Based in Loughborough, England and founded in 2013, Nemaura Medical (NASDAQ: NMRD) is expected to launch SugarBEAT® in the UK this year. Launches in key markets across Europe and beyond are anticipated to quickly follow.

The company has made significant progress toward completion of its CE Mark for SugarBEAT®.

watch and phone showing Nemaura Medical app

In its recent shareholder update, CEO Dr. Faz Chowdhury commented, “We are working closely with our designated European Notified Body, British Standards Institute (BSI), a global leader in accreditation services, on a Fast Track application. The clinical review was completed in December 2018, and based on the ongoing dialogue, we are now in the final stages of the review process, after which Nemaura expects CE approval will be issued.”

Nemaura is also pursuing FDA approval and recently announced successful completion of the clinical studies needed to support the De-Novo 510(k) submission.

The clinical studies used were split between Type I and Type II diabetics, and 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.

The study design was based on two previous pre-sub meetings Nemaura held with the FDA, ensuring that the study meet adequacy requirements to provide statistically valid results.

In April, Nemaura announced the completion of the final step ahead of filing its de novo application with the FDA with the successful completion of two summative human factors usability studies for SugarBEAT®.

“We are pleased to have successfully completed these important studies and we are preparing our FDA filing at this time,” commented Dr. Chowdhury.

Combining clinical research with patient-friendly technology, sugarBEAT® is expected to deliver a non-invasive, affordable and flexible method of tracking blood glucose for better diabetes management.

Nemaura Medical arm patch

Nemaura’s 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.

SugarBEAT® is expected to help person with diabetes and pre-diabetics better track how lifestyle factors can impact daily glucose level trends (known as an Ambulatory Glucose Profile) thereby significantly improving the amount of daily time spent in range.

This behavioral change in turn should help delay or even prevent long term health damage typically caused by diabetes.

Passing a mild, non-perceptible electric current across the skin, sugarBEAT® painlessly draws a small amount of glucose molecules out of the interstitial fluid which naturally sits just below the top layer of skin, into a chamber within the patch.

The rechargeable transmitter then measures the glucose levels present within the chamber, and securely transmits this clinically relevant data every five minutes via Bluetooth to a pre-downloaded smart phone / device app.

Using a proprietary algorithm, the app then converts this data into glucose values. In order to better understand how glucose levels are affected by lifestyle factors, diet / medication / exercise / mood data can also be inputted into the app.

traditional glucose monitoring
noninvasive gloocose monitor

Traditional way of glucose monitoring vs the the non-invasive sugarBEAT® device

Comparable continuous glucose monitoring devices from Abbott, Dexcom, and Senseonics average 2-3x the daily cost, involve invasive needles or implants, and have extended wear requirements of between 10 to 90 days.

Moreover, whilst both Dexcom and Abbott have blazed a path toward wider acceptance and strong patient adoption of CGM technology amongst insulin users, they have practically zero penetration in the much larger non-insulin using diabetic and pre-diabetic markets.

The real benefit comes from the fact that they have disrupted the market enough to allow for additional competitors, like Nemaura, that can better fill the voids initially opened by both Dexcom and Abbott.

Nemaura’s SugarBEAT® has a wear time of up to 24 hours, allowing for greater flexibility, with users able to wear on a non-consecutive day basis, unlike other glucose monitors.

SugarBEAT’s® easy monitoring provides a visible indicator of fluctuations in glucose levels, helping patients better understand the factors that affect these levels, while reducing diabetic complications and improving quality of life.

Although it already has multiple advantages over similar technologies, Nemaura continues to seek ways to improve the technology.

Earlier this year, the company announced that it reduced the skin-patch warm-up period of SugarBEAT® from over an hour to a period of less than 30 minutes. This is important as faster application is expected to result in increased device adoption.

In April, Nemaura announced the addition of new predictive alert functionality to SugarBEAT®.

Alerts have been designed to provide visual indication when glucose levels are falling or rising above minimum and maximum thresholds. Audible and vibration alerts are also available through Bluetooth-connected mobile phones.

In May, the company announced it will allow third-party applications, such as diabetes management, exercise and nutrition focused apps royalty free access to SugarBEAT® CGM app data.

daily-disposable adhesive skin-patch connected to a rechargeable transmitter

As a result, users will be able to directly access SugarBEAT® generated glucose data through their preferred participating mobile aplications, empowering users with greater choice over when to use this data to better understand how food choices and other lifestyle factors impact glucose levels.

This development is part of the company’s broader go-to-market strategy, which is being led by Dr. Fred Schaebsdau.

Dr. Schaebsdau joined the Company earlier this year to advance the commercialization and business development of SugarBEAT®, building on his success with earlier CGM products at Abbott Diabetes Care and Dexcom Germany.

Dr. Schaebsdau commented, “We believe integrating SugarBEAT® data into the leading health and fitness apps will help to expand our target market among health-conscious consumers, providing them with seamless access to their CGM data within a familiar environment, which will assist in understanding how diet, sleep, stress, exercise and other lifestyle factors can impact glucose levels. Given SugarBEAT® is non-invasive, we believe it is uniquely placed amongst CGMs to appeal to the health-conscious consumer market.”

Further enhancements to the SugarBEAT® platform are likely as user feedback pours in post-launch.

SugarBEAT® is based on a platform technology that can be adapted to a broad range of diagnostics beyond glucose monitoring.

Current development projects underway include products for wellness and pre-diabetics, including pediatric coverage.

Longer-term, development plans include monitoring/diagnostic solutions for Phenylketonuria, inflammation, anaerobic metabolism, drug treatment regimen optimization, and lactate monitoring (ideal for performance training).

In preparation for its impending launch in the UK and beyond, Nemaura has secured multiple key distribution relationships.

Throughout the UK and Ireland, Nemaura has enlisted the help of Dallas Burston Ethitronix (DBE).

DBE was founded by Dr. Dallas Burston, a pharma marketing entrepreneur with a strong track record of selling breakthrough medical products into European markets.

Dr. Burston has generated $200M+ selling medical companies he founded to big pharma players.

SugarBEAT® was also licensed to Dubai-based TPM for sales in the Middle East, a region with an estimated 35 million diabetics, and a leading device distributor has signed on for sales in Australia and New Zealand.

After hitting the market later this quarter, Nemaura believes that they can substantially grow the CGM market which typically targets insulin using patients, where Dexcom is projected by end of 2018 to have sales of circa $950 million across 300,000 device users and Abbott is projecting sales of circa $1+ billion with 950,000 users estimated by end of 2018 alone.

Given there are more than 400 million persons with diabetes globally, of which an estimated 25% or 100 million require insulin, the opportunity for market growth of CGM is very large.

Not only is Nemaura capable of winning substantial market share in the $82 billion global CGM market, SugarBEAT® can also bring glucose trending to the 300 million non-insulin using persons with diabetes and more than one billion pre-diabetic market that is currently grossly underserved. And for investors, that is where a substantial portion of the value opportunity lies

Combining the sum of the parts, investors should pay close attention to Nemaura as it continues to develop innovative opportunities that may quickly seize a significant portion of the global glucose and lactate monitoring markets.

From an investment standpoint, Nemaura’s stock, at these levels, may offer a sizable opportunity for investment growth based on untapped, near-term, and emerging potential.

Like other successful emerging biomedical companies, Nemaura Medical is taking advantage of a real-time medical need. And, in serving the pre-diabetic market, they are also seizing a massive global opportunity in the process.

The primary market advantage of sugarBEAT® is that it provides real-time data to patients that often struggle to know how their glucose levels are fluctuating. While finger-stick methods allow for quick reading, they falter in comparison by not providing a constant stream of current data that allows for a patient to modify lifestyle to maximize optimum glucose levels.

Hence, sugarBEAT® is in the right market at the right time. Starved for innovation that utilizes the latest available technology, Nemaura's SugarBEAT® may ultimately be positioned as the potential best alternative to currently marketed glucose monitoring products based on its inherent advantages.

By providing vital data throughout the day without the need to adjust lifestyle or diet, sugarBEAT® allows patients an opportunity to benefit tremendously from its unique and proprietary platform that is intended to transform the landscape of how patients receive and utilize data. While other devices and monitors provide a snapshot of a given moment, they can't offer the continuous flow of information that sugarBEAT® can provide, which is an essential aspect of actually understanding how to live with diabetes in a manner that can help to minimize the fluctuations of abnormal glucose levels.

For Nemaura Medical, the opportunity is not only marketable but is a practical solution to glucose trending for a current market of more than one billion people. Understanding the market potential for not only sugarBEAT® but for the entire BEAT® platform, NMRD appears to be significantly undervalued at current share price levels and has significant opportunity to grow into a much higher valuation.

Based on the devices price point, its ease of use and real time provision of data to patients, sugarBEAT® may indeed become a strong competitor in the glucose monitoring market, especially attractive to the pre-diabetic market where lifestyle changes can help to prevent the onset of the disease. While others are entering the CGM market, only Nemaura Medical's SugarBEAT® appears to currently provide the complete package of non-invasive, real-time results that patients need when treating and monitoring both diabetes and blood glucose levels.

Combining the sum of the parts, investors should pay close attention to Nemaura Medical as it continues to develop innovative opportunities that may quickly seize a significant portion of the global glucose and lactate monitoring markets. From an investment standpoint, Nemaura Medical stock, at these levels, may offer a sizable opportunity for investment growth based on untapped, near-term, and emerging potential.