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MediBeacon receives regulatory approval to sell the Transdermal GFR System in China
Globenewswireยท 2025-10-21 12:05
Core Viewpoint - MediBeacon's Transdermal GFR System (TGFR) has received approval in China, marking a significant advancement in kidney function assessment technology, which is expected to improve patient management in chronic kidney disease (CKD) [1][4][5]. Company Overview - INNOVATE Corp. is the parent company of MediBeacon, focusing on medical technology and has a commitment to expanding access to innovative healthcare solutions globally [8]. - MediBeacon specializes in fluorescent tracer agents and their transdermal detection, holding over 60 U.S. patents and more than 245 patents worldwide [9][10]. Product Details - The TGFR system includes Lumitrace (relmapirazin) injection, MediBeacon TGFR Monitor, and MediBeacon TGFR Sensor, which together facilitate the assessment of kidney function by measuring the clearance rate of the fluorescent agent [2][12]. - Lumitrace is a non-radioactive, non-iodinated compound designed for effective kidney function measurement without interference from medications or demographic factors [11][7]. Market Opportunity - Chronic Kidney Disease (CKD) affects approximately 11% of the 1.4 billion population in China, presenting a substantial market opportunity for the TGFR system [3]. - The approval of the TGFR system in China is seen as a major step in enhancing access to kidney health management tools [5]. Clinical Implications - The TGFR system aims to provide a more accurate and immediate assessment of kidney function compared to traditional methods, which can be influenced by various non-renal factors [5][6]. - The technology is expected to transform kidney disease management by allowing real-time assessment at the point of care, potentially improving patient outcomes [7].