Sensible Medical Innovations Receives CE Mark

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Commercial pilots in Europe will launch in collaboration with Boston Scientific Corporation

Sensible Medical Innovations (Sensible), the developer of a non-invasive thoracic fluid status monitor, today announced that it received CE mark for the ReDS™ Wearable System, intended for the measurement and monitoring of lung fluid by patients and healthcare professionals in hospital, clinic and home. The system will be introduced via commercial pilots in Europe together with Boston Scientific Corporation.

“We are excited to have the ReDS™ technology approved for use in Europe.” Said Amir Ronen, CEO of Sensible. “This innovative technology, which has the potential to improve the lives of millions, is now ready to be used in market by physicians and patients”

Commercial pilots will focus on heart failure patients in Europe. Heart failure, a global epidemic, impacts approximately 26 million patients worldwide and 10 million patients in Europe. The disease poses a significant cost to society with an estimated $40B spent of heart failure in the US alone. Readmissions account for a significant portion of these costs, once admitted to the hospital, 25% of heart failure patients will be readmitted within the first month and 50% within the first six months. Effective non-invasive lung fluid status management is expected to improve the quality of care while reducing the overall cost of care related to hospitalizations.

Professor John Cleland, Chair in Clinical Cardiology, National Heart & Lung Institute, Royal Brompton & Harefield Hospitals, Imperial College, London and a member of Sensible’s Physician Steering Committee, noted: “Worsening congestion is a key driver of hospital admission and mortality in patients with heart failure. Identifying and appropriately managing congestion is challenging. We look forward to seeing how treatment based on accurate lung fluid measurement may help keep patients safe at home and potentially reduce hospitalizations and perhaps even mortality”

The Sensible solution is designed to enable patients and physicians to monitor patients’ lung fluid more precisely than monitoring alternatives used today. In addition, the non-invasive, wearable device does not require patients to undergo the surgery required with invasive implantable hemodynamic monitors. Effective lung fluid status management is intended to improve the quality of care while reducing the overall cost related to hospitalizations.

“We are pleased to see this non-invasive lung fluid measurement device help us take care of heart failure patients in Europe.” said Professor Stefan Anker, President of the Heart Failure Association of the European Society of Cardiology and member of Sensible’s Physician Steering Committee. "We look forward to exploring how treatment based on ReDS™ may improve health outcomes"

About Sensible Medical Innovations
Sensible has developed a wearable thoracic fluid status monitor for non-invasive measurement and monitoring of Lung fluid, for patients with fluid management problems such as patients living with heart failure, taking diuretic medication or recovering from a coronary artery disease related event. The company, headquartered in Kfar Neter, Israel was founded in 2007, by Amir Ronen, Amir Saroka, Dan Rappaport, Nadav Mizrahi and Shlomi Bergida

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Yael Kwiat
Sensible Medical Innovations
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