INNOVATE Corp. Receives Approval for Lumitrace Injection in China.

MediBeacon's Transdermal GFR System (TGFR) has received approval from China's National Medical Products Administration (NMPA) for its fluorescent GFR agent, Lumitrace. The system will be available for sale in China before the end of the year and allows for point-of-care assessment of kidney function in patients with normal or impaired renal function. Lumitrace injection, TGFR Monitor, and TGFR Sensor work together to measure the clearance rate of the fluorescent agent, enabling kidney function assessment.

MediBeacon Inc., a medical technology company specializing in fluorescent tracer agents and their transdermal detection, has received regulatory approval from China's National Medical Products Administration (NMPA) to sell its Transdermal GFR System (TGFR) in the country. The system, which includes the Lumitrace® injection, TGFR Monitor, and TGFR Sensor, will be available for sale in China before the end of the year.

The TGFR system allows for point-of-care assessment of kidney function in patients with normal or impaired renal function. It measures the clearance rate of the fluorescent agent Lumitrace as it leaves the body, providing a transdermal assessment of Glomerular Filtration Rate (tGFR). This technology aims to address the limitations of current methods, which can be influenced by factors such as muscle mass, diet, and hydration status.

MediBeacon's Lumitrace injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the NMPA for use in China. The TGFR system, which includes the MediBeacon TGFR Monitor and TGFR Sensor, was also approved for use in China. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin, providing real-time kidney function assessments.

This approval is a significant step forward for MediBeacon, which aims to expand access to transdermal GFR technology globally. The company has been working on a commercial and clinical development partnership with Huadong Medicine since July 2019. The TGFR system is designed to be an important tool for physicians who care for patients with kidney health concerns, particularly in light of the high prevalence of Chronic Kidney Disease (CKD) in China, affecting an estimated 11% of the 1.4 billion people in the country MediBeacon receives regulatory approval to sell the Transdermal GFR System in China^[1].

The TGFR system's ability to provide accurate and timely kidney function assessments without the need for serial blood sampling or sophisticated laboratory analysis could transform patient care and outcomes. This technology has the potential to improve patient management and reduce the burden on healthcare systems.