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Life, illuminated.
Advancing fluorescent technology to help improve patient care.

MediBeacon is a medical technology company specializing in the advances of fluorescent tracer agents and transdermal measurement. The science is complex, but the outcomes are simple to understand. How it works >>

PRECLINICAL
MediBeacon technology is available for preclinical use.
CLINICAL
MediBeacon technologies are progressing through clinical trials.*
Focused on Providing Kidney Insights to Clinicians
GOAL: Target the Accuracy of Measured GFR in Real-Time

The MediBeacon Transdermal GFR Measurement System (TGFR) is engineered to allow non-invasive detection of the change in patient levels of a fluorescent GFR tracer agent over time via a sensor placed on the patient’s skin. The rate of decrease in the emitted fluorescence from Lumitrace®, a nonradioactive, non-iodinated fluorescent tracer agent, is automatically calculated and displayed on the monitor and is intended to provide information regarding the rate of clearance of Lumitrace injection which may be useful in the understanding of kidney function in real-time. The TGFR Monitor displays this information in the form of a transdermal GFR (tGFR).

The MediBeacon TGFR includes, Lumitrace (relmapirazin), an exogenous GFR marker administered as an IV bolus injection, the use of which is being shown in clinical studies to be equivalent to the use of iohexol plasma clearance for the determination of a measured GFR (mGFR).

The TGFR Sensor measures the intensity of Lumitrace fluorescence 2.5 times per second. The rate of decrease of Lumitrace fluorescence measured on the skin is being shown in clinical studies to be highly correlated with measured GFR (mGFR) as determined via Lumitrace plasma clearance.

The TGFR Monitor displays real-time information regarding the rate of decrease in Lumitrace fluorescence and how this changes over time. The monitoring of tGFR changes may prove clinically useful in the assessment of GFR at the point of care.

During a TGFR monitoring session the TGFR Monitor displays fluorescence data collected by the TGFR Sensor. This data is intended to provide an indication of changes in tGFR over time. The duration of a transdermal GFR monitoring session depends on a patient’s kidney function.

GOAL: tGFR Measurement Across All Skin Tones

The Medibeacon Transdermal GFR Measurement System (TGFR) has been designed to measure tGFR across the full range of human skin colors as quantified by the Fitzpatrick Skin Prototype (FSP). The FSP classifies human skin colors into six broad categories.

1 Australian Government – ARPANSA
(Note: Number one should be superscripted. Can use the same styling as the Food and Drug Administration text under the body copy in the section below this,)

Understanding Renal Function is a Significant Clinical Challenge
The Medibeacon TGFR Designated a Breakthrough Device by FDA

The Medibeacon TGFR proposed indications for use include the measurement of Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. Better tools for the management of kidney patients are needed. Consistent with this 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. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating diseases or conditions. More >>

– Food and Drug Administration. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM581664.pdf

There are no limits to our thinking or what that thinking can accomplish.
Focus areas for
fluorescent agent-
based systems include:
Nephrology

Point of care measurement of renal function **
-Learn More

Gastroenterology

Point of care gastrointestinal
permeability measurement
-Learn More

Ophthalmology

Fluorescent agent angiography
-Learn More

Surgery

Fluorescent tracer agent
use in surgery
-Learn More

United States
425 N. New Ballas Road
Suite 100
St. Louis, MO 63141
P: (314) 269-5808

Germany
Cubex41
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
P: +49 (0)621-150283-15

Greater China
Huadong Medicine Co., Ltd
Telephone: 4008-269-985
+86-(0)571-89908581
Zip: 310011
Address: No.866. Moganshan Road, Hangzhou, Zhejiang Province, China
Email: info@eastchinapharm.com

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*MediBeacon products are in various stages of clinical development and are not yet approved for human use.

**The Transdermal GFR Measurement System (TGFR) is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. References on this website to measured kidney function and measured renal function refer to the measured GFR.

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