Nemaura announces CE mark approval of SugarBEAT®

Loughborough,England, (GLOBE NEWSWIRE) — Nemaura Medical, ( NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, announced that it has received CE Mark approval for SugarBEAT®.  With this Approval, Nemaura is permitted to commence sales of SugarBEAT® throughout the European Union.

Key Highlights:

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.”

Continuous Glucose Monitoring has transformed diabetes management by providing real-time, continuous glucose readings, typically at 5 min intervals (12 per hour) which accumulate to provide an Ambulatory Glucose Profile (AGP) whereby glucose profiles over multiple can be overlaid to observe trends, patterns, and the extent of fluctuations and out of range glucose profiles.

Dr. Chowdhury continued, “SugarBEAT® is unique in that it can be worn on non-continuous, enhancing the flexibility and price savings.  As a result, we plan to initially target the Type II diabetes market (95% of diabetics) who have traditionally relied on periodic A1c readings (every 3-6 months) to manage glucose levels. A1c measurements have significant limitations in that they are derived from a lab blood test providing a single value representing the average glucose level over the past.  In contrast, CGM transforms glucose control by widening the focus from the limited ‘gold standard’ A1c metric to more meaningful ‘time in range’ (TIR) metric—measuring how much time per glucose is kept within the normal range.  The SugarBEAT® smartphone app displays glucose readings every five minutes for the duration of wear. Independent studies have shown that diabetes can be put into remission if glucose levels are consistently maintained in range. SugarBEAT® may also reduce the frequency of daily ‘finger prick’ tests utilized by many diabetics.”

The CE Mark approval includes recently added predictive alerts to the product design, which provide visual indication when glucose levels are falling or rising above minimum and maximum thresholds. Additional audible alerts or physical vibration of the Bluetooth-enabled mobile phone connected to SugarBEAT® occur in instances where glucose levels are deemed to fall to dangerously low levels, until switched off by the user.

“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.  In addition, given the flexibility and non-invasive nature of the device, we look forward to targeting the growing $60 billion wearable health tech market through partnerships with smartphone and wearable manufacturers.  Researchers, physicians and health-conscious consumers are increasingly recognizing the importance of maintaining glucose within appropriate ranges to minimize long-term health complications,” added Dr. Chowdhury.

The Company’s clinical studies were split between Type I and Type II diabetics and consisted of 75 patients over 225 patient.  The studies generated over 12,000 paired data points, with blood samples taken via catheter every 15 minutes over a 12-hour period for three non-consecutive for each patient.  The study design was based on two previous pre-sub meetings Nemaura held with the FDA, ensuring that the study would provide statistically valid results.  The clinical study results indicated a MARD (Mean Absolute Relative Difference) of 11.92% (with a lower figure denoting greater accuracy), using a single point finger stick calibration. No device-related adverse events were noted. The Company remains on track to apply for FDA approval in mid-2019.