Saturday, April 4, 2020
Breaking Medical Device Industry News

Wearable Medical Tech Ushers in a New Era for Patients

Saturday, April 4, 2020

Wearable medical devices are designed to measure various metrics on the human body without doctor intervention. 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. Thanks to innovative technologies such as the Internet of Things (IoT) advanced data analytics, these devices have demonstrated efficacy in the management of chronic diseases of diabetes, asthma, and heart diseases, the occurrence of which is increasing around the world. Wearables have even attracted mainstream attention thanks to widely available and easy to use devices such as smartwatches. And insurance companies as well as healthcare organizations are contemplating the benefits of wearables to patients in the long run. Additionally, patient awareness relating to healthcare wearables and the high healthcare expenses in developed countries are projected to further boost market growth. Furthermore, the global wearable medical device market size is expected to reach USD 93.19 Billion by 2027 while expanding at a CAGR of 27.9%, according to Grand View Research. Nemaura Medical, Inc. (NASDAQ: NMRD), Tandem Diabetes Care, Inc. (NASDAQ: TNDM), Koninklijke Philips N.V. (NASDAQ: PHG), Livongo Health, Inc. (NASDAQ: LVGO), Insulet Corporation (NASDAQ: PODD)

Currently, the U.S. healthcare system is facing major obstacles. According to a Reuters Health report, the U.S. spends nearly twice as much on healthcare when compared to other high-income countries but shows inferior life expectancy and high infant mortality rates. “There’s no doubt that administrative complexity and higher drug prices both matter – as do higher prices for pretty much everything in U.S. healthcare,” said lead study author Irene Papanicolas of the London School of Economics and the Harvard T.H. Chan School of Public Health in Boston. “These inefficiencies are likely the product of a number of factors including a reliance on fee-for-service reimbursement, the administrative complexity of the U.S. health care system and the lack of price transparency across the system.” To solve these issues on a systematic scale, a major policy change is required, but in the meantime, wearable devices can assist in bringing down certain costs. For example, until recently, recording medical data was no easy task. It required special-purpose devices which had to be used in a medical facility due to their cost, size and complexity. Nowadays, with the spread of wearable technology and constant connectivity, users are keeping sensors and computers on or near their bodies much of the time. Patients can now afford to use these sensors to collect their own health metrics on a regular basis, reducing the number of doctor visits as well as other medical procedures.

Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking FDA news earlier last week 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.

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.

Koninklijke Philips N.V. (NASDAQ: PHG) announced recently that the HealthSuite System of Engagement, an integrated, modular set of standards-based capabilities that support the development of digital health propositions, including new capabilities for cloud-based managed AI workflow and DICOM interoperability. “While there are compelling examples of digitalization improving healthcare delivery, too often patients and care providers struggle within a complex, fragmented technology and data landscape that hampers the deployment of innovative healthcare services,” said Jeroen Tas, Chief Innovation & Strategy Officer, member of the Executive Committee Royal Philips. “The HealthSuite System of Engagement is at the core of Philips’ digital transformation. It’s a highly secured, modular set of capabilities that can liberate and integrate data from disparate systems and accelerate the development and deployment of digital propositions across the health continuum in a secure environment.” Philips Care Orchestrator for sleep and respiratory therapy, a smart cloud-based application that connects homecare providers, physicians, and payers with patients quickly and easily to critical data across devices and locations.

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 continue 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.”

Insulet Corporation (NASDAQ: PODD) announced earlier this month that the Company’s Omnipod DASH™ System has been named the 2020 Product of the Year in the Health Systems category. Product of the Year is the largest consumer-voted award for product innovation with 40,000 U.S. consumers surveyed. “We are always listening to our consumers and as a result, we offer a product that meets our users where they are in life. Everything we do is with the end-user in mind and our Omnipod DASH System was designed to be intuitively simple and easy to use,” said Bret Christensen, Chief Commercial Officer. “We are honored to have been selected for this award. We have been recognized in the past for our technology and talent, however this award is powerful because it comes directly from consumers, many of whom are living with or touched by diabetes in some way. We are determined to continue advancing the space with our innovative consumer-centric solutions that make diabetes a smaller part of people’s lives.” Insulet’s Omnipod DASH System provides users with a simple and effective solution that fits easily into their daily lives by eliminating the burden of syringes, pens, and tubes and 97%1 of users would recommend it to others.

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