Nemaura Medical Inc. (NASDAQ: NMRD)
Nemaura Medical Inc. (NASDAQ: NMRD) is a medical technology company developing affordable diagnostic and digital tools for chronic disease management. Its flagship product, sugarBEAT®, is a wearable, non-invasive and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and prediabetes manage their glucose levels. Insulin users can adjunctively use sugarBEAT when calibrated with a finger-stick glucose reading.
sugarBEAT consists of a daily disposable adhesive skin patch connected to a rechargeable transmitter with a smartphone app displaying glucose readings at five-minute intervals for periods of up to 24 hours. One of the great advantages of the product, apart from the fact that users no longer need to draw blood samples or prick their fingers, is that a person can wear the CGM patch on whatever day they choose. Existing CGM devices must be implanted under the skin. Wearable disposability is a unique feature of sugarBEAT and a world first, opening up vast potential for changing the way people manage their chronic disease conditions. sugarBEAT received CE mark clearance in May 2019, allowing it to be marketed and sold within the European Union as a Class 2b Medical Device. The company submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration in 2020 which is currently under review.
Founded in 2011, Nemaura set out to develop a single platform technology to measure blood markers at the surface of the skin. Since then, the company has evolved with the creation of wearable technologies and digital health care solutions that encourage and empower people to take charge of their own health and well-being. Nemaura's skin surface blood monitoring technology has allowed the company to create additional products, which are in the pipeline, such as Lactate Monitoring.
Digital Solutions for Weight Loss and Potential Reversal of Type 2 Diabetes
This is a digital program that comes with more than a decade of clinical evidence demonstrating excellent efficacy. The company has combined this with its glucose-monitoring platform to bring a product to market to help people with diabetes manage their condition and potentially reverse Type 2 diabetes.
Glucose Monitoring Solutions for Diabetes Prevention and Reversal
Over 420 million people worldwide are living with diabetes, and prediabetes cases total almost three times that number. Undoubtedly, diabetes is an urgent global health crisis. Combining clinical research with patient-friendly technology, Nemaura's sugarBEAT product delivers a non-invasive, affordable and flexible method of blood glucose tracking for improved diabetes management.
Continuous Lactate Monitoring for Athletic Performance (Non-Medical)
Lactic acid is a key performance indicator for the body and a guide to how well muscles react to long term exertion and recovery. Well-trained athletes and those who regularly engage in sports are very efficient at faster lactate 'recycling' for extra energy (ATP). Nemaura expects to launch its lactate sensor to the sports and personal training market in 2022.
Continuous Lactate Monitoring in Disease State (Medical)
An increase in blood lactate levels is also a marker of critical disease states. Recent publications have indicated the presence of elevated lactate levels in patients with COVID-19 infection. Nemaura has developed a lactate sensor that is being integrated into the company's platform, which will be submitted for regulatory clearance upon completion of requisite clinical studies.
Continuous Temperature Monitoring for Viral Infection Detection and Disease Progression
A person's body temperature says a lot about their health. Several diseases, including COVID-19, are characterized by an increase in body temperature, so temperature monitoring is a vital tool in the detection, diagnosis and prevention of the spread of disease. Nemaura is expecting to submit this adaptation of the device for regulatory clearance in 2022.
On September 29, 2021, Nemaura announced the beta launch of MiBoKo, a new metabolic health program utilizing a non-invasive glucose sensor along with an AI based mobile application. In development for 18 months leading up to the announcement, MiBoKo addresses a significant mass market opportunity that Nemaura believes could benefit roughly a third to half of the population by measuring and monitoring users' metabolic health scores, which are based on glucose tolerance or insulin resistance.
"A person's response to sugar intake can influence a number of factors from appetite and body weight to sleep patterns, energy levels, and even mood, not to mention also being a considerable factor in chronic diseases like diabetes, heart disease and dementia," Dr. Faz Chowdhury, CEO of Nemaura, stated in announcing the beta launch. "With MiBoKo, we are able to extend our proprietary non-invasive device and sensor technology and interactive lifestyle and AI based coaching programs beyond the traditional diabetes market and into an adjacent, yet separate, market application of metabolic health. At Nemaura, we continue to look for the intersection of patient comfort and convenience through advanced and unique technology that addresses significant healthcare needs for large patient populations. We believe that MiBoKo offers insights into metabolic health in a user-friendly way unlike any other program on the market."
Anyone interested in participating as a MiBoKo user can now register for the beta program at www.MiBoKo.com. There is no cost during the beta period, with approved MiBoKo beta testers receiving the sensors and AI based program free of charge.
Obesity and diabetes are two of the major drivers of the current chronic disease epidemic. According to the International Diabetes Federation, there are more than 463 million people living with diabetes worldwide. In the U.S., about 28,000 people are diagnosed with diabetes every week, and more than 34 million suffer from diabetes. Another 88 million Americans have prediabetes. Other industrialized countries show similar numbers based on their populations. In the U.K., 4.8 million people have diabetes, with another diagnosed every two minutes. In Germany, 9.5 million have diabetes, with almost half estimated to be undiagnosed and so at greater risk.
On average, employers and insurers spend more than $9,000 annually on health care for an employee with diabetes, compared to $1,600 annually for a healthy employee. In the U.S. alone, more than $760 billion was spent on diabetes-related health care expenditures during 2019. Nemaura is positioned at the intersection of the global Type 2 diabetes market that is expected to reach nearly $59 billion by 2025, the $50-plus billion prediabetic market, and the wearable health-tech sector for weight loss and wellness applications forecast to hit $60 billion by 2023.
Dr. Faz Chowdhury has been CEO and chairman of the board of Nemaura Medical since 2013. He has more than 20 years of experience in the pharmaceutical and medical devices industry, taking products from concept to commercial launch. He is sole inventor on more than 100 granted and pending patents and has authored textbook chapters on nano-biosciences for Wiley and Elsevier. He holds a master's degree in microsystems and nanotechnology from Cranfield University, and a doctorate from the University of Oxford in nano-medicine and drug delivery.
Justin Mclarney is CFO at Nemaura. He most recently was the Senior Director, International Finance at Lands' End Inc. He also worked for Office Depot as Senior Director of Finance for the largest business unit within the European group. Prior to that, he spent more than 10 years in practice, the majority of which was with Ernst & Young LLP.
Dr. Fred Schaebsdau is Vice President of Strategy & Strategic Alliances at Nemaura. He has more than 15 years of executive experience in the CGM, blood glucose monitoring and insulin delivery industries, including time with Abbott Diabetes Care, as General Manager of Dexcom Germany and at Roche Diabetes Care, where he was Senior Vice-President, Head of Global Strategy and Business Development. The firm he founded is the exclusive distributor in Europe, the Middle East and Africa of UniStrip®, the world's first generic blood glucose test strip. He is licensed to practice medicine in the U.S. and Germany.
David Scott is Director of Commercial Development and Licensing at Nemaura. He is a trained chemist with over 35 years of experience in the pharmaceutical industry, including deal brokering, marketing, strategic planning, finance, business development and acquisitions. He has also provided licensing training for a number of multinational pharma companies and training organizations and is the author of best-selling report Scrip's Practical Guide to Pharmaceutical Licensing.