Nemaura Medical expands painless sugarBEAT glucose monitor footprint in Europe, and eyes entry into US market

The UK-based medtech company has developed sugarBEAT, the world’s first painless, non-invasive glucose monitor Nemaura is a player in the digital healthcare revolution through its offerings enveloping Artificial Intelligence, devices and digital platforms  In addition to sugarBEAT, the company plans to launch a health subscription service and its proBEAT wellbeing device in the US What Nemaura Medical does: Nemaura Medical Inc (NASDAQ:NMRD) is developing micro-systems based wearable diagnostic devices and commercializing sugarBEAT, the world’s first non-invasive continuous glucose monitor (CGM) for people with diabetes and pre-diabetes. The devices and sugarBEAT are offered with BEATdiabetes, a planned health subscription service designed to help people with Type 2 diabetes and pre-diabetes through personalized lifestyle coaching. SugarBEAT consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings every five minutes for up to 24 hours. The genius of sugarBEAT lies in its skin-patch technology which allows for better glucose management. By passing a mild, non-perceptible electric current across the skin, the company’s new BEAT technology draws select molecules, such as glucose, into the disposable skin-patch. These molecules are picked up from the tissue fluid which pools naturally below the top layer of skin. With the help of a Nano-sensor, the patch measures the molecules, giving the person a quick clinical read and diagnosis. In addition, Nemaura is evaluating new applications for continuous lactate monitoring (CLM) using its BEAT platform to keep tabs on disease progression in coronavirus (COVID-19) patients. Nemaura believes that by adapting the sensor chemistry, algorithm and mobile app interface initially developed for sugarBEAT, the BEAT platform has the potential to be utilized for several markets beyond glucose monitoring and diabetes. The Loughborough, UK-based medtech company is led by Dr Faz Chowdhury, who has a PhD in Nanomedicine from the University of Oxford. The pharmaceutical scientist holds 50 patents on drug delivery systems and sensors across 15 technology platforms. He is the inventor and driving force behind sugarBEAT. How is it doing: Medical technology companies live and die by regulatory decisions, so it has been a busy year for Nemaura since sugarBEAT received CE approval in May 2019. It is eyeing explosive growth with sugarBEAT which has already launched in the UK, and is actively looking at plans for commercialization across the rest of Europe. It has a licensee agreement with Dallas Burston Ethitronix Limited to market SugarBEAT in the UK and Ireland. To accelerate its commercial strategy, the company as of August had about $18 million in cash to help fund the commercialization of its diagnostic devices and subscription services. Nemaura also strengthened its financial position by reducing research and development as well as general and administrative expenses in the first fiscal quarter of of 2020.  Meanwhile, Nemaura submitted a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for sugarBEAT, which has been in the making for seven years. The US represents the largest single market for sugarBEAT, according to the company. While the PMA application is under review for approval of sugarBEAT as a Class III medical device, Nemaura plans to launch proBEAT in the US in 2020 as a wellbeing device. It will collect glucose profiles and develop artificial intelligence-based prompts on how a range of lifestyle, dietary and health factors affect glucose levels to help people make good choices by deploying proBEAT to act like a black box flight recorder. Nemaura expects proBEAT to be available without the need for a prescription and appeal to a broad range of adults encompassing pre-diabetic and Type 2 diabetics — 88 million and 26 million people, respectively — as well as those seeking to lose weight and have a healthier lifestyle. The company recently inked a letter of intent to acquire diabetes firm Healthimation LLC which it believes this could complement proBEAT. Healthimation is commercializing an application-based diabetes prevention program that has been developed over 12 years and is supported with clinical data. Since sugarBEAT doesn’t require needles or insertion it will challenge entrenched players like DexCom Inc (NASDAQ:DXCM) which markets the Dexcom G6 and Abbott Laboratories (NYSE:ABT) Libre System. 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 is painful, to put it mildly. Abbott’s Freestyle Libre 14-day system generates strong sales and netted roughly $1 billion in sales in 2018. Given the high rate of diabetes, Europe represents a $3 billion market opportunity, while the United States is a $4 billion market. Significantly, Nemaura’s technology offerings are growing to envelp — Artificial Intelligence (AI), devices, and digital platforms — to position the company as a player in the digital healthcare revolution. The company’s BEAT technology has applications in athletic performance monitoring through lactate monitoring. Based on recently published independent clinical evaluations, the company recently said “measurement of blood lactic acid has been established as an indicator for disease progression in COVID-19 patients” which could be an additional target market. Inflection points: Near-term revenue from sugarBEAT’s UK commercialization as it has received its CE mark and is currently in production After the first wave of shipments to the UK, the company plans to launch sugarBEAT in Germany at a price comparable to the cost of using glucose meters and strips There’s massive upside potential as Nemaura has submitted a Premarket Approval application to the US FDA for sugarBEAT Nemaura is also gearing up to sell its glucose device in other geographies like the Middle East and Australia that accept CE Mark approval On a long-term basis, the company will gain traction from its plan to launch a health subscription service and its proBEAT wellbeing device in the US It's a win-win as Nemaura establishes itself as a player in the booming digital healthcare space by cutting deals and embracing AI, devices, and digital platforms Beyond diabetes and glucose trend management, BEAT technology has applications in athletic performance monitoring (lactate monitoring) and alcohol addiction recovery through continuous alcohol monitoring What the boss says: “This is a very exciting period for Nemaura Medical as it has steadily transitioned toward commercialization of its lead product, sugarBEAT, initially in the UK and Germany,” said Nemaura Medical CEO Faz Chowdhury. “Our ability to simultaneously launch product in the US under the wellbeing category also provides a significant commercial opportunity. We intend to take full advantage of this opportunity, given the sheer scale of the market in the US.” What the broker says: Analysts at Ascendiant Capital Markets initiated coverage of Nemaura with a Buy rating, noting that CE mark approval was an "exciting achieved milestone." "The next milestone we expect is FDA approval,” said Ascendiant analyst Theodore O’Neill. “The technology has additional target markets that will also be pursued including continuous lactate monitoring which is aimed at elite athletes, those who train to become elites and those that simply want to perform at their best.”  The analyst said Nemaura is targeting a $179 billion global market opportunity including insulin and non-insulin dependent diabetics, pre-diabetics, and wearable health-tech markets. “Nemaura has game-changing technology to help those with diabetes and those who want to improve and extend life spans,” said O’Neill. O’Neill said the “fastest growing adopter group” for sugarBEAT will be biohacking’s poster boys like Geoffrey Woo, cofounder and CEO of specialized foods company HVMN and Twitter Inc (NYSE:TWTR) CEO Jack Dorsey. Meanwhile, analysts expect sugarBEAT’s “superior product” profile to drive market share gains. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive