MediBeacon® GFR System Gains FDA Approval for Kidney Function Assessment

MediBeacon Inc. has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approving their Transdermal GFR System (TGFR), a pioneering tool for assessing kidney function in individuals with either normal or impaired renal function. This novel system is unique in its ability to evaluate kidney function without the need for estimating equations, marking a considerable advancement in nephrology.

Chronic Kidney Disease (CKD) affects over 800 million people globally and is a major cause of mortality, with the death toll rising in recent years. Traditional methods for assessing kidney function typically require complex lab analyses involving multiple blood or urine samples. In contrast, the TGFR system offers a simpler, more direct approach by measuring the clearance rate of a fluorescent tracer agent, Lumitrace (relmapirazin), which is detected transdermally via a sensor. This innovative method eliminates the need for blood draws and can be conducted at the point of care.

The TGFR system comprises three main components: the TGFR Sensor, the TGFR Monitor, and the Lumitrace injection. The sensor, placed on the skin, records fluorescence intensity at a rate of 2.5 readings per second. These readings provide real-time data displayed on the TGFR Monitor, offering immediate insights into a patient's kidney function. The use of Lumitrace, a non-radioactive and non-iodinated fluorescent tracer, aids in this assessment by providing high-clarity readings without the complications associated with traditional radioactive or iodinated materials.

MediBeacon's CEO, Steve Hanley, highlighted the critical role of the TGFR in addressing CKD—a public health issue that causes more deaths annually than breast or prostate cancer. The TGFR can potentially offer numerous applications in both hospital and outpatient settings, thereby expanding the ways in which kidney function can be monitored and treated.

Dr. Mitchell Rosner, a nephrology expert, emphasized the importance of the TGFR system as a significant stride forward for kidney health assessment, especially for patients where conventional practices fall short. This sentiment is echoed by Dr. Pierre Galichon, who has been involved in preclinical trials and sees promise in applying TGFR technology in clinical settings to explore the interactions between kidney and other organ systems.

The recent FDA approval coincides with MediBeacon's publication in "Kidney International," which showcases supporting data for the efficacy of the Lumitrace tracer. The TGFR system demonstrated a P30 value of 94% during clinical trials, indicating that a high percentage of estimated GFR values fell within a 30% margin of error compared to measured values. This level of accuracy is particularly noteworthy given the diversity in GFR values and skin tones among trial participants.

MediBeacon, based in St. Louis, Missouri, is renowned for its specialization in fluorescent tracer agents and transdermal detection technology, holding over 55 patents in the U.S. and more than 215 globally. While the TGFR system is primarily aimed at assessing kidney function, the technology's potential applications extend to fields such as gastroenterology and ophthalmology, where it is currently undergoing various stages of clinical development.

The TGFR system is not only a testament to technological innovation in medical diagnostics but also offers a promising new tool in the ongoing battle against chronic kidney disease, enhancing the ability of healthcare providers to deliver timely and accurate assessments of renal function.