Improving Diagnostic Devices Expand Patient Monitoring Capabilities

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The medical device market is seeing steady growth thanks to new technologies and an emerging medical infrastructure around the world. Developing economies, which are investing more in healthcare, are also driving the expansion of the medical device market. Thus, by 2022, more than 30% of the global healthcare spending is expected to be from emerging economies. In developing countries, medical device companies leverage low manufacturing and labor costs to generate larger profit margins for investors.

As a result, the medical device market is projected to grow by USD 134.2 Billion during the period of 2020-2024 and at a CAGR of over 5%, according to Technavio. Among the many technologies that help transform the medical device market are the Internet of Things (IoT), machine learning and advanced 3D printing. For instance, IoT is increasingly being used in healthcare to promote active patient engagement and patient-centric service delivery through advanced devices that are constantly connected with each other. Yet, despite the market’s global growth, the United States is still the largest medical device market, with a value of USD 156 Billion, which accounted for 40% of the global industry in 2017. Research provided by SelectUSA, a U.S. government-wide program led by the U.S. Department of Commerce, approximates that by 2023, the medical device market is projected to grow to USD 208 Billion. Nemaura Medical, Inc. (NASDAQ: NMRD), Medtronic plc (NYSE: MDT), Pfizer Inc. (NYSE: PFE), Livongo Health, Inc. (NASDAQ: LVGO), NovoCure Limited (NASDAQ: NVCR)

Some of the fastest growing segments in the medical device market by application include diagnostic devices like patient-monitoring systems, MRI machines, diagnostic imaging equipment (including X-ray devices and other diagnostic imaging), and ultrasonic scanning devices. Remote patient-monitoring devices have become more popular due to the pandemic and social distancing measures which were implemented to combat it. Most commonly, medical wearable devices designed to collect data and measure vital signs such as heart rate, blood pressure, blood oxygen saturation, blood glucose levels and more. Remote medical monitoring is a complex sector. Herman Bonner, communication specialist at Firstbeat, which powers stress tracking features in a host of wearables from the likes of Garmin, Huawei and Suunto, explained in an article by Wareable that “it takes a lot of specialized expertise in mathematics, signal processing, pattern recognition, and programming to get to the point where you are providing useful information to people.”

Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news this week that, “it has licensed the rights to Healthimation, LLC’s mobile application based digital program, a well-validated and award-winning 12-week program to help patients manage their weight and pre-diabetes or early diabetes conditions. The program is intended to be combined with the company’s proBEAT™ non-invasive patch CGM (continuous glucose monitor) for an enhanced behavioral change experience.

Developed at a major diabetes center in the U.S. over more than 15 years, the digital program curriculum implements the most advanced approach to nutrition, exercise, and behavioral change and has been clinically tested and has demonstrated many benefits to a patient’s overall health, including weight reduction, significant improvements in A1C, lipid profile, and blood pressure, and a reduction in medications taken.

Healthimation, LLC has implemented this curriculum in an app that gamifies daily tasks and uses engaging high-quality animation and live coaching to encourage users to make healthy behavior changes, such as improvements in personal nutrition and exercise coaching, via the development and education of the app’s avatar Lena. Through machine-learning technology, the software makes Lena “smarter”, resulting in more personal recommendations for the patient over time.

Dr. Faz Chowdhury, Nemaura Medical’s Chief Executive Officer stated, “We are delighted and honored to be working with Healthimation to bring diabetic patients an easy-to-use solution that combines our proBEAT™ CGM product with a clinically validated diabetes management and reversal program. Our ultimate aim is to help patients with pre-diabetes from becoming diabetic while also providing support to those currently with Type 2 diabetes to potentially reverse their condition. Diabetes continues to be one of the largest growing medical problems in the U.S., and our aim is to provide an unparalleled product and suite of services that can compete favorably with existing products on the market that are less convenient and more invasive for patients.”

The Company believes that combination of the digital program with Nemaura’s proBEAT™ offering expected to launch this year, will allow for more beneficial outcomes in patients with Type 2 diabetes, help prevent high-risk pre-diabetic patients from becoming diabetic, and possibly even lead to diabetes remission in some patients. The integrated offering offers numerous advantages in breadth of application and depth of features over other competing digital platforms on the market attempting to address the weight control and/or diabetes markets, many of which are more expensive and more invasive than the Company’s anticipated solution.

SugarBEAT®, Nemaura’s patented, CE marked, needle-free CGM that is non-invasive, affordable, and painless, is easily applied to the skin via a small unobtrusive patch. The device transmits blood glucose data to users and/or healthcare professionals via a mobile app to allow for better monitoring or treatment. The Company’s BEAT™diabetes is a planned health subscription service driven by the personalized data provided by sugarBEAT® and processed through an artificial intelligence engine to provide personalized 1-on-1 lifestyle coaching and behavior change recommendations.

In the U.S., there are currently 88 million patients considered to be pre-diabetic and 25 million patients with Type 2 diabetes. Worldwide, there are 420 million patients with diabetes and over 1 billion people considered pre-diabetic.”

Medtronic plc announced this week first enrollments in the ALLEVIATE-HF clinical trial which will evaluate the ability of its Reveal LINQ™ Insertable Cardiac Monitor (ICM) in identifying patients at high-risk of worsening heart failure. The trial will determine if early information provided by the LINQ devices enable clinicians to take action before patients’ conditions worsen. The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health. The Reveal LINQ ICM allows physicians to continuously and wirelessly monitor a patient’s heart for arrhythmia disorders. With a proprietary algorithm added to the Reveal LINQ system for this study, clinicians will be alerted to signs of worsening heart failure. They will receive the information via nightly transmissions delivered to the Medtronic CareLink® Network from patients’ bedside monitors. Patient data will be stratified by risk level, providing physicians remote access to patient data and allowing them to intervene earlier than possible without this system.

Pfizer Inc. announced on August 7th, a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to manufacture and supply remdesivir for Gilead.  In March, Pfizer launched a five-point plan, which called on all members of the innovation ecosystem – from large pharmaceutical companies to the smallest of biotech companies, from government agencies to academic institutions – to commit to work together in addressing the dire COVID-19 crisis.  “From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions,” said Albert Bourla, Chairman and Chief Executive Officer. “Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible.”

Livongo Health, Inc. (NASDAQ: LVGO) announced earlier this year that its Applied Health Signals platform will be available to New Jersey State and School Employee Health Plan Members. Livongo, in partnership with Horizon Blue Cross Blue Shield of New Jersey (Horizon BCBSNJ), will make the Livongo for Diabetes solution available to over 460,000 public employees and their dependents. “As the prevalence and cost of chronic conditions continues to rise, we are excited to be able to offer these new tools and services to make it easier for our members to manage their health,” said Christin Deacon, Assistant Director for the State of New Jersey, Division of Pensions and Benefits. “Working within the partnership between Livongo and Horizon Blue Cross Blue Shield of New Jersey, we are now able to bring the industry leading Livongo benefit to the thousands of New Jersey State and School Health Plan Members living with diabetes.”

NovoCure Limited (NASDAQ: NVCR) reported back in June the launch of MyLink, a new tool that allows patients to download their Optune usage data from the comfort of home without the need for an in-person visit by a Novocure Device Support Specialist. Novocure initiated a phased launch with an initial wave of 30 U.S. patients to be followed by a broad rollout to all U.S. patients in the coming months. Novocure prioritized and accelerated the MyLink launch in response to recent U.S. FDA guidance supporting the expansion of remote patient monitoring. “Optune has a proven dose-response, and the establishment of usage goals coupled with regular review of Optune usage is key to maximizing treatment benefit,” said Pritesh Shah, Novocure’s Chief Commercial Officer. “MyLink is an important tool that provides a convenient way for patients to upload usage data. Early and ongoing monitoring of usage data coupled with effective patient counseling may drive increased average usage and improve patient outcomes.”