LITTLE RIVER, S.C.--(BUSINESS WIRE)--PCT LTD (OTC Pink: PCTL) ("PCTL") is pleased to announce that it has received approval for “emerging pathogens” labeling with the US EPA.
The application was filed under the guidance document “Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.” It was approved on March 26th, 2020. The guidance document provides the following information regarding different classes of viruses and their resistance to being killed by disinfectants:
EPA and the Centers for Disease Control and Prevention (CDC) recognize that certain microorganisms can be ranked with respect to their tolerance to chemical disinfectants. The Spaulding Classification model, used by CDC, tiers microorganisms in accordance with the level of resistance to being killed (inactivation) by typical disinfectant products. With this approach viruses are divided into three viral subgroups (small non-enveloped, large non-enveloped, and enveloped) based on their relative resistance to inactivation … According to this hierarchy, if an antimicrobial product can kill a small, non-enveloped virus it should be able to kill any large, non-enveloped virus or any enveloped virus. Similarly, a product that can kill a large, non-enveloped virus should be able to kill any enveloped virus.
Small, Non-Enveloped Viruses (<50 nm): These small, non-enveloped viruses can be highly resistant to inactivation by disinfection. Despite the lack of a lipid envelope, these organisms have a very resistant protein capsid…
Large, Non-Enveloped Viruses: Compared to small, non-enveloped viruses, these viruses are less resistant to inactivation by disinfection. Although they have a resistant protein capsid, their larger size (50-100nm) makes them more vulnerable than their smaller viral counterparts…
Enveloped Viruses: Enveloped viruses are the least resistant to inactivation by disinfection. The structure of these viruses includes a lipid envelope, which is easily compromised by most disinfectants. Once the lipid envelope is damaged, the integrity of the virus is compromised, thereby neutralizing its infectivity.
In addition to being “an EPA-registered, hospital/healthcare or broad-spectrum disinfectant …”, in order to meet product eligibility criteria, the product “should have disinfectant efficacy claims against at least one of the following viral pathogen groupings:
a) A product should be approved by EPA to inactivate at least one large or one small non-enveloped virus to be eligible for use against an enveloped emerging viral pathogen.
b) A product should be approved by EPA to inactivate at least one small, non-enveloped virus to be eligible for use against a large, non-enveloped emerging viral pathogen.
c) A product should be approved by EPA to inactivate at least two small, non-enveloped viruses with each from a different viral family to be eligible for use against a small, non-enveloped emerging viral pathogen.
This approach, where disinfectant products registered for use against viral pathogens in one category of the Spaulding Classification model can be presumed effective against viral pathogens in less-resistant categories, is intended to serve as a conservative approach to identifying disinfectant products likely to be effective against emerging pathogens.”
As a result of meeting all of the Product Eligibility Criteria, PCT LTD can now make the following statement “only through the following communication outlets: … "1-800" consumer information services, social media sites and company websites (non-label related) … [as well as] technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials”:
This Product meets the criteria to make claims against certain emerging viral pathogens from the following viral category[ies]:
- Enveloped Viruses
- Large Non-Enveloped Viruses
- Small Non-Enveloped Viruses
For an emerging viral pathogen that is a/an… |
…follow the directions for use for the following organisms on the label: |
Enveloped virus |
Norovirus |
Large, non-enveloped virus |
Norovirus |
Small, non-enveloped virus |
Norovirus, Rhinovirus (Type 16) |
Hydrolyte® has demonstrated effectiveness against viruses similar to SARS-CoV-2 virus on hard, non-porous surfaces. Therefore, Hydrolyte® can be used against SARS-CoV-2 virus when used in accordance with the directions for use against Norovirus and Rhinovirus type 16 on hard, non-porous surfaces. Refer to the CDC website at https://www.cdc.gov/coronavirus/2019-ncov/community/home/cleaning-disinfection.html for additional information.
COVID-19 is caused by SARS-CoV-2 virus. Hydrolyte® kills similar viruses and therefore can be used against SARS-CoV-2 virus when used in accordance with the directions for use against Norovirus and Rhinovirus type 16 on hard, non-porous surfaces. Refer to the CDC website at https://www.cdc.gov/coronavirus/2019-ncov/community/home/cleaning-disinfection.html for additional information.
“We are very pleased to receive approval for an “emerging pathogens” claim on our product label,” says CEO Gary Grieco. “It represents an important step for us as a business and in helping to control the spread of infectious disease as a whole. Additionally, we are now prequalified for future emerging pathogens of any virus classification.”
Due to the ongoing coronavirus pandemic, PCT LTD has seen an increased number of inquiries from existing clients, sub-registrants, and distributors; in addition to new and prospective customers. The company recently announced that they had temporarily shifted their focus towards producing mass quantities of disinfecting fluids to meet growing demand.
“Fluid sales have been tremendous for us,” says PCT Ltd CEO Gary Grieco. “To put it simply, we are routinely shipping fluids out at rapid pace and into the hands of trained professionals where our product can be put to good use fighting the spread of infectious disease in our communities. We are limited only by our capacity to produce the fluids, but we expect to double our production capacity by April 1st.”
Additional News and Corporate Updates:
PCTL would like to warn its stockholders and potential investors that material corporate information regarding sales, areas of business and other corporate updates will only be made through press releases or filings with the SEC. PCTL does not utilize social media, chatrooms or other online sources to disclose material information. The public should only rely on official press releases and corporate filings for accurate and up to date information regarding PCTL.
About PCT LTD:
PCT LTD ("PCTL") focuses its business on acquiring, developing and providing sustainable, environmentally safe disinfecting, cleaning and tracking technologies. The company acquires and holds rights to innovative products and technologies, which are commercialized through its wholly-owned operating subsidiary, Paradigm Convergence Technologies Corporation (PCT Corp). Currently trading on OTC, "PCTL" aspires to and is actively engaged in preparations for up-listing its common stock to a national securities exchange. The Company established entry into its target markets with commercially viable products in the United States and now continues to gain market share in the U.S. and U.K.
Forward-Looking Statements:
This press release contains "forward-looking statements" as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21B of the Securities Exchange Act of 1934, as amended. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact and may be "forward-looking statements."
Such statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties, which could cause actual results or events to differ materially from those presently anticipated. Such statements involve risks and uncertainties, including but not limited to: the impact of having met the EPA Criteria for use Against SARS-CoV-2, actual sales derived by the Company; the transition to producing large quantities of fluids; PCTL's and its subsidiary's business prospects; PCTL's ability to raise sufficient funds to satisfy its working capital requirements; the ability of PCTL to execute its business plan; any other effects resulting from the information disclosed above; risks and effects of legal and administrative proceedings and government regulation; future financial and operational results; competition; general economic conditions; and the ability to manage and continue growth. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual outcomes may vary materially from those indicated. Important factors that could cause actual results to differ materially from the forward-looking statements PCTL makes in this press release include market conditions and those set forth in reports or documents it files from time to time with the SEC. PCTL undertakes no obligation to revise or update such statements to reflect current events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
