Imricor receives ethics approval for VISABL-AFL clinical trial

Imricor Medical Systems, Inc. (ASX: $IMR) has received approval from the Ethics Committee at Lausanne University Hospital (CHUV) for the VISABL-AFL clinical trial. This approval marks the first step for CHUV to join the trial, with the final approval required from Swissmedic, the Competent Authority in Switzerland. VISABL-AFL is a global trial aimed at supporting US FDA approval of Imricor's products.

Executive Commentary on VISABL-AFL Clinical Trial Approval

We are one step closer to getting our FDA trial started at the CHUV. We expect enrolment of patients to commence shortly after Johns Hopkins begins their enrolment. Our clinical team's plans for executing an efficient multi-centre study for VISABL-AFL is on track, which means our FDA process and US launch are also on track.

Summary of Imricor's VISABL-AFL Clinical Trial Approval

Imricor (ASX: $IMR) has received ethics approval from the Ethics Committee at Lausanne University Hospital (CHUV) for the VISABL-AFL clinical trial, marking the first step for CHUV to join the trial. The final approval required is from Swissmedic, the Competent Authority in Switzerland. VISABL-AFL is a global trial aimed at supporting US FDA approval of Imricor's products. With CHUV expected to join Johns Hopkins as the second site to participate in the trial, and Amsterdam UMC and the Cardiovascular Institute of South Paris to follow, the Company anticipates completing the trial by year-end 2024. Imricor's Chair and CEO, Steve Wedan, expressed confidence in the progress, stating that the FDA process and US launch are on track. The Company's focus on executing an efficient multi-centre study for VISABL-AFL reflects its commitment to advancing its corporate strategy and achieving regulatory milestones.