CardiacSense develops wearable equipment (watches, bracelets, patches, etc.) which includes a number of highly advanced state of the art sensors, based on the illumination the body, processing the returns, and analysis using a unique algorithm developed in the company
The company development is focused on a clinically-proven medical solution that delivers reliable cardiac and blood pressure monitoring, 24/365, for as long as needed.
In June 2017 Merchavia invested $0.5 million in the company according to company value of $6 million.
The last financing round was completed in April 2019 at a company value of $20 million. Currently Merchavia holds approximately 6% on a fully diluted basis.
Atrial Fibrillation (A-Fib) is the most common heart arrhythmia disorder and a major cause of strokes (x5) and mortality (x2). It is estimated that 1 out of 3 patients is un-diagnosed. The only continues solution in the market for detecting A-Fib is invasive. A-Fib US annual cost is 26B$, 35B$ in China and 30B$ in Europe.
Global blood pressure monitoring devices market was valued at 2.08B$ in 2014 and is expected to grow at CAGR of over 11.0% over the forecast period. No solution for continues, cuff-less, non-invasive blood pressure monitor.
Sudden Cardiac Arrest is the largest cause of natural death in the U.S., causing about 325,000 adult deaths in the U.S. each year. Mortality rate from CA is 90%. There is no solution in the market today for continues (24/7) detection of Cardiac Arrest that doesn’t interfere with day to day life. The total aggregate cost of Out of Hospital CA in the United States was $33 billion each year (Kida et al., 2014).
A preliminary clinical trial conducted in March 2019, which included 24 subjects, compared heart rate indices obtained using Holter monitor (a time-limited method of measuring heart rhythm disorders), and heart rate indices obtained using the CardiacSense watch. The trial objective was to achieve an accuracy of 96%, and the results demonstrated an accuracy of 99%.
Upon completion of this preliminary trial with 24 subjects, CardiacSense intends to launch in April 2019 an expanded trial at Ichilov Hospital, Rambam Medical Center, Tel Hashomer Medical Center, and the Cleveland Clinic, in accordance with FDA requirements, subject to obtainment of final approvals. The extended trial is expected to last about 5 months, and will include about 100 subjects.