Advancing Wearable Devices Grant Patients and Doctors Greater Flexibility

NEW YORK, March 18, 2020 /PRNewswire/ -- 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.

About Nemaura Medical, Inc.: - Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. BEAT®diabetes is a planned health subscription service providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized data provided by sugarBEAT®. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading. For more information visit: www.NemauraMedical.com."

Abbott Laboratories (NYSE: ABT) announced back in 2019 the launch of a new, smarter heart monitor for better arrhythmia detection. With CE Mark in Europe and U.S. Food and Drug Administration (FDA) clearance, the next-generation Confirm Rx™ insertable cardiac monitor (ICM), a paperclip-sized implantable device, combines smartphone connectivity and continuous, remote monitoring to track unpredictable heart rhythm problems for fast and accurate diagnosis. Abbott's Confirm Rx ICM is helping advance how physicians remotely monitor arrhythmias in people most at risk. Inserted just under the skin in the chest above the heart during a quick, minimally invasive outpatient procedure, the Confirm Rx ICM device is the only ICM on the market that syncs to a smartphone via Bluetooth® and transmits information to the physician to help identify irregular heartbeats quickly. Abbott's mobile app eliminates the need for an additional transmitter and is user-friendly health technology translated in nearly 40 languages. "Through new advances like Abbott's next generation of Confirm Rx ICM, physicians can act more proactively and efficiently in their treatment approach, and patients can stay engaged and connected," said Avi Fischer, M.D., Medical Director of Abbott's Cardiac Rhythm Management therapies.

Masimo Corporation (NASDAQ: MASI) announced earlier this month that continuous RRp® (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97®, Radical-7®, and Radius-7® Pulse CO-Oximeters® has received FDA clearance. With this clearance, both continuous and spot-check RRp are now available in the US, supported in a variety of pulse oximetry sensors and configurations, including the new non-cabled, tetherless, wearable Radius PPG™. The availability of continuous RRp adds to Masimo's diverse portfolio of respiration rate monitoring modalities – acoustic respiration rate (RRa®), NomoLine® capnography (RRc™), and now photoplethysmographic respiration rate (RRp®) – to help clinicians ensure they have the right tools for each patient scenario. Determining RR, or the number of breaths taken per minute, in many situations typically requires manually counting breaths with a timer and then converting to a rate per minute, or being fitted with chest leads or straps that can be inconvenient. Acoustic respiration rate, RRa, has been shown to be an accurate, reliable, easy-to-use, and easy-to-tolerate, 3 method of monitoring respiration rate on a continuous basis. If RRa or RRc is not available, however, for patients whose arterial oxygen saturation (SpO2) is already being monitored using Masimo SET®, RRp offers a convenient way to accurately obtain RR. RRp is particularly well suited to lower acuity settings like the general ward, where patients are less likely to have respiration rate monitoring technologies available. In scenarios where the ability to detect respiratory pause is important, such as during surgery or recovery after surgery, RRp should not be used; RRa or RRc is more appropriate.

Fitbit, Inc. (NYSE: FIT) and WellCare Health Plans, Inc. announced last year their partnership, according to which Fitbit devices will be delivered to WellCare Medicaid members in Georgia who take positive steps to manage their diabetes by completing their annual diabetic eye exams. Beginning Jan. 1st, 2020, in an effort to help its members manage their condition and prevent complications from diabetes, WellCare is offering Georgia Medicaid members ages 18 and older with a diabetes diagnosis who are enrolled in the Fitbit Diabetes Program a Fitbit Inspire™ upon completing their annual diabetic eye exam. "We are excited to partner with Fitbit as we work to educate, motivate and support our members around the benefits of physical activity. Fitbit's fitness tracker complements WellCare's existing care management resources and will provide yet another resource to help our members living with diabetes manage their condition and improve their overall health and wellbeing," said Dr. Clarence Davis, WellCare's Senior Medical Director for Georgia.

DexCom, Inc. (NASDAQ: DXCM) and Insulet Corporation have announced last month a global commercialization agreement to combine current and future Dexcom continuous glucose monitoring systems (CGM) with Insulet's trusted tubeless insulin delivery Pod into the Omnipod Horizon^™ System for automated insulin delivery, currently in pivotal trial. Under the terms of the non-exclusive agreement, the Omnipod Horizon Automated Insulin Delivery (AID) System will use sensor values from the Dexcom G6 and next generation G7 CGM systems to predict glucose levels into the future and automatically adjust the insulin dose required to help reduce the occurrence of blood glucose highs and lows. "Everyone at Dexcom is excited to be in the final stages of integrating Dexcom CGM technology into the Omnipod Horizon System," said Kevin Sayer, Executive Chairman, President and CEO of Dexcom. "This system will bring together the demonstrated accuracy of Dexcom CGM with Omnipod's tubeless insulin delivery Pod which provides a simple user experience and freedom from injections and tubes. It will be a truly transformative, automated insulin delivery system giving more options to people with diabetes." "This agreement with Dexcom represents an incredible milestone for our two organizations in realizing the benefits of interoperability," said Shacey Petrovic, President and CEO of Insulet. "The ability to integrate with new innovation efficiently will offer consumers the latest and greatest in Pod and sensor technology, while providing the freedom of choice so they can live life to the fullest."

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