Update on MedMira’s Regulatory Path in Canada and the USA
Halifax, Nova Scotia, 27 September, 2023 – Today, MedMira Inc. (MedMira) (TSXV: MIR) provides an update on its progress to achieve regulatory approval in Canada and the USA for its infectious disease rapid tests. Currently the Company has two submissions filed with Health Canada and one submission with the US FDA. In addition, the Company is in the process to complete its clinical trials and subsequently gather all necessary data for the final submission of its Reveal® TP (Syphilis) antibody test and its Reveal® G4 rapid HIV antibody test. Further updates will follow in the course of the next weeks.
Canada Regulatory Progress
MedMira has taken important steps by submitting two product applications toward gaining Health Canada approvals. The company's primary goal is to combat the increasing prevalence of infectious diseases in Canada and meet the rising demand for such solutions in the country. The COVID-19 pandemic has underscored the urgent need for rapid testing, resulting in a significant surge in public demand for quick and affordable testing methods. These cost-effective and rapid testing options are vital to alleviate the strain on our healthcare system.
In the month of September, MedMira received the first communication with regard to the submission made in June 2023. The agency has provided valuable feedback, and MedMira's regulatory and compliance team promptly responded with comprehensive answers within the required ten business days.
USA Regulatory Progress
MedMira continued its US FDA clinical work for to achieve the CLIA waiver for its already US FDA PMA approved HIV rapid test. The designation of a CLIA Waiver will allow the Company to significantly extend the sales of its already existing product to screening programs supported by various State funded agencies, non-CLIA waived laboratories and other health care providers. This new designation will significantly amplify the potential market, elevating it from the current USD$2 million to a substantial USD$350 million per annum.
The primary purpose of obtaining FDA clearance for the Clinical Laboratory Improvement Amendments (CLIA) Waiver is to make simple and easy-to-use diagnostic tests more readily available in various healthcare settings, such as physician's offices, clinics, and pharmacies. This allows for quicker and more convenient testing for patients and can be particularly important for point-of-care testing and rapid diagnostics.
At this stage, the Company has submitted the first label claim through the 510(k) process for its HIV-2 component which is an integral part to achieve the CLIA waiver. MedMira has completed its clinical trial study in the Ivory Coast with a sensitivity of 100% for HIV-1 and an outstanding 98.18% for HIV-2. In addition, MedMira’s Reveal® G4 rapid HIV antibody test achieved a flawless 100% specificity and was reactive in early HIV-1 infections and seroconverts.
“We are enthusiastic about the prospect of our continued collaboration with Health Canada, and the FDA. While the high sensitivity and specificity of our tests has been confirmed over the years from the different sources, it is always an accomplishment to have the high quality of our products independently re-confirmed.” said Hermes Chan, CEO of MedMira Inc. “While the Company cannot guarantee the timeline for the review of our product submissions from the regulatory agencies, our team is dedicated to respond to any inquiry within the shortest possible time to achieve the approvals.”
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 Twitterand 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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