Jul 23, 2020

Modernized Approaches to Patient Monitoring Ease Pressure on

Bizclik Editor
10 min

- FinancialBuzz.com News Commentary

NEW YORK, July 22, 2020 /PRNewswire/ -- As healthcare systems come under severe pressure from the pandemic, significant changes to their infrastructure are required. In particular, technological changes to transform service delivery and to scale up the utilization of digital systems are key factors that currently lacking. According to data provided by a Price Waterhouse Cooper (PwC) report, the health industry is betting that digital transformation will make the difference in delivery and cost. The health industry's appetite for data has grown beyond medical histories. To provide better and cheaper services healthcare, professional are now collecting genetic information, counting calories, steps, fertility cycles and how often we toss and turn at night. Some innovative medical technologies that have already existed for many years, such as telemedicine, were not properly implemented in large part due to strict regulation. Across all industries surveyed by PwC, key obstacles to monetizing data include poor data reliability (34%), data protection and privacy regulations (33%), an inability to adequately protect and secure data (32%), and a lack of analytical talent (30%). Nemaura Medical, Inc. (NASDAQ: NMRD), Dynavax Technologies Corporation (NASDAQ: DVAX), Eli Lilly and Company (NYSE: LLY), Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN), CTI BioPharma Corp. (NASDAQ: CTIC)

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. For example, the article indicates that NHS England reported a partnership with British health tech start-up Huma, formerly Medopad, to study more than 160 patients recovering at home from the viral infection using the company's remote-monitoring technology. 

Nemaura Medical, Inc. (NASDAQ: NMRD) announced earlier last week 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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Dynavax Technologies Corporation (NASDAQ: DVAX) that the first participants have been dosed in the Phase 1 clinical trial evaluating Medicago's plant-derived vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19. The previously announced collaboration is evaluating the combination of Medicago's Coronavirus Virus-Like Particle (CoVLP) with Dynavax's CpG 1018, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine.  Adding CpG 1018 is intended to enhance the immune response of Medicago's COVID-19 vaccine which may reduce the amount of antigen required per dose, providing more doses to help protect a greater number of people. "We are committed to supporting the development of an adjuvanted vaccine to prevent COVID-19," commented Ryan Spencer, Chief Executive Officer of Dynavax. "CpG 1018's ability to enhance the immune response, as successfully demonstrated in HEPLISAV-B, is expected to reduce the dose of antigen needed, helping ensure broader availability to patients. Additionally, the unique mechanism of action of CpG 1018 may provide important enhancements including increased protection in populations traditionally less responsive to vaccination such as older adults who are at greatest risk for severe disease from COVID-19."

Eli Lilly and Company (NYSE: LLY) hat the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo–controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Baricitinib, marketed as OLUMIANT®, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA). Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry. "Lilly is committed to fighting this global pandemic, and this includes testing whether existing medicines including baricitinib could help treat the complications of COVID-19 in patients," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment."

Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for trans sodium crocetinate (TSC) in COVID-19 patients. This IND, which incorporates pre-IND regulatory guidance from the FDA, describes an international clinical development program in the U.S. and EU, newly titled as Phase 1b/2b, testing the Company's lead drug TSC in a total of approximately 424 COVID-19 patients with symptoms of impaired respiratory function and low oxygen levels. Low oxygen levels are a frequent result of damage to the lungs, often leading to organ failure – the leading cause of death in COVID-19 patients. Diffusion believes TSC's oxygen-enhancing mechanism could provide an important new treatment option. "We believe that filing our international clinical development plan as part of the IND is our best path to advance TSC as a new treatment to help boost low oxygen levels and alter the downward spiral in COVID-19," said David Kalergis, chief executive officer of Diffusion. "We expect this plan to allow dosing of the first patient in July, data read-out by the end of Q3 and – assuming positive data and regulatory approval – the commencement of follow-on Phase 2b trials in the U.S. and Romania shortly thereafter."

CTI BioPharma Corp. (NASDAQ: CTIC) reported last month that it had enrolled the first patient in the Phase 3 PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28. "Initiation of patient enrollment in the PRE-VENT Phase 3 trial is an important step for CTI as we work towards providing a new therapeutic option for patients with severe COVID-19," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "As a multi-kinase inhibitor, pactrinib has the potential to reduce the effects of the cytokine storm that occurs with the novel coronavirus infection, an inflammatory response that frequently leads to respiratory failure and need for mechanical ventilation."

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