Imricor Medical Systems has achieved multiple world-first procedures using real-time MRI guidance for cardiac ablation, advancing clinical trials and regulatory progress amid a strategic commercial expansion.
- World-first ischemic ventricular tachycardia ablation under real-time MRI guidance
- Expansion of U.S. clinical trial sites with procedures starting Q1 2026
- Completion of Philips integration and ongoing GE collaboration for market launch
- Q4 operating cash outflows of US$5.2 million with US$40.8 million in cash and investments
- New iCMR lab constructions underway in Saudi Arabia and strong regional physician interest
Pioneering MRI-Guided Cardiac Ablation
Imricor Medical Systems has marked a significant leap in cardiac care with multiple world-first procedures using real-time magnetic resonance imaging (MRI) guidance for ventricular tachycardia ablation. This breakthrough represents a shift from traditional x-ray fluoroscopy to MRI, offering superior imaging that promises safer, faster, and more effective treatments for complex heart rhythm disorders.
These clinical milestones underscore Imricor's leadership in interventional cardiac magnetic resonance (iCMR) technology, positioning the company at the forefront of a transformative approach to cardiac ablation.
Clinical Trial Expansion and Regulatory Progress
The company continues to broaden its clinical footprint in the United States, with UVA Health becoming the second hospital to join the VISABL-AFL trial supporting FDA approval. Additional U.S. sites are preparing to commence procedures in early 2026, complementing ongoing European and Middle Eastern efforts.
Regulatory activities remain on track, with FDA clearance processes advancing across Imricor’s device portfolio. The company’s second-generation Vision-MR Ablation Catheter has also achieved preclinical milestones, including the world’s first in vivo pulsed field ablation in the ventricle under MRI guidance.
Commercial Momentum and Strategic Partnerships
On the commercial front, Imricor has completed integration with Philips, enabling customers in Europe and the Middle East to progress toward site conversions. Collaboration with General Electric continues, timed to support the U.S. market launch where GE scanners are prevalent.
New iCMR labs are under construction in Saudi Arabia, with capital equipment orders expected soon. The region’s strong physician interest was highlighted by an education summit attended by approximately 100 doctors, signalling growing demand for MRI-guided interventions.
Board strengthening was also notable, with Aldo Denti, formerly of Johnson & Johnson MedTech, joining the board, bringing valuable industry expertise to support Imricor’s growth ambitions.
Financial Overview and Outlook
Financially, Imricor reported operating cash outflows of US$5.2 million in Q4, reflecting ongoing investment in clinical trials and commercial expansion. Cash receipts were modest at US$26,000 due to the non-revenue-generating nature of clinical trial enrolments in the short term.
The company ended the quarter with a solid liquidity position, holding US$19.5 million in cash and US$21.3 million in short-term investments. This financial foundation supports the near-term focus on converting a pipeline exceeding 40 sites rather than expanding it further.
CEO Steve Wedan emphasised the convergence of regulatory, clinical, and commercial milestones, expressing confidence that Imricor is poised to redefine cardiac arrhythmia treatment by eliminating reliance on x-ray and enhancing procedural safety and precision.
Bottom Line?
As Imricor advances its clinical trials and regulatory approvals, the coming quarters will be critical in translating innovation into commercial success and market adoption.
Questions in the middle?
- How quickly will FDA approvals translate into commercial revenue growth in the U.S.?
- What is the timeline for converting the pipeline of over 40 clinical sites into active revenue-generating centres?
- How will competition and adoption rates of MRI-guided ablation technology evolve globally?