Diagnostic Devices Give the Healthcare System New Avenues for Innovation

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Sep 17, 2020, 09:00 ET

NEW YORK, Sept. 17, 2020 /PRNewswire/ -- The recent pandemic, which has put a heavy toll on our economy and pushed the healthcare system into a severe scarcity problem, further illustrates the importance of medical devices and wearable remote monitoring devices in particular. As hospitals were struggling to make space for only the sickest patients, they were simultaneously evaluating the use of new technologies to monitor patients from their homes. Now, as companies, cities and communities are re-opening, it is paramount that they do so in a way that guarantees the safety of their employees, students, customers or visitors. Several innovative devices that are now available have been designed for that goal. For example, Sensoria Health, maker of wearable technology designed to improve healthcare, has a new Smart Band. According to the Company, "the Smart Band tracks key vitals such as temperature, heart rate and blood oxygenation to detect potential symptoms and identify high risk individuals allowing employers and healthcare professionals to intervene early and apply the appropriate measures to protect them and the rest of the population." Nemaura Medical, Inc. (NASDAQ: NMRD), iBio, Inc. (NYSE: IBIO), Co-Diagnostics, Inc. (NASDAQ: CODX), Novavax, Inc. (NASDAQ: NVAX), OPKO Health, Inc. (NASDAQ: OPK)

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." While biotech companies work on vaccines and possible treatments and medical device companies progress on patient monitoring solutions, many others have been working on improving testing options. For example, various companies are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus.

Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news last month that it had, "issued a presentation outlining how CGM is being used by quarantined and hospitalized COVID-19 patients.

The Company has previously reported the uses of continuous lactate measurements for the monitoring of diseases progression in COVID-19 patients. Today the company issued a report outlining how CGM has been used as an effective tool for the monitoring of disease progression in both quarantined and hospitalised COVID-19 patients. This includes improvement in glycaemic control in persons with Type 2 diabetes, monitoring and managing hyperglycaemia in patients with COVID-19, and remote monitoring of glucose levels in hospitalised COVID-19 patients leading to improved quality of care without compromising the safety of medical professionals.

Both the CGM and CLM (continuous lactate monitoring) 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, and the CGM device is a CE mark approved Class 2b medical device planned for launch this calendar year in the UK and Germany.

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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iBio, Inc. (NYSE: IBIO) reported back in June that IBM Watson Health had selected iBio to receive 18 months of use of the IBM Clinical Development (ICD) solution, free-of-charge. IBM Watson Health recently began offering its ICD solution to eligible trial sponsor organizations as part of its efforts to help support the medical community to address the COVID-19 pandemic. IBM Watson Health has received interest in the offering from numerous hospitals, sponsors, contract research organizations and academic institutions, and is currently enabling 15 COVID-19 disease trials. "We are deeply appreciative of IBM's vote-of-confidence, which recognizes the potential of iBio's COVID-19 vaccine development efforts from among the hundreds of organizations that applied for access to IBM's ICD solution," said Tom Isett, Co-Chairman & CEO of iBio. "This technology helps to support the rapid and efficient undertaking of clinical trials of iBio's COVID-19 vaccine candidates. It also complements our FastPharming System's core speed, quality and scale-up advantages in the development of vaccines and therapeutics. Through strategic collaborations like this one, we believe iBio is now poised with the tools, technology and capital necessary to compete in the fight against COVID-19."

Co-Diagnostics, Inc. (NASDAQ: CODX) earlier in May announced the publication of a paper showing its Logix Smart™ COVID-19 Test Kit was used to demonstrate that the SARS-CoV-2 virus can be detected in cancer tissue of coronavirus patients, even before symptoms occur. The peer-reviewed paper, published in the Journal of Clinical Pathology, described a study performed at the European Institute of Oncology in Milan, Italy. Researchers used the Company's test to determine whether SARS-CoV-2 was present in the removed tumor of a man who later become symptomatic and was diagnosed with COVID-19. "We are pleased that the quality of our innovative Logix Smart COVID-19 test kit has been demonstrated once again by this impressive and important study," said Dwight Egan, Co-Diagnostics CEO. "Being able to detect the presence of the virus before symptoms even occur illustrates the sensitivity and value of our test, especially in new sample types. The world needs every advantage we can get in our battle against this deadly disease, and we believe our test has the attributes needed to benefit millions across the globe."

Novavax, Inc. (NASDAQ: NVAX) announced last month Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID–19 vaccine with and without Matrix–M™ adjuvant in healthy adults 18-59 years of age. NVX–CoV2373, the Company's recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org. "The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well–tolerated COVID-19 vaccine with a robust immunogenicity profile," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX–CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID–19 patients with clinically significant disease."

OPKO Health, Inc. (NASDAQ: OPK) announced back in July that it will accept an Indefinite Delivery Indefinite Quantity (IDIQ) contract award to provide Commercial Surge Capacity Testing for COVID-19 Emergency Response to the Centers for Disease Control and Prevention (CDC). Under the contract with the CDC, BioReference will perform antibody testing to determine COVID-19 seroprevalence, and will provide results with key demographic information and analysis in collaboration with the CDC. The agreement's period of performance began July 20th, 2020, and is ongoing through November 19th, 2020. "Working with the CDC underscores the importance of public, private partnership to achieve a worthwhile COVID-19 response," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Many studies suggest that the majority of the public has not been infected with COVID-19, but multiple factors limit these findings. Together with the leading public health authority, we are leveraging extensive depth and breadth of testing expertise to increase overall understanding of the disease burden of the virus."

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