Imricor Medical Systems (ASX:IMR) announced its financial and operational results for the full year 2025, highlighting a pivotal period of regulatory achievements and global commercial expansion.
A primary highlight was receiving CE Mark approval under the EU Medical Device Regulation for its second-generation platform, which includes the Vision-MR Ablation Catheter and the NorthStar 3D mapping and guidance system—the first of its kind to be MRI-native.
Following this, the NorthStar system and Vision-MR Diagnostic Catheter also received FDA clearance in January.
Clinically, the company achieved a landmark milestone by performing the first-in-human ischemic ventricular tachycardia ablation under real-time MRI guidance at Amsterdam University Medical Centre.
Imricor also expanded its US presence, adding the University of Virginia, Virginia Commonwealth University, and Oklahoma Heart Institute to its VISABL-AFL clinical trial.
Furthermore, the company successfully completed the world’s first pre-clinical in vivo pulsed field ablation under real-time MRI guidance.
Imricor bolstered its European infrastructure by completing the hiring and training of its sales team, while its customer pipeline surged from 7 to 40 by year-end.
Expansion into the Middle East is also underway, with two iCMR labs currently under construction in Saudi Arabia.
The company reported US$292,000 in revenue, noting a temporary impact as customers focused on clinical trial enrolments.
Imricor concluded the year with a solid liquidity position, holding US$40.8 million in cash and marketable securities as of Dec. 31, 2025.
At the time of reporting, Imricor Medical Systems’ share price was $1.96.