- FinancialBuzz.com News Commentary
NEW YORK, Aug. 28, 2020 /PRNewswire/ -- The pandemic has caused an exponential growth in demand for healthcare products such as ventilators, medical clothing, face masks, testing kits, monitoring and diagnostic devises. As a result, there are high expectations from the medical technology industry. The Food and Drug Administration (FDA) provided guidance to medical technology makers to help the process of production and distribution become more efficient. According to the FDA the guidance is intended to assist manufacturers in providing the agency with informative notifications about changes in the production of certain medical devices that will help the Agency prevent or mitigate shortages of such devices during the public health emergency. These devices also include remote monitoring technology, which in a time of a pandemic helps eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities. Nemaura Medical, Inc. (NASDAQ: NMRD), Abbott Laboratories (NYSE: ABT), Johnson & Johnson (NYSE: JNJ), Novavax, Inc. (NASDAQ: NVAX), Moderna, Inc. (NASDAQ: MRNA)
Before the pandemic, wearables were being used by an increasing number of patients to diagnose, treat, and monitor their diseases. And according to Mordor Intelligence the Wearable Technology Market was valued at USD 27.91 billion in 2019 and is expected to reach USD 74.03 billion by 2025, at a CAGR of 17.65% over the forecast period 2020 - 2025. A recent example of how such devices are helpful in the pandemic includes Dexcom's recent partnership with Current Health to add continuous glucose monitoring capabilities to Current Health's AI-powered remote patient monitoring platform, which is particularly important for diabetic patients, who are at a higher risk of becoming infected during the pandemic.
Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news last week that it has, "issued a presentation outlining how CGM is being used by quarantined and hospitalized COVID-19 patients.
The Company has previously reported the uses of continuous lactate measurements for the monitoring of diseases progression in COVID-19 patients. Today the company issued a report outlining how CGM has been used as an effective tool for the monitoring of disease progression in both quarantined and hospitalised COVID-19 patients. This includes improvement in glycaemic control in persons with Type 2 diabetes, monitoring and managing hyperglycaemia in patients with COVID-19, and remote monitoring of glucose levels in hospitalised COVID-19 patients leading to improved quality of care without compromising the safety of medical professionals.
Both the CGM and CLM (continuous lactate monitoring) products are based on Nemaura's BEAT™ platform, which is designed to non-invasively extract a number of analytes through the skin. By adapting the sensor chemistry, algorithm and mobile app interface initially developed for sugarBEAT®, the BEAT™ platform has the potential to be utilized for several markets beyond glucose monitoring and diabetes. Nemaura is evaluating the timelines for bringing the CLM to market as a Class 2 approved Medical Device, and the CGM device is a CE mark approved Class 2b medical device planned for launch this calendar year in the UK and Germany.
About Nemaura Medical, Inc.: Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, and proBEAT™. sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. Nemaura has also submitted a PMA application for sugarBEAT® to the U.S. FDA. proBEAT™ comprises a non-invasive glucose monitor and a digital healthcare subscription service and is due to be launched in the US as a general wellness product."
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Abbott Laboratories (NYSE: ABT) announced this week that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.
Johnson & Johnson (NYSE: JNJ) announced earlier this month that its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen's SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). "Johnson & Johnson's global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to stop the spread of COVID-19. We greatly appreciate the U.S. government's confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
Novavax, Inc. (NASDAQ: NVAX) and Takeda Pharmaceutical Company Limited announced this month a partnership for the development, manufacturing and commercialization of NVX–CoV2373, Novavax' COVID–19 vaccine candidate, in Japan. NVX–CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant. Takeda will receive funding from the Government of Japan's Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. "Takeda's leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX–CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan."
Moderna, Inc. (NASDAQ: MRNA) announced this month that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government's goal of securing early access to safe and effective COVID-19 vaccines for the American people. Today's award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, today's announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
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