MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon^® TGFR for the assessment of kidney function in patients with normal or impaired renal function.

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.

The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient's point of care.

"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 the 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 timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon's Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International⁴ with data that supports the utility of MediBeacon's patented agent Lumitrace^®.