Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) continued to strengthen its global experience with the DurAVR® Transcatheter Heart Valve (THV) in the second quarter of 2025. By June 30, the company had successfully implanted the device in 130 patients since the start of clinical development. This included 49 procedures in the first half of the year and 21 in the June quarter.
The growing body of data demonstrates strong performance of the biomimetic TAVR system across a variety of patient anatomies, including complex cases such as bicuspid valves and valve-in-valve procedures. Notably, the company achieved a world-first “double DurAVR®” implant in a patient requiring replacement in both the mitral and aortic positions.
Quarter highlights:
- 130 patients implanted with DurAVR® THV since the start of clinical development, with 49 treated year-to-date and 21 in the quarter.
- World-first “double DurAVR®” implant in both mitral and aortic valve positions.
- Preparations advanced for the global PARADIGM Trial, with 79 clinical sites qualified.
- Global investigator meeting held in June; Dr Michael J. Reardon and Professor Stephan Windecker confirmed as co-chairs.
- Continued FDA engagement to progress Investigational Device Exemption (IDE) application.
- Appointment of David Roberts and Gregory Moss as non-executive directors.
“I’m extremely pleased with the progess achieved during the second quarter as the company enters a new phase in its life cycle. The data generated to date from 130 patients treated with DurAVR® across multiple settings, including complex anatomies, different annular sizes, bicuspids and valve-in-valve (including a double aortic and mitral replacement in the same patient) is highly compelling,” Anteris vice chairman and CEO Wayne Paterson said.
“By adopting a “total disease management” approach, the development of this first-in-class biomimetic transcatheter heart valve has delivered meaningful clinical benefits across a range of clinical use cases. As such, we are excited by physician enthusiasm across the globe to recruit into the PARADIGM study, which is designed to further support the growing body of evidence demonstrating DurAVR® THV’s impact on patients.”
Preparations for the PARADIGM Trial
During the quarter, Anteris advanced preparatory work for its global, pivotal PARADIGM Trial. The company qualified 79 trial sites following feasibility assessments to ensure each centre’s ability to recruit suitable aortic stenosis patients and adhere to trial protocols. Site contracting progressed across the United States, Europe and Canada.
In May, a European Investigator Meeting brought together principal investigators from leading institutions across Denmark, France, Germany, the Netherlands, and Switzerland. A global investigator meeting in June, held alongside New York Valves, confirmed Dr Michael J. Reardon and Professor Stephan Windecker as co-chairs, both bringing extensive interventional cardiology expertise. Anteris continued to work with the US Food and Drug Administration (FDA) on its IDE application, while scaling manufacturing to meet anticipated trial demand.
Board appointments strengthen leadership
On June 10, Anteris appointed David Roberts and Gregory Moss as non-executive directors. Roberts adds extensive operational leadership experience, while Moss brings legal and corporate governance expertise.
These appointments are intended to support the company’s clinical and commercial objectives as it transitions into a pivotal stage of product validation and market readiness.
Financial performance
For the six months to June 30, 2025, Anteris reported net operating cash outflows of US$41 million, reflecting increased clinical, regulatory and manufacturing investment for the PARADIGM Trial.
Research and development expenses in the quarter totalled US$16.3 million, driven by regulatory preparations, investigator engagement, and manufacturing scale-up.
Selling, general and administrative expenses were US$5 million. Cash and cash equivalents stood at US$28.4 million at quarter-end.