FinancialBuzz.com News Commentary
New York, NY (8/25/2020) – Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and closed loop artificial pancreas systems. In addition, in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters as well as certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. In recent years, wearable devices have also become part of the industry. There is a wide range of wearables, including many used for medical purposes. According to Healthcare Information and Management Systems Society, Inc. (HIMSS), wearable technologies can be innovative solutions for healthcare problems, enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters during daily life. Nemaura Medical, Inc. (NASDAQ: NMRD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), BioNTech SE (NASDAQ: BNTX), GlaxoSmithKline plc (NYSE: GSK), Eli Lilly and Company (NYSE: LLY)
Wearable devices have started to play an important role in the healthcare industry even before the pandemic. Nowadays, during a severe viral pandemic, remote monitoring medical devices have become a crucial component of healthcare. In fact, earlier in March, the U.S. Food and Drug Administration (FDA) allowed certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. For example, the Taiwan-founded healthcare wearable device company iWEECARE announced, according to MobiHealthNews, that its flagship product, Temp Pal, has been in use to help combat the spread of the virus in hospitals and self-quarantine. The cloud-based continuous temperature monitoring system can lower the risk of infections and prevents the overwhelming of health systems by reducing physical contact between caregivers and patient
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 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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Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced back in May the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications titled, “Immunogenicity of a DNA vaccine candidate for COVID-19” by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Dr. Kate Broderick, INOVIO’s Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, “These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials.”
BioNTech SE (NASDAQ: BNTX) announced this month that the first 72 participants have already been dosed with BNT162b1 following IND approval by the Chinese regulatory authority, National Medical Products Administration (NMPA). BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China. The trial is part of BioNTech’s global development program aimed at supporting a global supply upon regulatory approval. The randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection. The first group of subjects immunized in Stage 1 of the study will be healthy adults aged 18 to 55 years, followed by elderly healthy participants (>55 years). As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart, of 10µg or 30µg of the vaccine candidate or placebo. The dose range selection was determined based on early data from clinical trials conducted in Germany and the United States. The participants will be dosed in Taizhou Clinical Phase1 Center, Jiangsu province.
GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology, Inc. announced back in April that they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
Eli Lilly and Company (NYSE: LLY) announced earlier this month the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population. “COVID-19 has had a devastating impact on nursing home residents. We’re working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals. While it’s not easy to conduct clinical trials in this setting, we’re taking on the challenge in an effort to help those who need us the most,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.
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