THE JEWEL® IDE STUDYPivotal study demonstrates the life-saving benefits of the Jewel® Patch Wearable Defibrillator (P-WCD). THIS PRODUCT IS NOT CURRENTLY COMMERCIALLY AVAILABLE FOR SALE IN THE U.S.The Jewel® IDE StudyA clinical evaluation of the Jewel® Patch WCD in subjects at high risk for sudden cardiac arrest.The Jewel® P-WCD is a safe and effective WCD that, due to its design, led to high patient compliance. Compared to traditional WCDs, in the Jewel® IDE Study, there were no deaths due to non-compliance as well as a high number of patient saves. 1 8Successful conversions 11 Data on file0Deaths in the study population 1 ResultsUser Friendly Design Led to High Daily Protected Time 1Jewel® patients had a median compliance of 97.8% (IQR: 86.1%,99.7%)23.5HRSmedian daily protected time91.0% of patients wore the Jewel® for longer than the prespecified threshold of 14.1* hours per dayMean protection time*Average daily protected time as reported in the VEST trial was 14.0 hours: J.E. Olgin, et al. NEJM (2018) 379:1205-1215, DOI: 10.1056/NEJMoa18007811 Data on filePowerful ML Algorithm Led to Low False Alarm Rate 1Median false alarms: Jewel® 0 per month vs LifeVest 3 per month*88.9%patients with <1 alarm per day61.7% of patients experienced 0 alarms / dayAn additional 27.2% of patients experienced less than 1 alarms / day* Kovacs B at al. J Clin Med 2021; 10:38111 Data on fileEffective Defibrillation Led to Successful Conversions and Numerous Lives Saved 18 successful conversions in 6 patients6LIVESsaved with 8 single conversionsRhythm AdjudicationOutcome1Polymorphic VT/VFReceived ICD2Polymorphic VT/VFReceived CRT-D3VTReceived ICD4Pleomorphic VTReceived ICD5*Coarse VFReceived ICD5*Polymorphic VTReceived ICD5*Coarse VF/Polymorphic VTReceived ICD6Monomorphic VTReceived ICD* One (1) patient experienced three (3) separate episodes of arrhythmia that were successfully converted1 Data on filePatient Save 1Subject 132-007:75-year old male with ischemic cardiomyopathy (EF 30%)Driving when he felt himself “passing out” and pulled off to the side of the roadWife reported he was unresponsive but immediately gained consciousness after receiving a shock from the Jewel® P-WCDUpon study exit, patient received an ICD* Kovacs B at al. J Clin Med 2021; 10:38111 Data on file A positive patient experience comes from putting people first.Jewel® is a patch wearable defibrillator (P-WCD) intentionally designed to not get in the way of living. Being discreet, comfortable, and safe to shower with, the Jewel® delivers a completely new patient experience.Designed to be worn.Designed to save lives. ResourcesPress Release:Successful Results of the Jewel® IDE Study AnnouncementReadAHA Presentation:Get the presentation by John Hummel, MD, FACCReadVideo:Jewel Pivotal Study Patient ExperienceRead Principal Investigators Javed Butler, MDBaylor Scott and White Research InstitutePresident of the Baylor Scott and White Research Institute, Dallas, TX Distinguished Professor of Medicine at the University of Mississippi Medical Center, Jackson, MS Over 650 Peer-reviewed Publications Member of Editorial Boards of Several Peer-reviewed Cardiovascular Journals John Hummel, MDThe Ohio State UniversityDirector, Electrophysiology Section Professor of Cardiovascular Medicine Over 150 Publications in Cardiac Electrophysiology Roxana Mehran, MDMount SinaiDirector of Interventional Cardiovascular Research and Clinical Trials Chief Scientific Officer, Clinical Trials Center, Cardiovascular Research Foundation Member, Board of Trustees, Society of Cardiac Angiography and Interventions Scientific Advisors Christine Albert, MD, MPHCedars Sinai Medical CenterProfessor and Founding Chair of the Department of Cardiology at Cedars Sinai Epidemiologist at Brigham and Women’s Hospital Visiting Professor of Harvard Medical School Past President and current editorial member of the Heart Rhythm Society (HRS) Lee and Harold Kapelovitz Distinguished Chair in Cardiology in the Smidt Heart Institute at Cedars-Sinai Bob Harrington, MDWeill Cornell Medicine, Cornell UniversityStephen and Suzanne Weiss Dean of Weill Cornell Medicine and Provost for Medical Affairs of Cornell University Former Arthur L. Bloomfield Professor of Medicine and Chairman of the Department of Medicine at Stanford University Former Director of the Duke Clinical Research Institute (DCRI) Author of more than 700 Articles and Edited Five Textbooks Former Member and Chair of US FDA Cardiovascular and Renal Drugs Advisory Committee Past President, American Heart Association Harlan Krumholz, MDYale School of MedicineCardiologist Director of Yale Center for Outcomes Research and Evaluation Harold H. Hines Jr Professor Yale School of Medicine Global Thought Leader on Outcomes Research Author of more than 1,400 Articles and Two Books National Academy of Medicine; Distinguished Scientist of the AHA Karol Watson, MD, PhDDavid Geffen School of Medicine at UCLADirector of the UCLA Women’s Cardiovascular Health Center, the UCLA-Barbra Streisand Women’s Heart Health Program, and the UCLA Fellowship Program In Cardiovascular Diseases Co-Director of the UCLA Program in Preventive Cardiology Ad hoc Chair of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Food and Drug Administration (FDA) Past chairperson of the scientific advisory board For Womenheart Past Vice President for the Association of Black Cardiologists (ABC) More than 100 publications and presentations
Javed Butler, MDBaylor Scott and White Research InstitutePresident of the Baylor Scott and White Research Institute, Dallas, TX Distinguished Professor of Medicine at the University of Mississippi Medical Center, Jackson, MS Over 650 Peer-reviewed Publications Member of Editorial Boards of Several Peer-reviewed Cardiovascular Journals
John Hummel, MDThe Ohio State UniversityDirector, Electrophysiology Section Professor of Cardiovascular Medicine Over 150 Publications in Cardiac Electrophysiology
Roxana Mehran, MDMount SinaiDirector of Interventional Cardiovascular Research and Clinical Trials Chief Scientific Officer, Clinical Trials Center, Cardiovascular Research Foundation Member, Board of Trustees, Society of Cardiac Angiography and Interventions
Christine Albert, MD, MPHCedars Sinai Medical CenterProfessor and Founding Chair of the Department of Cardiology at Cedars Sinai Epidemiologist at Brigham and Women’s Hospital Visiting Professor of Harvard Medical School Past President and current editorial member of the Heart Rhythm Society (HRS) Lee and Harold Kapelovitz Distinguished Chair in Cardiology in the Smidt Heart Institute at Cedars-Sinai
Bob Harrington, MDWeill Cornell Medicine, Cornell UniversityStephen and Suzanne Weiss Dean of Weill Cornell Medicine and Provost for Medical Affairs of Cornell University Former Arthur L. Bloomfield Professor of Medicine and Chairman of the Department of Medicine at Stanford University Former Director of the Duke Clinical Research Institute (DCRI) Author of more than 700 Articles and Edited Five Textbooks Former Member and Chair of US FDA Cardiovascular and Renal Drugs Advisory Committee Past President, American Heart Association
Harlan Krumholz, MDYale School of MedicineCardiologist Director of Yale Center for Outcomes Research and Evaluation Harold H. Hines Jr Professor Yale School of Medicine Global Thought Leader on Outcomes Research Author of more than 1,400 Articles and Two Books National Academy of Medicine; Distinguished Scientist of the AHA
Karol Watson, MD, PhDDavid Geffen School of Medicine at UCLADirector of the UCLA Women’s Cardiovascular Health Center, the UCLA-Barbra Streisand Women’s Heart Health Program, and the UCLA Fellowship Program In Cardiovascular Diseases Co-Director of the UCLA Program in Preventive Cardiology Ad hoc Chair of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Food and Drug Administration (FDA) Past chairperson of the scientific advisory board For Womenheart Past Vice President for the Association of Black Cardiologists (ABC) More than 100 publications and presentations
