• Successful completion of Human Factors study across Imricor's full product portfolio
• Study involved 46 healthcare professionals from close to 20 U.S. hospitals
• Comprehensive risk documentation review and finalization of Instructions for Use (IFUs)

Imricor Medical Systems, Inc. (ASX: IMR) has announced the successful completion of its Human Factors (HF) study covering all of the company's devices currently under review by the U.S. Food and Drug Administration (FDA). The HF study is a critical step in the FDA approval process, ensuring that each device can be used safely and effectively by clinicians in real-world settings. Completion of this extensive study across Imricor's full product portfolio represents a major milestone in advancing toward FDA market approval. The study involved a 7-month usability study with 46 healthcare professionals, comprising 23 electrophysiologists and 23 EP nurses/technologists from hospitals across the U.S. Physicians from close to 20 U.S. hospitals participated in the study, which evaluated and successfully completed safety and usability testing for nine separate Imricor products. This is an extraordinary achievement, as most companies typically test only one or two devices. The comprehensive risk documentation review, improvements, and finalization of Instructions for Use (IFUs) are now complete. Imricor's Chair and CEO, Steve Wedan, commented that the scale of this study cannot be overstated, having taken the team over a year from planning through execution. Completing human factors testing across the entire product portfolio is a clear demonstration of the strength and dedication of the Imricor team and marks a major milestone on the path to FDA approval.