RealWorld4Clinic creates device connected by artificial intelligence (AI) to enhance patient care.

Heart failure is responsible for five per cent of emergency hospital stays and two per cent of national health expenditure within Europe¹ – figures that are unacceptably high.

The difficulty is that developing a new cardiac drug from idea to market costs up to €1.5 billion and takes approximately 15 years – and a high proportion of new drugs are unsuccessful. This lack of drugs to address heart failure threatens citizens’ lives, generates significant costs and increases unrealistic expectations from patients, healthcare providers and payers.

Meanwhile it’s widely accepted that real-world data is vital for diagnosing heart failure early. Yet clinical research and heart failure management still buy in data, limiting the predictive power of clinical trials.

Inspired by consumer wearable devices, RealWorld4Clinic, set about creating a wearable that could collect data suitable for drug approval trials and guide interventions in heart failure management.

The coin-sized device transforming heart research

RealWorld4Clinic has created MyHeartSentinel, a medical device that dovetails greater patient data, clinical research and clinical care.

Anchored to the fundus of the stomach in immediate proximity to the heart and the lung, the device gathers continuous real-world data about the state of the patient’s cardio-respiratory health. AI then makes sense of the data to aid drug development and telecardiology.

RealWorld4Clinic aims to enhance the quality of early decision-making by pharmaceutical companies on clinical development programmes. It’s estimated that this device could help to improve the predictive ability of clinical trials by 50%.

Big ambitions to move from reactive to proactive heart health

MyHeartSentinel is just the beginning. Supported by EIT Health, the RealWorld4Clinic consortium is committed to transforming the standard of care from reactive to proactive heart health management. By diagnosing heart failure aggravation from 30 days before an emergency event occurs, RealWorld4Clinic will halve the number of days patients spend in a hospital, while reducing hospital costs.

In addition to co-creating the wearable MyHeartSentinel product, EIT Health will help resolve the ethical, legal and social issues involved with buying and using AI to maximise heart health data.

Looking forward, EIT Health will help RealWorld4Clinic navigate the process to gain the certification mark application for MyHeartSentinel and prepare to scale up the business for drug  development for the outpatient heart care market.

External partners

• aQua Institute
• CHU Rennes
• LINQ
• SurgiQual Institute
• Zana Technologies
• PrYv

Linked Third Parties

• CHUGA
• Profil Mainz

Notes

[1] The Heart Failure Policy Network: A policy brief on heart failure in Europe, March 2015: http://www.healthpolicypartnership.com/wp-content/uploads/HFPN-Policy-Backgrounder-March2015-FINAL-EXTERNAL1.pdf (accessed March 2020)