First Patient Enrolled in the SMILE Study, Sensible Medical Innovation's Randomized Controlled Trial (RCT) Designed to Measure ReDS™ Technology Impact on Heart Failure Rehospitalizations

Sensible Medical Innovations, focused on the commercialization of a non-invasive thoracic fluid status monitor based on ReDS™ medical radar technology, today announced enrollment of the first patient in the SMILE^[1]study. SMILE is designed as a prospective, randomized, controlled, multi-center trial and is expected to enroll approximately 380 patients in 35 centers in the US. Its primary efficacy endpoint is the rate of recurrent Heart Failure re-hospitalization during the entire follow-up period of ReDS-guided fluid management. Additional endpoints include clinical outcomes and healthcare economics assessment. The first patient was enrolled atOhio State University in Columbus Ohio by Dr. Rami Kawash, site principal investigator.

"Based on our recent experience in the ReDS-HF^[2] study we believe that ReDS-guided Heart Failure management is likely to succeed. It provides an accurate, absolute, and actionable measurement of lung fluid content" said Dr. William T. Abraham, Director of Cardiovascular Medicine at The Ohio State University Wexner Medical Center and overall principal investigator of the SMILE trial. "Given the very high rate of hospital readmission associated with Heart Failure, there is a critical need for this type of technology in clinical practice. The SMILE trial has the potential to establish ReDS-guided HF management as a standard of care for recently hospitalized Heart Failure patients."

"The SMILE study is the first Randomized Control Trial (RCT) with a non-invasive lung fluid monitoring and remote management technology. It was carefully designed to leverage the cumulative experience of other large scale HF trials of implantable devices while introducing a few substantial improvements that we were able to implement due to the non-invasive nature of the ReDS technology" said Dr. Ronnie Abbo, VP Clinical Affairs at Sensible Medical Innovations. "For example, patients are recruited during the index acute hospitalization and are immediately monitored during their most vulnerable period; there is no need to wait until patients are clinically stable and fit for an implantation".

"Today we begin the SMILE study at Ohio State's Richard M. Ross Heart Hospital, one of the nation's leading heart hospitals" said Amir Ronen, CEO of Sensible Medical Innovations. "We are experiencing a genuine excitement among HF physicians, nurses and hospital administrators in anticipation of this important study. This study will prove that our non-invasive solution for HF management can help millions of patients around the world and save billions of dollars to the healthcare system".

Source: Sensible Medical Innovations