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 >>
The MediBeacon Transdermal GFR 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® 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 Transdermal GFR System (TGFR) is being studied across a range of GFR levels.
The MediBeacon TGFR proposed indications for use include the measurement of Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. The FDA granted the TGFR a Breakthrough Device Designation because better tools are needed for the management of kidney patients. Subsequent to an eventual regulatory approval any improvement in the standard of care would need to be demonstrated in the clinic.
ST. LOUIS, October 22, 2018 – MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the company’s Transdermal GFR System (TGFR). The device is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.1
MediBeacon’s TGFR, which is designated by the FDA to be a combination product, includes an optical skin sensor, monitor and MB-102, which is a proprietary fluorescent tracer agent that glows in the presence of light. The TGFR is designed to provide clinicians continuous real-time measurement of GFR at the point of care with no need for blood sampling or urine collection.
The ability to measure GFR is of high clinical interest especially in patients with or at risk of kidney disease. Kidney disease is a hidden epidemic, affecting more than 850 million people worldwide. This is twice the number of people who have diabetes and more than 20 times the number of people with cancer. 2
Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with companies to expedite regulatory review in order to give patients more timely access to diagnostic and therapeutic technologies. According to the FDA, a “Breakthrough Device” like the TGFR is a product that has the potential to be more effective at diagnosing a life-threatening or irreversibly debilitating disease or condition compared to the current standard of care. 3
“We are delighted that the FDA has recognized the Transdermal GFR Measurement System meets the requirements for this designation,” said Steve Hanley, MediBeacon CEO. “We look forward to continued close collaboration with the FDA as we begin our pivotal multicenter clinical study in the United States and Europe.”
“We are extremely excited about MediBeacon’s breakthrough real-time kidney function measurement system,” said Philip Falcone, HC2’s Chairman, Chief Executive Officer and President. “HC2 is committed to continued support of this remarkable innovation which has the potential to help millions of people around the world.”
MediBeacon tracer agents and devices, including the TGFR, are not approved or cleared for human use by any regulatory agency.
1 Data on file. MediBeacon Inc., St. Louis, MO.
2 Joint Press Release, June 27, 2018 “The hidden epidemic: Worldwide, over 850 million people suffer from kidney diseases”, American Society of Nephrology – ASN(https://www.asn-online.org ), ERA-EDTA (http://web.era-edta.org) and ISN (https://www.theisn.org).
3 Food and Drug Administration. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM581664.pdf