Anteris Reports 130 Patients Treated and 79 Sites Ready for PARADIGM Trial
Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.
- 130 patients implanted with DurAVR transcatheter heart valve to date
- World-first double valve implant performed in a single patient
- 79 clinical sites qualified for global PARADIGM pivotal trial
- Two new non-executive directors appointed to the board
- Net operating cash outflows of $41 million in H1 2025 reflecting trial preparations
Clinical Milestones and Innovation
Anteris Technologies Global Corp. has marked a significant milestone in its journey to revolutionize structural heart disease treatment with its DurAVR Transcatheter Heart Valve (THV). As of the second quarter of 2025, 130 patients have been successfully implanted with the DurAVR valve, including a remarkable world-first case where a patient received a double valve-in-valve replacement in both the mitral and aortic positions. This achievement underscores the device's versatility and potential to address complex cardiac anatomies.
Preparing for the PARADIGM Trial
Building on this clinical momentum, Anteris is advancing preparations for its global pivotal clinical trial, named PARADIGM. The company has qualified 79 clinical sites across the United States, Europe, and Canada, demonstrating broad geographic engagement and readiness. The trial aims to further validate the DurAVR THV’s clinical benefits and is supported by a leadership team of renowned cardiologists, including Dr. Michael J. Reardon and Professor Stephan Windecker, who serve as co-chairs.
Operational alignment was strengthened through investigator meetings held in Europe and globally, fostering collaboration and ensuring trial sites meet rigorous standards. Concurrently, Anteris continues its active dialogue with the U.S. Food and Drug Administration to secure the Investigational Device Exemption (IDE) necessary to commence the trial.
Corporate and Financial Developments
In a strategic move to bolster governance and oversight, Anteris appointed two experienced non-executive directors, David Roberts and Gregory Moss, to its board. Their expertise in operational leadership and corporate governance is expected to support the company’s clinical and commercial objectives as it scales.
Financially, Anteris reported net operating cash outflows of $41 million for the first half of 2025, reflecting increased investment in research and development, clinical trial preparations, and manufacturing scale-up. Research and development expenses alone accounted for $16.3 million in the second quarter, highlighting the company’s commitment to advancing its innovative heart valve technology. As of June 30, 2025, the company held $28.4 million in cash and equivalents, providing a runway as it progresses through this critical phase.
Looking Ahead
With a growing body of clinical evidence and a robust trial infrastructure in place, Anteris is poised to make a significant impact in the transcatheter heart valve market. The upcoming PARADIGM trial will be a pivotal test of the DurAVR THV’s potential to improve patient outcomes across diverse clinical scenarios. Investors and clinicians alike will be watching closely as the company navigates regulatory milestones and patient enrollment in the months ahead.
Bottom Line?
Anteris’ clinical and corporate strides set the stage for a defining year as it prepares to validate its DurAVR valve in a global trial.
Questions in the middle?
- When will the FDA grant the Investigational Device Exemption to officially start the PARADIGM trial?
- How quickly can Anteris enroll patients across its 79 qualified sites to meet trial timelines?
- What impact will the new board appointments have on the company’s strategic direction and commercialization efforts?
