Imricor's VISABL-AFL trial receives final approval at ICPS

Imricor Medical Systems, Inc. (ASX: $IMR) has received the final approval from the French National Agency for Medicines and Health Products (ANSM) for the VISABL-AFL clinical trial to commence at the Cardiovascular Institute of South Paris (ICPS). This approval marks a significant milestone for Imricor as it paves the way for ICPS to join the trial, with installation planning already underway at the site and cases expected to commence during the current quarter.

Executive Commentary on VISABL-AFL Trial Approval

Imricor's Chair and CEO, Steve Wedan, expressed his satisfaction with the progress, stating, 'All the behind-the-scenes planning and execution by our world-class clinical team, led by Katherine Lindborg, is resulting in a rapid and steady stream of achievements that demonstrate the success of her team's work and the success of our execution toward FDA approval.'

Summary of Imricor's VISABL-AFL Trial Approval

The approval from the French Competent Authority for the VISABL-AFL clinical trial at ICPS signifies a significant step forward for Imricor's global trial to support US FDA approval of its products. With installation planning underway and cases expected to commence in the current quarter, Imricor is on track to complete all required procedures by year-end 2024. The company's Chair and CEO, Steve Wedan, highlighted the success of the clinical team's efforts and the progress towards FDA approval. This development underscores Imricor's commitment to advancing innovative MRI-compatible medical devices and its dedication to making a meaningful impact on patients, healthcare professionals, and healthcare facilities worldwide.