NEW YORK, May 13, 2020 /PRNewswire/ -- The role medical devices play in our healthcare system has suddenly changed. With a catastrophic viral pandemic still very much affecting our healthcare systems and the economy, the reliance devices that can be used outside the hospital arena, like remote monitoring devices, has grown. Many wearable medical devices focus on continuous remote monitoring of numerous vital signs and other medical indicators. Remote patient monitoring technologies are akin to telemedicine technologies, since they automatically observe and report on patients, often with chronic illnesses, so caregivers can remotely observe the patient's condition. For example, a type of device that is helpful at a time of mandatory social distancing is Continuous Temperature Monitoring (CTM) or Continuous Glucose Monitoring (CGM) device. The FDA has recognized the importance of such devices, and earlier in March the agency issued a new policy that allowed manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers could begin to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. Nemaura Medical, Inc. (NASDAQ: NMRD), Remark Holdings, Inc. (NASDAQ: MARK), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ: NVAX)
Additionally, there have been some impressive innovations across various fields of medicine during the pandemic, including potential vaccines, personal protective equipment and monitoring devices. Recently, researchers at Northwestern University and Shirley Ryan AbilityLab in Chicago developed a novel wearable device and are creating a set of data algorithms specifically designed for early signs and symptoms associated with the viral infection and to monitor patients over time. The device can be worn 24/7 as it produces continuous streams of data and uses artificial intelligence to uncover subtle, but potentially life-saving, insights. Northwestern's John A. Rogers, who led the technology development explained that some of the early signs of the infection are "fever, coughing and difficulty in breathing. Our device sits at the perfect location on the body — the suprasternal notch — to measure respiratory rate, sounds and activity because that's where airflow occurs near the surface of the skin… We developed customized devices, data algorithms, user interfaces and cloud-based data systems in direct response to specific needs brought to us by frontline healthcare workers."
Nemaura Medical, Inc. (NASDAQ: NMRD) announced earlier this week breaking news regarding, "positive initial user-volunteer data from its head-to-head comparison with a major incumbent CGM device.
Earlier this year Nemaura announced that following discussions with various healthcare insurers, it was planning head-to-head comparisons with one or more major incumbent CGM devices. The aim of these studies was to position sugarBEATÒ as a cost-effective, flexible alternative to marketed invasive CGM, allowing continuous glucose monitoring on days the user chooses, and therefore, we believe, reducing the overall cost burden to users and healthcare insurers alike. Today, the Company reported early results comparing data between sugarBEATÒ and a major incumbent CGM device, demonstrating sugarBEATÒ accuracy on par with the incumbent CGM device, using a single finger prick calibration. Further details can be viewed on a report published on the company's website at: https://nemauramedical.com/publications/
Dr Faz Chowdhury, CEO of Nemaura, stated: 'The primary objective of these user studies comparing sugarBEATÒ with marketed CGMs was to demonstrate that similar long term clinical outcomes can be achieved irrespective of whether CGM is used every day of the month or only on a few days of the week or month. We believe that the implications of this would be that the annual cost per user would dramatically fall, making it affordable for the 90% of the diabetic population that are Type 2, the majority of whom do not require continuous daily monitoring, and those persons with Type 1 diabetes who are not currently using any CGM for whom having an occasional daily glucose profile would provide a powerful insight into the control over their blood sugar levels and Time-in-Range profiles. Our overall goal is to empower users with data that helps them develop control over their glucose fluctuations and guide them towards improved Time-in-Range profiles to reduce the long term complications of diabetes and help potentially reverse Type 2 diabetes, and also help those with pre-diabetes from developing diabetes. We believe that sugarBEAT is uniquely positioned to be able to achieve these goals, given that existing invasive CGMs are costly and do not have the flexibility of wear and resulting cost-advantage that we believe sugarBEAT provides.'
Dr Chowdhury discussed the commercial rollout and unique positioning of sugarBEATÒ in an exclusive interview with Redchip, which can be viewed here: https://youtu.be/7Mujq9_wDOw
Nemaura also plans to launch proBEAT™ in the USA later this year, which is expected to help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by deploying sugarBEATÒ to act like a black box flight recorder. It is planned that big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently "fine-tuning" predictive algorithms and artificial intelligence based feedback and prompts. We believe that these will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle, targeting over 85 million people that are pre-diabetic and over 24 million people who have Type 2 diabetes in the US. Nemaura is intending to pursue reimbursement from healthcare insurers in the US for proBEAT™."
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Remark Holdings, Inc. (NASDAQ: MARK), a diversified global technology company with leading artificial intelligence ("AI") solutions and digital media properties, announced on March 3rd, a significant upgrade to its AI-based product offerings. KanKan AI improved its already-robust Smart Monitor technology by adding thermal detection, including body temperature detection, and improved its facial recognition capability to include compliance with public sanitary regulations such as the wearing of protective masks. This builds upon the successful technology platform that has already been deployed among students within the Hangzhou school systems for early flu detection. "For reasons that have become obvious in recent weeks, there is an international priority to detect infectious diseases in patients before it spreads to the general population," stated Kai-Shing Tao, Chairman and Chief Executive Officer of Remark Holdings. "Though many countries have advocated the use of masks to try to prevent the spread of infectious diseases, the ability of governmental authorities in some countries to monitor the use of preventative measures such as masks has been limited by lack of efficient technology and reliance on manual methods. We now see an opportunity to expand our health and safety capabilities to retail stores and areas with high traffic."
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced last month it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIO's investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. for COVID-19 and could potentially advance to Phase 2/3 efficacy trials this summer. The agreement is being partly funded by an initial grant of USD 1.3 Million from the Coalition for Epidemic Preparedness Innovations (CEPI), which brings CEPI's total support to date for the development of INO-4800 to USD 17.2 Million. "We are grateful to CEPI for its continued generous funding and pleased to expand our work with Richter-Helm BioLogics to support large-scale manufacturing capacity for INO-4800," said INOVIO's President & CEO, Dr. J. Joseph Kim. "Richter-Helm has deep experience working with our optimized DNA plasmids, which are the building blocks of our DNA vaccines, and have consistently produced DNA medicines of the highest quality under stringent GMP standards."
Moderna, Inc. (NASDAQ: MRNA) announced on May 12th, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). "Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2."
Novavax, Inc. (NASDAQ: NVAX) announced last month that it had identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax' proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax' proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies. "Our scientists identified an ideal vaccine candidate selected from a number of constructs and, in partnership with Dr. Matthew Frieman, demonstrated that NVX-CoV2373 produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies," said Gregory Glenn, M.D., President of Research and Development at Novavax. "In addition, we have worked closely with our colleagues at Emergent BioSolutions to transfer our production technology that allows the manufacture of GMP vaccine for clinical trials. With preliminary CEPI funding, these heroic efforts, combined with the candidate's excellent early results, put us in position to have preliminary human data in July.
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