The current pandemic has created the need for new technologies in order to improve population-level screening and patient monitoring. One sector that has emerged in recent years and spiked in popularity this year is telemedicine, which is the distribution of health-related services and information via electronic information and telecommunication technologies. As telemedicine has evolved, remote monitoring devices emerged as a new and powerful tool within the healthcare system. Such devices allow for scaled interactions with populations in near real-time. Generally, medical monitoring devices are used to gather vital signs and nowadays can also be used to gather pandemic data and obtain real-time clinical feedback. As the telemedicine market continues to grow and advance, remote monitoring devices are emerging as a valuable tool for payers, providers, and public health officials as well. Nemaura Medical, Inc. (NASDAQ: NMRD), Vaxart, Inc. (NASDAQ: VXRT), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO) .
Research facilities and healthcare institutions are conducting research on new technologies and their usefulness in a time a pandemic, including remote monitoring devices. For instance, the Mayo Clinic's new clinical studies aimed at determining whether remote monitoring can be used to help stop the spread of the virus or improve care for people who've already contracted it. According to the nonprofit academic medical center, researchers at the clinic are working to create remote health care monitoring tools that allow people who've contracted the coronavirus to safely and effectively self-quarantine. Continuous remote monitoring devices could have the potential to give health care providers reliable, up-to-the-minute information about their patients' statuses. Remote monitoring devices can yield a full spectrum of data, including patient-reported information about symptoms, activities, self-quarantine and personal readings of their own health needs as well physical measurements such as temperature, pulse, lung function (spirometry), oxygen levels and more.
Nemaura Medical, Inc. (NASDAQ: NMRD) announced yesterday breaking news that it has, "issued a presentation outlining potential new applications for monitoring disease progression in Covid-19 patients using Continuous Lactate Monitoring (CLM).
The Company has previously discussed the market for athletic performance monitoring using its non-invasive continuous lactate monitor (CLM), and based on recently published independent clinical evaluations, the measurement of blood lactic acid has been established as an indicator for disease progression in Covid-19 patients. The company has issued a presentation on this subject, which can be found here: https://nemauramedical.com/wp-content/uploads/2020/07/BEAT-CLM-in-Covid19-July-2020-1.pdf
Both the CGM and CLM products are based on Nemaura's BEAT(TM) 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(R), the BEAT(TM) 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.
About Nemaura Medical, Inc.: Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT(R), and proBEAT(TM). sugarBEAT(R), 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(R) to the U.S. FDA. proBEAT(TM) 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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Vaxart, Inc. (NASDAQ: VXRT) announced back in June that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. The study is designed to demonstrate the efficacy of Vaxart's oral COVID-19 vaccine candidate. "We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated. SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa - nose, mouth or eyes - strongly suggesting that mucosal immunity could serve as the first line of defense," said Andrei Floroiu, Chief Executive Officer of Vaxart Inc. "In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns."
Moderna, Inc. (NASDAQ: MRNA) announced last week 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."
Gilead Sciences, Inc. (NASDAQ: GILD) announced last week additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir. The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care - an important finding that requires confirmation in prospective clinical trials. Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.
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."
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