A new clinically proven and reliable medical solution for continuous heart arrhythmia and blood pressure monitoring

Project Information

CARDIACSENSE

Grant agreement ID: 836167

DOI

10.3030/836167

Project closed

EC signature date 7 December 2018

Start date 1 December 2018

End date 31 March 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

CARDIACSENSE
Israel

Periodic Reporting for period 1 - CARDIACSENSE (A new clinically proven and reliable medical solution for continuous heart arrhythmia and blood pressure monitoring)

Reporting period: 2018-12-01 to 2019-03-31

Summary of the context and overall objectives of the project

Almost 40% of adults suffer from hypertension (HTN) worldwide; a condition that can lead to heart attacks, ischemic heart disease and strokes. Likewise, 2,9% of the global population suffers from Atrial Fibrillation (AF), which may likewise lead to strokes, debility and death. It is estimated that the global extrapolated cost of AF is approximately €500 billion annually. Monitoring blood-pressure and heart-rate can cut the rate of heart-failure in patients by 33%. Monitoring is done on-site at clinics, placing a time and cost burden on these facilities that remote monitoring could prevent. Remote monitoring necessitates a clinical-grade monitoring system, however. CS Ltd has developed a clinically-proven, remote cardiac monitoring wearable that is comfortable, easy to use and allows long term continuous monitoring of all markers essential for management of conditions like AF and HTN. Worn as a watch that interacts with an app on the doctor’s and patient’s mobile phones, our technology is affordable and simple. It is the only technology capable of eliminating all movement artefacts, making it the most accurate method of heart-rhythm monitoring worldwide. Our device stands to save around €800M to EU healthcare and save up to 5000 lives yearly, by relieving the burden of monitoring visits and reducing the risk of heart attacks and strokes.

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

To date, CS Ltd has produced an alpha prototype of their innovation. During the study period, we refined the prototype and performed clinical trials, testing our device on a variety of skin-types and tissue depths and comparing it to the current predicate (ECG). These trials show sensitivity of 99% and false-detection-rate of below 1%. We have begun to establish links to distribution and production partners, refined our business plan, identified competitors and made a full risk analysis. We have performed a thorough FTO analysis and secured additional funding. We stand at TRL7.

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)

CS Ltd produce a clinical-grade wearable monitoring device (watch) based on PPG (photoplesythmography), a technique that monitors the fluid motion in patient blood-vessels by monitoring how visible (LED) light reflects from them. This is different to other clinical-grade monitoring devices, which are based on electrocardiogram (ECG/EKG) technology and must therefore be worn on the chest or implanted. Unlike “consumer grade” wearables and smartwatches (such as the Apple Watch), CardiacSense is a medical-grade wearable: it can provide continuous monitoring at the level of accuracy required for detecting arrythmias like AF. A major drawback to PPG is “motion artefacts” that happen when a wearer moves their hand. We are the only company worldwide to develop a PPG sensor that eliminates all motion artefacts. This makes us the only device with enough sensitivity to accurately signal the onset of heart arrhythmias (such as Atrial Fibrillation and Cardiac Arrest).

image-1.png