First Patient Enrolled in the SMILE Study, Sensible Medical Innovation’s Randomized Controlled Trial (RCT) Designed to Measure ReDS™ Technology Impact on Heart Failure Rehospitalisations – Fluid Status Monitor
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 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 at Ohio State University in Columbus Ohio by Dr. Rami Kawash, site principal investigator.
“Based on our recent experience in the ReDS-HF 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”.
About Sensible Medical Innovations
Sensible Medical Innovations has set out to develop a new standard of care in lung fluid management. Sensible developed the ReDS™ medical radar technology that stems from defense “see through wall” application. The technology is well positioned to be a game changer in a wide range of applications and become the next generation monitoring and imaging modality.
Recently Sensible Medical Innovations received FDA 510(k) clearance for its non-invasive thoracic fluid status monitor. The Sensible product is intended for monitoring and management of patients with fluid management problems, including patients living with heart failure, patients taking diuretic medication or patients recovering from a coronary artery disease related event. It is intended to be used by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment.
1. Sensible Medical Innovations lung fluid status monitor allows reducing readmission rate of heart failure patients – a randomized controlled study
2 Evaluation of ReDS-guided patient management in ambulatory heart failure patients at-risk for rehospitalization, Abraham et al, HFSA Late Breaking Clinical Trials oral presentation HFSA 2015 – 19th Annual Scientific Meeting [https://www.hfsa.org/upcoming-meetings/19th-annual-scientific-meeting-september-26-29-2015 ]