Why Is Virginia Commonwealth University Joining Imricor’s VISABL-AFL Trial?

Imricor Expands US Clinical Trial Footprint

Imricor Medical Systems (ASX – IMR) has announced a significant milestone in its journey towards US regulatory approval with Virginia Commonwealth University Health (VCU Health) becoming the third US site to join its VISABL-AFL clinical trial. The Institutional Review Board at VCU Health has given the green light for patient enrolment, marking a key step in supporting Imricor’s FDA approval process for its innovative MRI-compatible cardiac ablation products.

VCU Health, a prominent academic health system based in Richmond, Virginia, is renowned for its extensive hospital network and nationally recognised specialty programs. Its participation adds considerable weight to the trial, reflecting growing clinical interest in Imricor’s technology that aims to improve the safety and effectiveness of cardiac ablation procedures.

Advancing MRI-Guided Cardiac Ablation

The VISABL-AFL trial evaluates Imricor’s NorthStar Mapping System and Vision-MR mapping and ablation catheters, which leverage real-time MRI guidance rather than traditional x-ray fluoroscopy. This approach offers superior imaging capabilities, enabling clinicians to visualise arrhythmogenic substrates and the effects of ablation with unprecedented clarity. Dr Ajay Pillai, the Principal Investigator at VCU Health, described the technology as a “paradigm shift” that could meaningfully improve patient outcomes.

Following final budgeting, installation, and training scheduled for completion in February, VCU Health expects to commence procedures in March 2026. This timeline underscores the momentum behind the trial and Imricor’s commitment to progressing its US regulatory pathway.

Strategic Implications for Imricor

Imricor’s Chair and CEO, Steve Wedan, emphasised the importance of VCU Health’s involvement, highlighting the urgency and purpose with which US sites are joining the trial. The expansion to a third site not only broadens the clinical data pool but also signals growing confidence in the technology’s potential within the medical community.

While the announcement does not specify timelines for FDA approval or commercial launch, the addition of VCU Health strengthens Imricor’s position as it navigates these critical regulatory milestones. The company’s products are already approved in several international markets, and successful US approval would open a substantial commercial opportunity.

Investors and observers will be watching closely as the VISABL-AFL trial progresses, with the potential to reshape cardiac ablation procedures and establish Imricor as a leader in MRI-guided interventional cardiology.