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CardioSignal – Breakthrough apps to detect cardiac conditions to prevent stroke and heart attacks

Periodic Reporting for period 1 - CARDIOSIGNAL (CardioSignal – Breakthrough apps to detect cardiac conditions to prevent stroke and heart attacks)

Reporting period: 2020-06-01 to 2021-05-31

Heart and cardiovascular diseases - such as atrial fibrillation (AFib), heart failure (HF) and coronary artery disease (CAD) and subsequent heart attack - are the most common causes of death in Europe, accounting for 3.9 million fatalities, and €210 billion in health costs per year.

Early identification and treatment of AFib, HF and CAD would help prevent strokes and heart attacks, and improve outcomes for individuals and society. This is currently hindered by several key problems:

(1) Hard to Detect: Heart conditions are dangerously asymptomatic: for example 2/3 of all AFib cases present no perceivable symptoms. For 30% of CAD patients, the first symptom is a heart attack. Up to 90% of HF patients can’t identify the symptoms. For
at-risk individuals, regular monitoring and detection would enable early treatment and save lives.

(2) Expensive Equipment: Cardiologists now diagnose heart conditions using electrocardiography (ECG) and computed tomography angiography (CTA). These expensive processes require professional operation in clinics. Other health gadgets require purchasing additional hardware to use in conjunction with a smartphone, which can be costly. Therefore with current solutions regular monitoring of large numbers of patients is not scalable.

(3) Patient Confusion: Patient delay is a major cause of mortality from heart attacks. Unaware of the severity, patients are often reluctant to seek help. Others are over-precautious burdening doctors with unnecessary screenings. Early detection and at-home follow-up would cut costs and save lives.

CardioSignal, the smartphone application by Precordior, acts as a measurement device that records heart movement using the built-in motion sensors. The sensor data is sent for analysis to the CardioSignal cloud service. This enables scalable technology with virtually infinite possibilities to introduce cardiac detection and monitoring capabilities for any telehealth, digital therapy, and self-monitoring solutions in the future – a true point-of-care solution in heart diseases.

Precordior’s mobile application CardioSignal already has the detection capability for the most common cardiac arrhythmia, atrial fibrillation (AFib), and is a certified CE Class IIa medical device. Up to ¼ of the population will suffer from AFib during their lifetime, and it’s the single most important cause for strokes. The detection of AFib with CardioSignal is in the core of Precordior’s mission – Your Life, Our Priority. In this EU-funded project, Precordior will bring new detection capabilities to the market for increased heart health: the detection of Heart Failure and the detection of Coronary Artery Disease, using the same measurement method with a simple smartphone and its built-in motion sensors. The market entry for these revolutionizing new capabilities will take place in 2022.
The project has been structured into four work packages (WPs). The progress in each WP is described briefly below:
WP1 - Technical Development: Work to expand technical capacity of CardioSignal for detection of CAD & monitoring HF to TRL 8
- Mobile app & cloud service infrastructure have been under development.
- Measurement data gathered from clinical studies has been analysed.
- Algorithms for detection of CAD and HF have been under development.
- Quality Control system has been developed.
- Main WP results to date: D1.3 Dataset for CAD & HF, D1.5 Web & EHR Portal Codebase.
WP2 - Clinical Validation: Trials to verify the efficacy and safety of developed modules for detection of CAD and monitoring HF.
- Clinical studies have been prepared and in part carried out for CAD and HF patients.
- Main WP results to date: D2.1 Clinical Study Plan.
WP3 - Business Development: Research & partnership to prepare for commercialisation of HF & CAD.
- Several negotiations have been ongoing with 3rd parties regarding go-to-market after project ends.
- Marketing infrastructure has been under development in preparation for commercial product launch.
- Brand identity has been under development.
- Main WP results to date: D3.4 Brand Identity Kit.
WP4 - Project Management: All project administration and controlling tasks.
- Day-tp-day project administration and finances have been managed.
- Deliverables and due dates have been followed and ensured timely delivery.
- Main WP results to date: D4.1 Project Management Plan, D4.2 Interim Project and Financial Report
WP5 Deliverables (requirements by the EC)
- D5.1 H - Requirement No. 2 and D5.2 POPD - Requirement No. 4 have been submitted.
Progress beyond stae-of-the-art:

Gyrocardiography (GCG) is a new patented method for heart monitoring. GCG measures micro-motions of the chest using the accelerometer and gyroscope in a smartphone. It measures heart angular velocity and acceleration according to six parameters. This directly indicates heart function, and is therefore highly accurate. Results of patient readings are compared algorithmically with a database of known cardiac patterns to identify abnormalities. Currently Cardiosignal has a database and module for AFib. It is now developing its HF and CAD databases and modules. This will push it ahead of all competing methods in terms of scope, functionality and accuracy.

Impacts:
- CardioSignal is entering the large and growing market for mobile health (mHealth) products and services. The global mHealth market has been valued at €37.6 ($42.5) billion in 2019, and is expected to grow to €90.5 ($102.4) billion by 2022.6 Of this, monitoring services make up 34.5%.
- The mHealth market for cardiovascular detection is approximately one quarter of the total market, and is estimated at €9.1 billion in 2019 and expected to grow to €22.0 billion by 2022.
- The serviceable addressable mHealth market in the cardiovascular area is estimated at €6.4 billion in 2019 and is expected to grow to €15.3 billion in 2022. This covers the in 69 nations considered high or very high in the UN/World Bank human development index.
- By 2025 CardioSignal will be used CAD and HF patients in major global economies and by 2030 worldwide.

Socio-economic impact and the wider societal implications of the project so far:
- N/A as the products have not yet been launched.
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