SAN FRANCISCO--(BUSINESS WIRE)--Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, today announced the successful completion and presentation of the results of the Jewel IDE Study. This study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD), which enrolled 305 patients, marks a significant milestone in the field of sudden cardiac arrest (SCA) protection.
While wearable cardioverter defibrillators (WCDs) have shown promise in preventing SCA, a leading cause of death in the United States, challenges related to patient comfort and compliance have limited their widespread adoption resulting in potentially avoidable deaths.
The Jewel P-WCD was developed with the patient experience in mind. This innovative device boasts a low-profile, lightweight design and is water-resistant, allowing patients to comfortably wear it during their daily activities, including showering and exercise. Powered by a proprietary machine learning algorithm, the Jewel P-WCD also accurately detects abnormal heart rhythms resulting in a low false alarm rate and timely defibrillation when needed.
Dr. Uday N. Kumar, Founder, President & CEO of Element Science stated, "From the outset, our goal has been to improve the outcomes of patients who have a temporary risk of experiencing sudden cardiac arrest by creating a solution based of the realities of patients’ lives. The findings from the study demonstrate that a diverse group of patients, from a wide variety of geographies and climates, can achieve high wear-time compliance with the Jewel P-WCD, translating into extended protection from SCA and the best opportunity for a favorable outcome in their daily lives."
Key Findings from the Clinical Study
The recently completed Jewel IDE Study, presented by Dr. John Hummel as a Featured Science presentation at the American Heart Association’s 2023 Annual Scientific Sessions (AHA ’23) in Philadelphia, PA on November 13th, 2023, demonstrated the safety and efficacy of the Jewel P-WCD:
- No Deaths or Serious Adverse Events Related to the Device.
- High Compliance and Protected Time: Patients wearing the Jewel P-WCD achieved a median wear-time of over 23 hours per day, showcasing its ease of use and integration into daily life.
- High Number of Successful VT/VF Conversions: The Jewel P-WCD successfully converted 8 separate ventricular tachycardia or ventricular fibrillation events in 6 patients, resulting in all being successfully saved.
- Low False Alarms and Inappropriate Shock Rates: There was a low false alarm rate and a very low inappropriate shock rate of just 0.36 shocks per 100 patient-months, providing patients with peace of mind and reducing the inconvenience associated with false alarms.
Dr. John Hummel, one of the study National Principal Investigators and the presenter of the study results at AHA ’23 stated, “The results of the Jewel IDE Study are extremely encouraging. No currently available technology appears to provide the level of protection and compliance we saw in this study, indicating the true value of patient-centric innovation for those at risk of sudden cardiac arrest.”
What This Means for Healthcare Providers and Patients
Healthcare providers now have access to the Jewel P-WCD, an innovative solution for patients at temporary risk of SCA who may not be eligible or who decline to receive an Implantable Cardioverter Defibrillator (ICD). In these cases, WCDs can be used to provide protection until a patient is no longer at risk or an ICD can be implanted. Guidelines recommend WCD use in patients at risk of SCA when clinical improvement is anticipated or if a temporary contraindication to ICD exists. With the availability of the Jewel P-WCD, which has now been shown to result in high compliance leading to more continuous protection time, physicians can provide the highest standard of care to their patients.
By integrating seamlessly into their daily routines, including during showering, the Jewel P-WCD allows patients to benefit from near continuous protection from SCA, without an impact on their quality of life. This is in contrast traditional WCDs which have lower patient compliance due to patient discomfort and the need for frequent removal, which leaves patients unprotected and has resulted in avoidable arrhythmic deaths.
Dr. Zubin Eapen, Element Science’s Chief Medical Officer, said, "Patients with significant heart disease face an alarming frequency of out-of-hospital cardiac arrest. Element Science has concentrated its efforts on enhancing these patients' survival prospects by utilizing advancements in technology that bolster home-based care. Seeing the Jewel platform achieve this critical milestone is indeed thrilling. Element Science is committed to advancing cardiovascular care through innovation, and the Jewel P-WCD is a testament to this commitment.”
His sentiments were echoed by Dr. Robert Harrington of the Weill Cornell School of Medicine, who said, “After experiencing an out-of-hospital cardiac arrest, survival to hospital discharge is less than 10%. As a cardiologist, it has been my focus to drive impactful solutions to this problem. Element Science has the same goal. The results from this study are very promising, and I am looking forward to seeing the Jewel used to protect more patients from these very adverse outcomes.”
About the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
The Jewel P-WCD is a low-profile wearable defibrillator designed to detect and treat life-threatening arrhythmias in patients with a temporarily elevated risk for SCA. 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 enables timely patient care by transmitting therapy information to the patient’s medical team in near real-time.
The Jewel P-WCD is an investigational device and is limited by U.S. law to investigational use only. It is not available for sale.
About the Jewel IDE Study
The Jewel IDE Study (NCT05201495) was a multicenter, prospective, single-arm study that enrolled 305 patients for up to 180 days. The study objective was to evaluate the safety and effectiveness of the Jewel P-WCD in patients at high risk for sudden cardiac arrest. Endpoints included: patient compliance / wear-time, number of patient saves / conversions, arrhythmia detection, therapy effectiveness, inappropriate shock rate, and cutaneous adverse device effects.
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 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.
LEARN ABOUT THE STUDY: www.ElementScience.com/ide-study/
LEARN MORE ABOUT ELEMENT SCIENCE: https://elementscience.com/company