Key Highlights

  • Net operating cash outflows were $22.9 million for the three months ended 30 September 2026.
  • R&D expenses reached $21.3 million as manufacturing, quality and clinical activity scaled up.
  • Following the quarter, the PARADIGM Trial received regulatory clearance in Germany and approval in Australia.
  • The DurAVR THV remains an investigational device and is not available for commercial sale.

Anteris Technologies Global Corp. (NASDAQ:AVR) (ASX:AVR) has reported its results for the quarter ended 30 September 2026, in an update dated 11 November 2026. The update covers progress in the global PARADIGM Trial of its DurAVR transcatheter heart valve, the company’s move into a larger Manufacturing Facility in Minnesota and a change to its senior finance team, as the company prepares for a potential commercial launch.

Trial expansion and regulatory progress

The PARADIGM Trial is a prospective, randomised study designed to enrol about 1,000 patients in an all-comers cohort, with a 1:1 split between the DurAVR valve and commercially available transcatheter aortic valves. The primary endpoint is non-inferiority on a composite of all-cause mortality, all stroke and cardiovascular hospitalisation at one year after the procedure. Enrolment is under way at sites in the United States, Canada, Denmark, the Netherlands and France.

After the quarter ended, the trial received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices, supporting an expansion into Germany. In Australia, the trial received Human Research Ethics Committee approval and authorisation under the Clinical Trial Notification pathway. The company said US site activation timing reflected the CMS coverage determination it received in April 2026.

Manufacturing capacity and the cash outflow

Anteris assumed occupancy of the Northcross facility in Brooklyn Park, Minnesota, on 1 September 2026. The site adds capacity to produce the DurAVR valves and the ComASUR delivery system before commercial launch. The company’s net operating cash outflows for the quarter were $22.9 million, which it attributed to clinical, regulatory and manufacturing requirements supporting the trial.

Research and development expenses of $21.3 million were driven by the scaling of manufacturing and quality capabilities, including process development, validation activity and higher headcount. Clinical costs linked to patient enrolment and the field-based clinical team added to the total, and the outflow was partly offset by lower DurAVR product research costs.

Leadership and the path to market

Brent Moen was appointed Chief Financial Officer effective 11 September 2026. The company said the appointment supports its financial and governance priorities as the DurAVR valve moves toward commercialisation, alongside other hires intended to strengthen its operating model.

The company is clear that the DurAVR valve is for investigational use only and is not available for commercial sale or use anywhere in the world. Its ADAPT tissue, which the company says is FDA-cleared and has been used clinically for more than a decade, is distinct from the valve itself. Commercial timing will depend on the trial results and on the regulatory steps that follow them.

Final Word

Anteris is funding a large clinical and manufacturing program ahead of any product sales, and the quarter’s cash outflow reflects that stage. The pace of enrolment across the new sites, the progress of the Northcross facility and the outcome of the PARADIGM Trial will determine whether the company can move from investigational use to commercial supply. Shareholders will be watching those milestones in the quarters ahead.