Injectable biosensors that become one with the body's tissue may one day replace the clinical lab for making our body chemistry continuously accessible for improved personal wellbeing in health and disease.
Promising a new era in digital health, Profusa, Inc., based in South San Francisco, Calif., today debuted its injectable Lumee™ biosensor technology at the Pioneers Festival held at the grand Hofburg Imperial Palace in Vienna, Austria.
Ben Hwang, Ph.D., Profusa's chairman and chief executive officer, showcased the company's tissue-integrated sensors for long-term, continuous tracking of body chemistry in a talk entitled, "Beyond Fitness Trackers: Let Your Body Speak." Hwang explained how the capability to provide a continuous stream of live data could have the power to revolutionize the relationship we have with our bodies and transform the entire healthcare ecosystem — from individuals, to care providers and payers.
"Most of us only get a once-a-year peek at what's happening inside our body when we visit our doctor," said Hwang. "Yet the most valuable and important information comes from having a 'conversation' with your body in order to make timely choices when your body data is available in real time and when it matters. We believe our technology can impact the entire spectrum of stakeholders in the healthcare system to fundamentally alter the way they do things."
The company's biosensors will have applications for consumer health and wellness, as well as the management of chronic diseases such as peripheral artery disease (PAD), diabetes, and chronic obstructive pulmonary disease (COPD).
"Our tissue-integrated biosensor technology meets three key criteria for continuous monitoring: First, the data needs to be clinical-grade so that you and your healthcare provider can make medical decisions about your health and wellbeing. Second, the user experience needs to be seamless so adoption can fit into any workflow environment. And finally, the technology needs to be accessible at a reasonable cost in a form function that's easy to use," added Hwang.
With grant support by the Defense Advanced Research Project Agency (DARPA, a U.S. Department of Defense agency), the U.S. National Institutes of Health, and other funding agencies, Profusa's technology and novel bioengineering approach overcomes the effects of the largest hurdle in long-term use of biosensors in the body: the foreign body response. Placed under the skin with a specially designed injector, each tiny biosensor is a flexible fiber, 3mm-to-5 mm long and approximately 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.
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. The smart gel is linked to a fluorescent light-emitting molecule that continuously signals the presence of a body chemical such as oxygen, glucose, or other biomarker.
Adhered to the skin's surface or held by hand, a separate optical reader is used to read the fluorescent signal from the embedded biosensor. The reader sends excitation signals through the skin to the biosensor, which then emits light proportional to the concentration of molecules of interest. The data can be relayed to a smart phone for an encrypted personal record and historical tracking. Data can be shared securely via HIPAA-compliant digital networks with healthcare providers.
Lumee Oxygen Sensing System™
Profusa's first medical product, the Lumee Oxygen Sensing System, is a single-biomarker sensor designed to measure dissolved oxygen in the tissue. The system is being commercialized as the only long-term monitoring technology that guides therapeutic action and measures tissue oxygen levels during the treatment and healing process for peripheral artery disease (PAD). Pending CE Mark, the Lumee system is slated to be available in Europe in 2016 for use by vascular surgeons and wound-healing specialists.
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. As the disease advances, patients can experience significant leg pain with impaired mobility (claudication), and in its most severe form, critical limb ischemia (CLI), gangrene and limb amputation.