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 CasanovaPhilips North AmericaTel.: +1 781 879 0692Email:
silvie.casanova@philips.com
Steve KlinkPhilips Global Press OfficeTel.: +31 6 10888824Email:
steve.klink@philips.com
Carolyn WalshBioIntelliSense, Inc.Chief Commercial
Officercwalsh@BioIntelliSense.com
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 BioIntelliSenseBioIntelliSense 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 info@biointellisense.com or visit
our website at BioIntelliSense.com.
About the University of Colorado Anschutz Medical
CampusThe 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/.
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