• Submitted IDE for global, pivotal PARADIGM Trial of DurAVR® THV
• Reached 100 patients treated with DurAVR®, demonstrating strong clinical outcomes
• Reported favorable one-year data for DurAVR® THV patients

Anteris Technologies reported financial results for the first quarter of 2025 and provided a corporate update. Key highlights include the submission of an Investigational Device Exemption (IDE) application to the FDA for the global, pivotal PARADIGM Trial of the DurAVR® Transcatheter Heart Valve (THV). The PARADIGM Trial is designed to provide the clinical evidence required to support a Premarket Approval (PMA) application in the U.S. and CE Mark approval in parallel. The company remains on track to commence the PARADIGM Trial in Q3 2025, pending FDA approval of the IDE. Anteris also achieved a major clinical milestone, successfully treating the 100th patient with the DurAVR® THV, including de novo aortic stenosis cases and valve-in-valve patients. The company reported one-year clinical data for DurAVR® THV patients, demonstrating sustained favorable hemodynamics, a consistent safety profile, and high implant success. Anteris continued to expand its global manufacturing capacity to support the PARADIGM Trial and anticipated commercial demand. The company's financial results showed a decrease in net sales but an increase in R&D expenses related to manufacturing scale-up and PARADIGM Trial preparation. Anteris was also included in the FTSE Russell 2000® Index during the quarter.

Anteris did not provide any high-importance, price-sensitive forward-looking financial metrics in the announcement.

Anteris did not provide a specific forward-looking outlook in the announcement, but the company stated it remains on track to commence the PARADIGM Trial in the third quarter of 2025, pending FDA approval of the IDE.