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Nephrology
Goal: Provide tools to help physicians make timely decisions.
Now Approved
Transdermal Kidney Function Technology
Via PMA No. P2300019 for human use
For approved transdermal kidney function products see ifu.medibeacon.com for Indication for Use and Important Safety Information about the TGFR including Lumitrace® injection.
MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function. More >>
MediBeacon Transdermal GFR System (TGFR)

The TGFR is engineered to allow 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 Monitor displays this information in the form of a transdermal GFR (tGFR) which may be useful in the understanding of kidney function.

The MediBeacon TGFR includes, Lumitrace (relmapirazin), an exogenous GFR tracer agent administered as an IV bolus injection. For the determination of a measured GFR, Lumitrace (relmapirazin) has been shown to be equivalent to the use of iohexol plasma clearance.1

1 Dorshow RB, Debreczeny MP, Goldstein SL, Shieh JJ. Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102). Kidney Int. 2024 Oct;106(4):679-687. doi: 10.1016/j.kint.2024.06.012.

The TGFR Sensor is engineered to non-invasively measure the intensity of the Lumitrace injection 2.5 times per second continuously throughout the session. The sensor is placed on the patient’s skin and measures the fluorescence of Lumitrace transdermally.

During a monitoring session, the TGFR Monitor displays fluorescence data as it is collected. The Average Session GFR is displayed on the monitor at the end of a full session, which may last 6 to 24 hours depending on renal function.

Understanding Renal Function is a Significant Clinical Challenge
Epidemiology of Chronic Kidney Disease2

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. This is up 41.5% from 2013 when CKD was only the 19th leading cause of death.

For approved transdermal kidney function products see ifu.medibeacon.com for Indication for Use and Important Safety Information about the TGFR including Lumitrace® injection.

2 Csab P. Kovesdy, Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplements, Volume 12, Issue 1, P7-11, April 2022, 12,doi: 10.1016/j.kisu.2021.11.003.
Focused on Providing
Insights to Clinicians
Possible Clinical Uses for Transdermal GFR

Chronic Kidney Disease (CKD)
CKD is a growing epidemic and has devastating consequences.

Therapy Dosing (CKD)
An assessment of GFR is used to determine if patients are eligible for receiving some therapies, such as guideline-directed medical therapy for heart failure and anticancer drugs. Accurate assessment of kidney function can help reduce the risk of patients experiencing hyperkalemia from mineralocorticoid antagonists and toxicity from renally cleared chemotherapy.

Transplantation Donor Evaluation3
Evaluation of GFR is required as part of donor evaluation and is receiving increasing emphasis. Recent data from the general population demonstrate increased risks associated with reduced GFR. Data from kidney donors demonstrate increased risks of kidney disease after donation, including a small increase in the risk of kidney failure.

Kidney Function Assessment in the Hospital
Clinicians base patient categorization and sophisticated treatment decisions, sometimes extremely invasive and expensive therapies, on GFR levels. Bedside renal function assessments have the potential to yield information to aid in patient management. Identification of high-risk patients preoperatively could affect clinical decision making around surgical technique.

3 J Am Soc Nephrol. 2017 Apr; 28(4): 1062–1071.
For healthcare and patient fact sheets for approved transdermal
kidney function products see ifu.medibeacon.com.

The TGFR is designed to accurately detect the change in patient levels of a fluorescent GFR tracer agent over time via a sensor placed on the patient’s skin. The TGFR system includes a novel fluorescent tracer agent, Lumitrace®, utilized in combination with a highly engineered transdermal sensor.

MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable assessment of organ function.*

Indication for Use:
The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function.

The MediBeacon® TGFR is not approved for use in patients with GFR <15ml/min/1.73m2, GFR >120ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).

The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR.

The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient’s skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor.

Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment.

Contraindication:
There are no known contraindications.

Warnings and Precautions:

  • See ifu.medibeacon.com for full instructions, warnings, and cautions.
  • In clinical studies no serious or severe adverse events have been observed.
  • Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace.
  • Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing.
  • Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established.
  • During a TGFR session, the patient should be as still as possible, especially during the “Establishing Baseline” stage. The system is designed to compensate for light activity such as reading or eating after the Baseline stage.

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

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

Greater China
(Commercial Partner)
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 development.

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