Customer Interest in Wearable Devices Grows as Innovative Applications are Added

NEW YORK, July 8, 2020 /PRNewswire/ -- The wearable device market is largely driven by the increasing awareness of the importance of leading a healthy lifestyle and fitness. In addition, recent technological advancements such the Internet of Things (IoT), which has opened the door to more sophisticated applications being integrated into wearable devices, has also pushed the popularity of some of the devices to new highs. Nowadays, with a global pandemic putting pressure on healthcare systems, such technological innovations can play a crucial role in helping to manage the infrastructure. Additionally, the wearable technology market size has the potential to grow by USD 35.48 Billion during 2020-2024 according to data provided to Technavio. The research also indicates that the market's growth momentum will accelerate during the forecast period because of the steady increase in year-over-year growth. Nemaura Medical, Inc. (NASDAQ: NMRD), Co-Diagnostics, Inc. (NASDAQ: CODX), iBio, Inc. (NYSE: IBIO), FLIR Systems, Inc. (NASDAQ: FLIR), Johnson & Johnson (NYSE: JNJ)

Generally, the broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. And, many medical devices now have the ability to connect to and communicate with other devices or systems. The FDA has recognized the importance of such devices in the recent crises, and has cleared 2 wearable devices for monitoring patient vital signs. For example, back in April, Current Health, an artificial intelligence (AI)-powered wearable remote patient monitoring platform (RPM), announced that it had received Class II clearance from the FDA for post-acute care. In addition, in the same month, the FDA permitted an mHealth device aimed at improving care management for children with attention deficit hyperactivity disorder (ADHD). The prescription-only digital therapeutic treatment is designed for children ages 7-12, and aimed at replacing ADHD medication and, in effect, training their brains to deal with attention, emotion and behavior.

Nemaura Medical, Inc. (NASDAQ: NMRD) announced earlier in April, "plans for a new product line by seeking to immediately repurpose sugarBEAT(®) as a CTM since its inbuilt temperature sensor is capable of continuously tracking body temperature through the skin. Nemaura is considering various options to expedite the launch of a CTM, including potential partnerships and direct to consumer sales.

CTM's have been recognised as potentially having a key role to play in battling COVID-19, with Google's Verily announcing plans to develop a small body worn temperature patch that transmits data to a phone application to provide timely notification of fever and support earlier diagnosis and treatment of viral infections like the flu or coronavirus(1). Nemaura's body worn skin patch designed to monitor glucose levels on the skin at 5 minute intervals also contains a thermistor which measures skin temperature as an integral part of the device, and we believe that the device could easily be repurposed for this standalone function. The CGM device is CE approved in Europe and in commercial production in the UK.

'We see a significant commercial opportunity to utilise our BEAT(®) platform technology specifically for CTM purposes with data being automatically sent by low energy Bluetooth to a mobile phone app from which it can then be reviewed by the user and/or sent to a family member or caregiver. We believe that there are parallels between family members and caregivers remotely monitoring glucose fluctuations in a person, and monitoring fever caused by viral infections, providing a means of remote tracking and intervention. In the current climate we see this as an opportunity to contribute to general wellbeing and patient management' stated Dr. Faz Chowdhury, Nemaura's CEO.

Several diseases including COVID-19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring can be a vital tool in the detection of such conditions and consequently a potential means of containing the spread of the disease through early self-isolation. Measuring body temperature on a continuous basis may also be used to track the course of a disease and so allow physicians to analyse the effectiveness of treatments and thus pro-actively adapt to improve outcomes.

Dr. Chowdhury further stated 'body temperature can vary depending on the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the temperature is taken. For this reason, I believe that the ability to track the temperature continuously over time and measure the rate at which it is rising or falling would be a superior form of monitoring a person than sporadic measurements taken using a more traditional thermometer.'

We believe that multiple other future uses are foreseen for a CTM including tracking ovulation to improve the chances of conception and for predicting/preventing diabetes related foot complications such as ulcers which can eventually lead to amputation if not detected early enough, whereby poor blood circulation can be rapidly detected by continuous temperature monitoring of the affected region. Further details are provided in a publication on the company's website: https://nemauramedical.com/wp-content/uploads/2020/04/NMRD-Temp-Monitoring-USA-March-2020-FINAL-V1.1.pdf

Nemaura is establishing the regulatory framework for launching the CTM in a number of worldwide territories, including initial immediate use to provide qualitative indications without disease diagnosis."

(1.) https://www.blog.google/inside-google/company-announcements/coronavirus-covid19-response/

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Co-Diagnostics, Inc. (NASDAQ: CODX) announced earlier in May the publication of a paper showing its Logix Smart(TM) COVID-19 Test Kit was used to demonstrate that the SARS-CoV-2 virus can be detected in cancer tissue of coronavirus patients, even before symptoms occur. The peer-reviewed paper, published in the Journal of Clinical Pathology, described a study performed at the European Institute of Oncology in Milan, Italy. Researchers used the Company's test to determine whether SARS-CoV-2 was present in the removed tumor of a man who later become symptomatic and was diagnosed with COVID-19. The tumor, removed from the patient's tongue, was embedded in formalin-fixed paraffin (a "FFPE" sample) and later tested with the Company's COVID-19 test kit, along with non-cancer tissue removed from the patient's salivary glands and lymph nodes. 10 FFPE samples and six bronchoalveolar samples from other patients without COVID-19 were also tested.

iBio, Inc. (NYSE: IBIO) announced back in June that IBM Watson Health had selected iBio to receive 18 months of use of the IBM Clinical Development (ICD) solution, free-of-charge. IBM Watson Health recently began offering its ICD solution to eligible trial sponsor organizations as part of its efforts to help support the medical community to address the COVID-19 pandemic. IBM Watson Health has received interest in the offering from numerous hospitals, sponsors, contract research organizations and academic institutions, and is currently enabling 15 COVID-19 disease trials. "We are deeply appreciative of IBM's vote-of-confidence, which recognizes the potential of iBio's COVID-19 vaccine development efforts from among the hundreds of organizations that applied for access to IBM's ICD solution," said Tom Isett, Co-Chairman & CEO of iBio. "This technology helps to support the rapid and efficient undertaking of clinical trials of iBio's COVID-19 vaccine candidates. It also complements our FastPharming System's core speed, quality and scale-up advantages in the development of vaccines and therapeutics. Through strategic collaborations like this one, we believe iBio is now poised with the tools, technology and capital necessary to compete in the fight against COVID-19."

FLIR Systems, Inc. (NASDAQ: FLIR) announced earlier in June the FLIR Screen-ESTTM software for FLIR T-Series, Exx-Series, and A-Series thermal imaging cameras. The software provides automatic measurement tools that perform elevated skin temperature screenings of individuals in two seconds or less at entries, checkpoints, and other high-traffic areas while maintaining recommended social distancing guidelines. "Governments and businesses across the globe are hard at work developing new processes to ensure public health and safety from COVID-19, including the use of radiometric thermal imaging cameras as part of a comprehensive frontline screening program," said Jim Cannon, President and CEO at FLIR. "Now with FLIR Screen-EST software, those organizations can increase the speed and accuracy of frontline screening when using FLIR's thermal cameras."

Johnson & Johnson (NYSE: JNJ) announced back in June that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic."

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