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).
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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)
WEST PALM BEACH, Fla. (AP) — Former President Donald Trump wasn’t harmed in Sunday’s apparent assassination attempt as he golfed near his Florida club. But the second attack on his life in barely two months is likely to further unsettle an election cycle already marked by upheaval.
The man suspected in the incident, Ryan Wesley Routh, camped outside the golf course in West Palm Beach with food and a rifle for nearly 12 hours, according to court documents filed Monday. He is accused of lying in wait for the former president before a Secret Service agent opened fire, thwarting the potential attack.
Here are five things to know about what happened and where the investigation stands:
Routh, 58, faces charges of possessing a firearm despite a prior felony conviction and of possessing a firearm with an obliterated serial number. Additional charges are possible.
The suspect lived in North Carolina for most of his life before moving in 2018 to Kaaawa, Hawaii. He and his son operated a company building sheds, according to an archived version of the webpage for the business.
Routh appeared briefly in federal court in West Palm Beach on Monday. He had frequently posted on social media about the war in Ukraine and had a website where he sought to raise money and recruit volunteers to go to Kyiv to join the fight against the Russian invasion.
“Fight and die to stop aggression,” he posted on X in February 2023 about Ukraine. “Everyone should be outraged and helping.” In a video circulating online Routh said, “This is about good versus evil.”
He also wrote separately on X, “I am going to fight and die for Ukraine,” and he even traveled there.
Video shot by The Associated Press showed Routh at a small demonstration in Kyiv’s Independence Square in April 2022, two months after Russian President Vladimir Putin ordered an invasion of the country. A placard he was holding said: “We cannot tolerate corruption and evil for another 50+ years. End Russia for our kids.” Routh wore a blue vest with the U.S. flag on the back.
That same day, Routh also visited a makeshift memorial to “Foreigners killed by Putin.”
But Routh never served in the Ukrainian army or worked with its military, said Oleksandr Shahuri of the Foreigners Coordination Department of the Ukrainian Ground Forces Command.
Routh's politics, meanwhile, don't appear consistently aligned to one party or the other.
In June 2020, he offered a post on X directed at then-President Trump to say he would win reelection if he issued an executive order for the Justice Department to prosecute police misconduct. That year, he also posted in support of the Democratic presidential campaign of then-U.S. Rep. Tulsi Gabbard of Hawaii, who has since left the party and endorsed Trump.
However, in recent years, his posts suggest he soured on Trump, and he expressed support for President Joe Biden and Vice President Kamala Harris.
In July, following the assassination attempt on Trump in Pennsylvania, Routh urged Biden and Harris to visit those wounded in the shooting at the hospital and to attend the funeral of a former fire chief killed at the rally.
Voter records show he registered as an unaffiliated voter in North Carolina in 2012, most recently voting in person during the state’s Democratic Party primary in March 2024. Federal campaign finance records show Routh made 19 small political donations totaling $140 since 2019 using his Hawaii address through a political action committee that supports Democratic candidates.
Records show that while living in Greensboro, North Carolina, Routh had multiple run-ins with law enforcement. The top FBI official in the Miami, Jeffrey B. Veltri, said Routh has numerous felony charges for stolen goods between 1997 and 2010. He also was the subject of a closed investigation in 2019 when someone reported he was in possession of a firearm despite his felony convictions, but Veltri said the tipster would not confirm making the report.
Routh was convicted in 2002 of possessing a weapon of mass destruction, according to online North Carolina Department of Adult Correction records.
Authorities spotted a firearm poking out of shrubbery on the West Palm Beach golf course around 400 to 500 yards from where Trump was playing. As the former president was moving through the fifth hole's fairway, an agent who was visually sweeping the area of the sixth hole's green saw the subject, armed with what he perceived to be a rifle, and immediately discharged his firearm, said acting Director Ronald Rowe Jr. of the U.S. Secret Service.
Rowe said Routh “did not have a line of sight to the former president” and did not fire at Secret Service agents before fleeing.
Routh sped away before being captured in a neighboring county. Body camera footage of Routh’s arrest showed him walking backward with his hands over his head on the side of a road before being handcuffed and led away.
The suspect is believed to have been positioned at the tree line of the golf course from about 1:59 a.m. to 1:31 p.m. Sunday. A digital camera, a loaded SKS-style rifle with a scope and a plastic bag containing food were recovered from the area.
Trump’s protective detail has been higher than some of his peers because of his high visibility and his campaign to seek the White House again. His security was bolstered days before the July 13 assassination attempt in Pennsylvania because of a threat on Trump’s life from Iran, U.S. officials said.
Trump initially posted, “I AM SAFE AND WELL!” and subsequently praised the Secret Service for protecting him.
But the former president pivoted Monday to the politics surrounding the incident, claiming — without evidence — that Biden and Harris comments that he is a threat to democracy had inspired the latest attempt on his life.
“Their rhetoric is causing me to be shot at," Trump told Fox News Digital. In a subsequent post on his social media site Monday, Trump wrote that the left “has taken politics in our Country to a whole new level of Hatred, Abuse, and Distrust.” He said “it will only get worse,” then veered into comments about immigration, even though there is no evidence immigrants were involved in the incident.
The former president made those comments despite his own long history of inflammatory campaign rhetoric and advocacy for jailing or prosecuting his political enemies.
Harris, Trump's Democratic opponent in the presidential election, posted on X that she was "glad he is safe. Violence has no place in America.”
Biden also avoided politics in his reaction. He said Monday that the Secret Service “needs more help” and urged Congress to provide additional resources to help the agency.
“America has suffered too many times the tragedy of an assassin’s bullet,” Biden said at the start of an address to the National HBCU Week Conference in Philadelphia. “It solves nothing. It just tears the country apart. We must do everything we can to prevent it and never give it any oxygen.”
Trump hasn't announced any changes to his schedule and spoke live on X on Monday night from his Mar-a-Lago resort.
Still, a presidential race already rocked by Biden giving up his reelection bid and the first attack on Trump now is being further shaped by a second one. The leaders of a congressional bipartisan task force investigating Trump's Pennsylvania shooting said they have requested a briefing by the Secret Service.
“We are thankful that the former President was not harmed, but remain deeply concerned about political violence and condemn it in all of its forms,” Reps. Mike Kelly, R-Pa., and Jason Crow, D-Colo., said in a statement.
Weissert reported from Washington.
Ryan Wesley Routh holds up a banner during a rally in central Kyiv, Ukraine on Saturday April 30, 2022. (AP Photo/Alex Babenko)
Photos that show an AK-47 rifle, a backpack and a Go-Pro camera on a fence outside Trump International Golf Club taken after an apparent assassination attempt of Republican presidential candidate former President Donald Trump, are displayed during a news conference at the Palm Beach County Main Library, Sunday. Sept. 15, 2024, in West Palm Beach, Fla. (AP Photo/Stephany Matat)
This photo provided by the Martin County Sheriff's Office shows Sheriff's vehicles surrounding an SUV on the northbound I-95 in Martin County on Sunday, Sept. 15, 2024. (Martin County Sheriff's Office via AP)
