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Publication of Strongly Positive Findings Demonstrate Benefits of Innovative Jewel® Patch Wearable Cardioverter Defibrillator for Patients at Risk of Sudden Cardiac Arrest

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Publication of Strongly Positive Findings Demonstrate Benefits of Innovative Jewel® Patch Wearable Cardioverter Defibrillator for Patients at Risk of Sudden Cardiac Arrest
News

News

Publication of Strongly Positive Findings Demonstrate Benefits of Innovative Jewel® Patch Wearable Cardioverter Defibrillator for Patients at Risk of Sudden Cardiac Arrest

2024-08-01 03:47 Last Updated At:03:50

SAN FRANCISCO--(BUSINESS WIRE)--Jul 31, 2024--

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 Europace 2. 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).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240731209934/en/

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 Study 1, which enrolled 305 patients and successfully exceeded all pre-specified endpoints, provides crucial data on Jewel’s safety, compliance, and efficacy.

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 Study 2 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 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)

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)

DEIR AL BALAH, Gaza (AP) — Israeli strikes killed more than a dozen people in the Gaza Strip early Friday, as Israel sent more ground troops into the Palestinian territory to ramp up its offensive against Hamas.

At least 17 people, some from the same family, were killed after an airstrike hit the southern city of Khan Younis, according to hospital staff. Hours later, people were still searching through the rubble, looking for survivors.

The attack follows days of Israeli strikes, which have killed at least 100 people, as it intensifies operations, intended to pressure Hamas to release its hostages. On Friday, Israel said it had begun ground activity in northern Gaza, in order to expand its security zone.

Israel’s military had issued sweeping evacuation orders for parts of northern Gaza before expected ground operations. The U.N. humanitarian office said around 280,000 Palestinians have been displaced since Israel ended the ceasefire with Hamas last month.

In recent days, Israel's vowed to seize large parts of the Palestinian territory and establish a new security corridor across it.

To pressure Hamas, Israel has imposed a monthlong blockade on food, fuel and humanitarian aid that has left civilians facing acute shortages as supplies dwindle — a tactic that rights groups say is a war crime. Israel said earlier this week that enough food had entered Gaza during a six-week truce to sustain the territory’s roughly 2 million Palestinians for a long time.

Hamas says it will only release the remaining 59 hostages — 24 of whom are believed to be alive — in exchange for the release of more Palestinian prisoners, a lasting ceasefire and an Israeli pullout from Gaza. The group has rejected demands that it lay down its arms or leave the territory.

The predawn strike on Friday hit a three-story building. In addition to the dead, the attack wounded at least 16 people from the same family. Associated Press reporters saw bodies being carried out in blankets, while others searched for people trapped under the rubble and collected charred remains.

“We don’t know how to collect them and how to bury them. We don’t know whose remains these are. They were burned and dismembered,” said Ismail Al-Aqqad, whose brother died in the strike, as well as his brother’s family.

On Thursday, more than 30 bodies, including women and children, were taken to hospitals in and around Khan Younis, according to hospital staff.

Israel said Friday that it had killed a top Hamas commander in a strike in Lebanon’s coastal city of Sidon. Israel said that Hassan Farhat was a commander of Hamas’ western area in Lebanon and that he was responsible for numerous attacks against Israel, including one in February 2024, which killed an Israeli soldier and injured others.

The war began when Hamas-led militants attacked southern Israel on Oct. 7, 2023, killing around 1,200 people, mostly civilians, and taking 251 hostages, most of whom have since been released in ceasefire agreements and other deals. Israel rescued eight living hostages and has recovered dozens of bodies.

More than 50,000 Palestinians have been killed in Gaza as part of Israel's offensive, according to Gaza’s Health Ministry, which doesn’t say whether those killed are civilians or combatants. The ministry says more than half of those killed were women and children. Israel says it has killed around 20,000 militants, without providing evidence.

The war has left most of Gaza in ruins, and at its height displaced around 90% of the population.

Follow AP’s war coverage at https://apnews.com/hub/israel-hamas-war

Palestinians grieve over the bodies of their relatives, who were killed in an Israeli airstrike, at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

Palestinians grieve over the bodies of their relatives, who were killed in an Israeli airstrike, at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

Relatives mourn the body of Ashraf Al Aqqad, who was killed in an Israeli army strike, before his burial at the hospital in Khan Younis, southern Gaza Strip, Thursday, April 3, 2025. (AP Photo/Abdel Kareem Hana)

Relatives mourn the body of Ashraf Al Aqqad, who was killed in an Israeli army strike, before his burial at the hospital in Khan Younis, southern Gaza Strip, Thursday, April 3, 2025. (AP Photo/Abdel Kareem Hana)

Mourners pray over the body of a woman killed in an Israeli army strike, before her burial at the hospital in Khan Younis, southern Gaza Strip, Thursday, April 3, 2025. (AP Photo/Abdel Kareem Hana)

Mourners pray over the body of a woman killed in an Israeli army strike, before her burial at the hospital in Khan Younis, southern Gaza Strip, Thursday, April 3, 2025. (AP Photo/Abdel Kareem Hana)

Palestinians who were injured in an Israeli airstrike, are brought for a treatment at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

Palestinians who were injured in an Israeli airstrike, are brought for a treatment at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

A young Palestinian girl who was injured in an Israeli airstrike, is brought for a treatment at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

A young Palestinian girl who was injured in an Israeli airstrike, is brought for a treatment at the Baptist Hospital in Gaza City, on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

Smoke rises after an explosion in the Gaza Strip as seen from southern Israel, Friday, April 4, 2025. (AP Photo/Leo Correa)

Smoke rises after an explosion in the Gaza Strip as seen from southern Israel, Friday, April 4, 2025. (AP Photo/Leo Correa)

Yamama Jundia, 13, injured in an Israeli airstrike, grieves alongside others over the bodies of their relatives, who were killed in the same strike, at the Baptist Hospital in Gaza City on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

Yamama Jundia, 13, injured in an Israeli airstrike, grieves alongside others over the bodies of their relatives, who were killed in the same strike, at the Baptist Hospital in Gaza City on Thursday, April 3, 2025. (AP Photo/Jehad Alshrafi)

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