Core Insights - INNOVATE Corp. announced the approval of the MediBeacon® TGFR Monitor and TGFR Sensor by the National Medical Products Administration (NMPA) in China for kidney function assessment in patients with normal or impaired renal function [1] - The Lumitrace® (relmapirazin) injection is under review in China, with a target approval date set for late 2025 [1] - The TGFR technology, which includes Lumitrace, is a non-invasive method for assessing kidney function by measuring the clearance rate of a fluorescent agent [1][10] Regulatory and Clinical Developments - The NMPA granted the TGFR Innovative Medical Device Designation in 2021, with only 10% of applications receiving this designation, allowing for early product promotion [2] - Recent studies published in the Clinical Kidney Journal and the Journal of the American Society of Nephrology highlight the effectiveness of relmapirazin in accurately classifying Chronic Kidney Disease (CKD) stages, revealing that over one-third of subjects had misclassified eGFR [3][4][6] Technological Advancements - The TGFR system is the first of its kind for point-of-care kidney function assessment, utilizing a wearable, transdermal device that does not require blood samples [5][10] - The fluorescence-based test demonstrated a strong correlation (r² = 0.90) with plasma mGFR across various skin types, indicating its potential for equitable kidney function assessment [5] Company Background - INNOVATE Corp. operates in three key areas: Infrastructure, Life Sciences, and Spectrum, employing approximately 4,000 people [7] - MediBeacon specializes in fluorescent tracer agents and their transdermal detection, holding over 55 granted U.S. patents and more than 215 patents worldwide [8]
MediBeacon® Transdermal GFR System receives device approval in China