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GOAL: Provide tools to help physicians make timely decisions.
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MediBeacon products are in various stages of clinical development and are not yet approved for human use.
The TGFR Designated a
Breakthrough Device by FDA

Better tools for the management of kidney patients are needed. This is one of the reasons FDA granted the TGFR a Breakthrough Device Designation in recognition that the technology has the potential to provide for more effective patient management. Subsequent to an eventual regulatory approval any improvement in the standard of care would need to be demonstrated in the clinic.

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Transdermal GFR Measurement System (TGFR) Animation

Understanding Renal Function is a Significant Clinical Challenge
Epidemiology of Chronic Kidney Disease1

Extremely Common:
Approximately one in ten individuals has Chronic Kidney Disease (CKD). As of 2017 this was over 843 million people.

Increased Prevalence:
CKD is more common in individuals with diabetes, racial minorities, women, the elderly and individuals with hypertension.

Increasing Death Rate:
It is projected that by 2040 CKD will be the 5th leading cause of death. As of 2022 this is up 41.5% from 2013 when CKD was only the 19th leading cause of death.

The TGFR phase 3 study enrollment is complete.

The MediBeacon® Transdermal GFR Measurement System (TGFR) is engineered for noninvasive detection of the change in levels of a fluorescent GFR tracer agent over time via a sensor placed on the patient’s skin. The TGFR Sensor measures the intensity of Lumitrace® fluorescence 2.5 times per second. The rate of change in the emitted fluorescence from Lumitrace is automatically calculated and displayed on the monitor yielding a transdermal GFR (tGFR).

Focused on Providing Insights to Clinicians
Clinical Situations Where GFR is Important

Chronic Kidney Disease (CKD)
CKD is a growing epidemic and has devastating consequences. This is prompting major efforts to develop preventive and therapeutic measures that are effective. Tools to measure GFR as an indicator of kidney function are needed.

Therapy Dosing (CKD)
Underestimation of GFR may exclude patients from receiving optimal therapies. Conversely, overestimation of GFR may result in patients experiencing adverse effects.2 Tools to measure GFR may be helpful in this context.

Transplantation Donor Evaluation
Evaluation of GFR is required as part of donor evaluation and is receiving increasing emphasis, as recent data from the general population demonstrate increased risks associated with reduced GFR, and data from kidney donors demonstrate increased risks of kidney disease after donation, including a small increase in the risk of kidney failure.3

Kidney Function Assessment in the Hospital
Clinicians base patient categorization and sophisticated treatment decisions, sometimes extremely invasive and expensive therapies, on GFR levels.4 Bedside renal function measurements have the potential to yield information to aid in patient management.

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.*