Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced the initiation of a study that will use the Company’s minimally invasive injectable biosensor technology, the Lumee® Oxygen Platform, as a platform to potentially assist in the early detection of influenza outbreaks. The study is part of a collaboration with RTI International, a nonprofit research institute developing algorithms for illness detection, and research centers including Duke University and Imperial College London.
The study, conducted at Imperial College London, will examine how sensors monitoring physiological status, including the Lumee Oxygen Platform which measures tissue oxygen levels, provide potential indicators of human response to infection or exposure to disease in healthy volunteers. The goal of the study is to develop an early identification system to detect not only disease outbreaks, but biological attacks and pandemics up to three weeks earlier than current methods. The results of the study are anticipated to be available in 2021.
“This research marks an exciting step forward in the development of game-changing preventive care,” said Ben Hwang, chairman and CEO of Profusa. “The Lumee Oxygen Platform can potentially function as a sort of canary in a coal mine for infectious disease, since subtle changes in oxygen at the tissue level may signal trouble and can help clinicians course correct quickly to avoid outbreaks.”
Changes in oxygen levels and other physiological measures, such as heart rate, as a result of a respiratory infection may assist researchers in the study to develop algorithms that can detect early, pre-symptomatic flu activity more quickly than what is currently possible.
Despite the availability of antivirals and vaccines, influenza remains one of the greatest causes of illness and premature death worldwide. Seasonal influenza affects between 10% and 46% of the population each year, with mortality of up to approximately 12 deaths per 100,000 in developed countries. During the 2009 H1N1 virus pandemic, many severe cases occurred in previously healthy young adults. With the entire worldwide population potentially at risk, the prevention and improved management of seasonal and pandemic influenza are of major importance.
“The potential significance of this new technology should not be underestimated, and Profusa is proud to be part of a joint effort funded by a DARPA, or Defense Advanced Research Projects Agency, award,” said Sean Givens, head of government business for Profusa. “This is particularly exciting for Profusa as we look forward to leveraging learnings for future platform applications.”
Profusa’s Lumee Patch, a wireless reader that adheres to the skin and collects and reports tissue oxygen levels sensed by the Lumee Oxygen sensor to a mobile device for real-time data visualization, will be used in the clinical study.
The Lumee Patch and software being used in this study received approval as an investigational device from Medicines and Healthcare products Regulatory Agency (MHRA) in the UK to be used in conjunction with other devices. The injectable Lumee Oxygen sensor and injector Lumee Pen being used in this study are CE Marked for use in the European Union and EEA.
The project is part of DARPA’s SIGMA+ program in the Defense Sciences Office (DSO).