Novel Methods of Patient Monitoring Expand Diagnostic Capabilities

NEW YORK, July 20, 2020 /PRNewswire/ -- Wearable technologies can be innovative solutions for healthcare problems. According to a literature review of wearable technology applications by Healthcare Information and Management Systems Society, Inc. (HIMSS), wearable applications can directly impact clinical decision making. Wearable technologies enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters during daily life. The most commonly measured data include vital signs such as heart rate, blood pressure, and body temperature, as well as blood oxygen saturation, posture, and physical activities through the use of electrocardiogram (ECG), ballistocardiogram (BCG) and other devices. When it comes to patients with heart disorders for example, wearable technology can assess patient heart activity outside of a laboratory or clinical environment. It is even possible to perform heart assessments during a wide range of everyday conditions without interfering with a patient's activity tasks. For example, researchers designed a textile-based wearable device for the unobtrusive recording of ECG, respiration and accelerometric data and to assess the 3D sternal seismocardiogram (SCG) in daily life. Nemaura Medical, Inc. (NASDAQ: NMRD), OPKO Health, Inc. (NASDAQ: OPK), Moderna, Inc. (NASDAQ: MRNA), Koninklijke Philips N.V. (NYSE: PHG), iBio, Inc. (NYSE: IBIO)

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. For example, according to Harvard University, Edmond J. Safra Center for Ethics, in March 2020, the South Korean government implemented a smartphone app to supervise the self-quarantine of those who met criteria for confirmed contact with individuals who were confirmed to have the viral infection. "The purpose of the app was to enable disease surveillance, including symptom reporting, mobile testing, and, critically, GPS monitoring of location with triggered warnings for those who leave their prescribed quarantine locations. The major purpose was to prevent asymptomatic "super spreaders" from unknowingly spreading the virus. However, some asymptomatic individuals were incentivized to leave their phones at home so they could leave their quarantined location undetected. A rash of successful attempts to fool the app prompted the Korean government to implement tracing wristbands as mandatory for those under quarantine who violated restrictions," the report indicates.

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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OPKO Health, Inc. (NASDAQ: OPK) announced earlier this month that it will conduct COVID-19 testing for all Major League Soccer (MLS) players as well as match officials, and Club and League staff participating in the MLS is Back Tournament. MLS has chosen BioReference as its laboratory to assist in informing its return-to-play policies for the Tournament kicking off in Orlando in early July. "We are honored to be providing testing solutions to Major League Soccer as it prepares to restart its season," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The leadership of MLS worked diligently with us to develop a COVID-19 PCR and antibody testing strategy with the goal of providing the safest possible environment for the players, coaches and staff to begin to play again."

Moderna, Inc. (NASDAQ: MRNA) announced last week the publication of an interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of Medicine. This interim analysis evaluated a two-dose vaccination schedule of mRNA-1273 given 28 days apart across three dose levels (25, 100, 250 µg) in 45 healthy adult participants ages 18-55 years, and reports results through Day 57. Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints reaffirm the positive interim data assessment announced on May 18th and show mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2. The study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Koninklijke Philips N.V. (NYSE: PHG) reported earlier this month that it had introduced first-of-its-kind mobile Intensive Care Units (ICUs) in India. Designed to meet the critical-care requirements of patients, each prefabricated ICU has a capacity of nine beds. The units will be locally manufactured by Philips in India, with each ICU unit capable of being deployed in one day. India is in the top 5 countries with the highest amount of COVID-19 cases. The country's healthcare system is under immense pressure as infections spike. Leveraging its clinical, technical and design expertise, Philips has developed new mobile ICUs to address the challenging needs of critical-care services in India. They will be useful to government agencies and health systems looking to rapidly increase ICU capacity and enhance community outreach with the aim to mitigate the impact of natural disasters and pandemics such as the ongoing COVID-19 outbreak. "Aligned with the government's commitment to providing quality and accessible healthcare to India's population, we are proud to introduce our state-of-the-art mobile ICUs for India," said Daniel Mazon, General Manager Philips India. "We believe this solution will help the country to tackle COVID-19 in an effective manner as it enables healthcare institutions to increase their critical-care bed capacities. The solution will also be significant in the long term to address future critical care requirements."

iBio, Inc. (NYSE: IBIO) announced back in June that IBM Watson Health had selected iBio to receive 18 months of use of the IBM Clinical Development (ICD) solution, free-of-charge. IBM Watson Health recently began offering its ICD solution to eligible trial sponsor organizations as part of its efforts to help support the medical community to address the COVID-19 pandemic. IBM Watson Health has received interest in the offering from numerous hospitals, sponsors, contract research organizations and academic institutions, and is currently enabling 15 COVID-19 disease trials. "We are deeply appreciative of IBM's vote-of-confidence, which recognizes the potential of iBio's COVID-19 vaccine development efforts from among the hundreds of organizations that applied for access to IBM's ICD solution," said Tom Isett, Co-Chairman & CEO of iBio. "This technology helps to support the rapid and efficient undertaking of clinical trials of iBio's COVID-19 vaccine candidates. It also complements our FastPharming System's core speed, quality and scale-up advantages in the development of vaccines and therapeutics. Through strategic collaborations like this one, we believe iBio is now poised with the tools, technology and capital necessary to compete in the fight against COVID-19."   

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