Profusa's injectable oxygen biosensor earns CE mark

Lumee Oxygen Platform--Courtesy of Profusa

Profusa scored a CE mark for its injectable biosensor system that continuously monitors dissolved oxygen in tissues. The company will initially market the platform for tissue oxygen monitoring in the treatment of peripheral artery disease (PAD).

The Lumee Oxygen Platform comprises an oxygen-sensitive biosensor, a biosensor injector, an optical reader and instrument console and a tablet with custom software, the company said in a statement. This summer, Profusa picked up $7.5 million in DARPA funding to support its development.

The biosensor is a 5-mm-long flexible fiber made of a “smart hydrogel.” Once implanted, the biosensor forms a porous, tissue-integrating scaffold that causes capillaries and cells to grow into it from the surrounding tissue. The optical reader, which can be adhered or held to the skin, sends light to the biosensor, which emits fluorescent light to signal the concentration of molecules in the tissue, such as oxygen or glucose.

In addition to its initial focus on PAD, the company names chronic wounds and reconstructive surgery among the system’s potential applications. PAD affects 202 million people worldwide, including 27 million people who live in Europe and North America. It is characterized by the narrowing of the peripheral arteries, most commonly in the legs. Those with PAD have an increased risk of heart attack and stroke, and if left undiagnosed, the disease can lead to gangrene and amputation.

Lumee provides a way to continuously measure tissue oxygen levels in limbs affected by PAD, helping clinicians intervene earlier to avoid advanced symptoms and potential amputations.

"In PAD the arteries that feed the extremity are blocked by plaque composed of cholesterol and other calcified substances,” said Dr. Miguel Montero, associate professor of surgery in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine, in the statement. “When low tissue oxygen is detected early, more treatment options can be considered and the need for catastrophic amputation can be avoided."