MediBeacon® Transdermal GFR System is a first-in-kind product for point of care kidney function assessmentCenters of Excellence commercialization in select academic medical centers began in January 2026 NEW YORK, Feb. 10, 2026 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc. (“MediBeacon”), a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, in which INNOVATE owns a 44.7% ...

MediBeacon® Transdermal GFR System is a first-in-kind product for point of care kidney function assessmentCenters of Excellence commercialization in select academic medical centers began in January 2026 NEW YORK, Feb. 10, 2026 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc. (“MediBeacon”), a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, in which INNOVATE owns a 44.7% ...

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].

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].

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, received approval from the National Medical Products Administration (NMPA) for the new drug, Remabizine Injection, which is a non-radioactive, non-iodinated fluorescent GFR tracer used in conjunction with MediBeacon Inc.'s TGFR device for assessing kidney function [1][2]. Group 1: Product Approval and Development - Remabizine Injection is classified as a Class 1 chemical drug and is designed to evaluate glomerular filtration rate (GFR) in patients with normal or impaired kidney function [1]. - The TGFR device, developed in collaboration with MediBeacon Inc., has been approved by the FDA in the U.S. for the same purpose as of January 17, 2025 [1]. - Both Remabizine Injection and the TGFR device must be submitted separately for drug and medical device approvals according to Chinese registration regulations [2]. Group 2: Commercialization and Market Strategy - Huadong Medicine has established exclusive commercialization rights for the product in 25 Asian countries or regions [1]. - The company has reported significant growth in its innovative product business, achieving sales and agency service revenue of 1.084 billion yuan, a year-on-year increase of 59% [2]. - The company is actively planning to transfer the production of TGFR to domestic facilities and has received procurement orders from distributors and medical institutions for research and clinical use [3]. Group 3: Pipeline and R&D Focus - Huadong Medicine is focusing on three core therapeutic areas: endocrinology, autoimmune diseases, and oncology, with a dual approach of "independent development + external introduction" [2]. - The company is advancing over 80 projects in its innovative drug R&D center, indicating a rich pipeline of differentiated innovative drugs [2].

Core Viewpoint - The announcement highlights that Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received approval from the National Medical Products Administration (NMPA) for the marketing authorization of Relmapirazin Injection, a new drug aimed at assessing kidney function in patients [1][2][3]. Drug Information - The drug is named Relmapirazin Injection, with a specification of 7ml:130.2mg, classified as a Class 1 chemical drug [1][3]. - It is designed to be used in conjunction with MediBeacon Inc.'s transdermal glomerular filtration rate measurement device (TGFR) to evaluate patients' glomerular filtration rate (GFR) [1][3]. Development and Registration Status - Relmapirazin Injection is a non-radioactive, non-iodinated fluorescent GFR tracer, developed in collaboration with MediBeacon Inc. [3][4]. - The drug's international multi-center Phase III clinical trial application was approved by NMPA in May 2021, and a key clinical trial in China was approved in December 2022 [5]. - As of September 30, 2025, the company has invested approximately 273 million yuan in the development of Relmapirazin Injection and TGFR [5]. Market Impact and Future Prospects - Chronic kidney disease (CKD) is a significant global health burden, with a median prevalence of 9.5% worldwide and 8.2% to 13.8% in China [6]. - The approval of Relmapirazin Injection is a milestone in the development of MediBeacon?TGFR, which has already received FDA approval in the U.S. [7]. - The company anticipates stable supply and market penetration for the product, with plans to produce and sell Relmapirazin Injection in China while also supplying the U.S. market [7].