Market Overview

Patient Monitoring Capabilities Expand Treatment Possibilities

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NEW YORK, Aug. 10, 2020 /PRNewswire/ -- The patient monitoring device market is a large and diverse segment of the medical device industry. Traditionally, patient monitoring devices were used in hospitals to monitor patient's vital signs. Nowadays, with the advancements in wireless technology, these devices can be used to monitor patient remotely. In addition, new wearable monitoring devices, equipped with the Internet of Things (IoT) technology, are able to communicate with smartphones, transferring crucial data through user friendly applications. Besides technological advancements, other driving factors for the growth of the patient monitoring devices market include the rise in the prevalence of lifestyle diseases such as diabetes, cancer, and atherosclerosis. The current pandemic and the pressure put on hospitals and medical professionals has also helped this segment gain more popularity. According to UC San Diego Health, patients who test positive for the virus but aren't in need of hospitalization are sent home to recover, with care team members calling patients daily to monitor symptoms and determine whether additional care is necessary. Nemaura Medical, Inc. (NASDAQ:NMRD), Heat Biologics, Inc. (NASDAQ: HTBX), Novavax, Inc. (NASDAQ:NVAX), Vaxart, Inc. (NASDAQ:VXRT), Koninklijke Philips N.V. (NYSE:PHG)

The Food and Drug Administration (FDA) recognizes the role remote monitoring devices could play in the time of the pandemic. The FDA changed guidance on use of non-invasive remote monitoring devices for patient care during the public health emergency. The FDA explained that in the context of the pandemic, the leveraging of current non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the pandemic as it relates to diagnosis and treatment of patients who tested positive for the viral infection. Overall, the pandemic has caused a shift in operations for many segments of the healthcare industry, including biotechs, personal protective equipment manufacturers, medical device technologies and others.

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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Heat Biologics, Inc. (NASDAQ: HTBX) reported back in June further progress on its COVID-19 vaccine program. Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell line, enabling selection of our COVID-19 vaccine. These steps are important milestones and necessary precursors to completion of our vaccine in preparation for its manufacture and use in clinical trials." Jeff Wolf, CEO of Heat, commented, "We remain on track to complete design and development of our COVID-19 vaccine in July, and expect that our gp96/nCoV-2 expressing cell line will be available for clinical-grade manufacturing with our partner, Waisman Biomanufacturing, in early August. Given our progress to date, we remain encouraged by the potential of our unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses."

Novavax, Inc. (NASDAQ: NVAX) announced last week 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."

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."

Koninklijke Philips N.V. (NYSE:PHG) reported earlier last month that it had introduced first-of-its-kind mobile Intensive Care Units (ICUs) in India. Designed to meet the critical-care requirements of patients, each prefabricated ICU has a capacity of nine beds. The units will be locally manufactured by Philips in India, with each ICU unit capable of being deployed in one day. India is in the top 5 countries with the highest amount of COVID-19 cases. The country's healthcare system is under immense pressure as infections spike. Leveraging its clinical, technical and design expertise, Philips has developed new mobile ICUs to address the challenging needs of critical-care services in India. They will be useful to government agencies and health systems looking to rapidly increase ICU capacity and enhance community outreach with the aim to mitigate the impact of natural disasters and pandemics such as the ongoing COVID-19 outbreak. "Aligned with the government's commitment to providing quality and accessible healthcare to India's population, we are proud to introduce our state-of-the-art mobile ICUs for India," said Daniel Mazon, General Manager Philips India.

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