Element Science's Wearable Defibrillator Patch Secures FDA Approval

Element Science has achieved a significant milestone with the FDA approval of its Jewel wearable cardioverter defibrillator (WCD) system. This innovative device offers a non-invasive solution for patients at temporarily elevated risk of sudden cardiac arrest, including those recovering from heart attacks or with significant cardiovascular disease.

A Seamless Integration of Life-Saving Technology

The Jewel WCD system boasts a low-profile, water-resistant design that allows patients to wear it during sleep and showers. The device consists of a reusable defibrillator unit and battery pack, complemented by two single-use electrode skin patches that require weekly replacement.

Uday Kumar, President and CEO of Element Science, emphasized the device's potential impact: "The Jewel Patch-WCD is the culmination of a vision to give patients a life-saving device that seamlessly integrates into their daily lives. FDA approval represents more than a regulatory milestone; it's a leap forward in how we, as clinicians, think about using cutting-edge therapeutic technology to empower patients to live their fullest lives, even when at risk of sudden cardiac arrest."

Robust Clinical Data Supporting Efficacy

Element Science's FDA approval follows successful market entry in the UK and Europe in early 2024. The company's U.S. pivotal trial, involving approximately 300 participants, demonstrated impressive results:

• Median wear-time exceeded 23 hours per day
• Successfully detected and delivered corrective shocks in eight separate cases of ventricular tachycardia or fibrillation among six patients
• All potentially dangerous heart rhythms were converted with the first shock
• No deaths or serious complications were observed during the study

The trial data, published in the Journal of the American College of Cardiology, also reported a low rate of false-positive alerts, with 0.357 inappropriate shocks per 100 patient-months.

Funding and Future Prospects

Element Science's journey to FDA approval has been supported by significant venture capital funding. In March 2020, the San Francisco-based company raised $145 million in a Series C round led by Deerfield Healthcare and Qiming Venture Partners USA. Other notable investors included Cormorant Asset Management, Invus Opportunities, Third Rock Ventures, and Google Ventures.

With FDA approval secured, Element Science is poised to expand its market presence and potentially revolutionize cardiac care for at-risk patients. The Jewel WCD system represents a significant advancement in wearable medical technology, offering a balance of efficacy, comfort, and seamless integration into patients' daily lives.