Royal Philips and BioIntelliSense Inc1 were selected to receive nearly $2.8 million from the US Department of Defense (DoD) 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, according to a Philips press release.
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. 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.
Individuals may learn more about the study eligibility and enroll online at www.BioStickerCOVIDstudy.com.
“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.”
 Since 2020, Philips has owned a minority interest in BioIntelliSense.