Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has secured shareholder approval for an ASX waiver to issue new securities without further shareholder votes, while also updating the market on the timeline for its pivotal PARADIGM trial of the DurAVR® Transcatheter Heart Valve (THV).
At a special meeting held on September 29, around 51.8% of Anteris’ outstanding shares were represented, with stockholders voting strongly in favour of the waiver proposal. The measure passed with more than 13.6 million votes in support against 2.6 million opposed, while a secondary adjournment proposal also cleared comfortably, though ultimately no adjournment was needed.
The waiver provides Anteris with additional flexibility in future capital management, giving the company capacity to raise funds or issue securities on terms consistent with ASX’s listing rule exemptions.
PARADIGM trial update
The company also reported a revised timeline for the commencement of patient enrolment in its global pivotal registration study of the DurAVR® THV system, known as the PARADIGM trial.
Originally slated to begin in the September quarter, patient recruitment is now expected to commence in the December quarter of 2025. The adjustment follows a review of Anteris’ Investigational Device Exemption (IDE) application by the US Food and Drug Administration (FDA).
The FDA requested additional information — primarily related to bench testing — which the company has since addressed through a formal response. The IDE package includes both the clinical study protocol and supporting technology data, designed to show that the DurAVR® THV System is appropriately developed and tested for use in the trial.
Alongside its US efforts, Anteris confirmed that regulatory submissions to competent authorities in Europe are progressing in parallel, underscoring the company’s multi-regional strategy for advancing its biomimetic heart valve technology.
Restorative approach
Anteris’ lead product, the DurAVR® THV, is the first biomimetic transcatheter valve shaped to mimic a healthy human aortic valve. It is built from the company’s patented ADAPT® anti-calcification tissue technology, which has been FDA-cleared and used in more than 55,000 patients worldwide.
The company has been repositioning its R&D spend towards clinical and regulatory execution as it scales for the pivotal PARADIGM trial, a process highlighted in earlier updates this year.
Read more: Anteris scales for pivotal PARADIGM Trial, plunging R&D investment into clinical activities
Anteris shares were trading nearly 6% higher at $6.98 as of 1:30 pm AEST on Tuesday.