Profusa Receives CE Mark Approval to Market the Wireless Lumee® Oxygen Platform for Continuous, Real-Time Monitoring of Tissue Oxygen
EMERYVILLE, Calif., Jan. 28, 2020 /PRNewswire/ -- Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced it has received Conformité Européenne (CE) Mark approval to market its Wireless Lumee® Oxygen Platform for continuous, real-time monitoring of tissue oxygen in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The company will initially market the new wearable, wireless system for use in physician offices, hospitals, ambulatory care and sports medicine clinics in the European Union.
The system is designed to monitor compromised tissue in conditions such as peripheral artery disease (PAD) and critical limb ischemia (CLI). Both conditions result from a narrowing of blood vessels and reduced blood flow to the lower limbs.
The Wireless Lumee Oxygen Platform consists of a tiny biosensor with an intelligent data platform. A low profile, lightweight wireless patch, which adheres to the skin, "reads" the fluorescent signal from the biosensor injected in the upper arm, shoulder or leg. The wearable patch then transmits the data wirelessly to a tablet, which displays real-time data visualization using the Lumee app.
In addition, the Wireless Lumee Oxygen Platform provides a broader data picture than the previous platform, which was a wired version. The data include changes in oxygen, comparison of current patient's data with historical data from a clinical registry study, and a data report. The new outputs allow physicians to monitor a patient's oxygen levels before, during and after an endovascular procedure, in which blocked arteries are cleared.
"The Wireless Lumee Oxygen system does a few important things. It measures information that is key for patient care, giving feedback via the tablet. And the wireless reader is easy to set up and incorporate into clinical procedures," said Marianne Brodmann, M.D., a vascular specialist at the Medical University of Graz, Austria.
"The more comprehensive and detailed we can make our data, the better we are able to help people living with peripheral artery disease and other serious conditions in which blood flow to the limbs is impeded," said Ben Hwang, Ph.D., chairman and CEO of Profusa. "We designed the Wireless Lumee Oxygen Platform to be small and wearable in order to increase its uptake and use. Our goal with both generations of the Lumee Oxygen Platform is to transform care for patients who could benefit from continuous, real-time monitoring of tissue oxygen levels. We believe that the Wireless Lumee Oxygen Platform will especially help realize the promise of remote patient monitoring and digital health applications."
About Peripheral Arterial Disease and Critical Limb Ischemia
Peripheral artery disease (PAD) affects more than 200 million people worldwide and occurs when arteries narrowed by a build-up of plaque cannot deliver the oxygen-rich blood needed for the extremities. Legs and feet can be painful and develop sores that do not heal. Critical limb ischemia (CLI) is a severe form of PAD in which affected limbs can become gangrenous, putting the patient at risk of amputation. Tissue oxygen levels can be significantly compromised in people with PAD and CLI.
About the Lumee® Oxygen Platform
Profusa's first clinical offering, the Lumee® Oxygen Platform, and the next-generation Wireless Lumee® Oxygen Platform, which are CE marked for use in the European Union, are indicated for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The Lumee Oxygen sensor provides continuous and long-term monitoring of the oxygen in subcutaneous tissue. After a single injection, measurement thereafter is obtained non-invasively using an optical reader. In contrast to external pulse oximeters, which measure oxygen bound to the hemoglobin in larger blood vessels, the Lumee Oxygen Platform measures dissolved oxygen at the tissue level in the fluid that bathes our cells.
In the United States, the Lumee Oxygen Platform is an Investigational Device limited by federal law to Investigational Use.
Based in Emeryville, Calif., Profusa is a digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors who share the long-term goal of improving health and well-being for patients worldwide. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians trust and rely upon. These data may allow people to act as an active and educated participant alongside their care team and understand how their choices and decisions impact health and well-being, day-in and day-out. For more information, visit https://profusa.com.
"LUMEE," "PROFUSA" and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.
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SOURCE Profusa, Inc.