MediBeacon TGFR System Receives FDA Approval for Kidney Function Assessment

INNOVATE Corp.

FDA approved MediBeacon Transdermal GFR (tGFR) for assessing kidney function in adults with normal or impaired renal function without input of age, sex, race.
TGFR uses a non-radioactive fluorescent agent (Lumitrace) with a transdermal sensor; no blood draws or urine analysis needed.
Primary efficacy endpoint met: P30 value of 94% (95% CI: 89.4%-96.9%) in clinical study across GFR ranges and skin tones.
More than 800 million people globally have chronic kidney disease; TGFR aims to improve point-of-care assessment.

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