Companies Focus on Producing Personal Protection Equipment (PPE) to Address Critically Short Supply for COVID-19 Crises

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, April 1, 2020 /PRNewswire/ -- The need for protective gear and advanced technology/equipment for healthcare workers is high atop almost every checklist to fight this worldwide healthcare crises. Personal protective equipment – masks, goggles, gloves and gowns – shield medical workers against viral or bacterial infection from blood, body fluids, respiratory secretions and excretions from patients. Though the eyes, nose and mouth require special protection, the Centers for Disease Control and Prevention says gloves and gowns are the most-used articles of PPE. The lack of protective gear has front-line health care providers worried. They fear getting infected by the patients they care for – then passing on the infection to their own families.  USA Today said: "As the U.S. health care system struggles with a dearth of beds and hospital space for the rising number of coronavirus-infected people, another type of shortage looms – basic protective equipment for workers. USA TODAY recently reported that stockpiles of medical supplies created for disaster use were not sufficiently funded, leaving storage facilities undersupplied with ventilators, respiratory masks and other personal protective equipment. A U.S. Conference of Mayors survey of more than 200 cities in 41 states found that 88% said their safety and medical personnel lacked an adequate supply of personal protective equipment, or PPE.  Active healthcare stocks in news today include:  Nemaura Medical Inc. (NASDAQ: NMRD), Co-Diagnostics, Inc. (NASDAQ: CODX), Aytu BioScience, Inc. (NASDAQ: AYTU), Laboratory Corporation of America Holdings (NYSE: LH), Roche Holding AG (OTCQX: RHHBY).

USA TODAY added: "In California, nurses protested outside Bay Area hospitals last week, pleading for medical supplies and PPE. The New England Journal of Medicine said Wednesday that a review of medical shortages found health care workers in Italy "experienced high rates of infection and death partly because of inadequate access to PPE."   An article from NPR echoed that saying that: "… around the country first responders are bracing themselves for an increase in calls as more states confirm cases of the new virus… Around the country EMS departments are preparing. One concern they share is a looming shortage of masks. State EMS directors are worried agencies could run out "in the next couple weeks," says Leslee Stein-Spencer, a program advisor at the National Association of State EMS Officials. The shortage will have significant consequences, Stein-Spencer says. When workers get sick, it gets harder to keep ambulance services running.

Nemaura Medical Inc. (NASDAQ: NMRD) BREAKING NEWS - Nemaura To Launch Body-Worn Continuous Temperature Monitor (CTM) to Track Fever Caused by Viral Infections such as COVID-19 - Nemaura Medical, ("Nemaura" or the "Company"), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT^®, its non-invasive and flexible continuous glucose monitor ("CGM"), announced plans for a significant new product line by immediately repurposing sugarBEAT^® as a CTM since its inbuilt temperature sensor is capable of continuously tracking body temperature through the skin. Nemaura is considering various options to expedite the launch of a CTM, including potential partnerships and direct to consumer sales.

CTM's have been recognised as having a key role to play in combatting COVID-19, with Google's Verily announcing plans to develop a small body worn temperature patch that transmits data to a phone application to provide timely notification of fever and support earlier diagnosis and treatment of viral infections like the flu or coronavirus.  Nemaura's sugarBEAT^Ò body worn skin patch is designed to monitor glucose levels on the skin at 5 minute intervals. However, the skin patch also contains a thermistor which measures skin temperature as an integral part of the device meaning the device could easily be repurposed for this standalone function. The CGM device is CE approved in Europe and in commercial production in the UK.

"We see a significant commercial opportunity to utilise the sugarBEAT^® technology specifically for CTM purposes with data being automatically sent by low energy Bluetooth to a mobile phone app from which it can then be reviewed by the user and / or sent to a family member or caregiver. There are parallels between family members and caregivers remotely monitoring glucose fluctuations in a person, and monitoring fever caused by viral infections, providing a means of remote tracking and intervention. In the current climate we see this as an opportunity to contribute to general wellbeing and patient management" stated Dr. Faz Chowdhury, Nemaura's CEO.

Several diseases including COVID-19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring is a vital tool in the detection of such conditions and consequently a means of containing the spread of the disease through early self-isolation. Measuring body temperature on a continuous basis may also be used to track the course of a disease and so allow physicians to analyse the effectiveness of treatments and thus pro-actively adapt to improve outcomes.

Dr. Chowdhury further stated "body temperature can vary depending on the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the temperature is taken. For this reason the ability to track the temperature continuously over time and measure the rate at which it is rising or falling would be a superior form of monitoring a person than sporadic measurements taken using a more traditional thermometer".

Multiple other future uses are foreseen for a CTM including tracking ovulation to improve the chances of conception and for predicting / preventing diabetes related foot complications such as ulcers which can eventually lead to amputation if not detected early enough, whereby poor blood circulation can be rapidly detected by continuous temperature monitoring of the affected region. 

Nemaura is establishing the regulatory framework for launching the CTM with and without clinical claims. For the US, plans are being made to request accelerated assessment and approval from the FDA owing to the potential benefits this simple class II device could offer in the current climate. The US FDA recently announced emergency guidance for remote non-invasive monitoring in light of the Covid-19 public health emergency.

In other healthcare news of note:

Co-Diagnostics, Inc. (NASDAQ: CODX) a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, recently announced the filing of their financial results for the fiscal year ending December 31, 2019, as well as updates on the Company's growth and progress for 2019 and 2020 to date in the following areas:

Following the outbreak in China beginning at the end of 2019, the Company was able to successfully leverage its unique, proprietary test design platform to design a test for COVID-19, to become the first U.S. company with a CE marking for that test, and to begin marketing as the pandemic grew. As a result of the Company's high-quality test design, Co-Diagnostics was able to quickly establish a global network of clients, resulting in revenue in the first quarter of 2020 since the time that the CE marking was obtained. Sales will be further bolstered following an FDA policy which facilitated sales of the Company's clinically evaluated coronavirus test to U.S. markets.

Aytu BioScience, Inc. (NASDAQ: AYTU) recently announced that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Laboratory Corporation of America Holdings (NYSE: LH) recently announced that it is exploring all options to prioritize COVID-19 testing for the hospital inpatient population who are being treated for what the physician suspects may be the COVID-19 virus. The company anticipates finalizing options through the week and will subsequently work with hospitals to begin implementation.

LabCorp continues to add capacity to perform testing for patients who should be tested in accordance with CDC and other health authority guidelines.

"LabCorp colleagues around the world are working tirelessly alongside our industry partners and governmental and health authorities to increase testing and capacity," said Adam Schechter, president and CEO of LabCorp. "We are aligned with the Administration's guidance and are actively encouraging all healthcare providers to follow the guidance to prioritize testing for patients who are hospitalized and being treated for suspected COVID-19. We are exploring all options to make this happen and will continue to do all we can to help fight this unprecedented health crisis."

Roche Holding AG (OTCQX: RHHBY) recently provided an update on the various actions the company is taking to address the COVID-19 pandemic. On March 19, 2020, Roche confirmed initiation of a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care.

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