This clears the path for Nemaura’s commercial launch of sugarBEAT, which has taken seven years to hone and perfect. The approval extends to sugarBEAT’s newly added predictive alert and alarm functionality. With this approval, Nemaura is permitted to start selling SugarBEAT throughout the European Union.
Shares in the Loughborough, England-based medtech company were up 27.5 % to $1.39 in trade.
“We are very pleased to report CE Mark approval in Europe for SugarBEAT,” said Nemaura Medical CEO Dr Faz Chowdhury in a statement. “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.”
A predecessor sugarBEAT device from Nemaura based on a wired wristwatch received CE Mark approval in 2016.
Chowdhury said Nemaura planned to target the wearable health tech market 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,” said Chowdhury. “Moreover, we have a unique competitive advantage, which we believe will make SugarBEAT the lowest priced CGM device in the industry.”
With sugarBEAT, Nemaura is sizing up a $3 billion European market opportunity for continuous glucose monitor (CGM) devices. The advanced device could prove a boon for 3.7 million people aged 18 or older who are living with diabetes in the UK.
• On track to submit US Food and Drug Administration application in mid-2019
• SugarBEAT symposia planned for the European Association for the Study of Diabetes (EASD) in the Barcelona Congress in September where end-user feedback will be presented
• Product launch in United Kingdom and Germany planned for next quarter
• Targeting $179 billion global market opportunity including insulin and non-insulin dependent diabetics, pre-diabetics, and wearable health-tech markets
• Dr Fred Schaebsdau, former General Manager of Dexcom Germany, to help Nemaura craft SugarBEAT's launch
Perfect for diabetics with needle phobia
Currently, diabetics and pre-diabetics have no option but to either prick their finger to draw a blood sample, or insert a sensor wire just under their skin using an automatic applicator. The insertion of a CGM device is painful, to put it mildly.
“I can’t see a scenario where a pre-diabetic would want to stick a sensor inside his arm and keep the device there for a few days,” Chowdhury earlier told Proactive Investors.
“The key difference between existing technologies and sugarBEAT is that with those you have a sensor which is up to 10 to 12 millimeters long that has to be inserted inside the skin. To insert it you need a needle and once you remove the sensor you can’t re-use it as it must be sterile. That’s one of the biggest downsides of the technology.”
“If you want to wear sugarBEAT for eight hours, you can do that. If you choose to wear it three times a week, you can do that whereas with the Libre and Dexcom once you’ve inserted the sensors you are stuck with wearing the devices for 10 to 14 days,” said Chowdhury.
SugarBEAT consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings every five minutes for periods up to 24 hours. The genius of sugarBEAT lies in its skin-patch technology which allows for better glucose management.
The diabetes market is so large that it can easily support Nemaura, Abbott, and Dexcom.
“The market unfortunately is vast. There are literally over 450 million diabetics and over twice as many prediabetics in the world,” said Chowdhury.
Given the high rate of diabetes, Europe represents a $3 billion market opportunity, while the United States is a $4 billion market.
Abbott’s Freestyle Libre 14-day system which has one million patients is expected to net approximately $1 billion in sales in 2018.
Nemaura is on track to submit a US Food and Drug Administration application in mid-2019, which could speed up sugarBEAT’s arrival on American shores.
Protected by patents
With sugarBEAT likely to disrupt the diabetes market, Nemaura has been careful to craft a smart patent strategy.
“We’ve got patents covering the algorithms and sensor platform which is fundamental,” said Chowdhury. “SugarBEAT is protected by a solid IP portfolio with over 30 issued and pending patents across multiple patent families.”
Chowdhury, a serial inventor and entrepreneur, is the brains behind sugarBEAT. The pharmaceutical scientist received his PhD in Nanomedicine from the University of Oxford. Today, Chowdhury holds 50 patents on drug delivery systems and sensors, across 15 technology platforms.
“For sugarBEAT, we have three core platform patents and they are filed in multiple countries. You can call it three patent families,” said Chowdhury.
—(Updates with UK, Germany launch, market size, CEO quotes)—
Contact Uttara Choudhury at [email protected]