MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

FDA Approval and Product Overview - The FDA has approved INNOVATE Corp's MediBeacon TGFR for assessing kidney function in patients with normal or impaired renal function [1] - The TGFR system includes a sensor, monitor, and Lumitrace injection, which measures kidney function by tracking the clearance rate of a fluorescent agent [2] - The system records fluorescence intensity transdermally at 2.5 readings per second and displays average session tGFR readings at the patient's bedside [2] Clinical Advantages and Validation - The TGFR eliminates the need for blood draws or urine analysis, unlike current GFR assessment methods [3] - It has been validated for use in patients with stable kidney function at the point of care [3] - The TGFR met its primary efficacy endpoint with a P30 value of 94%, indicating high accuracy in GFR estimation [5] - Clinical studies showed no serious or severe adverse events [6] Industry Impact and Expert Opinions - The TGFR represents a significant milestone for nephrology, offering a non-invasive method to assess kidney function [4] - Experts highlight its potential to improve clinical practice, particularly in cases where current methods are suboptimal [4] - Chronic Kidney Disease (CKD) affects over 800 million people globally and is a leading cause of mortality [7] Company and Product Background - INNOVATE Corp operates in Infrastructure, Life Sciences, and Spectrum, employing approximately 4,000 people [8] - MediBeacon, a subsidiary, specializes in fluorescent tracer agents and transdermal detection technology, holding over 55 U.S. patents and 215 worldwide [9] - Lumitrace injection, a key component of the TGFR, has been administered to over 850 subjects and is designed for non-invasive GFR measurement [10] Technical and Safety Information - The TGFR is not approved for patients with GFR <15ml/min/1.73m2 or >120ml/min/1.73m2, or for those on dialysis [13] - Lumitrace injection may interfere with clinical laboratory tests, and its use is contraindicated in patients requiring such tests within 72 hours [17]