FinancialBuzz.com News Commentary
NEW YORK, July 10, 2020 /PRNewswire/ -- Healthcare systems around the world and in the United States have been under severe pressure in recent months as the global pandemic continues to spread. To help maintain the infrastructure and provide quality care to as many patients as possible, healthcare workers and facilities have had to adopt to rapid changes and new technologies. For example, remote monitoring devices, which are designed to keep track of various vital signs, are now playing a larger role in the healthcare process. Among the recent innovations in this segment, an exciting product comes from the Taiwan-founded healthcare wearable device company iWEECARE. The company recently announced that its flagship product, Temp Pal, has been in use to help combat the spread of the viral infection in hospitals and help during self-quarantine. According to a report published by MobiHealthNews, the cloud-based continuous temperature monitoring system has potential to lower the risk of infections and prevent an overwhelming of health systems. Nemaura Medical, Inc. (NASDAQ: NMRD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ: NVAX), Vir Biotechnology, Inc. (NASDAQ: VIR).
Earlier this May, engineers at the University of California San Diego developed a remote monitoring platform for patients who have tested positive for the viral infection but are not necessarily in need of hospitalization. According to UC San Diego Health, patients who test positive for the virus but aren't in need of hospitalization are sent home to recover, with care team members calling patients daily to monitor symptoms and determine whether additional care is necessary. However, not all health systems have the resources and capacity to support such an effort. With the remote monitoring platform, that process is automated. Patients use a wearable device to continuously monitor vital signs such as heart rate and oxygen saturation levels, and also activities such as sleep levels. "We wanted to jump in and help in a real translational way," said Sujit Dey, professor of Electrical and Computer Engineering at UC San Diego, Director of the UC San Diego Center for Wireless Communications, and lead of this remote monitoring platform. "We looked to see what technology we had in our arsenal that we could repurpose to help… patients and the health care workers treating them."
Nemaura Medical, Inc. (NASDAQ: NMRD) earlier in April, announced "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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Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced back in June positive interim clinical data of INO-4800, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence. Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO would like to thank all of the trial participants and the investigator staff who have made this trial possible. We are very encouraged by the positive interim safety and preliminary cellular and humoral immune response results to date as well as the inclusion of INO-4800 in Operation Warp Speed. We are also pleased that INO-4800 vaccination abrogated viral replication in the lungs of mice challenged with SARS-CoV-2. We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."
Moderna, Inc. (NASDAQ: MRNA) recently announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna's mRNA vaccine candidate against COVID-19 (mRNA-1273) at ROVI's facility in Madrid, Spain. As part of the agreement, ROVI will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate intended in principle to supply markets outside of the U.S. starting in early 2021. ROVI will also hire additional staffing required to support manufacturing operations and production. "Moderna is committed to helping address the COVID-19 crisis. We are pleased to partner with ROVI to potentially supply hundreds of millions of doses of finished mRNA-1273, once approved, and help address the need for a vaccine against COVID-19 around the world," said Juan Andres, Moderna's Chief Technology Operations and Quality Officer. "ROVI's experience as a global manufacturer of drug product and expertise in fill-finish will be an important partnership for us to establish dedicated supply chains that can meet the needs of different countries and regions. I am delighted to be working with ROVI again."
Novavax, Inc. (NASDAQ: NVAX) announced recently that it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373, Novavax' COVID-19 vaccine candidate, as early as late 2020. NVX–CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant. "The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together. We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation's population," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis."
Vir Biotechnology, Inc. (NASDAQ: VIR) announced back in May that is had finalized a process development and manufacturing agreement with Biogen Inc. 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."
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