Medical Device Innovation Helps Propel Healthcare Systems to New Standards

NEW YORK, Sept. 8, 2020 /PRNewswire/ -- In response to the outbreak, governments around the world have focused their resources on curing the viral infection. Beyond the longer-term promise of vaccines, a growing range of actions are being taken to change medical procedures, including point of care testing, temperature screening, wearing of masks, social distancing, sterilization of surfaces, PPE, and symptom reporting. During this crisis, the main objective of companies is to sustain their businesses by finding safe ways to continue their manufacturing operations or explore other sustainable ways to get their revenue streams flowing. The demand for medical device TIC (Testing, Inspection and Certification) services has always been on the rise as these services play a vital role across the world in protecting consumers from poor quality, unsafe medical device products. And according to a report by MarketsandMarkets, the Medical Device Testing Market was valued at USD 9.3 billion in 2020 and is projected to reach USD 11.8 billion by 2025; growing at a CAGR of 4.8% from 2020 to 2025. Nemaura Medical, Inc. (NASDAQ: NMRD), BioNTech SE (NASDAQ: BNTX), Amgen Inc. (NASDAQ: AMGN), AstraZeneca PLC (NYSE: AZN), Gilead Sciences, Inc. (Nasdaq: GILD)

Among the many technologies that are now being integrated with healthcare systems are wearable devices. Just in June, the Financial Times reported that researchers were turning to wearable technologies such as Fitbits and Apple Watches in a bid to tackle the pandemic issue, using the technology to collect large volumes of real-time patient data to track the course of the disease. In addition, earlier in March, according to mHealthIntelligence, San Diego-based SRTI launched DETECT, a national effort to gather data from smartwatches and activity trackers to analyze how activity, heart rate, sleep patterns and other connected health data can be integrated into a public health surveillance program. Participants were asked to upload their data through the MyDataHelps app.

Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news last week that it has, "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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BioNTech SE (NASDAQ: BNTX) reported last month additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data from the U.S. Phase 1 trial for the BNT162b2 vaccine candidate, which at 30ug recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. "The totality of the clinical and preclinical data informed Pfizer and BioNTech's decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "We are especially pleased to offer these early data showing our vaccine candidate's promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future."

Amgen Inc. (NASDAQ: AMGN), AbbVie, Inc. and Takeda Pharmaceutical Co., members of the COVID R&D Alliance AbbVie, Inc., on August 3rd, announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.  "Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19," said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation."

AstraZeneca PLC (NYSE: AZN) announced on August 31st their commitment to the highest safety standards and to broad and equitable access around the world for its COVID-19 vaccine AZD1222.  At the heart of AstraZeneca's core values is to "follow the science" and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance. The Company's submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world. To this end, AstraZeneca is implementing a clinical development program that will enroll in excess of 50,000 volunteers, including 30,000 in the US, in Latin America, Asia, Europe, Russia and Africa that will provide data for ethnically diverse populations.  Pascal Soriot, Chief Executive Officer, said: "In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work. We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVD-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world."

Gilead Sciences, Inc. (Nasdaq: GILD) announced on August 28th, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.  "With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA's decision to expand emergency use authorization," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today's action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury."

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