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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ReDS (A disruptive, life-saving solution for home monitoring and management of lung fluid congestion in heart failure patients)

Teaser

Summary

Congestive heart failure (CHF), often referred to simply as â€œheart failure,â€ is a chronic progressive condition that specifically refers to the stage in which fluid builds up around the heart and causes it to pump inefficiently. Heart failure (HF) is one of the main causes of mortality and hospitalization worldwide, affecting approximately 26M people globally and 15M people in Europe. Pulmonary edema also known as lung fluid congestion is one of the main clinical conditions associated with HF, leading to hospitalization and high mortality rates. The median survival after its onset is approximately 5 years. One-year mortality is estimated at 16.5% globallyand 9.3% in Europe. Lung fluid congestion leads to a vicious cycle of repeated hospitalizations of HF patients, with 24% of patients readmitted to hospital within 30 days and 50% of patients readmitted within 6 months. The key challenge is to enable early detection and timely treatment of symptoms, before the patient undergoes respiratory distress leading to hospitalization. ReDSâ„¢ is a groundbreaking non-invasive home monitoring system for accurate, actionable and absolute measurement of lung fluid content. The monitoring procedure takes only 90 seconds and the results are shared automatically with the healthcare professionals through cloud based deterioration prediction platform. ReDSâ„¢ uses unique radar technology, and is the first solution that enables accurate measurement, remote monitoring and management of fluid congestion in HF patients. Crucially, ReDSâ„¢ provides early, pre-symptomatic detection of lung fluid accumulation allowing preventative measures to be taken. The overall objective is to commercialize ReDS in the European market and beyond for patient home monitoring, substantially reducing readmissions to hospital for HF patients.

Work performed

Sensible Medical reviewed the current stage of development and produced a detailed product development plan for the next 2 years. The technical feasibility of this plan was assessed and the resources required were calculated. Sensible Medical assessed, contacted and secured the necessary external partners to execute the proposed innovation project. Sensible Medical also performed a full economic assessment of the home monitoring system, including market analysis, competitor analysis, FTO search, and calculated financial projections for the next 5 years. It was determined that the project is both technically and economically feasible and would deliver a strong return on investment.

Final results

ReDSâ„¢ uses radar technology to introduce a new paradigm in lung fluid measurement for Heart Failure patients. The technology provides accurate, absolute, actionable lung fluid measurement for heart failure patients and clinical trials performed to date in the setting of home monitoring have demonstrated an almost 60% reduction in hospital readmission rates among the trial population. This would translate to huge savings for healthcare systems worldwide and a significant improvement in patient outcomes/Quality of Life when fully commercialized. The next steps in the project include further upgrades to hardware and software, manufacturing considerations and further validation activities.