Innovative Diagnostic Devices Help Ease the Burden on Healthcare Systems

NEW YORK, Aug. 12, 2020 /PRNewswire/ -- As of this week, over 5 million people have been confirmed to be infected with the virus in the United States alone, with more than 20 million globally. As a result, health care systems are overwhelmed and the effective delivery of medical care to all patients has become a challenge worldwide. Among the many factors that had likely affected the spread of the disease are inadequate attention to early warning signs, insufficient stockpiling, lack of access to testing kits and personal protective equipment (PPE), and nationwide variability in the approaches to testing and distribution of PPE. Of course, medical device companies have not escaped the pandemic's impact. Similar to biotech companies, medical device makers count on healthcare facilities for their clinical trial data collection. Nemaura Medical, Inc. (NASDAQ: NMRD), FLIR Systems, Inc. (NASDAQ: FLIR), Johnson & Johnson (NYSE: JNJ), iBio, Inc. (NYSE: IBIO), Pfizer Inc. (NASDAQ: PFE).

Innovation is a crucial component of the medical device industry. For example, in recent years the trend of wearable devices has been catching up. When it comes to health tracking, both at a personal as well as medical level, the wearable medical devices in healthcare help patients and caregivers to continuously monitor the health status of patients. The medical journal, The Lancet, indicates that "Digital health technology can facilitate pandemic strategy and response in ways that are difficult to achieve manually. Countries such as South Korea have integrated digital technology into government-coordinated containment and mitigation processes—including surveillance, testing, contact tracing, and strict quarantine—which could be associated with the early flattening of their incidence curves."

Nemaura Medical, Inc. (NASDAQ: 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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FLIR Systems, Inc. (NASDAQ: FLIR) announced earlier in June the FLIR Screen-ESTTM software for FLIR T-Series, Exx-Series, and A-Series thermal imaging cameras. The software provides automatic measurement tools that perform elevated skin temperature screenings of individuals in two seconds or less at entries, checkpoints, and other high-traffic areas while maintaining recommended social distancing guidelines. "Governments and businesses across the globe are hard at work developing new processes to ensure public health and safety from COVID-19, including the use of radiometric thermal imaging cameras as part of a comprehensive frontline screening program," said Jim Cannon, President and CEO at FLIR. "Now with FLIR Screen-EST software, those organizations can increase the speed and accuracy of frontline screening when using FLIR's thermal cameras."

Johnson & Johnson (NYSE: JNJ) announced back in June that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic."

iBio, Inc. (NYSE: IBIO) announced this week an update on one of its proprietary vaccine candidates being designed to prevent infection from the SARS-CoV-2 virus. iBio is investigating an array of adjuvants in combination with iBio's proprietary lichenase carrier molecule ("LicKMTM") fused to a coronavirus subunit protein ("IBIO-201") with the goal of producing a safe and effective vaccine for COVID-19 disease, and especially one for our most vulnerable populations, including the elderly. Ten distinct preclinical study arms for the IBIO-201 antigen-adjuvant combinations have been concluded.  These include combinations delivered via intramuscular and intranasal routes, and datasets are under evaluation. "We are encouraged by these pre-clinical data, which demonstrate IBIO-201's ability to generate an immune response to SARS-CoV-2 sequences and neutralize protein interaction," said Tom Isett, Chairman & CEO of iBio. "We expect to gain more insight as we complete data analysis of both of our COVID-19 vaccine candidates."

Pfizer Inc. (NASDAQ: PFE) announced last week a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead's investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer's McPherson, Kansas facility to manufacture and supply remdesivir for Gilead. "From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer's agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions," said Albert Bourla, Chairman and Chief Executive Officer. "Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible."

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