A disruptive life-saving solution for early detection of lung edema in heart failure patients

Project Information

EGM

Grant agreement ID: 855062

DOI

10.3030/855062

Project closed

EC signature date 31 January 2019

Start date 1 February 2019

End date 31 May 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

CARDIOSET MEDICAL LTD
Israel

Periodic Reporting for period 1 - EGM (A disruptive life-saving solution for early detection of lung edema in heart failure patients)

Reporting period: 2019-02-01 to 2019-05-31

Summary of the context and overall objectives of the project

Heart Failure (HF) is one of the main causes of mortality and morbidity globally, affecting around 26M people globally. Lung fluid congestion is one of the main clinical conditions related to HF and represents the leading cause of hospitalizations (90%) and death in HF patients. One-year mortality is estimated at 16,5% globally, and 30% in Europe. Lung fluid congestion leads to a vicious cycle of hospital readmissions of HF patients, with 1 in 4 patients readmitted to hospital within 30 days, and 1 in 2 patients readmitted within 6 months. The key challenge is to enable early detection and timely treatment of symptoms, before the patient undergoes respiratory distress (i.e. congestion in the lungs). CardioSet is introducing the Edema Guard Monitor (EGM), a non-invasive home monitoring system for lung congestion in heart failure (HF). EGM is the only non-invasive and easy to use home monitoring system which enables early and quick detection of lung fluid accumulation, days before visible clinical signs of lung congestion.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

CardioSet undertook a full analysis of both the technical and business potential of the EGM concluding that it will be highly valuable for the medical industry and specifically for cardiology. CardioSet defined the remaining activities to reach commercialisation including a large clinical study to demonstrate the safety and accuracy of EGM in reducing the hospital readmissions. CardioSet utilised the feasibility study to validate the regulatory pathway, and secure key medical and strategic partners to assist in the product development and later commercialisation. CardioSet also analysed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The expected outcome of the project is to successfully miniaturised a wearable device, scale-up production and validate the efficacy of EGM in a large clinical study in order to achieve the CE Marking for commercialisation in Europe. The EGM development will boost economic growth and create jobs within CardioSet, and have a wider impact on the European market.

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