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MedMira Inc MMIRF


Primary Symbol: V.MIR

MedMira Inc. is a Canada-based biotechnology company. The Company, through its subsidiaries, is engaged in the business of research, development and manufacturing of rapid diagnostics and technologies. The Company invests in research in order to maintain and expand its position in the global diagnostics market. Its research is focused on specific areas of the broader diagnostics market, namely the rapid, point-of-care, and in vitro sectors. The Company is the developer and owner of Rapid Vertical Flow (RVF) Technology. The Company's rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as Human Immunodeficiency Virus (HIV), Syphilis and hepatitis C in just three easy steps. The Company's tests are sold under the Reveal, Multiplo and Miriad brands in global markets. The Company's manufacturing facilities are located in Halifax, Nova Scotia, Canada.


TSXV:MIR - Post by User

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Post by goldyhawkon Apr 04, 2022 9:20am
128 Views
Post# 34572541

extremely easy not to believe in Medmira

extremely easy not to believe in Medmira
  Halifax, Nova Scotia, 30 December, 2020 – Today, MedMira Inc. (MedMira) (TSXV: MIR), is pleased to announce its validated REVEALCOVID-19TM PLUS Total Antibody Test for the detection of total antibodies against both the Nucleocapsid and Spike regions of the SARS-CoV-2. REVEALCOVID-19TM PLUS Total Antibody Test is an update to MedMira’s REVEALCOVID-19TM Total Antibody Test that addresses the total antibody testing demands arising from recent developments in COVID-19 vaccines across global markets. 
 
 
   To ensure the EUA application for the enhanced product, REVEALCOVID-19™ PLUS Total Antibody Test, satisfies the EUA guidelines, MedMira is required to withdraw the current application for the REVEALCOVID-19TM from the EUA notification list to obtain a new EUA listing for the REVEALCOVID-19TM PLUS Total Antibody Test. At the same time, MedMira will submit a new interim order application to seek Health Canada authorization of REVEALCOVID-19TM PLUS Total Antibody Test. “
 
  “The beauty of MedMira’s RVF® Technology is the ability to pivot toward the current needs. As the stage of the pandemic shifts to vaccination, it is imperative that MedMira can adjust. As a result, and in consultation with our partners, MedMira decided to move forward with a simple solution by launching REVEALCOVID-19TM PLUS Total Antibody,” said Hermes Chan, CEO of MedMira Inc. “This shall enable us to introduce the new product version and address the additional market demands, focussing our attention on the production of 50,000 units of REVEALCOVID19™ PLUS Total Antibody Test daily. This will position MedMira as a major contender in the coming months, as the vaccines are now being administered globally. The knowledge gained during the original EUA application has been invaluable”.   
 
feb4 2022
Furthermore, the Company has made further progress on its regulatory work in United States. While the EUA process is on-going, the Company has prepared the necessary De Novo 510(k) pre-submissions for its REVEALCOVID-19® and VYRATM product lines. At this stage the regulators are yet to release the final requirements for the acceptance. The Company is confident to fulfill these requirements for all its products and has completed all the necessary preparations to immediately commence.
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