Submission of the Third PMA Module to the US FDA for Review

• Imricor submitted the third PMA module to the FDA
• Module 3 includes non-clinical bench test results
• Vision-MR Ablation Catheter 2.0, RF-5000 Generator, and Tubing Set included
• Module 4 will cover clinical data from the VISABL-AFL trial
• Aim to achieve FDA approval for iMR cardiac ablation therapy

Imricor Medical Systems, Inc. has submitted the third module of its four-module Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). The third module comprises non-clinical bench testing results for the Vision-MR Ablation Catheter 2.0, RF-5000 Ablation Generator, and RF-5000 Irrigation Tubing Set. These bench tests include product performance, sterile shelf life, packaging integrity, software testing, electrical safety, electromagnetic compatibility, magnetic resonance safety, and usability. The company is executing a modular review process with the FDA to achieve a more streamlined review process. Imricor's Chair and CEO, Steve Wedan, expressed that this submission represents years of design, manufacturing, and testing of the most sophisticated interventional MR tools in existence.