At the request of IIROC, Investment Industry Regulatory Organization of Canada, Covalon Technologies Ltd. (the “Company” or “Covalon”) (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, has been asked to clarify the press release issued earlier today. At IIROC’s request, the Company retracts the title to its last press release because IIROC has deemed the title overly promotional. At IIROC’s request, the Company modifies the title to “Covalon Announces New Antimicrobial Technology”.
The Company clarifies that the testing to date on the CovaGuard technology has been based on industry standard ASTM International and CLSI test methods for antimicrobial testing and was performed on surgical masks in the Company’s ISO 13485:2016 compliant medical labs. Covalon has extensively tested the CovaGuard technology using surrogate pathogens that mimic the responses of coronaviruses to antimicrobials because the live COVID-19 virus was not available. The Company is in the process of working with specialized third-party labs licensed to test CovaGuard on live COVID-19 viruses. All testing was performed in a similar manner to the thousands of antimicrobial tests that the Covalon R&D team has performed over the past 20 years and reviewed under the Company’s extensive quality control system. Independent verification is not required and as a result was not obtained. At IIROC’s request, the Company states that it is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 virus.
The research and development team was staffed with experts in antimicrobial technology development and supervised by Dr. Val DiTizio, PhD, who is a co-founder and Chief Scientific Officer of Covalon, and who is a recognized expert in antimicrobial technology. Dr. DiTizio and his team have developed and patented numerous novel antimicrobial technologies and products, tissue viability and repair products and innovations in drug delivery systems over the past 25 years, for Covalon’s own products and under engagements with dozens of globally recognized medical companies. The CovaGuard technology was based in part on several of Covalon’s proprietary antimicrobial delivery systems and expertise. The Company intends to continue testing the efficacy of the CovaGuard technology and the resulting products that are intended to be released that are based on the CovaGuard technology.
Covalon has identified and formulated several initial products from the CovaGuard technology, including a hand sanitizer and a medical mask spray that comply with current United States Food and Drug Administration (“FDA”) and Health Canada Regulations. These products have been formulated to meet the current regulatory rules in Canada under the monograph for a Class I Drug Identification Number – Disinfectant Product and in the United States under 21 CFR Part 330.1 as an OTC Drug and Class I Exemption status with Product Code LRJ under Covalon’s FDA Registration and can be legally marketed in Canada and the United States immediately. The Company is in the process of sourcing raw materials in order to commence manufacturing of these products in its facility in Mississauga, Ontario. The Company intends to fund the initial production of these products derived from the CovaGuard technology with the Company’s current working capital and is not anticipating the need to materially hire additional personnel or acquire additional equipment to commence production. The supply of raw materials are intended to be sourced from the Company’s existing supplier relationships. Contemporaneously, the Company is in the process of seeking partnerships with large medical companies and other manufacturers to satisfy demand.
The Company has not paid, nor engaged any investor relations firm or promotion services at this time.
Covalon Technologies Ltd. researches, develops, and commercializes new healthcare technologies that help save lives around the world. Covalon’s patented technologies, products, and services address the advanced healthcare needs of medical device companies, healthcare providers, and individual consumers. Covalon’s technologies are used to prevent, detect, and manage medical conditions in specialty areas such as infection control, vascular access, surgical procedures, advanced wound care, and medical device coatings. To learn more about Covalon, visit our website at www.covalon.com.
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This news release contains forward-looking statements which reflect the Company’s current expectations regarding future events. The forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “plan, “estimate”, “expect”, “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. These forward-looking statements involve risk and uncertainties, including completion of integration of the AquaGuard acquisition, the difficulty in predicting product approvals, acceptance of and demands for new products, the impact of the products and pricing strategies of competitors, delays in developing and launching new products, the regulatory environment, fluctuations in operating results and other risks, any of which could cause results, performance, or achievements to differ materially from the results discussed or implied in the forward-looking statements. Many risks are inherent in the industry; others are more specific to the Company. Investors should consult the Company’s ongoing quarterly filings for additional information on risks and uncertainties relating to these forward-looking statements. Investors should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update or alter any forward-looking statements whether as a result of new information, further events or otherwise.