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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)

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Liverpool shocked by Fulham and Southampton relegated from the Premier League

2025-04-07 01:26 Last Updated At:01:31

MANCHESTER, England (AP) — Liverpool fell to a shock defeat on its march to the Premier League title after a 3-2 loss at Fulham on Sunday.

At the other end of the standings, Southampton became the first team to be relegated from England’s top flight this season after a 3-1 defeat to Tottenham.

Elsewhere, Manchester United and Manchester City played out a dismal 0-0 draw at Old Trafford.

Liverpool’s loss meant it missed the chance to move 14 points clear of second-placed Arsenal and a step closer to a record-equaling 20th English league title. A stunning first-half fightback from Fulham at Craven Cottage saw Arne Slot’s team lose for only the second time in the league this term.

“A very poor first half in terms of the goals we conceded, it was so unnecessary and then you’re fighting a very tough battle. A very poor half as a collective,” Liverpool captain Virgil van Dijk said. “We tried everything in the second half but when you ship three goals in the first half it’s very difficult.”

Arsenal’s 1-1 draw with Everton on Saturday had given Liverpool an unexpected boost in the race for the title, but despite going ahead through Alexis Mac Allister’s goal in the 14th minute, the visitors were 3-1 down at halftime.

Ryan Sessegnon, Alex Iwobi and Rodrigo Muniz all found the back of the net in a thrilling 14-minute spell. Luis Diaz got Liverpool’s second after the break.

Liverpool remains 11 points ahead of Arsenal and on course to win the title with seven games remaining. It needs 11 more points to be assured of being crowned champion.

With just 10 points from 31 games, last-placed Southampton’s fate was sealed with defeat at the Tottenham Hotspur Stadium.

Its relegation is the joint fourth earliest in the Premier League era, according to the league’s statistician Opta.

Derby’s drop on March 29 in 2008 is still the earliest relegation since the league began in 1992. Huddersfield and Fulham suffered earlier relegations than Southampton, which is now joint with Leicester in 2002.

According to Opta, Southampton is the first Premier League team to be relegated with seven or more games to play in the campaign.

“We are disappointed. It has to be a big school for everything – for us, for me, for the players, for the club – to see what we did wrong,” Southampton manager Ivan Juric said.

Two first-half goals from Brennan Johnson put Southampton on course for a 25th league defeat of the season. Mateus Fernandes pulled one back late on for the visitors before Mathys Tel struck a third for Spurs from the penalty spot in added time.

Brentford and Chelsea drew 0-0.

James Robson is at https://twitter.com/jamesalanrobson

AP soccer: https://apnews.com/hub/soccer

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