The ongoing pandemic has caught people as well as various healthcare systems off guard. While the world is coming up with ways to battle the pandemic, some countries have already started to slowly get back to a more normal state of affairs. Overall, new technology and innovative medical devices offer a possible solution to various issues the medical field is currently struggling with. For example, a report by WIRED indicates that a wearable device, which had been approved by the US Food and Drug Administration (FDA) in May 2019 as a tool for remotely monitoring patients recovering from opioid overdoses, has recently been retooled to help doctors manage patients suffering from the pandemic virus. FDA officials approved the modified version of the device within days. "This way, the caregivers can go about their normal days and only get alerts, only pay attention when they need to," explains Joe Kiani, inventor and founder of Masimo. "And then, if for some reason they don't respond within a period, it elevates the alarm to other care providers." Nemaura Medical, Inc. (NASDAQ: NMRD), Moderna, Inc. (NASDAQ: MRNA), Co-Diagnostics, Inc. (NASDAQ: CODX), Merck & Co., Inc. (NYSE: MRK), Inovio Pharmaceuticals, Inc. (NASDAQ: INO)
Wearable devices have started to play an important role in the healthcare industry even before the pandemic. Around the world, there is an increasing number of people who are diagnosed with lifestyle-associated diseases, such as hypertension and diabetes, which has created the need to monitor their health on a regular basis. By using self-monitoring wearable devices, patients are now able to gather crucial data related to various conditions, as well as other health parameters and forward the data to their doctor for review. Of course, technology plays a very important role in the growing acceptance of wearables as a legitimate medical device. And the growing adoption of mobile platforms around the world, the increasing adoption of AI and 5G, and the growing awareness and preference for home healthcare are all expected to help boost the market. Overall, the global wearable healthcare devices market is projected to reach USD 46.6 Bllion by 2025 from just USD 18.4 Billion in 2020 and while at a CAGR of 20.5% from 2020 to 2025, according to MarketsandMarkets.
Nemaura Medical, Inc. (NASDAQ: NMRD) announced earlier in April, "plans for a new product line by seeking to immediately repurpose sugarBEAT(R) 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(R) 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 progress on late-stage development of mRNA-1273, the Company's mRNA vaccine candidate against COVID-19. Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S. and is expected to be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial's primary endpoint will be the prevention of symptomatic COVID-19 disease; key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. Based on the results of the Phase 1 study, the 100 g dose level was chosen as the optimal dose level to maximize the immune response while minimizing adverse reactions. Moderna has completed manufacture of vaccine required to start the Phase 3 study. The Company expects dosing in the Phase 3 study to begin in July.
Co-Diagnostics, Inc. (NASDAQ: CODX) announced that Company CEO Dwight Egan has been invited to present at The Role of Cell Therapy & Clarity on Testing COVID-19 virtual conference, presented by Maxim Group and M-Vest on Wednesday May 27th, 2020. In addition to the Company's presentation, Co-Diagnostics will participate in a panel discussion on the need, lack, and confusion surrounding COVID-19 testing titled "Testing and Susceptibility - Clearing the Air" at 12:00 PM. The Co-Diagnostics Logix Smart(TM) COVID-19 test is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.
Merck & Co., Inc. (NYSE: MRK) announced earlier in May three significant scientific initiatives to combat COVID-19: two agreements to develop potential vaccines against SARS-CoV-2, and a research collaboration to advance the development of a novel antiviral candidate. Merck to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19; IAVI and Merck collaborate to develop vaccine against COVID-19; Merck and Ridgeback Bio collaborate to advance development of an oral antiviral candidate for COVID-19, EIDD-2801. "With our singular legacy and expertise in vaccines and anti-infective medicines, we know Merck has a responsibility to engage in the scientific community's efforts to find new medicines and vaccines to bring this pandemic to an end," said Kenneth C. Frazier, chairman and Chief Executive Officer, Merck.
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced back in May the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications titled, "Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Dr. Kate Broderick, INOVIO's Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, "These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials."
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