Technological Breakthroughs Give Rise to Wearable Patient Monitoring Devices

FinancialBuzz.com News Commentary

NEW YORK, Feb. 26, 2020 /PRNewswire/ -- The patient monitoring device market is a large and diverse segment of the medical device industry. Traditionally, patient monitoring devices are used in hospitals to monitor patient's vital signs. Nowadays, with the advancements in wireless technology, these devices can be used to remotely monitor a patient's various physiological parameters. In addition, new wearable monitoring devices, equipped with the Internet of Things (IoT) technology, are able to communicate with smartphones, transferring crucial data to right to user friendly applications. Besides technological advancements, other driving factors for the growth of the patient monitoring devices market include the rise in the prevalence of lifestyle diseases such as diabetes, cancer, and atherosclerosis. Diabetes, in particular, is a major segment of this market, as people suffering from diabetes must constantly monitor blood glucose levels. Blood glucose monitoring devices (BGMD) are used to measure these levels in diabetic patients, and help analyze glucose level patterns by providing continuous and real-time readings. Furthermore, the International Diabetes Federation indicates that, globally, approximately 424 million people were living with diabetes in 2017 and this number is expected to reach 629 million by 2045. Overall, the global blood glucose monitoring device market size is expected to reach USD 17.8 Billion by 2026 while registering a 7.1% CAGR, according to a new report by Grand View Research, Inc. Nemaura Medical, Inc. (NASDAQ: NMRD), Abbott Laboratories (NYSE: ABT), Tandem Diabetes Care, Inc. (NASDAQ: TNDM), Medtronic plc (NYSE: MDT), Insulet Corporation (NASDAQ: PODD)

Diabetes is a lifelong disease and according to data provided by the FDA, approximately 18.2 million Americans are afflicted while almost one third (or approximately 5.2 million) are unaware that they have it. An additional 41 million people are considered pre-diabetic. People with diabetes need to manage their disease to stay healthy, as there is currently no available cure. The amount of glucose in your bloodstream is tightly regulated by the hormone insulin. Insulin is always being released in small amounts by the pancreas and when the amount of glucose in your blood rises to a certain level, the pancreas will release more insulin to push more glucose into the cells. This causes the glucose levels in your blood to drop. In recent times, the resurgence of medical devices that help consumers monitor their glucose levels has attracted the FDA's attention. According to MedCity News, Courtney Lias, Director of the Division of Chemistry and Toxicology Devices Office, part of FDA's Center for Devices and Radiological Health, spoke strongly in support of developing interoperable devices that could wirelessly communicate not only with each other but with other digital apps. "We want to incentivize interoperability and open systems through optimized regulatory pathways," Lias said, noting that the agency has taken two regulatory actions to create a "pathway for devices to become integrated with each other including apps."

Nemaura Medical, Inc. (NASDAQ: NMRD) yesterday announced breaking news that, "it's planning to initiate a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor, seeking to position sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative.

"Our decision to go head-to-head vs. a hugely successful CGM sensor was based on positive feedback we received from recent meetings with public health insurers in key territories in Europe," stated Dr. Faz Chowdhury, CEO of Nemaura. "We believe that most people with diabetes do not currently use any continuous glucose monitoring system. We believe that sugarBEAT® is a world first providing an option for daily monitoring whenever a person chooses. We believe, that this level of flexibility is a better option than any alternative CGM devices with either 7 day, 10 day, or 14 day sensor wear time currently available."

We believe that sugarBEAT®'s flexibility empowers users with very powerful trend data at a lower cost compared to current CGM's, which we believe will encourage many users to adopt the system.

Several studies are planned over the course of this year designed to demonstrate the effectiveness of sugarBEAT® to increase Time-In-Range, thus reducing HbA1C with intermittent (non-consecutive days) use over a few days per week or even month. Initial results from studies comparing the devices indicate sugarBEAT® has accuracy (MARD mean absolute relative difference), on par with major incumbent CGM sensors, using single finger-stick blood glucose meter calibration in real-life settings.

The first phase of the commercial launch of sugarBEAT® began in the UK 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 sought to ramp up its manufacturing operations.

The UK licensee of sugarBEAT®, DB Ethitronix, are currently finalizing the launch of online sales of sugarBEAT®. Concurrently, Nemaura is finalizing the launch of its subscription-based service, BEAT®diabetes, aimed at reversing Type 2 diabetes and preventing prediabetes from the onset of diabetes.

About Nemaura Medical, Inc.: Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing BEAT®diabetes, a health subscription service designed to help people with diabetes and prediabetes better manage diabetes and reverse Type 2 diabetes or prevent diabetes through 1-on-1 lifestyle coaching and behavior driven by real time continuous glucose monitoring (CGM) and daily glucose trend data provided by sugarBEAT®, a non-invasive and flexible CGM. For more information visit: www.NemauraMedical.com ."

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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.

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), an insulin delivery and diabetes technology company, announced back in January its commercial launch of the t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL). It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no fingersticks for calibration or diabetes treatment decisions. The Company will soon begin sending emails with update instructions to all in-warranty t:slim X2 users in the United States, who have the option to add the new feature free of charge via remote software update. t:slim X2 pumps pre-loaded with Control-IQ technology are now shipping to new customers. "Control-IQ technology has been described by study participants and investigators as 'life-changing,' 'easy to use,' and 'a new standard of care in insulin therapy management,' which is incredible feedback as we commence this commercial launch and begin bringing its benefits to more people with diabetes," said John Sheridan, President and Chief Executive Officer.

Medtronic plc (NYSE: MDT) announced earlier in December that it had completed the acquisition of Klue, a software company focused on behavior tracking that can provide real-time insights into when a person is consuming food. Klue's technology is expected to be incorporated into the Medtronic Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL system is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user, with a goal of dramatically simplifying diabetes management for the patient. In addition, the Klue technology can be leveraged to enhance the company's market-leading analytics and insights in their smart CGM technology to help people using multiple daily injections (MDI) stay ahead of high and low glucose events. "Bringing Klue and their unique meal detection capabilities into our organization will accelerate our progress to help people with diabetes live with greater freedom and better health," said Alejandro Galindo,

President of the Advanced Insulin Management division, which is part of the Diabetes Group at Medtronic. "Based on our learnings from a first-generation hybrid closed loop system around the importance of simplifying diabetes management, we believe the Personalized Closed Loop system will be transformational for diabetes management, and the integration of the Klue technology helps clears the path to a true hands-free closed loop system."

Insulet Corporation (NASDAQ: PODD) announced back in October the FDA clearance for use of Fiasp® (fast-acting insulin aspart) with the Omnipod® Insulin Management System and the Omnipod DASH™ Insulin Management System for adults. Fiasp is a new-generation, ultra fast-acting insulin developed by Novo Nordisk that enters the bloodstream two times faster than Novo Nordisk's NovoLog®, so it more closely matches a body's typical insulin response to a meal, thereby improving glycemic control. As a result, Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. "Omnipod can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, and we are thrilled to deliver this additional flexibility for people to use their insulin of choice with the Omnipod System," said Dr. Trang Ly, Senior Vice President, Medical Director. "Expanding our labeling to include Fiasp also opens the door for existing Fiasp users to seamlessly transition to an Omnipod System for their insulin delivery needs and further demonstrates our commitment to innovation."

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