MediBeacon Inc. has received U.S. Food and Drug Administration (FDA) approval for its Transdermal Glomerular Filtration Rate (TGFR) system, designed to assess kidney function in patients with normal or impaired renal health. The system includes the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a fluorescent GFR tracer agent that enables point-of-care kidney function evaluation without the need for blood draws or urine analysis.
The TGFR system operates by measuring the clearance rate of the Lumitrace tracer through transdermal fluorescence intensity. A sensor placed on the skin records 2.5 readings per second, displaying results in real-time at the patient’s bedside or in outpatient settings. This innovative method offers an alternative to traditional GFR assessments, which require complex lab analyses and multiple blood or urine samples.
“The development of a system such as the TGFR that assesses a patient’s kidney function without the need to use estimating equations is an important milestone for the nephrology community,” said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. “We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal.”
Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: “It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice.”
“The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function,” said Steve Hanley, CEO of MediBeacon. “According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is an under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”
The FDA approval coincides with the publication of supporting data in Kidney International, showcasing the efficacy of the Lumitrace agent. The TGFR system achieved a primary efficacy endpoint with a P30 value of 94%, demonstrating reliable GFR estimation across diverse patient groups and skin tones.
MediBeacon’s TGFR approval marks a pivotal advancement in kidney function evaluation, offering a streamlined and effective approach to addressing CKD and enhancing patient care.