“Profusa’s vision is to replace a point-in-time chemistry panel that measures multiple biomarkers, such as oxygen, glucose, lactate, urea, and ions with a biosensor that provides a continuous stream of wireless data,” said Ben Hwang, Ph.D., Profusa’s chairman and chief executive officer. “DARPA’s mission is to make pivotal investments in breakthrough technologies for national security. We are gratified to be awarded this grant to accelerate the development of our novel tissue-integrating sensors for application to soldier health and peak performance.”
Tissue-integrating Biosensors for Multiple Biomarkers
Supported by DARPA, ARO and the National Institutes of Health, Profusa’s technology and unique bioengineering approach overcomes the largest hurdle in long-term use of biosensors in the body: the foreign body response. Placed just under the skin with a specially designed injector, each tiny biosensor is a flexible fiber, 2 mm-to-5 mm long and 200-500 microns in diameter. Rather than being isolated from the body, Profusa’s biosensors work fully integrated within the body’s tissue — without any metal device or electronics — overcoming the effects of the foreign body response for more than one year.
Each biosensor is comprised of a bioengineered “smart hydrogel” (similar to contact lens material) forming a porous, tissue-integrating scaffold that induces capillary and cellular in-growth from surrounding tissue. A unique property of the smart gel is its ability to luminesce upon exposure to light in proportion to the concentration of a chemical such as oxygen, glucose or other biomarker.
“Long-lasting, implantable biosensors that provide continuous measurement of multiple body chemistries will enable monitoring of a soldier’s metabolic and dehydration status, ion panels, blood gases, and other key physiological biomarkers,” said Natalie Wisniewski, Ph.D., the principal investigator leading the grant work and Profusa’s co-founder and chief technology officer. “Our ongoing program with DARPA builds on Profusa’s tissue-integrating sensor that overcomes the foreign body response and serves as a technology platform for the detection of multiple analytes.”
Lumee Oxygen Sensing System™
Profusa’s first medical product, the Lumee Oxygen Sensing System, is a single-biomarker sensor designed to measure oxygen. In contrast to blood oxygen reported by other devices, the system incorporates the only technology that can monitor local tissue oxygen. When applied to the treatment of peripheral artery disease (PAD), it prompts the clinician to provide therapeutic action to ensure tissue oxygen levels persist throughout the treatment and healing process.
Pending CE Mark, the Lumee system is slated to be available in Europe in 2016 for use by vascular surgeons, wound-healing specialists and other licensed healthcare providers who may benefit in monitoring local tissue oxygen. PAD affects 202 million people worldwide, 27 million of whom live in Europe and North America, with an annual economic burden of more than $74 billion in the U.S. alone.
Profusa, Inc., based in South San Francisco, Calif., is leading the development of novel tissue-integrated sensors that empowers an individual with the ability to monitor their unique body chemistry in unprecedented ways to transform the management of personal health and disease. Overcoming the body’s response to foreign material for long-term use, its technology promises to be the foundational platform of real-time biochemical detection through the development of tiny bioengineered sensors that become one with the body to detect and continuously transmit actionable, medical-grade data for personal and medical use.
The research is based upon work supported by DARPA, the Biological Technologies Office (BTO), and ARO grant [W911NF-16-1-0341]. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of DARPA, BTO, the ARO, or the U.S. Government. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright annotation thereon.