MediBeacon® Transdermal GFR System receives device approval in China; Peer-reviewed articles on MediBeacon technology published

ST. LOUIS, Feb. 25, 2025 /PRNewswire/ -- MediBeacon Inc. today announced the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function. Lumitrace® (relmapirazin) injection, categorized as a drug in China, is under review and is targeted for approval in late 2025. The transdermal GFR technology includes Lumitrace (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together with the TGFR Monitor and TGFR Sensor allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body.

In 2021, the NMPA granted the TGFR Innovative Medical Device Designation. Only 10% of applications are granted this designation. Benefits of this registration route including early product promotion are considerable.

In February, the Clinical Kidney Journal published MediBeacon data in an article on Chronic Kidney Disease (CKD) stage misclassification via estimated GFR (eGFR) compared to measured GFR (mGFR) using relmapirazin. In a stable CKD population, more than one-third of the subjects had an actual mGFR (relmapirazin) that differed by at least one CKD stage from their estimated GFR (eGFR).1  Relmapirazin is indicated for use with the TGFR.

“The Clinical Kidney Journal study raises serious concerns about how chronic kidney disease is diagnosed today,” said Dr. Ira Kurtz, Chief of the Division of Nephrology at UCLA Medical Center. “Researchers found that current eGFR methods misclassified 35% of patients, leading to potentially incorrect treatments and delayed interventions.”

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