NEW YORK, March 10, 2020
NEW YORK, March 10, 2020 /PRNewswire/ -- Wearable devices provide innovative solutions for various major issues in the healthcare industry. For example, wearable technologies enable continuous and remote monitoring of biochemical parameters as well as human physical activities and behaviors. The most commonly measured data include vital signs such as heart rate, blood pressure, and body temperature, as well as blood oxygen saturation, glucose levels, and physical activities through the use of electrocardiogram (ECG), ballistocardiogram (BCG) and other devices. In recent years, wearable medical devices have evolved and can now be attached to the user's skin, similar to a patch. In addition, with the more advanced devices, users can embed sensors into the environment, such as chairs, car seats and mattresses. To make the devices efficient and user friendly, a smartphone is typically used to collect information and transmit it to a remote server for storage and analysis. And according to a report by HIMSS, there are two major types of wearable devices. Some devices have been developed for healthcare professionals to monitor walking patterns, including the accelerometer, multi-angle video recorders, and gyroscopes. While other devices have been developed for health consumers, including on-wrist activity trackers such as Fitbit. Overall, the wearable medical devices market value is projected to reach USD 14.41 Billion by 2022 from USD 6.22 Billion in 2017 and at a Compound Annual Growth Rate (CAGR) of 18.3%, according to a report by MarketsandMarkets. Nemaura Medical, Inc. (NASDAQ: NMRD), Fitbit, Inc. (NYSE: FIT), Masimo Corporation (NASDAQ: MASI), Tandem Diabetes Care, Inc. (NASDAQ: TNDM), Medtronic plc (NYSE: MDT)
Some of the data monitoring necessary for users can be complicated and depend on several variables. For examples, both patients and healthcare providers need to track many factors that influence blood glucose dynamics including medication, activity, diet, stress, sleep quality and more. All of these factors are necessary in order to effectively manage diabetes. And thanks to recent innovation, consumer technologies are helping the diabetic community to properly monitor data in real-time. In order to make monitoring and analytics of data effective, wearable devices must be integrated with each other as well as various apps. 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. Thanks to such interoperability the Continuous Glucose Monitoring (CGM) is possible. In fact, the Continuous Glucose Monitoring (CGM) is a market segment on its own, and it is expected to surpass USD 5.6 Billion by the end of 2025, according to Renub Research.
Nemaura Medical, Inc. (NASDAQ: NMRD) announced today breaking news that it has, "entered in to multiple verbal non-binding agreements for sugarBEAT® with the aim of securing regional and global partnerships.
"As we've discussed with investors in the past, collaborating with highly capable strategic partners as we bring the first ever non-invasive continuous glucose monitoring system to market is a key initiative for management. Given the importance of this initiative we thought it appropriate to update investors on the significant progress over the course of the last few months that has been made with potential partners for large scale collaborations that we believe will help us accelerate our speed to market by leveraging off the resources and established networks of multinational companies in this field possess. We have entered in to several verbal non-binding agreements covering a diverse range of potential applications for sugarBEAT® in the medical and non-medical field"stated Dr. Faz Chowdhury, CEO of Nemaura.
The verbal non-binding agreements are expected to lead to discussions for licensing and collaboration on a regional or global scale, following the appropriate mutual due diligence processes. However, there can be no assurance that the foregoing will occur as planned, or at all.
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 focused on scaling up its manufacturing operations. The UK licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®.
The Company is 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 global total addressable market for CGM is estimated at $82 billion per annum, consisting of $12.7 billion for Type 1 insulin users (5% of diabetes), $38.0 billion for Type 2 insulin users (15% of diabetes) and $31.4 billion for Type 2 non-insulin users (80% of diabetes). These numbers exclude the prediabetes population which is estimated at nearly three times as large as the diabetes population.1
1. PiperJaffray Company Note DXCM Sep 5, 2018
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 prediabetes 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."
Fitbit, Inc. (NYSE: FIT) and WellCare Health Plans, Inc. announced their partnership last year, 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.
Masimo Corporation (NASDAQ: MASI) earlier in December 2019 reported that RD SET® sensors with Masimo Measure-through Motion and Low Perfusion™ SET® pulse oximetry have received FDA clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (< 3 kg). The updated RD SET® sensors' SpO2 accuracy specifications have improved significantly, from 3% to 1.5% ARMS (at 1 standard deviation), in conditions of motion and no motion, providing clinicians with even greater confidence when monitoring the oxygenation status of neonates. With this clearance, the improved performance specifications, which were incorporated into RD SET® sensors for patients > 3 kg in 2018, are now available to all patient populations in the United States. Joe Kiani, Founder and CEO of Masimo, said, "We're delighted to announce the latest result of our continued innovation in our foundational SET® pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to the brilliance and dedication of our engineers and the continuing support of our customers, we've been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET®, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry."
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,
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