NEW YORK, Aug. 20, 2020
FinancialBuzz.com News Commentary
NEW YORK, Aug. 20, 2020 /PRNewswire/ -- The medical technology sector, alongside others such as biotech and medical equipment companies providing various test kits, has been in the center of attention due to the current pandemic. A segment of the medical technology industry is the wearable device market; it is largely driven by the recent increasing widespread awareness of the importance of leading a healthy lifestyle and fitness. Currently, with a global pandemic putting pressure on healthcare systems, such technological innovations play a crucial role in helping buttress the overall infrastructure. Today, during a severe viral pandemic, remote monitoring medical devices have become a crucial component of healthcare. Nemaura Medical, Inc. (NASDAQ: NMRD), Co-Diagnostics, Inc. (NASDAQ: CODX), Aytu BioScience, Inc. (NASDAQ: AYTU), Dynavax Technologies Corporation (NASDAQ: DVAX), OPKO Health, Inc. (NASDAQ: OPK)
The current pandemic is the first to occur against the backdrop of unprecedented technological advancement, particularly of information technology, which is widely applied in a medical setting. Wearable technologies play a crucial role in that regard. The resurgence of medical devices that help consumers monitor their vital signs has also attracted the FDA's attention. According to MedCity News, Courtney Lias, Director of the Division of Chemistry and Toxicology Devices Office, part of FDA's Center for Devices and Radiological Health, spoke strongly in support of developing interoperable devices that could wirelessly communicate, not only with each other, but with other digital apps as well. "We want to incentivize interoperability and open systems through optimized regulatory pathways," Lias said, noting that the agency has taken two regulatory actions to create a "pathway for devices to become integrated with each other including apps."
Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news yesterday that it has, "issued a presentation outlining how CGM is being used by quarantined and hospitalised 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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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."
Aytu BioScience, Inc. (NASDAQ: AYTU) reported earlier last month that the Company has signed a distribution agreement with Apollo Med Innovations, Inc. ("Apollo") to distribute the COVID-19 IgG/IgM Rapid Test Cassette to Apollo's network of over 1,000 practices across the United States. This distribution relationship expands the Company's coverage of clinician and professional customers to a large network of medical clinics, clinical laboratories, and wellness centers. Apollo is also engaged with a growing number of employers and municipalities in offering their COVID-19 testing services. Through Apollo's introduction of innovative research-based COVID-19 testing protocols and their offering of comprehensive laboratory support services, this distribution relationship significantly expands the Company's COVID-19 potential user base. Through this relationship between the Company and Apollo, Apollo has begun to introduce the COVID-19 IgG/IgM Rapid Test Cassette as part of a comprehensive support program for professional medical organizations, integrated wellness centers, employers, and municipalities.
Dynavax Technologies Corporation (NASDAQ: DVAX) and commercializing novel vaccines, and Medigen Vaccine Biologics Corporation (MVC) reported last month, their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of MVC's stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax's advanced adjuvant CpG 1018™, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine. "The COVID-19 pandemic is straining healthcare systems across the globe, making a safe, effective and affordable vaccine an important tool in combatting the disease and protecting patients, especially for low and middle-income countries (LMICs)," said Charles Chen, Chief Executive Officer of Medigen. "In preclinical testing, the combination of Dynavax's proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralizing antibody responses and cellular immunity. These results support advancing evaluation of the combination into Phase 1 human testing, which we expect to begin in September of this year."
OPKO Health, Inc. (NASDAQ: OPK) announced last month 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 20, 2020, and is ongoing through November 19, 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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