- **Anteris Technologies Global Corp. (AVR)** has received its **first European regulatory clearance** from the Danish Medicines Agency to initiate the **DurAVR® Transcatheter Heart Valve (THV) global pivotal trial** (PARADIGM Trial).  **[2011514_0001140361-25-038166_ef20056802_ex99-1.htm:0]** 
- Patient recruitment for the PARADIGM Trial in Danish centers is expected to commence in **4Q 2025**.  **[2011514_0001140361-25-038166_ef20056802_ex99-1.htm:0]** 
- This multi-center global study will evaluate the **safety and effectiveness of the DurAVR® THV** compared to commercially available transcatheter aortic valve replacements (TAVRs), with planned expansion across the United States, Europe, and Canada.  **[2011514_0001140361-25-038166_ef20056802_ex99-1.htm:0]** **[2011514_0001140361-25-038166_ef20056802_ex99-1.htm:1]** 
- An Investigational Device Exemption (IDE) application for the U.S. is currently **under review by the FDA**, with approval anticipated in the near term.  **[2011514_0001140361-25-038166_ef20056802_ex99-1.htm:0]**

Anteris Technologies Global (AVR)