Imricor Medical Systems, Inc. (ASX: $IMR) has received the final approval from the Swiss Competent Authority for the VISABL-AFL clinical trial to commence at the Lausanne University Hospital (CHUV) in Lausanne, Switzerland. This approval marks a significant milestone in the company's execution of the trial and its efforts to open the US market for Imricor.
Imricor's Chair and CEO, Steve Wedan, stated, 'This is another major milestone in our execution of VISABL-AFL clinical trial and in the opening of the US market for Imricor. This marks the third site fully approved to commence the trial, and we are nearing the phase where patients are enrolled and treated. We are right on track with our plans and schedules.'
The approval from the Swiss Competent Authority for the VISABL-AFL clinical trial at Lausanne University Hospital signifies a significant step forward for Imricor's global trial to support FDA approval of its products in the United States. With the completion of construction of a cardiology-owned dedicated iCMR lab at CHUV, the company expects cases to commence during the current quarter. Imricor aims to complete all required procedures by year-end 2024, demonstrating its commitment to advancing its corporate strategy and expanding its market presence. The company's focus on increasing the success rates and reducing the overall costs of cardiac ablation procedures aligns with its goal to make a meaningful impact on patients, healthcare professionals, and healthcare facilities worldwide.