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The Renal Function System

The Transdermal GFR Monitor is MediBeacon’s first product platform. This innovative system is focused on real-time, easy to use, and cost-effective monitoring of kidney function.

MediBeacon’s noninvasive monitoring technology works in a similar fashion to pulse oximetry by using a light sensor placed on the skin. After the sensor has been placed, a proprietary biocompatible tracer is administered. The system can then monitor the patient’s real-time point of care kidney function. This information will allow for earlier detection of renal issues enabling clinicians to provide earlier, and hence more effective interventions.

MediBeacon has created a research grade technique that is clinically applicable for real-time point of care Glomerular Filtration Rate measurement (mGFR). MediBeacon has invented a fluorescent tracer agent (MB-102) that is removed from the blood exclusively by the GFR mechanism of the kidneys. Together with our non-invasive detection device, this will deliver a real-time point of care measurement of GFR.

Animation of the Transdermal GFR Monitor system:

GFR measurement using Transdermal GFR Monitor:

  • An external probe (similar to that of a pulse oximeter) is placed on the skin (i.e. arm, forehead, chest wall, or sternum) and measures fluorescence as a function of time.
  • The patient is administered MediBeacon’s patented fluorescent tracer agent via IV bolus. MB-102 distributes throughout the body.
  • Measured fluorescence decreases over time as tracer agent is removed from the body via circulation through the kidneys. The removal rate of MB-102 is dependent on GFR (impaired kidney function has the lower rate of removal than normal kidney function).
  • The measured fluorescence time dependent curve is converted to an mGFR using algorithms embedded in the device monitor.
  • This non-invasive tool can be used throughout any procedure, or for as long as a patient’s renal function requires monitoring. The system has the potential to provide early detection of problems, enable rapid intervention, and thus improve patient outcomes in a cost-effective manner.

The Fluorescent Tracer Agent:

MB-102 is a pyrazine based small molecule. It is has been shown to be a GFR tracer agent in animal studies. Toxicity tests completed to date in animal studies show no adverse reactions detected for doses up to 200-300 times the estimated human dose. This agent and chemical analogs are either patented or have patents pending by MediBeacon.

Current Status:

  • Four peer-reviewed papers on the chemistry of our fluorophore platform have been published. The most recent paper, which covered the Pre-clinical toxicity evaluation of MB-102, was published in 2015 in the journal of Regulatory Toxicology and Pharmacology.
  • Target market segments were identified, major market research studies were performed, and market models constructed resulting in NPV values of multiple hundreds of millions of dollars.
  • A next generation noninvasive monitoring system for the continuing clinical studies is being built.

Who benefits?

The patient:

  • Optimizing care while minimizing the risk for renal failure and the need for dialysis or kidney transplant.
  • Earlier release from the hospital if renal function is shown to be ‘normal’ at the time of discharge even if serum creatinine is not yet back to normal.

The providers:

  • Provide new ‘gold standard’ of treatment.
  • Better utilize chemotherapeutic and antibiotic therapies while better managing the patient’s kidney health.
  • Provide the best possible outcome for patients under their care.

The payors:

  • Avoid the high cost of life-long dialysis and/or a kidney transplant.
  • Benefit from earlier patient discharge if kidney function is known to be normal.