HALIFAX, NS / ACCESSWIRE / March 14, 2023 / Today, MedMira Inc. (MedMira) (TSXV:MIR) provides an update on its progress to achieve regulatory approval in Canada for its Reveal® TP (Syphilis) antibody test. The Company has successfully started its clinical trials in Saskatchewan in early March 2023 and commences its the other trial in British Colombia by the end of this month.
MedMira's Reveal® TP (Syphilis) antibody rapid test is going to be the first Health Canada approved rapid test and a direct response to the increasing infection rates for infectious and congenital syphilis. Whereas the infection rates over the past 10 years increased by 73% among males, the rate among females increased by 773%. As a result, congenital syphilis (syphilis transmitted during pregnancy to babies) led to a rise in severe and life-threatening illnesses with up to 40% of babies being stillborn.
With this recent trend, infectious and congenital syphilis rates have become an epidemic across Canada and with it are of concern to the government. MedMira's Reveal® TP clinical trials in Saskatchewan are funded by Canadian Institutes of Health Research (CIHR) Centre, for REACH at MAP St. Michael's Hospital. Whereas the clinical trial in BCCDC Vancouver is funded by the National Microbiology Laboratory (NML), Public Health Agency of Canada, Winnipeg, Manitoba.
MedMira's Reveal® TP is currently tested at 10 clinical sites in Saskatchewan with an additional clinical site in British Colombia with NML. Based on the current plan, the Company anticipates the submission of the data by October 2023 and achieve Health Canada approval by late 2023. The Company is going to provide an update at time when the clinical trials have been completed.
'MedMira has been working with REACH Nexus since March 2022 on this highly valuable project and with NML since May 2022. As of today, we have received the Investigational Testing Authorization (ITA), completed the training, and have started our clinical trials. We are grateful to our partners for their hard work to organise these trials which has been not easy due to various COVID-19 related restrictions.' said Hermes Chan, CEO of MedMira. 'What we have seen and experienced so far, confirms that our Reveal® TP is in line with MedMira's high standards in terms of sensitivity and performance. With this feedback and the great work by our partners, we are confident to complete these trials as quickly as possible and may achieve Health Canada approval earlier.'
MedMira is a leading developer and manufacturer of Rapid Vertical Flow Technology® diagnostics. The Company's tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV, syphilis, hepatitis and SARS-CoV-2, in just three easy steps. The Company's tests are sold globally under the Reveal®, REVEALCOVID-19®, 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 www.medmira.com and 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, product launch, 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.
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Chief Financial Officer
SOURCE: MedMira, Inc.
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