Element Science acquired a CE mark in Europe and a green light in the U.K. for its patch-based cardioverter defibrillator, designed to provide an easier-to-wear device for people in danger of sudden cardiac arrest who may not be eligible for or don't want a long-term implant.
The low-profile Jewel patch aims to overcome the problems seen with traditional wearable cardioverter defibrillators, or WCDs, that feature typically bulky hardware, with straps around the back and waist plus a separate wired battery pack.
“The Jewel was developed to address the compliance issues of garment-based WCDs by focusing on user experience design and by incorporating advanced machine learning algorithms, both of which are approaches common in consumer wearables but relatively uncommon in medical device development,” Element Science President and CEO Uday Kumar said in a statement.
The company estimates that in Europe, out of the about 300,000 people who have a cardiac arrest outside the hospital setting each year, only 8% to 10% survive. A previous clinical trial in the Czech Republic included 16 patients who had a ventricular arrhythmia converted to a normal heart rhythm after a single shock.
A separate U.S. pivotal study, which followed 305 patients for up to six months, was presented last fall at the Annual Scientific Sessions of the American Heart Association. That trial showed a high rate of patient compliance, with people wearing the device for a median of over 23 hours per day, including during daily tasks such as showering.
The Jewel successfully converted eight potentially lethal cases of ventricular tachycardia or fibrillation in six patients, the company said. In addition, the study recorded a false alarm rate of 0.36 unnecessary shocks per 100 patient-months. Element announced its first save of the study, of a patient living in a rural area, in August 2022. The device is not yet approved in the U.S.
Element Science previously raised more than $145 million in a March 2020 series C, marking one of the largest medtech venture capital rounds of that year. At the time, the company said the proceeds would also support the development of similar wearables designed for inpatient settings and the remote diagnosis of heart conditions.
The financing was led by Deerfield Healthcare and Qiming Venture Partners USA, and joined by Cormorant Asset Management, Invus Opportunities and Google Ventures—as well as Third Rock Ventures, where Kumar formerly served as an entrepreneur-in-residence and helped to found the cardiac monitoring company iRhythm Technologies.