Feb 28, 2020

Wearable Devices Open a New Frontier for Medical Tech

11 min
FinancialBuzz.com News Commentary NEW YORK, Feb. 25...

FinancialBuzz.com News Commentary

NEW YORK, Feb. 25, 2020 /PRNewswire/ -- A new trend has been evolving in the medical technology sector – wearable medical devices. By segment, the diagnostic devices segment dominated the market in 2019. Generally, such devices enable patients, medical personal and other consumers to continuously monitor physiological and biochemical parameters. The most commonly measured data include vital signs such as heart rate, blood pressure, blood oxygen saturation, blood glucose levels as well as physical activities through the use of electrocardiogram (ECG), ballistocardiogram (BCG) and other devices. In recent years, technological breakthroughs continued to push the boundaries. For example, wearable medical devices can now be skin-attachable devices, or sensors can be embedded into the environment, such as chairs, car seats and mattresses. Overall, it is a surprisingly large and diversified market of the healthcare technology industry, to which medical device manufacturers and big tech companies contribute. Additionally, companies such as Google, Fitbit, Apple, and Nike are working toward launching new innovative products, which are anticipated to boost the wearable medical devices market growth over the next decade. Generally, smart watches and wristbands are the current focal point of product development and innovation, leading to an abundant availability of such products. And according to Grand View Research, the global wearable medical device market size is expected to reach USD 93.19 Billion by 2027, according to a new report by Grand View Research, Inc. It is also projected to progress at a CAGR of 27.9% during the forecast period. Nemaura Medical, Inc. (NASDAQ: NMRD), Abbott Laboratories (NYSE: ABT), Masimo Corporation (NASDAQ: MASI), Fitbit, Inc. (NYSE: FIT), DexCom, Inc. (NASDAQ: DXCM)

There has been an increasing focus on the development of smaller, more reliable, and more energy-efficient devices compared to the previous generations of wearables focused on diagnostics. As an example, wearable skin patches are becoming more and more widely used within the wearable devices market. Skin patches can be covered by clothing, and were designed to record and transmit more accurate data without being interrupted by movement. Wearable patches have also been used as cardiovascular, sweat, strain and temperature sensors. Moreover, the miniaturization of wearable health devices is anticipated to have a positive impact on the rapidly growing Internet of Things (IoT) market. The advances in IoT technology will also enable future health systems to use wearables to establish connections and come up with standard solutions for various medical conditions. A recent example of an innovative medical device was reported by Two Louisiana Tech University biomedical engineering students who designed a wearable medical device that can track and classify Parkinson's disease tremors and their severity. The device creators explained in a press release that, "Our senior design project consisted of a wrist-worn wearable device that tracks the progression of Parkinson's disease tremors. Through supervised machine learning, the device predicts whether a patient's tremors are parkinsonian or non-parkinsonian, as well as the severity of these tremors. A quantitative analysis of parkinsonian tremors provides a more detailed disease state."  

Nemaura Medical, Inc. (NASDAQ: NMRD) announced today 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."

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) 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."

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) a leader in continuous glucose monitoring (CGM), had partnered with Tandem Diabetes Care in the UK, Sweden, Italy and Spain to distribute the Dexcom G6 CGM System integrated with the Tandem Diabetes Care t:slim X2 insulin pump for people with diabetes. Tandem's t:slim X2 insulin pump with Basal-IQ™ technology uses Dexcom G6 CGM readings to predict glucose levels 30 minutes ahead and suspend insulin delivery when glucose is predicted to go low. Insulin delivery resumes as soon as sensor glucose values begin to rise. Use of the integrated system reduced the time spent below 3.9 mmol/L (70 mg/dL) by 31 percent compared to use of a CGM-integrated pump without automated insulin suspension1. "Combining the Dexcom G6 with Tandem's t:slim X2 insulin pump will meaningfully improve diabetes management. Not only does the system eliminate the need for fingersticks, but it also helps patients reduce the frequency and duration of low-glucose events," said Erik Bjorkman, Dexcom's General Manager for EMEA.

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