SAN FRANCISCO–(BUSINESS WIRE)–Element Science, an innovative health technology company pioneering a next-generation digital wearable platform for high-risk cardiovascular patients transitioning from hospital to home, today announced the first patient save from a successful defibrillation early in the enrollment of the Investigational Device Exception (IDE) Study of its 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 high temporary risk for Sudden Cardiac Arrest (SCA), a condition that affects more than 500,000 patients in the US annually.
Jewel P-WCD Patient Save
As the first real-world demonstration of the Jewel P-WCD’s therapeutic benefit, a patient enrolled in the study experienced SCA at home due to a life-threatening arrhythmia that was both appropriately detected and treated by the Jewel P-WCD the patient was wearing. This patient experienced the life-threatening arrhythmia in the first week after returning home to a rural area where emergency response teams are not immediately available. In this instance, the Jewel successfully saved the patient, restoring a normal rhythm with one defibrillation shock and allowing time for first responders to arrive. The patient was transported to the hospital for further care and has since received an implantable defibrillator and is recovering well.
“At Element Science, our goal has always been to redefine the paradigm of care as patients return home after being treated for significant cardiovascular events such as a heart attack or a diagnosis of heart failure,” said Uday N. Kumar, MD, Founder, President and CEO. “Our entire team is grateful to have been able to meaningfully help this patient. The continuous protection afforded by the Jewel P-WCD that helped ensure the patient was wearing the device when needed is precisely the situation for which this device was developed.”
He added, “As a cardiac electrophysiologist, I know that during the first weeks and months after patients have suffered an acute cardiovascular event, they are at high risk of experiencing a life-threatening arrhythmia as they recover. We are delighted to have partnered with leading physicians across the country to conduct this study and this first patient save early in the IDE study clearly demonstrates the benefits of this important technology.”
Jewel P-WCD IDE Study
The Principal Investigators for the Jewel IDE Study were selected for their diverse practices as well as their personal backgrounds and locations to ensure that a wide range of eligible patients, representing significant racial, ethnic and gender diversity, are represented in this landmark trial. They are: John Hummel, MD, The Ohio State University, Director, Electrophysiology Section; Javed Butler, MD, University of Mississippi, Patrick H. Lehan Chair in Cardiovascular Research; and Roxana Mehran, MD, Mount Sinai, Director of Interventional Cardiovascular Research and Clinical Trials.
Dr. Butler commented, “Participating in a study that is evaluating the real-world potential of a personalized wearable patch for high-risk cardiovascular patients is very important to hospitals and clinics across the country. Cardiologists in Mississippi treat a broad array of patients for whom there is an enormous unmet need to help them confidently return home following a cardiovascular episode and we welcome the opportunity to include these patients in the study.”
“I am honored to work with dedicated cardiologists across the country who share my passion for moving care safely from hospital to home,” said Zubin J. Eapen, MD, MHS, Chief Medical Officer, Element Science. “By designing the Jewel P-WCD to provide continuous life-saving therapy, even during activities like showering when other wearable defibrillators typically cannot be used, we are able to assure physicians that their vulnerable patients are receiving the highest level of protection.”
Dr. Robert Harrington, a cardiologist who is currently a Professor and Chair of the Department of Medicine at Stanford University and who is also a long-time member of the Company’s Scientific Advisory Board, stated: “As a clinician, I am acutely aware of the risk patients face when returning home after an acute cardiac event. The Jewel P-WCD coming to fruition is an important advancement to help protect patients in the case of out-of-hospital SCA. I am looking forward to continued progress in this ongoing clinical trial.”
The study is designed to evaluate the safety and effectiveness of the Jewel P-WCD and is enrolling up to 370 patients across the U.S. who are at high risk for life threatening cardiac arrhythmias. The Jewel P-WCD will be used in the trial to monitor heart rhythms and treat subjects with defibrillation as needed. The trial is expected to be completed in 2023.
*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.