Profusa has announced that receiving the CE mark to market its Lumee Oxygen Platform for continuous, real-time monitoring of tissue oxygen.
The company will initially market the system for monitoring tissue oxygen in the treatment of peripheral artery disease. With an annual economic burden of more than US$74 billion dollars in the USA alone, the disease affects 202 million people worldwide.
“Acquiring the CE mark is a major milestone our development team and regulatory partners have worked hard to achieve,” said Ben Hwang, Profusa’s chairman and CEO. “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.”
Profusa’s Lumee Oxygen Platform is comprised of an optical reader and instrument console; a custom software-installed tablet computer; a biosensor injector; and an oxygen-sensitive biosensor. The Lumee Oxygen Platform is an investigational device limited by US law to investigational use.
In addition to allowing for European sales and marketing, the CE mark lays the regulatory path for multicentre clinical studies that will be conducted in Europe and the United States to support Profusa’s application for US marketing clearance by the US FDA. Results obtained from an initial study of the Lumee showed it successfully reported local tissue oxygen levels during surgical intervention, as well as postoperatively for 28 days in patients with peripheral arterial disease. Moreover, the device posed a low risk to patients during the study.
Decreased tissue oxygen levels in the lower limbs of peripheral arterial disease patients can lead to disabled walking, or in more advanced cases, gangrene and amputation. Lumee may help salvage limbs from amputation by providing the medical practitioner with a way to continuously measure tissue oxygen levels in the ischaemic limb before, during, and after treatment, enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear.
“The muscles and other tissues of the arms and legs need oxygen and nutrients to function properly,” explained Miguel Montero, associate professor of Surgery, Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine. “In peripheral arterial disease 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 Lumee Oxygen Platform comprises novel hydrogel biosensors, a specially designed biosensor injector, an optical reader, and a touchscreen user interface. Adhered to the skin’s surface or held by hand, the optical reader is used to read the fluorescent signal from the embedded biosensor. The reader sends light through the skin to the biosensor, which then emits fluorescent light proportional to the concentration of molecules of interest. The data is relayed to the touch-screen tablet computer for an encrypted personal record and historical tracking.