Groundbreaking Designs Expand Remote Patient Monitoring Capabilities

PALM BEACH, Florida, June 8, 2020 /PRNewswire/ -- Since the pandemic has started and social distancing measured were put in place, the global economy has struggled to stay afloat. Now, as businesses begin slowly reopening, there are concerns that the number of infected will spike again. Yet, technology may provide some solutions. Just last week, according to a report by The Straits Times in Singapore, the Minister-in-charge of the Smart Nation Initiative, Vivian Balakrishnan, announced that a wearable device for contact tracing may be issued to everyone in Singapore to help curb the spread of the virus. In fact, earlier in March, the U.S. Food and Drug Administration (FDA) allowed certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can utilize them to monitor patients remotely. Traditionally, patient monitoring devices are used in hospitals to monitor patient's vital signs. Nowadays, with the advancements in wireless technology, these devices can be used to remotely monitor a patient's various physiological parameters. Overall, the global wearable medical device market size is expected to reach USD 29.6 Billion by 2026 and at a compound annual growth rate (CAGR) of 17.7%, according to Transparency Market Research. Nemaura Medical, Inc. (NASDAQ: NMRD), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ: NVAX), iBio, Inc. (NYSE: IBIO), Pfizer Inc. (NYSE: PFE)

Other important developments in the medical wearable devices segment include various studies designed to illustrate the role of such devices in a time of a pandemic. Recently, the Stanford Healthcare Innovation Lab launched a study with the goal of determine if information from wearable devices, like Fitbit and Apple Watch, can be used to track infectious diseases. In addition, earlier in March, according to mHealthIntelligence, San Diego-based SRTI launched DETECT, a national effort to gather data from smartwatches and activity trackers to analyze how activity, heart rate, sleep patterns and other connected health data can be integrated into a public health surveillance program. Participants were asked to upload their data through the MyDataHelps app. Jennifer Radin, PhD, an SRTI epidemiologist who is leading the study, explained that "in light of the ongoing flu season and the global pandemic… we see enormous opportunity to enhance disease tracking for improved population health." She continued, "One way to do this is to leverage and analyze the rich health data that's already being collected by the millions of Americans who regularly use wearable devices."

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 coronavirus¹.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."

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Moderna, Inc. (NASDAQ: MRNA) announced last week that the first participants in each age cohort have been dosed in the Company's Phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 2 study, being conducted by Moderna under its own Investigational New Drug (IND) application, will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination. Given the 25 μg and 100 μg dose levels in the Phase 1 study showed neutralizing antibody titers at or above convalescent sera and were generally well tolerated, the Company has decided not to pursue the 250 μg dose level in the Phase 2 study.

Novavax, Inc. (NASDAQ: NVAX) announced last month enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX–CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX–CoV2373 includes Novavax' proprietary Matrix–M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020. "Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID–19 pandemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial."

iBio, Inc. (NYSE: IBIO) provided back in April an update on its COVID-19 vaccine manufacturing capacity and announced that it has joined the National Institute for Innovation in Manufacturing Biopharmaceuticals ("NIIMBL"), one of 14 institutes in the Manufacturing USA Network. "If our own proprietary SARS-CoV-2 Virus-Like Particle ("VLP") program, IBIO-200, results in an approved vaccine, we estimate that we could make about 500 million doses of high-quality product annually at our Texas facility, depending upon the potency we see in the clinic," said Tom Isett, Co-Chairman & CEO of iBio. "That scalability links directly to the modular technology behind our FastPharming Manufacturing System, which uses a relative of the tobacco plant as the 'bioreactor' to produce biopharmaceuticals," continued Mr. Isett. "So, the amount of product generated by a single plant is consistent from research- to commercial-scale, and scale-up is achieved by simply growing thousands more plants within our 130,000 square foot facility.  This is real innovation in the manufacture of biopharmaceuticals, thus our significant synergy with the NIIMBL community."

Pfizer Inc. (NYSE: PFE) and BioNTech SE have announced in April that the first cohort of BioNTech's Phase 1/2 clinical trial has been dosed. Twelve study participants were dosed with vaccine candidate BNT162 in Germany since dosing began on April 23rd, 2020. The trial is the first clinical trial of a COVID-19 vaccine candidate in Germany. Pfizer and BioNTech plan to initiate trials for BNT162 in the United States upon regulatory approval, which is expected shortly. The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine. The study will also assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that contain uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA). A fourth vaccine candidate, which contains self-amplifying mRNA (saRNA) will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study.

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

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