Results of Special Meeting and PARADIGM Trial Update
| Stock | Anteris Technologies Ltd (AVR.ASX) |
|---|---|
| Release Time | 30 Sep 2025, 8:27 a.m. |
| Price Sensitive | Yes |
Anteris Announces PARADIGM Trial Update, Shareholder Meeting Results
- Shareholders approved ASX waiver to issue new securities without shareholder approval
- Patient enrolment in PARADIGM trial now expected in Q4 2025 due to FDA information request
- Regulatory submissions underway in Europe to advance PARADIGM trial globally
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) announced the results of its Special Meeting of Stockholders held on September 29, 2025. At the meeting, a quorum was present, and shareholders approved the ASX Waiver Proposal, which grants Anteris a waiver from ASX Listing Rule 7.1 to permit the company to issue new securities without obtaining shareholder approval. Shareholders also approved the Adjournment Proposal, though no adjournment was necessary as the ASX Waiver Proposal was approved. In a separate update, Anteris announced that patient enrolment in its global pivotal PARADIGM Trial, initially expected in Q3 2025, is now anticipated to commence in Q4 2025. This delay is due to the Federal Drug Administration (FDA) requesting additional information, primarily related to bench testing, which Anteris has now addressed. The company has also initiated regulatory submissions to competent authorities in Europe to advance the PARADIGM Trial across multiple regions. Anteris is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, with its lead product being the DurAVR® Transcatheter Heart Valve (THV) system.