Anteris Technologies (AVR) 8-K Summary

Date: November 3, 2025

Material Event: Anteris Technologies Global Corp. announced receipt of FDA approval to commence its DurAVR® Transcatheter Heart Valve (THV) Global Pivotal Trial, named the PARADIGM Trial.

• This represents a critical regulatory milestone for the company’s lead product.
• The filing is furnished under Regulation FD disclosure.

No new financial performance metrics or explicit guidance were provided in this report; the focus is strictly on the regulatory event enabling the pivotal trial phase.

The Company