May 23, 2023 05:18 PM Eastern Daylight Time--SAN FRANCISCO--Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients transitioning from hospital to home, announced the completion of enrollment in its Jewel IDE Study (NCT05201495). A case study was also presented at Heart Rhythm 2023 on May 21, 2023. Study results are expected in the fall of 2023. Data from the study will be submitted for U.S. regulatory approval of the Jewel P-WCD to protect patients at temporary elevated risk of sudden cardiac arrest (SCA).

“We are grateful to the study participants and clinical research professionals for their commitment and contributions to the Jewel IDE Study. Completing enrollment is an important milestone toward reaching our goal of changing the paradigm of treatment for cardiovascular patients so they can safely return to their normal daily lives without fear or discomfort,” said Zubin J. Eapen, MD, MHS, Element Science’s Chief Medical Officer.

The Jewel P-WCD is a low-profile wearable defibrillator designed to detect and treat life-threatening arrhythmias in patients with a high temporary risk for SCA, a condition that affects more than 500,000 patients in the US annually. The device continuously monitors the patient’s heart and treats specific life-threatening rhythms. It is designed for continued protection during normal daily activities, including showering, sleeping, and moderate exercise. The Jewel Mobile App, as demonstrated by the case presented at Heart Rhythm 2023, enables timely patient care by transmitting therapy information to the patient’s medical team in near real-time.

Early results have shown the promise of the Jewel P-WCD’s therapeutic benefit as numerous patients have been successfully rescued from SCA. The Jewel P-WCD successfully recognized lethal arrhythmias and restored a normal heart rhythm after a single therapeutic shock. With the ability for 24/7 wear-time, including during regular daily activities like showering and exercise, compliance has been very high such that there have been no deaths in study for any reason, and none due to missed lethal arrhythmias.

A patient case from the Jewel IDE Study presented at Heart Rhythm 2023 demonstrated the benefits of the Jewel P-WCD and Mobile App. The Jewel P-WCD was able to successfully recognize and convert a patient’s lethal rhythm shortly after onset and the Jewel Mobile App provided emergency team caregivers access to important diagnostic information in near real-time to support rapid and accurate patient triage upon arrival at the emergency department. (PO-05-154 Aasbo, Johan D. et al. Heart Rhythm, Volume 20, Issue 5, S695 - S696)

“As a high-volume prescriber, I am excited that this case was presented as it highlights many of the key features of the Jewel P-WCD that distinguish it from other WCDs. Given the high compliance rate and the successful saves we have seen in our patient population, I believe this device has the potential to significantly benefit patients and become a first-line therapy to help manage high-risk cardiac patients who need protection from SCA while awaiting implantation of an ICD (implantable cardioverter defibrillator) or as a bridge to getting better,” said Dr. Gery Tomassoni, a Principal Investigator in the study and co-author on the case presented at Heart Rhythm 2023.

“We are delighted to have partnered with leading physicians across the country to conduct this study to demonstrate the safety and effectiveness of the Jewel P-WCD and its usefulness in bridging patients to important decision points in their lives,” said Uday N. Kumar, MD, Founder, President and CEO. “By truly continuously protecting patients from SCA, the Jewel P-WCD is enabling patients, their families, and their physicians to have the time they need to engage in meaningful discussions about the optimal long-term care pathway best for them. Everyone at Element Science is grateful to be able to play a role in improving the overall patient care journey for these patients.”

Jewel IDE Study

The Jewel IDE Study (NCT05201495), which recently completed the enrollment phase, was designed to evaluate the safety and effectiveness of the Jewel P-WCD to monitor heart rhythms and treat subjects with defibrillation as needed.

The Jewel P-WCD is an investigational device and limited by U.S. law to investigational use only. It is not available for sale.

About Element Science, Inc.

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the U.S. with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Management, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities. For more information, please visit www.elementscience.com.