MediBeacon has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Transdermal GFR Measurement System (TGFR).
MediBeacon, whose largest shareholder is Pansend Life Sciences of HC2 Holdings, aims to commercialize biocompatible optical diagnostic agents for physiological monitoring, surgical guidance, and imaging of pathological disease in the human population.
The TGFR device has been designed to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.
The FDA has designatedthe device TGFR as a combination product which includes an optical skin sensor, monitor and MB-102, a fluorescent tracer agent that glows in the presence of light.
TGFR offers clinicians with continuous and real-time measurement of GFR at point of care, removing the need for blood sampling or urine collection.
According to MediBeacon, GFR’s measurement can be of high clinical interest for patients who are at risk of kidney disease. It is claimed that kidney disease can affect more than 850 million people worldwide. The number is twice as much as people with diabetes and 20 times the number of people with cancer.
MediBeacon CEO Steve Hanley said: “We are delighted that the FDA has recognized the Transdermal GFR Measurement System meets the requirements for this designation.
“We look forward to continued close collaboration with the FDA as we begin our pivotal multicenter clinical study in the United States and Europe.”
Under the Breakthrough Devices program, the FDA will work with companies to expedite regulatory review to give patients more timely access to diagnostic and therapeutic technologies.
HC2 chairman, CEO and president Philip Falcone said: “We are extremely excited about MediBeacon’s breakthrough real-time kidney function measurement system.
“HC2 is committed to continued support of this remarkable innovation which has the potential to help millions of people around the world.”
Founded in 2012, MediBeacon is engaged in the development of biocompatible optical diagnostic agents for physiological monitoring, surgical guidance, and imaging of pathological diseases. The company has developed several product concepts.