MediBeacon is developing the first real-time monitoring of kidney function which has received ”breakthrough device designation” from the FDA and is being developed to address a $7bn market with no equivalent product currently available. According to the FDA, a “Breakthrough Device” like the Transdermal GFR Measurement System is a product that has the potential to be more effective at diagnosing a life threatening or irreversible debilitating disease or condition compared to the current standard of care.
Significant medical opinions exist that current diagnostic tests to measure kidney function are inaccurate, providing indirect measurements and are not real-time. Accurate kidney measurement is critical for treating patients in the hospital. 20-40% of patients are at risk for kidney failure in critical care settings (such as the ER, ICU, OR & recovery room).
MediBeacon’s Transdermal GFR (kidney function) Measurement System includes a patented compound, Lumitrace that is entirely eliminated by the kidneys. Lumitrace fluorescence is detected by a sensor placed on the skin, analogous to pulse oximetry for oxygen saturation.
Medibeacon’s technology platform can be expanded for use in gastrointestinal, ocular, and surgical visualization markets:
Gastrointestinal permeability is estimated to be a $1 billion market, fluorescent angiography of the eye is estimated to be a $200 million market, and surgical visualization is estimated to be a $100 million market.
US & global pivotal studies are expected to begin in late 2021/early 2022 with premarket approval submission expected in 2022.
The founders of MediBeacon are Steve Hanley, past President of Covidien’s $1.2 billion Imaging Diagnostic Platform and Dr. Richard Dorshow, the physicist inventor of the technology.
Strong patent portfolio: 139 granted patents and 199 pending applications.