Periodic Reporting for period 1 - NIRT MONITOR (ACCURATE EASY-TO-USE AND NON-INVASIVE DEVICE FOR EARLY DETECTION AND MONITORING OF HEART FAILURE IN REAL TIME)
Reporting period: 2019-08-01 to 2019-11-30
Heart failure (HF), defined as the heart’s inability to efficiently pump blood to the body and maintain blood flow, is a common, costly, and potentially fatal condition affecting more than 37.7 million people worldwide. The global economic burden of HF is estimated at €98 billons per annum, with €59 billons attributed to direct and €39 billons to indirect costs. Although heart failure is a serious condition, safe and effective treatments are available, therefore early diagnosis is crucial to improve patient’s condition. Nevertheless, to date, there is no reliable, non-invasive method to diagnose and monitor HF in real-time, leading to: 1) misdiagnosis of first time events in one out of four patients; 2) longer hospitalizations; and 3) lack of monitoring possibilities at the home care and out-patient settings causing high rate of re-hospitalisations (up to 80%); which reduce survival chances, worsen the standard of living of the patients, and cause HF to be one of the leading medical expenses. NIRT monitor is a unique non-invasive device designed for early detection and monitoring of HF in real-time. The objective of the project was to assess its technical, commercial and financial feasibility.
The feasibility study has shown positive results, proving NIRT monitor is:
- Technologically feasible: It is possible to achieve a manufacturing cost reduction of 75%. A phase 2 project addressing technical improvements as well as clinical validation and regulatory roadmap have been defined to reach the market successfully.
- Commercially feasible: NIRT monitor targets the attractive Cardiac Monitoring and Cardiac Rhythm management market ($20.85b in 2017; CAGR: 3.9% 2017- 2022). NIRT monitor’s business plan has been developed to ensure a successful market entry by Q1 2023.
- Economically feasible: The financial requirements for NIRT monitor commercialisation have been estimated and sales forecast update demonstrating the scalability of the project and the company growth.
- Technologically feasible: It is possible to achieve a manufacturing cost reduction of 75%. A phase 2 project addressing technical improvements as well as clinical validation and regulatory roadmap have been defined to reach the market successfully.
- Commercially feasible: NIRT monitor targets the attractive Cardiac Monitoring and Cardiac Rhythm management market ($20.85b in 2017; CAGR: 3.9% 2017- 2022). NIRT monitor’s business plan has been developed to ensure a successful market entry by Q1 2023.
- Economically feasible: The financial requirements for NIRT monitor commercialisation have been estimated and sales forecast update demonstrating the scalability of the project and the company growth.
As today, NIRT monitor, is the only solution capable to detect changes in Left Ventricular End Diastolic Pressure, along with other vital hemodynamic indices, allowing to accurately determine the exact type and severity of heart failure, in an easy-to-use, non-invasive way, at point of care and in real-time. It provides the alternative to invasive methods that cardiologists have been seeking for years to support their decision making and adjust the correct treatment, improving HF patients’ quality of life and their life expectancy. Its use will lead to improved HF management, and reduced hospitalizations frequency and length.