INNOVATE Corp. announced that China's National Medical Products Administration (NMPA) has approved the MediBeacon TGFR Monitor and TGFR Sensor for assessing kidney function. This approval applies to patients with normal or impaired renal function, opening a significant new market for the company's innovative technology.
The NMPA had previously granted the TGFR Innovative Medical Device Designation in 2021, a status awarded to only 10% of applications, which provides considerable benefits for early product promotion. While the device components are approved, the Lumitrace (relmapirazin) injection, categorized as a drug in China, is currently under review with approval targeted for late 2025.
Recent clinical data published in the Clinical Kidney Journal highlighted that current estimated GFR (eGFR) methods misclassified 35% of patients, underscoring the urgent need for improved assessment tools like the TGFR. Additionally, data posted in the Journal of the American Society of Nephrology (JASN) showed the transdermal device achieved an exceptional correlation (r² = 0.90) with plasma measured GFR across all skin types, reinforcing its effectiveness and potential for equitable kidney function assessment.
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