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.”