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Helping physicians to make better decisions sooner.

MB-102 brand name is Lumitrace™

24-72 HOURS

Using SCr is like waiting for the quarterly financial report rather than realizing that the market is crashing today.

- Richard J. Solomon, MD, FASN, FACP
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Creating a new vital sign.*

Correct determination of GFR as an indicator of kidney function has the potential to bear great importance in the treatment of patients because experts believe that clinical decision-making could be aided by it in many situations.

In October of 2018 the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the Transdermal GFR Measurement System (TGFR). The device is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.

TGFR global Pivotal Study is underway.

The TGFR is engineered to allow non-invasive detection of the change in patient levels of fluorescent GFR tracer agent (Lumitrace™) over time via a sensor placed on the patient’s skin. The rate of decrease in the emitted fluorescence from Lumitrace™ is automatically calculated and displayed on the monitor yielding a measured GFR or kidney function.*

MediBeacon’s vision of a renal function vital sign is one where real-time measurements are accurate and responsive to changes in actual organ function. There are a vast number of situations in which real-time renal function data could have utility to physicians. Many of the uses for real time kidney function measurements will only be discovered with continued research. Some of the areas where real-time renal function measurements may have value may require repeat injections of MediBeacon’s proprietary dye to enable long-term, or repeat renal function measurements.**

Nephrology consultations that would include measurement of renal function are common in many clinical situations. Some possible uses for accurate real-time renal function measurements are presented below.

Intensive Care
Patients with numerous comorbidities involving the kidney commonly present in the ICU. Real-time, bed side renal function measurements have the potential to yield important information to aid in patient management.
Chronic Kidney Disease (CKD)

Experts believe that proactive and accurate diagnosis and monitoring of kidney function may potentially help delay the onset of End Stage Renal Disease (ESRD). Over 30 million adults are estimated to have CKD. 48% of those with severely reduced kidney function and 96% of those with mildly reduced kidney function are not aware they have CKD.

- Centers for Disease Control and Prevention of the United States (CDC) - National Chronic Kidney Disease Fact Sheet, 2017

Cardiac Catheterization Lab

Experts believe that accurate real-time GFR measurements could aid in the management of patients undergoing Percutaneous Coronary Interventions (PCI) in cases where kidney damage is perceived to be a risk.

Cardiac Surgery

Physicians are exploring ways to mitigate perioperative kidney damage risks. Accurate real-time GFR is anticipated to provide useful information which may contribute to improved management of cardiothoracic surgery patients.

Transplants (kidney, heart and liver transplants)

Monitoring kidney function for organ transplants is critical. Well-identified interventions exist to improve transplantation success rates. Earlier organ function knowledge could help clinicians in their efforts to improve the standard of care.

The TGFR is designed to accurately measure GFR in a clinically practical manner. The TGFR system includes a novel fluorescent tracer agent utilized in combination with a highly engineered transdermal sensor.*