FDA has granted breakthrough device status to the Transdermal GFR measurement system (TGFR) by MediBeacon Inc, St Louis. The device is intended to measure glomerular filtration rate (GFR) in patients with impaired or normal renal function.
Designated by FDA as a combination product, the TGFR system includes an optical skin sensor, a monitor, and MB-102, a proprietary fluorescent tracing agent that glows in the presence of light. The TGFR system is designed to provide clinicians with 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 for patients who have been diagnosed with kidney disease or are at risk of developing the disease. Kidney disease is a hidden epidemic, affecting more than 850 million people worldwide—twice the number of people who have diabetes, and more than 20 times the number of people with cancer.1–3
Under the breakthrough devices program, FDA works with companies to expedite regulatory review in order to give patients more timely access to diagnostic and therapeutic technologies. According to FDA, a breakthrough device is a product that has the potential to be more effective than the current standard of care for diagnosing or treating a life-threatening or irreversibly debilitating disease or condition.4
“We are delighted that FDA has recognized that the Transdermal GFR measurement system meets the requirements for this designation,” says Steve Hanley, CEO of MediBeacon. “We look forward to continued close collaboration with 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,” says Philip Falcone, chairman, CEO, and president of HC2, New York City, the holding company for MediBeacon’s principal shareholder, Pansend Life Sciences. “HC2 is committed to continued support of this remarkable innovation which has the potential to help millions of people around the world.”
The MediBeacon devices and tracer agents, including the TGFR system, are not yet cleared or approved for human use by any regulatory agency. Designed to enable clinically practical point-of-care measurement of a patient’s kidney function, the TGFR system is currently undergoing human clinical trials.
For further information, visit MediBeacon.
- The hidden epidemic: worldwide, over 850 million people suffer from kidney diseases [joint press release, online]. Washington, DC: American Society of Nephrology, 2018. Available at: www.asn-online.org/news/2018/0626-joint_hidden_epidem.pdf. Accessed December 4, 2018.
- The hidden epidemic: worldwide, over 850 million people suffer from kidney diseases [joint press release, online]. Parma, Italy: European Renal Association–European Dialysis and Transplant Association (ERA–EDTA), 2018. Available at: http://web.era-edta.org/uploads/180627-press-era-asn-isn.pdf. Accessed December 4, 2018.
- The hidden epidemic: worldwide, over 850 million people suffer from kidney diseases [joint press release, online]. Brussels: International Society of Nephrology, 2018. Available at: www.theisn.org/news/item/3317-the-under-recognized-epidemic-worldwide-over-850-million-people-suffer-from-kidney-diseases. Accessed December 4, 2018.
- Breakthrough Devices Program: Draft Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Md: FDA, 2017. Available at: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm581664.pdf. Accessed December 4, 2018.