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Report

Teaser, summary, work performed and final results

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

Teaser

Summary

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

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.

Final results

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.