MediBeacon Receives FDA Approval for Breakthrough Product

Former Helix Center tenant develops kidney function test

MediBeacon, Inc., a medical technology company based out of Creve Coeur, Mo., has received approval from the U.S. Food and Drug Administration for its Transdermal GFR System (TGFR), which can test kidney function without the need of a blood test. The system uses light on the patient’s skin to measure kidney function.

According to the FDA approval announcement, “The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.”

MediBeacon, a former tenant of St. Louis Economic Development Partnership’s Helix Center, partnered with BioGenerator and BioSTL on the breakthrough technology. According to BioSTL, “BioGenerator and BioSTL were critical partners, providing early funding, strategic advice, lab space, and high-touch mentorship that helped the company navigate its riskiest phases.”

To learn more about the TGFR and its FDA approval, click here.