• Imricor receives CE Mark certification for the Advantage-MR system under new European Medical Device Regulation (MDR)
• Approval follows CE Mark certification for the 2nd generation Vision-MR Ablation Catheter in February 2025
• Commercial launch of the 2nd generation Vision-MR Ablation Catheter and the new Advantage-MR system planned to commence in June across new and existing sites in the EU

Imricor Medical Systems, Inc. (ASX: IMR) is pleased to announce that the Company's Advantage-MR EP Recorder/Stimulator (Advantage-MR) has received CE mark certification under the European Union's new Medical Device Regulation (MDR). This follows the earlier CE mark approval of Imricor's 2nd generation Vision-MR Ablation Catheter under the MDR regime, as announced on 19 February 2025. Commercial launch of the 2nd generation Vision-MR Ablation Catheter and the new Advantage-MR system is planned to commence in June across new and existing sites in the EU. Imricor's Chair and CEO, Steve Wedan, commented: 'As of today, our entire commercial product portfolio in Europe is approved under MDR. This was a huge undertaking over the past several years to transition from the old European Medical Device Directive rules to the new, more stringent Medical Device Regulations. Our Vice President of Regulatory and Quality, Jennifer Weisz, has built a world-class team, and that team continues to deliver approvals for multiple products across multiple geographies, all with varying regulations and requirements. During this regulatory transition, we also took the opportunity to significantly improve our Vision-MR Ablation Catheter, and early feedback from physicians who have used the new 2nd generation catheter in our VISABL-AFL and VISABL-VT clinical trials has been very positive, noting improved manoeuvrability characteristics and robustness. We will soon commence phasing out the 1st generation products from the market, replacing them with these new MDR CE mark approved devices.'