Profusa has secured CE mark for its injectable biosensor system which will continuously monitors dissolved oxygen in tissues.
The Lumee Oxygen Platform system will initially be used for monitoring tissue oxygen in the treatment of peripheral artery disease (PAD).
The CE mark approval has also created regulatory path for multi-center clinical studies, which will be conducted in Europe and the US to support the firm’s application for marketing clearance by the US Food and Drug Administration.
The platform features novel hydrogel biosensors, specially designed biosensor injector, optical reader and touch-screen user interface.
Bound to the skin’s surface or held by hand, the optical reader will study the fluorescent signal from the embedded biosensor.
Via skin, the reader sends light to the biosensor, which then emits fluorescent light proportional to the concentration of molecules of interest.
Later, the data will be passed to the touch-screen tablet computer for an encrypted personal record and historical tracking.
Profusa’s biosensors can be used in multiple consumer health and wellness applications, in addition to managing chronic diseases such as PAD, diabetes, and chronic obstructive pulmonary disease (COPD).
Profusa chairman and CEO Ben Hwang said: “Acquiring the CE Mark is a major milestone our development team and regulatory partners have worked hard to achieve.
“Thanks to their dedication and commitment, vascular interventionalists in Europe can now have a revolutionary monitoring device that enables them to better treat their patients and improve their quality of life.”
Image: The Lumee oxygen platform is an investigational device limited by United States Law to Investigational Use. Photo: courtesy of Profusa, Inc.