US-based medical technology company MediBeacon has received the US Food and Drug Administration (FDA) approval for its TGFR system to assess kidney function.
The TGFR system features a TGFR Sensor, TGFR Monitor, and Lumitrace (relmapirazin) injection, a non-radioactive, and non-iodinated fluorescent GFR tracer agent.
It facilitates the assessment of kidney function in patients with normal or impaired renal function, by measuring the clearance rate of the fluorescent agent from the body.
The system transdermally records the Lumitrace fluorescence intensity as a function of time through 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 outpatient setting.
MediBeacon CEO Steve Hanley said: “The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function.
“According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognised public health crisis.
“The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”
According to MediBeacon, TGFR is validated for the assessment of the Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care.
Unlike current methods needing multiple blood draws or urine samples, the TGFR system leverages only an intravenous Lumitrace injection, instead of blood draws or urine analysis.
Also, current clinical practice measured GFR (mGFR) assessment requires complex clinical laboratory analysis, carried out away from the point of care.
MediBeacon said that TGFR met its primary efficacy endpoint, showing a P30 value of 94% while recruiting patients with a range of GFR values and skin tones.
P30 is the percentage of GFR estimation within +/- 30% of measured GFR (mGFR) values.
University of Virginia department of medicine chair Mitchell Rosner said: “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.”
