Mr. Hermes Chan reports

UPDATE ON MEDMIRA'S REGULATORY PATH IN CANADA AND THE USA

Medmira Inc. has provided an update on its progress to achieve regulatory approval in Canada and the United States for its infectious disease rapid tests. Currently, the company has two submissions filed with Health Canada and one submission with the U.S. Food and Drug Administration. 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 the health care 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 10 business days.

U.S. regulatory progress

Medmira continued its U.S. FDA clinical work for to achieve the clinical laboratory improvement amendment waiver for its already U.S. 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 $2-million (U.S.) to a substantial $350-million (U.S.) per annum.

The primary purpose of obtaining FDA clearance for the clinical laboratory improvement amendment waiver is to make simple and easy-to-use diagnostic tests more readily available in various health care 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 per cent for HIV-1 and an outstanding 98.18 per cent for HIV-2. In addition, Medmira's Reveal G4 rapid HIV antibody test achieved a flawless 100-per-cent 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 reconfirmed," said Hermes Chan, chief executive officer of Medmira. "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."

About Medmira Inc.

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, N.S., Canada.

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