Wearable Diagnostic Devices Help Ease Pressure on Healthcare Systems

NEW YORK, July 27, 2020 /PRNewswire/ -- The wearable technology ecosystem continues to rapidly evolve around the world as several technological developments help stir up demand. The medical technology sector, among others such as biotechs developing vaccines and medical equipment companies providing various test kits, has been in the center of attention because of the current pandemic. Companies in this sector have the potential to ease pressure from healthcare facilities and from medical personal. In terms of wearable technology evolution, body area networks have started becoming a larger factor, along with Internet of Things (IoT) integration involving sensors and user-friendly interfaces to provide a feedback loop of various data. Furthermore, and particularly in the medical field, the accuracy of the data provided back to the consumer is of critical importance. Therefore, medical device manufactures have to focus on continuously improving sensor technology as well as the accuracy of data. Nemaura Medical, Inc. NMRD, CytoDyn Inc. CYDY, Aytu BioScience, Inc. AYTU, Johnson & Johnson JNJ, BioNTech SE BNTX

The wearable device market is largely driven by the increasing awareness of the importance of leading a healthy lifestyle and fitness. Currently, with a global pandemic putting pressure on healthcare systems, such technological innovations can play a crucial role in helping to manage the overall infrastructure. For example, a report by WIRED indicates that a wearable device, which had been approved by the US Food and Drug Administration (FDA) in May 2019 as a tool for remotely monitoring patients recovering from opioid overdoses, has recently been retooled to help doctors manage patients suffering from the pandemic virus. FDA officials approved the modified version of the device within days. "This way, the caregivers can go about their normal days and only get alerts, only pay attention when they need to," explains Joe Kiani, inventor and founder of Masimo. "And then, if for some reason they don't respond within a period, it elevates the alarm to other care providers."

Nemaura Medical, Inc. NMRD announced earlier this 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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CytoDyn Inc. CYDY announced last week the results of the patient safety data from the Company's over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications. A total of 84 patients were treated across 8 study sites in the randomized, double-blind, placebo-controlled Phase 2 study. Fifty-six (56) patients were assigned to the leronlimab arm compared to 28 patients in the randomized placebo arm with a 2:1 active drug to placebo ratio. This trial was designed to evaluate the safety and efficacy of leronlimab and the results of efficacy portion of the data is anticipated to be released as soon as the statistical analyses of all primary and secondary endpoints are completed. Scott Kelly, M.D., CytoDyn's Chief Medical Officer, commented, "We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population. When considering treatment options in the COVID-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs. We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results."

Aytu BioScience, Inc. AYTU reported earlier this 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. In addition to offering the COVID-19 IgG/IgM rapid antibody test Aytu distributes to their client practices, Apollo has partnered with clinical laboratories to offer an expanded menu of testing. Apollo is also offering consultation services to enable client-specific implementation of COVID testing research protocols along with a variety of environmental safety products such as ultraviolet light sanitation products.

Johnson & Johnson JNJ announced back in June that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic."

BioNTech SE BNTX and Pfizer Inc. announced last week an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval. Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. "In the face of this global health crisis, Pfizer's purpose – breakthroughs that change patients' lives – has taken on an even greater urgency. Consequently, we're harnessing our scientific expertise, and we're marshaling our manufacturing resources to ensure that the vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted," said Albert Bourla, Chairman and Chief Executive Office, Pfizer.  "This agreement is a testament to our shared goal to have millions of doses of a vaccine against COVID-19 available before the end of the year.  We would like to thank the U.K. government for its commitment and support in helping to protect the people of the United Kingdom from this deadly virus."

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