Nemaura Receives CE Mark Approval of SugarBEAT

Nemaura Medical (NASDAQ:NMRD) has announced it has received CE Mark approval for SugarBEAT, a non-invasive device for diabetics and pre-diabetics.

As quoted in the press release:

With this Approval, Nemaura is permitted to commence sales of SugarBEAT® throughout the European Union.

Key Highlights:

• SugarBEAT® consists of a non-invasive, needle-free, disposable adhesive skin-patch connected to a rechargeable transmitter
• Lowest priced CGM in the industry
• Enables users to spend more time in range (TIR) by providing an ambulatory glucose profile (AGP) chart
• Targeting $179 billion global market opportunity including insulin and non-insulin dependent diabetics, pre-diabetics, and wearable health-tech markets
• On track to submit U.S. Food and Drug Administration (FDA) application in mid-2019
• Dedicated SugarBEAT® Symposia planned for the European Association for the Study of Diabetes (EASD) Barcelona Congress in September 2019, where key opinion leader data and end-user feedback are to be presented
• CE Mark approval issued by British Standards Institute (BSI), including newly added predictive alert and alarm functionality
• Product launch in United Kingdom and Germany planned for next quarter
• Dr. Fred Schaebsdau, former General Manager of Dexcom Germany, to advise on SugarBEAT® launch

Dr. Faz Chowdhury, CEO of Nemaura, said, “We are very pleased to report CE Mark approval in Europe for SugarBEAT®, which is the world’s first non-invasive, needle-free, continuous glucose monitor (CGM).  Importantly, as a daily disposable adhesive skin-patch that sits on the surface of the skin, SugarBEAT® is painless, and versatile in terms of wear time. Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets.  In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth. Due to the non-invasive nature of the sensor patch and connection to a rechargeable transmitter, SugarBEAT® will allow users the freedom to decide when, and for how long to wear the patch. Moreover, we have a unique competitive advantage, which we believe will make SugarBEAT® the lowest priced CGM device in the industry.  SugarBEAT® is protected by a solid IP portfolio with over 30 issued and pending patents across multiple patent families.”

Click here to read the full press release.