Sensible Medical Innovations Release: ReDS HF Study Demonstrating Benefits Of ReDS Guided Patient Management Presented At HFSA Conference


Today at the 19th Annual Heart Failure Society of America Meeting, during the Heart Failure Trials: The Year in Review Session, Dr. William T. Abraham, Director of Cardiovascular Medicine at The Ohio State University Wexner Medical Center presented final results from the ReDS™ HF Study (Evaluation of ReDS Guided Patient Management in Ambulatory Heart Failure Patients At Risk for Re Hospitalization).

The study assessed the feasibility and safety of heart failure management guided by ReDS system as an adjunct to standard of care in 50 outpatients for 90 days following discharge from index ADHF hospitalization. The number of readmissions during the ReDS guided management was compared to 3 month pre-ReDS period and 3 months post-ReDS period. The study was conducted in 3 centers in Israel.

The results from this multi-center, prospective, single-armed, interventional study indicate that ReDS guided management decreased the amount of hospitalizations by 87% compared to the 3 month prior to the index admission (pre-ReDS). No device related adverse events were noted.

Comparison between the periods was performed by calculating the Hazard Ratio (HR) between the different periods using Andersen-Gill model. The HR between the pre-ReDS™ period and the ReDS guided management period was 0.07, 95% CI [0.01-0.54], P=0.01. The HR between the ReDS guided management period and the post-ReDS™ period was 0.11, 95% CI [0.14-0.88], P=0.037. This represents 14 times and 9 times more risk for readmission event in the pre-ReDS period and in the post-ReDS period than during ReDS guided management period, respectively.

The SensiVest™, powered by ReDS technology (developed by Sensible Medical Innovations Ltd.) is based on medical radar technology. The proprietary technology allows a direct and actionable lung fluid measurement. Results from measurement may be automatically uploaded to a secure cloud application for a healthcare professional to review and act upon, based on his discretion.

The current findings from the ReDS HF study suggest that ReDS guided management reduces HF readmissions in patients recently discharged following ADHF hospitalization. The results also demonstrate that remote pulmonary fluid assessment with ReDS technology is feasible and may aid in optimizing treatment of patients recently discharged after ADHF hospitalization. The follow on study to the ReDS study is the SMILE randomized control trial currently recruiting patients in select centers in the US. The SMILE study is designed to measure the readmission reduction effect in US HF patients and the health economics impact of ReDS based remote patient monitoring.

“By providing a quantitative and actionable measurement of lung fluid content, ReDS enables a proactive approach to heart failure management that promises to keep the most vulnerable heart failure patients well and out of the hospital,” said William T. Abraham, MD, Director of Cardiovascular Medicine at The Ohio State University Wexner Medical Center “The data from the current trial support this benefit and will be further explored in the ongoing SMILE trial.”

HEART FAILURE

Lung fluid management problems, including heart failure (HF), are a leading cause for hospital admissions for the elderly. Millions of patients suffering from fluid management problems are repeatedly admitted to the hospital due to recurring symptoms, resulting in one of the top expenditure items for hospitals and the US healthcare system altogether. Unfortunately, healthcare professionals have very limited tools to evaluate the status of lung congestion to assist in management. The Sensible non-invasive solution is designed to enable patients and healthcare professionals to monitor patients’ lung fluid directly and in a non-invasive manner.

ABOUT THE COMPANY

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. In a pilot study, ReDS-guided HF management significantly reduced the number of HF re-hospitalizations.[1]

Sensible was founded in 2007 by Amir Ronen, Amir Saroka, Dan Rappaport, Nadav Mizrahi and Shlomi Bergida. Its headquarters are located in Israel with commercial offices in the US.

(1) Evaluation of ReDS-guided patient management in ambulatory heart failure patients at-risk for rehospitalization. Abraham et al. ESC-HF Late Breaking Clinical Trials oral presentation. ESC HF 2015 – 2nd World Congress on Acute Heart Failure.