HALIFAX, Nova Scotia, July 10, 2020 (GLOBE NEWSWIRE) — Today, MedMira Inc. (MedMira) (TSXV: MIR) would like to issue a statement to address the request form the Investment Industry Regulatory Organization of Canada (IIROC) and comment on the recent increase in the price of the company’s shares. MedMira is not aware of any material change in its business affairs that has not been publicly disclosed and could account for the recent increase in market activity.
REVEALCOVID-19™ Total Antibody Test is being currently manufactured at MedMira’s FDA-licensed (establishment license 3003595936) and ISO-certified Halifax facility under strict Good Manufacturing Practices (GMPs). MedMira has ramped up its weekly production within a short period of time and has substantially increased its existing and trained work force in order to meet the increasing demand for its product. The Company has started shipping REVEALCOVID-19™ Total Antibody Test, RVF®-based rapid serological assay that detects total antibodies to the SARS-CoV-2 virus, the causative agent of COVID-19, in human serum, plasma and venipuncture whole blood, to its exclusive distribution partner, WebbDX. MedMira is extremely pleased that, at the time of the ongoing COVID-19 crisis, the company could bring REVEALCOVID-19™ Total Antibody Test to the market as well as create new jobs.
In April, MedMira has announced the development of REVEALCOVID-19™ Total Antibody Test. In early May, the Emergency Use Authorization (EUA) application has been successfully submitted to seek the United States FDA product authorization. At this time, MedMira’s EUA application is still being reviewed. MedMira would like to reemphasize that EUA review is a very interactive process that involves ongoing communications between the FDA and MedMira. Time required to receive the FDA product authorization under EUA varies on a case-by-case basis, thus, the timeline of the EUA review cannot be defined. MedMira’s unique and patented Rapid Vertical Flow® platform differs from the commonly used Lateral Flow technology prompting different questions from the FDA and may result in a longer lead time. While awaiting the FDA authorization, however, REVEALCOVID-19™ Total Antibody Test can be distributed in the United States as per the FDA policy.
MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV and Hepatitis C, in just three easy steps. (Read more…) The Company’s tests are sold globally under the Reveal®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval and launch of the REVEALCOVID-19TM Total Antibody Test, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Chief Financial Officer, MedMira Inc.