With the CE Mark approval, Nemaura Medical will be able to sell its SugarBEAT device across the European Union.
The device is the first non-invasive CGM that is also free of needles. It is made up of a disposable skin patch that connects to a rechargeable transmitter.
Thanks to the approval, the company will now be able to sell the device throughout the European Union.
“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,” Dr. Faz Chowdhury, CEO of Nemaura Medical, said in a press release. “Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets.”
According to Wednesday’s announcement, the CE Mark approval also applies to Nemaura’s recent addition of predictive alerts to the product design. These alerts give users a visual indication when glucose levels go below or above the minimum or maximum levels.
Chowdhury explained that the device can be worn on continuous days, which will allow the company to extend its reach to the Type II diabetes market. He added that the SugarBEAT’s smartphone app shows glucose readings every five minutes the entire time it is being worn.
“The inclusion of our new predictive alert capabilities will also have particular appeal to Type I diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Insulin users can adjunctively use SugarBEAT when calibrated with a finger-stick glucose reading,” Chowdhury said.
Following the CE Mark approval, the company said it remains on pace to submit its application to the US Food and Drug Administration (FDA) sometime in mid-2019, while its product lunch in the United Kingdom and Germany is planned for Q3.
On its path to achieving the CE Mark and FDA approval, the company conducted clinical studies of 75 patients with both Type I and Type II diabetes. The studies took place over 225 days and generated more than 12,000 paired data points. Blood samples for each patient were taken through a catheter every 15 minutes over the course of 12 hours for three non-consecutive days.
The CE Mark approval of Nemaura’s SugarBEAT device — and potential approval from the FDA — puts it in a comfortable position to compete in the diabetes device market in the coming years. According to a Grand View Researchreport, the global diabetes market is projected to reach US$35.5 billion by 2024, representing a compound annual growth rate of 7 percent during the period of 2018 to 2024.
Shares of Nemaura did not react favorably to Wednesday’s news. Following the announcement, the company’s stock dipped 3.68 percent to close the session at US$1.05.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.