DurAVR, designed to restore aortic valve function and healthy laminar flow, addressing limitations of existing TAVR devices.

• Achieved consistently low mean gradients (5-10 mmHg) in 140 patients, including challenging anatomies and valve-in-valve cases.

• Demonstrated unique benefits such as left ventricular remodeling and significant reduction in LV mass, indicating disease modification.

• Showed superior outcomes in small annuli and valve-in-valve settings, with better-than-first-valve mean gradients.

• Patient-prosthesis mismatch rate was only 3%, much lower than the typical 30% seen with other balloon-expandable devices.

Clinical trial strategy and milestones

• Large early feasibility cohort (140 patients) de-risked pivotal study and provided robust long-term data, with some patients followed for over four years.

• Ongoing and upcoming presentations at major conferences (CRT, New York Valves, TCT) will highlight flow, LV remodeling, and other clinical outcomes.

• Cardiac MRI (2D/4D) is increasingly used to assess flow post-implant, with pivotal studies incorporating these imaging endpoints.

• The pivotal PARADIGM IDE trial is a global, head-to-head study with 1,000+ patients, aiming for enrollment completion by Q1 2027 and potential approval in 2028.

• Study includes all risk categories and valve-in-valve, with secondary endpoints on hemodynamic superiority, laminar flow, and LV remodeling.

Competitive landscape and strategic partnerships

• Recent Medtronic investment reflects strong industry interest; no special rights granted, but potential for future co-development discussions.

• Medtronic's Evolut platform faces challenges with higher re-intervention rates, especially in small annuli, enhancing DurAVR's market opportunity.

• DurAVR's balloon-expandable delivery system was designed with extensive physician input and IP protection, offering ease of use and advanced features like commissural alignment.

• High enthusiasm and demand from leading global investigator sites, with rapid trial enrollment anticipated.

• Long-term follow-up data (up to 7.5 years) will be available by the time of potential approval, supporting robust safety and efficacy claims.