Tissue-integrating Scaffold

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 light-emitting molecule that contin­uously signals the presence of a body chemical such as oxygen, glucose, or other biomarker.


Optical Reader

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 fluorescent light proportional to the concentration of molecules of interest. The data is 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 aimed at being the only long-term monitoring technology that ensures tissue oxygen levels persist throughout the wound treatment and healing process. Taking as much as a year to heal, if at all, chronic wounds from diabetic ulcers, pressure sores, and reconstructive surgery take a financial toll on patients and the healthcare system.

Oxygen monitoring of localized tissues after surgical repair of blood vessels is an unmet medical need in the treatment of peripheral artery disease (PAD). PAD, in which plaque buildup obstructs arteries causing decreased tissue oxygen, 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.

Decreased tissue oxygen levels in the lower limbs of PAD patients can lead to disabled walking, or in more advanced cases, gangrene and amputation. The Lumee system may help salvage limbs from amputation by providing the medical practitioner with a way to continuously measure tissue oxygen levels in the ischemic limb before, during, and after treatment, enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear. The Lumee system is slated to be available in Europe in early 2016 for use by vascular surgeons and wound-healing specialists.

"When low tissue oxygen is detected early, more treatment options can be considered, and the need for catastrophic amputation can be avoided," said Christopher Owens, MD, MSc, Chief, Section of Vascular Surgery, Assoc. Prof. Surgery, San Francisco Veterans Medical Center, University of California, San Francisco.

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