NEW YORK, June 5, 2020 /PRNewswire/ -- Now that concerns from the pandemic are receding, states have begun to re-open and businesses are planning for a return to work. However, many employers are facing a challenge: determining how to create a safe work environment for employees while enforcing the still necessary social distancing measures. As for workers and medical professionals, it has become even more crucial to monitor symptoms in patients to help figure out who is fit to return to work and who may still pose a risk. Here, the use of wearable technology can be of help. For example, researchers at Northwestern University and Shirley Ryan AbilityLab in Chicago have recently developed a novel wearable device and are creating a set of data algorithms specifically tailored to catch early signs and symptoms associated with the viral infection and to monitor patients as the illness progresses. The device, according to the university, is capable of being worn 24/7 to produce continuous streams of data and uses artificial intelligence to uncover subtle, but potentially life-saving, insights. Nemaura Medical, Inc. (NASDAQ: NMRD), Vir Biotechnology, Inc. (NASDAQ: VIR), Co-Diagnostics, Inc. (NASDAQ: CODX), Johnson & Johnson (NYSE: JNJ), Aytu BioScience, Inc. (NASDAQ: AYTU)
Earlier in April, researchers from Stanford Medicine and their collaborators aimed to predict the onset of viral infection through data provided by wearable technology. Generally speaking, medical wearable devices are used for monitoring of various vital signs and other medically relevant data. By using wearable devices to measure things such as heart rate and skin temperature, which are acknowledged to rise when the body is fighting off an infection, the researchers working of developing a series of algorithms that would indicate when your immune system at work. "Smartwatches and other wearables make many, many measurements per day — at least 250,000, which is what makes them such powerful monitoring devices," said Michael Snyder, PhD, Professor and Chair of Genetics at the Stanford School of Medicine. "My lab wants to harness that data and see if we can identify who's becoming ill as early as possible — potentially before they even know they're sick."
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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Vir Biotechnology, Inc. (NASDAQ: VIR) announced back in May that is has finalized a process development and manufacturing agreement with Biogen Inc. (BIIB) based on the letter of intent that the companies announced in March. Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir's SARS-CoV-2 monoclonal antibodies. "Biogen's world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced," said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. "The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity."
Co-Diagnostics, Inc. (NASDAQ: CODX) announced earlier in May the publication of a paper showing its Logix Smart™ 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. "We are pleased that the quality of our innovative Logix Smart COVID-19 test kit has been demonstrated once again by this impressive and important study," said Dwight Egan, Co-Diagnostics CEO. "Being able to detect the presence of the virus before symptoms even occur illustrates the sensitivity and value of our test, especially in new sample types. The world needs every advantage we can get in our battle against this deadly disease, and we believe our test has the attributes needed to benefit millions across the globe."
Johnson & Johnson (NYSE: JNJ) announced back in April a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and Emergent BioSolutions, Inc. to support the manufacturing of its lead investigational COVID-19 vaccine candidate. This is the first in a series of prospective global collaboration agreements designed to accelerate manufacturing of Johnson & Johnson's COVID-19 vaccine candidate, and further the Company's goal to supply more than one billion doses of the vaccine globally. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We have set a high bar. Johnson & Johnson has committed to rapidly produce and supply more than one billion doses of a safe and effective vaccine globally. Our collaboration with Emergent is proof that we are moving quickly to deliver on that promise."
Aytu BioScience, Inc. (NASDAQ: AYTU) announced this week that the U.S. Food and Drug Administration (the "FDA") has granted Emergency Use Authorization (EUA) for the COVID-19 IgG/IgM Rapid Test Cassette distributed by the Company. This is only the fourth lateral flow COVID-19 rapid serology test authorized by the FDA. Additionally, more than 1.4 million COVID-19 IgG/IgM rapid tests have been delivered to the Company's warehouse in San Diego and are available for distribution. Emergency Use Authorization of the COVID-19 IgG/IgM Rapid Test Cassette was granted by the FDA on May 29, 2020 to Healgen Scientific, LLC, the U.S. subsidiary of manufacturer Zhejiang Orient Gene Biotech, Limited. Aytu BioScience announced a U.S. distribution agreement to distribute the Zhejiang Orient Gene rapid test on March 10, 2020.
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