Advancing Wearable Devices Grant Patients and Doctors Greater Flexibility

NEW YORK: The increasing trend of connectivity, as well as the spread of the Internet of Things (IoT) and its proliferation throughout wearable devices is expected to drive the growth of the wearable medical device market globally.

After the gradual integration of IoT technology in recent years, wearable devices are now capable of advanced remote monitoring of vital signs and health statistics. This has led to the development of remote patient monitoring (RPM) devices, which have seen a strong demand as the number of people with chronic medical conditions and the geriatric population are both growing. In the long run, IoT can help provide the public with better control over their health outcomes. This is due to the use of RPM devices, which can improve the management of chronic diseases by measuring critical risk indicators, such as glucose, blood pressure and others. RPM also has various benefits for end users and hospitals, such as low cost of healthcare, the reduction of extended hospitalization as well as fewer doctor appointments. Overall, the global wearable medical device market size is expected to reach USD 29.6 Billion by 2026 and at a Compound Annual Growth Rate (CAGR) of 17.7%, according to Transparency Market Research. Nemaura Medical, Inc. (NASDAQ NMRD), Abbott Laboratories (NYSE ABT), Masimo Corporation (NASDAQ MASI), Fitbit, Inc. (NYSE FIT), DexCom, Inc. (NASDAQ DXCM)

A major component of this market is the demand for blood glucose monitoring devices, which are used for effective diabetes diagnosis and treatment. Among the advancements made in blood glucose level monitoring technology is the development of continuous glucose monitoring (CGM) devices, which were designed to help track glucose levels in the interstitial fluid as a basis for improving metabolic control and contribute to better diabetes management. CGM devices can be used by both Type 1 and Type 2 diabetics, although they are primarily used by Type 1 diabetics due to the critical need for tight glucose control. However, they are also often utilized by younger users to reduce A1C without increasing hypoglycemia, or those suffer from frequent lows and potentially dangerous nighttime hypoglycemia. Overall, the global market for continuous glucose monitoring devices is estimated to reach USD 6.1 Billion by 2025 while expanding at a CAGR of 17.8% over the forecast period and being driven by a growing aging population, a rising diabetes population and pressure to cut health-care costs, according to data provided by iHealthcareAnalyst, Inc.

Nemaura Medical, Inc. (NASDAQ NMRD) announced breaking FDA news today that, it is preparing for the launch of sugarBEAT in the U.S. under the wellness category following recent feedback from the U.S. Food and Drug Administration (the FDA). The Company is prioritizing launch plans in the U.S. and is considering various options to expedite the launch, including potential partnering in continuation of its on-going discussions with multi-national companies.

Under the FDA’s wellness category, the Company intends to make sugarBEAT available to any adult wishing to be empowered with knowledge of how different lifestyle, dietary and health and wellbeing factors impact their sugar levels and is potentially appropriate to the pre-diabetic and diabetic market. This gives us access into the US market, which we believe is the world’s largest diabetic market by value. As sugarBEAT is adopted, we believe we will have the benefit of gathering data on a large scale, and from a diverse patient demographic, that we believe has never previously been achieved using CGM. Nemaura intends to use this data to develop artificial intelligence-based predictive algorithms that in the future potentially enable us to open up a number of new opportunities for the prevention and management of diabetes in an affordable and scalable manner. To the best of our knowledge, no other CGM has yet been allowed under the wellness category by the FDA, and this is one of the most important milestones for us thus far, stated Dr. Faz Chowdhury, Nemaura’s CEO.

The FDA general wellness category use is defined as (1) An intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or disease conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

The first phase of the commercial launch of sugarBEAT began in the U.K. after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The U.K. licensee of sugarBEAT, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT.

The Company is also currently planning a user study comparing sugarBEAT directly against a highly successful major incumbent CGM sensor, with the goal of positioning sugarBEAT as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive and invasive CGM.

The total global addressable market for CGM is estimated at $82.0 billion per annum, consisting of $12.7 billion for Type 1 insulin users (5% of diabetics), $38.0 billion for Type 2 insulin users (15% of diabetics) and $31.4 billion for Type 2 non-insulin users (80% of diabetics) . These numbers exclude the pre-diabetes population, which is estimated at nearly three times as large as the diabetes population.


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Advancing Wearable Devices Grant Patients and Doctors Greater Flexibility