• Successful submission of 2nd Premarket Approval (PMA) Module to US FDA
• CE Mark approval under MDR received for key products
• First-in-man ventricular ablation guided by real-time iCMR performed

Imricor Medical Systems, Inc. (ASX: IMR), the global leader in real-time iCMR cardiac ablation products, has released its 1H25 Financial Results for the period ended 30 June 2025 and provided an update on its operational performance. The key highlights include successful submission of the 2nd Premarket Approval (PMA) Module to the US FDA, CE Mark approval under MDR for the 2nd generation Vision-MR Ablation Catheter, 2nd generation Vision-MR Advantage EP Recorder/Stimulator, and NorthStar - the world's first and only MRI native 3D mapping & guidance system. The company also reported the first-in-man ventricular ablation guided by real-time iCMR, commencing the VISABL-VT clinical trial, and additional VISABL-VT clinical trial sites preparing to enrol, focusing on strong Key Opinion Leaders (KOL's) at high volume sites. On the commercial front, Imricor has a deeply experienced sales team in place in Europe with training now complete, and a material impact on the customer pipeline, which increased from 7 to 26 over the half. The company has also established Imricor B.V. in The Netherlands to accelerate the development of NorthStar and expand into the Middle East, with two iCMR labs currently under construction in the Kingdom of Saudi Arabia. Financially, the company reported revenue of $196k, temporarily impacted by the VISABL-AFL clinical trial participation by customer sites, but expects revenue to increase as the trial completes and the pipeline begins to convert, with a step change expected following US FDA approval. The balance sheet remains strong with US$50.3m cash at bank.

Revenue and profit are expected to increase as the VISABL-AFL clinical trial completes and the customer pipeline begins to convert, with a step change expected following US FDA approval. The company's target market of cardiac ablations is estimated to be US$8 billion worldwide.

Imricor is focused on executing the VISABL-VT and VISABL-AFL trials, re-establishing the iCMR-guided atrial flutter ablation market in Europe post-pandemic, and expanding into new geographies as key drivers of the company's growth.