Wireless Devices Offer New Ways to Diagnose Patients Remotely

NEW YORK, Aug. 13, 2020 /PRNewswire/ -- With over 5 million people confirmed to be infected with the virus in the United States alone, the pandemic has made it vital for hospitals to diagnose patients early and monitor their health in real time, limiting contact between patients and medical workers. Many wearable device startups have been updating their technology with additional uses to help support consumers during the pandemic to help fight the progression of the virus. For example, a report by WIRED indicates that a wearable device, which had been approved by the U.S. 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. NMRD, GlaxoSmithKline plc GSK, BioNTech SE BNTX, Eli Lilly and Company LLY, CytoDyn Inc. CYDY

According to ABI Research, several wearable, platform, and healthcare companies are working together on different projects that use healthcare wearable devices, smartwatches, or activity trackers to aid with tracking the progress of the virus or monitoring the vital statistics of potential sufferers. Tomsett, Wearables Analyst at ABI Research, explained that "the wearable trials and deployments that record vitals and monitor symptoms alert medical professionals if a patient's condition worsens. This becomes particularly important when the number of hospital beds is limited and so many patients are being sent home, ensuring that the seriously ill are cared for in a hospital while the less ill are still monitored when at home." In the meantime, various companies from a vast field of industries, including biotechs, medical device manufacturers, tech conglomerates and others have all made numerous announcements of products or services related to the pandemic.

Nemaura Medical, Inc. NMRD announced earlier last month 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™ 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.

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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GlaxoSmithKline plc GSK and Vir Biotechnology, Inc. announced back in April that they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

BioNTech SE BNTX announced last week that the first 72 participants have already been dosed with BNT162b1 following IND approval by the Chinese regulatory authority, National Medical Products Administration (NMPA). BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The trial is part of BioNTech's global development program aimed at supporting a global supply upon regulatory approval. The randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection. The first group of subjects immunized in Stage 1 of the study will be healthy adults aged 18 to 55 years, followed by elderly healthy participants (>55 years). As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart, of 10µg or 30µg of the vaccine candidate or placebo. The dose range selection was determined based on early data from clinical trials conducted in Germany and the United States. The participants will be dosed in Taizhou Clinical Phase1 Center, Jiangsu province.

Eli Lilly and Company LLY announced last week the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly's collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population. "COVID-19 has had a devastating impact on nursing home residents. We're working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals. While it's not easy to conduct clinical trials in this setting, we're taking on the challenge in an effort to help those who need us the most," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "We are grateful to the NIAID team for their exceptional partnership on this innovative trial and we are deeply appreciative of the care facilities, their staff and the many residents who will be participating in this important study."

CytoDyn Inc. CYDY announced last week an independent Data Safety Monitoring Committee ("DSMC") completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue. The Phase 3 study currently has 169 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial's protocol. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, "We thank the DSMC for its diligence, guidance and support. We are grateful to be less than 30 patients away from our planned interim analysis enrollment goal, and we look forward to sharing those interim efficacy results as soon as possible."

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