New Disinfection Technology and Wide Range of PPEs Emerge at a Time of Need

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NEW YORK, Nov. 5, 2020 /PRNewswire/ -- Because of the pandemic and the pressures the healthcare industry has to go through, various sectors within the industry have had to innovate in the field of vaccination, PPEs, medical devices and mass testing. With testing, various regulatory bodies can obtain the data necessary to help make informed decisions to keep communities safe and assist policymakers with decisions about activity levels, masking, etc. In addition, new disinfecting technology has appeared, utilizing UV light or, on a larger scale, automatic vehicle disinfections. According to Grand View Research, the Defense Research and Development Organisation (DRDO) has launched the UV Blaster, which is useful for disinfecting high-tech surfaces and areas with a large flow of people, such as airports, hotels, offices, metros, shopping malls, and factories. Its ease of installation and low maintenance, supervision, and space requirements have also led to the growing demand for this technology. Optec International, Inc. OPTI, OPKO Health company OPK, Chembio Diagnostics, Inc. CEMI, ADMA Biologics, Inc. ADMA, Tonix Pharmaceuticals Holding Corp. TNXP

As the economy slowly resumes its activity, there have been major innovations in disinfection technology and increase in production of PPEs. For example, according to a report by TechCrunch, Juganu, a company that makes lighting systems designed for emitting light at specified wavelengths, is now selling a product that it claims is capable of disinfecting surfaces and neutralizing pathogens in an attempt to provide buildings with new safety technologies that can prevent the spread of the virus. And as for PPEs, some are reviewed by the FDA before they can be legally sold in the United States. The manufacturers have to show they meet specific criteria for performance, labeling, and intended use to demonstrate substantial equivalence. The global personal protective equipment (PPE) market was valued at USD 52.7 Billion in 2019 and is expected to reach USD 92.5 Billion by 2025 while growing at a CAGR of 8.7% during 2020-2025, according to VynZ Research.

Optec International, Inc. OPTI just announced breaking news that, "it has successfully secured a fully executed definitive agreement for the supply of Brand Specific Personal Protection Equipment (PPE) products for a large International Commodities Consortium totaling in excess of $2 Billion Dollars US.

A  Senior OPTEC Spokesperson commented  'the company has been working for over a month to bring the transaction to successful closing and is extremely happy to announce the execution of the definitive agreement and preparation of the massive logistics operation for the distribution of the products, furthermore OPTEC has entered into an additional agreement with an established Freight and Logistics organization for the transportation of  products to the final destinations in the Medical and Hospital environments'.

The company recently filed the following 8-K in accordance with SEC regulations:

Item 1.01 Entry into A Material Definitive Agreement.

(a) If the registrant has entered into a material definitive agreement not made in the ordinary course of business of the registrant, or into any amendment of such agreement that is material to the registrant, disclose the following information:

On October 30, 2020 the Company (OPTEC) entered into a definitive agreement with a large International Commodities Consortium for the supply and distribution of Specific Brands of Personal Protection Equipment (PPE) for Medical & Hospital use throughout North America, totaling in excess of Two Billion Dollars $US. The agreement has been fully executed by the company and the buyer, along with proofed bank certified funds to complete the transaction in excess of $2 Billion Dollars US. The company (OPTEC) has already sourced and secured the products for the entire agreement, along with coordinating the logistics portion of the agreement. The product distribution is expected to be fully completed by December 2020.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed the undersigned hereunto duly authorized.

https://www.sec.gov/Archives/edgar/data/1557340/000107997320000919/optec_8k.htm

In addition to the financial benefits to the company, shareholders and Investors the contract increased the need for the company to expand operations and the requirement for additional staff to oversee all aspects of the company's rapid growth."

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OPKO Health company OPK, announced last month the beginning of its COVID-19 testing program for New York City schools throughout the 2020-2021 school year to help ensure a safer school environment. Continuing a strategic collaboration with New York City, the Department of Health, New York City Health and Hospital Corporation (NYC Health + Hospitals), the Test & Trace Corp, and the Department of Education, BioReference is performing COVID-19 molecular testing for NYC schools. In addition, BioReference is collecting specimens from principals, teachers, administration and students from over 950 schools across NYC. "This school year for New York City and other school systems around the world is vastly different due to the global pandemic, and BioReference is privileged to aid in keeping NYC schools safe," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.

Chembio Diagnostics, Inc. CEMI announced back in September its initiation of the notification process and submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG. "We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system," stated Richard Eberly, Chembio's President and Chief Executive Officer. "Submission of the EUA application for this test system has been the top priority for our organization because we understand there is a large need in the market for additional rapid tests – especially ones that offer the ability to decentralize testing locations. We are excited to offer a solution to patients and clinicians across the healthcare system that addresses these needs.

ADMA Biologics, Inc. ADMA announced earlier in September the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration with Leinco Technologies, Inc. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the U.S. Food and Drug Administration. We will report on material regulatory and commercial developments as we progress.  ADMA has submitted patents for ImmunoRank in the U.S. and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents.

Tonix Pharmaceuticals Holding Corp. TNXP announced last month that the first patient was enrolled in the observational COV-LOGIC study (TNX-C001), a study of humoral (antibody) and cellular (T cell) immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's TNX-1800, which is a live replicating, attenuated virus vaccine designed to protect against COVID-19. "This represents a significant milestone for the Company as the data we plan to collect from recovered and asymptomatic COVID-19 volunteers in this study will help inform vaccine development on how to safely provide the same immune responses that others got from recovering from actual SARS-CoV-2 infection," said Seth Lederman, M.D., President and CEO of Tonix.  "Our goal with TNX-1800 is to develop a vaccine that is well tolerated, produces strong, long-lasting immunity, and can be rapidly and broadly deployed.  The features of a protective immune response to SARS-CoV-2 remain unknown.  But since SARS-CoV-2 is a virus, we believe that T cell responses, in particular T Helper Type 1, or TH1 responses, will play an important, if not dominant, role in protecting against serious illness from COVID-19."

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