US-based Profusa has secured CE Mark approval for its Lumee Oxygen Platform for the continuous monitoring of tissue oxygen in real time to treat peripheral artery disease (PAD).
The Lumee Oxygen Platform features hydrogel biosensors, a specially designed biosensor injector, an optical reader, and a touch-screen user interface.
Held by hand or fitted to the skin’s surface, the optical reader can read the fluorescent signal from the embedded biosensor.
The reader transmits light through the skin to the biosensor, which then issues fluorescent light balanced with the concentration of molecules of interest.
The information is then conveyed to the touch-screen tablet computer for an encrypted personal record and historical tracking.
PAD causes reduced tissue oxygen levels in the lower limbs which lead to disabled walking, as well as gangrene and amputation in advanced cases.
The Lumee platform continuously monitors the oxygen levels in the ischemic limb tissue during or after the treatment which alerts the physicians to design the desired therapy thereby avoiding a potential amputation of limb.
Baylor College of Medicine surgery, division of vascular surgery and endovascular therapy associate professor Miguel Montero said: “The muscles and other tissues of the arms and legs need oxygen and nutrients to function properly.
“In PAD the arteries that feed the extremity are blocked by plaque composed of cholesterol and other calcified substances.
“When low-tissue oxygen is detected early, more treatment options can be considered and the need for catastrophic amputation can be avoided.”
The small and flexible fiber biosensors are placed under the skin by a specially designed injector which then forms a porous, tissue-integrating scaffold that results to capillary and cellular in-growth of the surrounding tissue.
The smart gel is connected to a light-emitting molecule that signals the presence of a body chemical such as oxygen, glucose, or other biomarker.
Profusa’s biosensors operate while being fully integrated within the body’s tissue without any metal device or electronics.
Image: Profusa’s Lumee Oxygen Platform. Photo: courtesy of PROFUSA, INC.