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December 22, 2020
In 2,500-person trial, partners to validate FDA-cleared BioSticker for clinical confidence in detecting infection
Cambridge, MA – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and BioIntelliSense, Inc. [1], a continuous health monitoring and clinical intelligence company, today announced they have been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly USD 2.8 million from the U.S. Department of Defense (DoD) through a Medical Technology Enterprise Consortium (MTEC) award to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms. The goal of the award is to accelerate the use of wearable diagnostics for the benefit of military and public health through the early identification and containment of pre-symptomatic COVID-19 cases.
Working with the University of Colorado Anschutz Medical Campus, the clinical study will consist of 2,500 eligible participants with a recent, known COVID-19 exposure and/or a person experiencing early COVID-19 symptoms. Individuals may learn more about the study eligibility and enrol online at www.BioStickerCOVIDstudy.com. The research will focus on the validation of BioIntelliSense’s BioSticker for early detection of COVID-like symptoms, as well as assessment of scalability, reliability, software interface, and user environment testing.
“Key industry and academic partnerships provide DoD a timely opportunity to field medical-grade wearables capable of high-frequency physiologic surveillance,” stated Commander Christopher Steele, Director of the Military Operational Medicine Research Program at USAMRDC. “Our goals are to capitalize on mature, wearable tech and validate predictive algorithms to identify COVID-19 positive individuals that have yet to show clear medical symptoms. Outputs can directly maximize military preparedness and provide immediate benefit for the general population as these tools can be used outside of medical treatment facilities.”
While previous studies have shown potential using consumer wearables in relation to COVID-19, this study will leverage BioIntelliSense’s medical grade wearable, the BioSticker, which enables continuous multi-parameter vital signs monitoring for 30 days and captures data across a broad set of vital signs, physiological biometrics and symptomatic events, including those directly associated with COVID-19. With its integration into Philips’ remote patient monitoring offerings, this is another example of how cloud-based data collection takes place seamlessly, across multiple settings, from the hospital to the home. Allowing data to be turned into actionable insights and care interventions, while providing connected, patient-centered care across the health continuum.
“The medical-grade BioSticker wearable, combined with advanced diagnostic algorithms, may serve as the basis for identifying pre- and very early symptomatic COVID-19 cases, allow for earlier treatment for infected individuals, as well as reduce the spread of the virus to others,” said James Mault, MD, Founder and CEO of BioIntelliSense.
Dr. Vik Bebarta, the Founder and Director of the CU Center for COMBAT Research and Professor of Emergency Medicine on the CU Anschutz Medical Campus added: “The University of Colorado School of Medicine and the CU Center for COMBAT Research in the Department of Emergency Medicine are excited to be a lead in this effort that will change how we care for our service members in garrison and our civilians in our communities. The COMBAT Center aims to solve the DoD’s toughest clinical challenges, and the pandemic is certainly one example. With this progressive solution, we aim to detect COVID in the pre-symptomatic or early symptomatic phase to reduce the spread and initiate early treatment. This trusted military-academic-industry partnership is our strength, as we optimize military readiness and reduce this COVID burden in our community and with frontline healthcare workers.”
For over 45 years, Philips has worked closely with the DoD and Veterans Affairs (VA), with over 50% of all VA Hospitals or VISNs using Philips imaging solutions and over 35% using Philips critical care systems. Philips is working closely with the DoD, VA and academic partners to drive innovations that can support better care, as well as telehealth technologies that can bring care closer to home for the nation’s veterans.
“To turn the tide on COVID-19, the public and private sectors need to use every available tool in their arsenal, which includes looking at new ways of how we can create solutions for early disease detection,” said Vitor Rocha, Chief Market Leader of Philips North America and member of the Executive Committee. “No one organization will be able to combat COVID-19 alone, but working together, we hope to develop a solution that will allow people to understand if they are in the early stages of illness, and take the appropriate actions to help limit spread and get the treatment they need. This could help give people confidence in getting back to school, work, travel, or just coming together as a family.”
[1] Since 2020, Philips has owned a minority interest in BioIntelliSense.
The views expressed in this news release/article are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
For further information, please contact:
Silvie Casanova
Philips North America
Tel.: +1 781 879 0692
Email: [email protected]
Steve Klink
Philips Global Press Office
Tel.: +31 6 10888824
Email: [email protected]
Carolyn Walsh
BioIntelliSense, Inc.
Chief Commercial Officer
[email protected]
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
About BioIntelliSense
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and BioButton™ devices make remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians will now have access to high-resolution patient trending and reporting to enable medical grade care at home.
For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please contact us at [email protected] or visit our website at BioIntelliSense.com.
About the University of Colorado Anschutz Medical Campus
The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, together we deliver life-changing treatments, patient care, professional training, and conduct world-renowned research. For more information, visit www.cuanschutz.edu.
About CU Center for COMBAT Research (Department of Emergency Medicine)
The CU Center for Combat Medicine and Battlefield (COMBAT) Research is based in the Department of Emergency Medicine at the University of Colorado Anschutz Medical Campus. The COMBAT Center’s primary mission is to solve the DoD’s toughest clinical challenges and requirements through research, innovation and advanced development. The Center collaborates the military leaders and researchers, industry partners, and academic scientists to create clinical breakthroughs and ahead of the curve solutions for our deployed medics and warfighters.
About US Army Medical Research and Development Command
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine.
About Medical Technology Enterprise Consortium
MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transactional Agreement with the U.S. Army Medical Research and Development Command. To find out more about MTEC, visit www.mtec-sc.org/.
