Nemaura Medical is seeking approval from the US Food & Drug Administration (FDA) for its SugarBEAT continuous glucose monitoring (CGM) system.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The company has submitted its de novo 510(k) medical device application to the FDA for SugarBEAT following the completion of clinical studies and two summative human factors usability studies.
Nemaura is involved in the development of SugarBEAT as a non-invasive, affordable and flexible CGM to facilitate people with diabetes and pre-diabetics better manage their glucose levels.
With split between Type I and Type II diabetics, the clinical studies assessed 75 patients for more than 225 patient days.
The studies are said to generate over 12,000 paired data points, with blood samples taken through catheter every 15 minutes over a 12-hour period for three non-consecutive days for each patient.
Nemaura Medical CEO Faz Chowdhury said: “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.
“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 US.”
In May, the company secured CE mark approval for SugarBEAT system to market across the European Union.
SugarBEAT system includes a non-invasive, needle-free and disposable adhesive skin-patch connected to a rechargeable transmitter.
It will be connected via Bluetooth to a specially designed mobile application, which shows glucose readings at five-minute intervals across the day.
The system has been designed to enable users to spend more time in range (TIR) through using an ambulatory glucose profile (AGP) chart.