“There were no patient deaths or missed
episodes requiring external rescue, and high patient compliance
enabled a high number of successful life-saving conversions.”
Element Science, an innovative health technology company
pioneering a digital wearable platform for high-risk cardiovascular
patients, today announced the publication of its Jewel IDE Study
results, conducted in sites across the United States, in the
prestigious Journal of the American College of Cardiology (JACC)1
as well the recent publication of its Jewel EP Lab Study, conducted
in the European Union, in Europace2. The publication of these
positive results underscores the potential impact of the Jewel®
Wearable Patch Cardioverter Defibrillator (Jewel) and highlights
the value of utilizing truly patient-centric technology when
managing patients at risk of sudden cardiac arrest (SCA).
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Jewel is a low-profile, water-resistant
wearable cardioverter defibrillator designed to continuously
monitor a patient’s heart rhythm in order to detect and treat
life-threatening arrhythmias in patients with a temporarily
elevated risk for SCA. It is designed for 24/7 protection,
including during normal daily activities like 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. (Photo: Business Wire)
Dr. Zubin Eapen, Element Science’s Chief Medical Officer, said,
"Patients with significant heart disease, especially those who are
recovering from certain events like a heart attack, face a high
frequency of out-of-hospital SCA, often accompanied by a low
survival rate. By enabling truly continuous SCA protection that
patients can easily manage while they recover at home, Jewel can
greatly enhance these patients' survival prospects and is an
important addition to the tools physicians have to protect their
patients.”
Wearable cardioverter defibrillators (WCDs) are effective at
restoring patient’s heart rhythms to a normal rhythm, but they have
faced challenges related to patient comfort, and therefore
compliance, limiting their widespread adoption and leading to
potentially avoidable deaths from SCA. Jewel addresses these
compliance issues with its low-profile, water-resistant design,
allowing patients to wear the device comfortably during daily
activities, including showering and moderate exercise. Jewel is
designed to integrate into patients' lives, allowing them to
comfortably carry out daily activities.
The Jewel IDE Study1, which enrolled 305 patients and
successfully exceeded all pre-specified endpoints, provides crucial
data on Jewel’s safety, compliance, and efficacy.
- High Compliance and Protected Time: Patients using Jewel
achieved a median wear-time of over 23 hours per day, showcasing
its ease of use and integration into patients’ daily lives.
- Lives Saved and No Deaths: The device successfully
converted eight separate ventricular tachycardia or ventricular
fibrillation events in six (6) different patients, effectively
preventing SCA. No deaths were observed in patients while enrolled
in the study.
- Low Inappropriate Shock Rates: The study observed a very
low inappropriate shock rate of just 0.36 shocks per 100
patient-months, providing patients with peace of mind.
Dr. Javed Butler, a National Principal Investigator for the
Jewel IDE Study and primary author, noted, "The results are a clear
indication that wearable defibrillators can be designed with the
patient in mind. Jewel’s comfortable and water-resistant design
allows patients to maintain their daily activities while still
receiving life-saving protection.”
Dr. Uday N. Kumar, Founder, President, and CEO of Element
Science, commented, "The study results presented in JACC represent
a significant achievement for the Company and provide clear
evidence of how the high compliance seen with the Jewel led to
patients wearing the device when they needed it, thereby saving
numerous patients from SCA. Jewel's unique design, accompanied by a
sophisticated machine learning algorithm, addresses many of the
challenges faced by traditional wearable defibrillators. We look
forward to seeing the positive impact Jewel will have in real-world
practice."
In addition to the Jewel IDE Study, the Jewel EP Lab Study2 was
conducted to provide foundational safety and effectiveness of the
Jewel in terminating life-threatening arrhythmias. This
first-in-human study, which also successfully met all pre-specified
endpoints, was crucial as it confirmed that Jewel could
successfully identify and convert life-threatening rhythms in a
single shock.
Dr. Karol Watson, a member of Element Science’s Scientific
Advisory Board, stated, "Improved adherence with wearable
defibrillators can significantly impact patient outcomes. Results
from the EP Lab Study followed by the Jewel IDE Study showcase the
potential of the Jewel P-WCD to provide continuous protection for
patients at risk of SCA, without the usual challenges related to
comfort and adherence. It's a large step forward in providing
effective solutions for those with significant heart disease."
About the Jewel® Patch Wearable Cardioverter Defibrillator
(P-WCD)
Jewel is a low-profile, water-resistant wearable cardioverter
defibrillator designed to continuously monitor a patient’s heart
rhythm in order to detect and treat life-threatening arrhythmias in
patients with a temporarily elevated risk for SCA. It is designed
for 24/7 protection, including during normal daily activities like
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.
Jewel is an investigational device and is limited by U.S. law to
investigational use only. It is not available for sale in the U.S.
Jewel received CE Mark and UK Conformity Assessed (UKCA) marking in
January 2024, but is currently not commercially available in the
European Union or Great Britain.
About the Jewel IDE Study
The Jewel IDE Study (NCT05201495) was a multicenter,
prospective, single-arm study that enrolled 305 patients and
followed them for up to 180 days in a primarily outpatient setting.
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, inappropriate shock rate, and
cutaneous adverse device effects. The Jewel IDE Study successfully
met its pre-defined endpoints.1
About the EP Lab Study
The EP Lab Study (NCT05490459) was a single-arm, open-label
evaluation of the Jewel P-WCD defibrillation waveform in up to 18
adult cardiac patients while undergoing care in an EP
(electrophysiology) lab setting. The objective was to demonstrate
the clinical effectiveness of Jewel in terminating life-threatening
ventricular arrhythmias (VT/VF) with a single defibrillation shock.
The EP Lab Study successfully met its pre-defined endpoint.2
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 MORE ABOUT THE JEWEL IDE STUDY:
www.ElementScience.com/ide-study/
LEARN MORE ABOUT ELEMENT SCIENCE:
www.ElementScience.com
- Jewel IDE Study Manuscript: JACC 84(6), p525-536: DOI
10.1016/j.jacc.2024.04.063 Editorial: Patch Wearable
Defibrillator: Excellent Therapy, But Patient Acceptance Is a
Sticky Issue, JACC 84(6) p537-539: DOI
10.1016/j.jacc.2024.06.014
- EP Lab Study Manuscript: EP Europace 26(7), e189: DOI
10.1093/europace/euae189
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version on businesswire.com: https://www.businesswire.com/news/home/20240731209934/en/
Sharon N. Buechler Element Science 650-218-6340
press@elementsci.com