The Loughborough, England-based company recently successfully completed clinical studies and two summative human factors usability studies needed to support De Novo submission.
“We are pleased to have submitted our De Novo 510(k) application to the FDA within our projected timelines thanks to our exemplary team of scientists and engineers,” CEO of Nemaura Faz Chowdhury said in a press release. “The global addressable market for CGM is estimated at $82 billion per year and over $13 billion in the U.S. alone. However, unlike type 1 diabetics, 30% of whom use CGM, the U.S. has an additional 84 million pre-diabetics. Currently, CGM usage amongst pre-diabetics and other non-insulin using diabetics is negligible.”
The SugarBEAT CGM is a flexible, disposable patch that’s connected to a rechargeable transmitter and Bluetooth-enabled smartphone app, designed to deliver glucose readings at five-minute intervals throughout the day. The company says the device allows users to spend more time in range by offering an ambulatory glucose profile chart.
“Unlike other devices on the market, as the world’s first non-invasive CGM, SugarBEAT does not puncture the skin to insert a sensor filament inside the skin. Instead, the sensor sits on top of the surface of the skin. For this reason, Nemaura believes the total addressable market for SugarBEAT is likely to be far greater at $179 billion, many times larger than the market addressable by the current competition,” Chowdhury said. “The FDA has a structured review process, which should allow the review to be expedited, and while awaiting feedback on the application, the company has now started to enter into discussions with key global companies in this space for commercialization in the U.S.”
Nemaura Medical won CE Mark approval for the SugarBEAT continuous glucose monitor earlier this year.