Imricor Nearly Doubles Sales Pipeline, Secures Key CE Mark Approvals

Regulatory Milestones Propel Imricor Forward

Imricor Medical Systems has marked a quarter of steady advancement in its pioneering real-time interventional cardiac magnetic resonance (iCMR) technology. The company successfully performed the first-in-human ventricular ablation guided by real-time iCMR at Amsterdam University Medical Centre, a critical clinical milestone that underscores the practical viability of its technology.

Further regulatory progress includes CE mark approvals for the Advantage-MR system under the new European Medical Device Regulation, following the earlier approval of its second-generation Vision-MR Ablation Catheter. Additionally, the NorthStar system, the world’s only MRI-native 3D mapping and guidance platform, also received CE mark clearance, positioning Imricor strongly in the European market.

Clinical Trials and Commercial Expansion Gain Momentum

The company has initiated the VISABL-VT clinical trial and is making solid headway in recruiting additional ventricular tachycardia (VT) sites. Interest is also growing among US hospitals equipped with MRI scanners for cardiology, which are potential participants in the VISABL-AFL trial. Commercially, Imricor has expanded its European sales team from two to six experienced field representatives, nearly doubling its sales pipeline from 14 to 27 sites. Semmelweis University in Hungary became the first hospital in the country to perform ablations guided by real-time iCMR, signaling geographic expansion and adoption.

Financial Discipline Amid Growth Initiatives

Financially, Imricor reported operating cash outflows of US$4.4 million for Q2, a 4% reduction from the previous quarter, reflecting disciplined cost management despite increased clinical trial and regulatory expenses. Cash receipts were modest at US$85,000, temporarily impacted by non-revenue generating clinical trial enrollments. The company ended the quarter with a robust cash balance of US$50.3 million, providing an estimated 11.4 quarters of funding at current burn rates, ensuring runway for ongoing development and commercialization efforts.

Navigating Regulatory Challenges and Market Opportunities

While the FDA premarket approval (PMA) process has experienced some delays, Imricor remains optimistic with module 2 under agency review and plans to submit module 3 early in Q4. The company anticipates a steady cadence of 510(k) submissions and approvals through the remainder of the year, which will be pivotal in accelerating US market entry. Integration efforts with Philips’ platform are nearing completion, expected to facilitate faster hospital adoption in the US and Europe.

Imricor’s focus on real-time iCMR cardiac ablation taps into a substantial global market estimated at US$10 billion. By advancing clinical trials, securing regulatory approvals, and expanding its commercial footprint across Europe, Australia, New Zealand, and the Middle East, the company is positioning itself as a leader in a transformative cardiac treatment modality that promises safer, faster, and more effective arrhythmia management without the risks of x-ray exposure.