Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) reported its financial results for the quarter ended September 30, 2025, which was dominated by regulatory and operational preparation for the PARADIGM pivotal trial of the DurAVR® transcatheter heart valve (THV), with the company subsequently announcing in November that the US Food and Drug Administration (FDA) had approved commencement of patient recruitment* in the United States.
In Europe, Denmark granted approval in October, and the first PARADIGM patients were enrolled and treated there soon after.
Wayne Paterson, vice chairman and CEO, said the quarter “set the company on its path for the rest of the year and into 2026,” noting that approvals to start in both Europe and the US followed in Q4.
Q3 2025 operational highlights
- Ongoing FDA engagement on the Investigational Device Exemption (IDE) for PARADIGM, including a formal response addressing requests for additional information and a completed simulated-use study; US recruitment cleared in November (recruitment refers to approval to commence US patient recruitment; actual enrolment is subject to site activation and IRB approvals).
- European activation advanced across multiple countries; Danish approval in October enabled first patient treatments.
- Site readiness completed across the US, Europe and Canada (investigator training, study materials, and logistics) ahead of enrolment pending final clearances/IRB approvals.
- Operations and quality systems strengthened and manufacturing scaled up for clinical demand, including ISO 13485 certification for DurAVR® THV production, alongside continued QMS buildout to mitigate audit risk.
Financials (US$)
- Anteris’ spending reflected the ramp toward PARADIGM execution.
- Net operating cash outflows (9M to September 30, 2025): $59.3 million.
- R&D expenses (Q3): $16.8 million, driven by IDE-related work, engagement with investigators and cath lab clinical support, manufacturing upscaling (design validation and documentation), and portfolio development.
- Selling, general & administrative (Q3): $5.8 million.
- Cash and cash equivalents (30 Sept 2025): $9.1 million.
PARADIGM trial overview
PARADIGM is a prospective, randomised controlled trial evaluating DurAVR® THV against commercially available TAVR devices.
Approximately 1,000 “all-comers” will be enrolled across the US, Europe and Canada with 1:1 randomisation.
The primary endpoint tests non-inferiority on a composite of all-cause mortality, all stroke and cardiovascular hospitalisation at one year post-procedure.
Data are intended to support a Premarket Approval (PMA)submission to the FDA, with CE Mark progress in parallel. (ClinicalTrials.gov NCT07194265.)