Imricor’s US Trial Growth Raises Questions on FDA Approval Timing
Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.
- University of Virginia Health approved as second US VISABL-AFL trial site
- Site initiation completed; contract finalisation and training planned for January 2026
- Clinical procedures expected to start in February 2026
- Supports Imricor’s MRI-guided cardiac ablation technology development
- Additional US sites anticipated to join, aiding FDA approval timeline
Imricor Expands US Clinical Trial Footprint
Imricor Medical Systems, a pioneer in MRI-guided cardiac ablation technology, has announced a significant milestone with the University of Virginia Health Medical Center becoming the second US site to participate in its VISABL-AFL clinical trial. This development follows the Institutional Review Board’s approval, a critical regulatory step that clears the way for patient enrolment and clinical procedures.
The University of Virginia Health team, led by Dr. Kenneth Bilchick, a respected electrophysiologist and professor of cardiology, has already undergone site initiation activities with Imricor personnel. The next steps include finalising the research contract and completing site installation and clinical training, both scheduled for January 2026. Procedures are expected to commence shortly thereafter in February.
Strategic Importance of VISABL-AFL Trial
The VISABL-AFL trial is central to Imricor’s strategy to revolutionise cardiac ablation by using real-time MRI guidance instead of traditional x-ray fluoroscopy. MRI offers superior imaging capabilities, potentially improving the safety and effectiveness of procedures for patients with atrial and ventricular arrhythmias. Dr. Bilchick highlighted the promise of this technology to advance therapeutic strategies and expand MRI-guided electrophysiology ablations globally.
Imricor’s CEO, Steve Wedan, emphasised the rapid progress made by UVA Health, noting that this site is the first of several expected to join the trial in the US. This expansion is crucial to maintaining the company’s enrolment pace and supporting ongoing FDA approval processes, which remain a key focus for Imricor as it seeks to commercialise its products in the US market.
Looking Ahead
The University of Virginia Health Medical Center is a prestigious academic health system with a strong reputation, consistently ranked among the top hospitals nationally. Its involvement lends credibility and momentum to Imricor’s clinical program. As additional US sites prepare to join the VISABL-AFL trial, investors and industry watchers will be keen to monitor enrolment progress, regulatory milestones, and eventual commercial rollout.
While the announcement does not specify detailed timelines for FDA approval or commercial launch, the swift onboarding of UVA Health signals positive momentum. Imricor’s innovative approach to cardiac ablation could reshape treatment paradigms if clinical and regulatory hurdles are successfully navigated.
Bottom Line?
With UVA Health on board, Imricor accelerates its US trial momentum, setting the stage for critical regulatory and commercial milestones ahead.
Questions in the middle?
- Which additional US sites will join the VISABL-AFL trial, and on what timeline?
- How will patient enrolment rates at UVA Health impact overall trial progress?
- When can investors expect updates on FDA approval and potential commercial launch?
