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Acorai Heart Monitor - Non-invasive multi-sensor device for heart failure monitoring

Project description

Non-invasive heart failure monitoring

Heart failure (HF) is a highly prevalent and costly condition with poor prognosis, threatening the lives of more than 60 million individuals worldwide. Funded by the European Innovation Council, the AHM project aims to overcome the challenges associated with current invasive tools by enabling non-invasive monitoring through a handheld device with an innovative sensor system. The project employs machine learning to process sensor data and provides intracardiac pressure information to healthcare professionals, helping guide HF treatment. The device has already been validated in a Swedish study, offering a breakthrough in HF management. Through AHM it seeks to enable final market validation, regulatory approval and market entry support to improve patient prognosis globally.

Objective

Heart Failure is a progressive clinical syndrome with multiple etiologies. It is associated with nearly three million hospitalizations in the EU annually, representing 30% of all readmissions, and accounts for up to 5% of the entire healthcare expenditure. Despite modern medical treatment, HF is a life-threatening and debilitating condition with a poor prognosis.

The Acorai Heart Monitor (AHM) is a monitoring device designed to detect and estimate hemodynamic parameters non-invasively. AHM is a handheld electronic device that features multiple sensors to collect data from 4 sensor types based upon patented the SAVE sensor system to estimate the absolute pressure of the heart failure patient's cardiac system. The sensor data are processed within the medical device with machine learning (ML) methods, the results are then displayed to be read by a qualified healthcare professional (HCP).

Delivering Intracardiac pressure to HCPs to guide the treatment of patients with HF leads to improved quality of life. It lowers the frequency of hospital admissions, yet all current tools require an invasive procedure. AHM is a multi-patient non-invasive device that would dramatically disrupt the paradigm of HF treatment and lead to significant cost saving in the EU whilst improving the overall prognosis of patients who suffers from HF. With the growing prevalence of HF globally the AHM is a tool with applicability in multiple workflows and represents a first-of-its-kind device to revolutionise HF management.

AHM has already been validated in 300 patients in a Swedish proof of concept study and now needs the support to bring this device to market and collect data via a large multi-national study to prove its effectiveness. The AHM is fully patent protected with three granted patent families and four patents pending covering the core components of the device and its clinical application. This is additionally protected by large proprietary datasets and a unique ML model.

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Coordinator

ACORAI AB
Net EU contribution
€ 2 299 633,00
Address
REDAREGATAN 48
252 36 Domsten
Sweden

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Södra Sverige Sydsverige Skåne län
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 3 358 822,91