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MediBeacon® Next Generation TGFR™ System Receives FDA Approval
Globenewswire· 2025-12-16 13:05
Core Viewpoint - MediBeacon Inc., in which INNOVATE Corp. holds a 44.7% equity interest, has received FDA approval for its next-generation TGFR System, which includes the TGFR Reusable Sensor, enhancing kidney function assessment technology [1][7]. Group 1: Product Details - The TGFR System allows for kidney function assessment at the point of care by measuring the clearance rate of Lumitrace (relmapirazin), a non-radioactive, non-iodinated fluorescent GFR agent [2]. - The TGFR Reusable Sensor is designed for patient comfort, ease of application, and reusability, reducing costs compared to the previously approved single-use TGFR Sensor [3]. - The TGFR System records Lumitrace fluorescence intensity transdermally at a rate of 2.5 readings per second, providing real-time data on kidney function [12]. Group 2: Clinical Validation and Research - The TGFR System was featured in a lead peer-reviewed article in the Journal of the American Society of Nephrology, highlighting its application across various levels of kidney function and skin colors [4]. - MediBeacon has a strong research background with over 700 peer-reviewed publications and conference abstracts utilizing the transdermal GFR methodology [5]. Group 3: Market Strategy and Future Plans - MediBeacon plans to offer early access to the TGFR System at leading academic medical centers in the U.S. and China, with initial sales expected to begin in the first quarter of 2026 [5][7]. - The company aims to integrate transdermal GFR technology into ongoing heart failure studies, emphasizing its potential to improve patient monitoring and accuracy in kidney function assessment [6]. Group 4: Company Overview - INNOVATE Corp. is focused on key areas of the new economy, including Infrastructure, Life Sciences, and Spectrum, employing approximately 3,100 people across its subsidiaries [8]. - MediBeacon specializes in fluorescent tracer agents and transdermal detection technology, holding over 60 granted U.S. patents and more than 245 patents worldwide [9].