• Received CE Mark approvals for second generation platform components
• Performed landmark first-in-human ischemic VT ablation under real-time MRI guidance
• Expanded VISABL-AFL trial to include new U.S. hospitals

Imricor Medical Systems, Inc. (ASX: IMR) released its FY25 financial results and provided an update on its operational performance. The company received CE Mark approvals under the EU Medical Device Regulation (MDR) for second generation platform components, including the 2nd generation Vision-MR Ablation Catheter, 2nd generation Advantage-MR EP Recorder/Stimulator, and NorthStar, the world's first and only MRI-native 3D mapping and guidance system. Imricor also performed the landmark first-in-human ischemic ventricular tachycardia (VT) ablation under real-time MRI guidance, commencing the VISABL-VT clinical trial. The company completed human factors usability studies for its products and made several 510(k) submissions for FDA clearance, with the Vision-MR Diagnostic Catheter and NorthStar subsequently cleared in January 2026. Imricor expanded the VISABL-AFL trial to include new U.S. hospitals and made progress in its Middle East expansion with two iCMR labs under construction in Saudi Arabia. On the commercial front, the company completed its European sales team hiring and training, increasing its European customer pipeline from 7 to 40 sites by the end of the year.