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 … Continued
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.
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