Mr. Hermes Chan reports

MEDMIRA ANNOUNCES LAUNCH OF CLINICAL TRIAL FOR ITS MULTIPLO(R) TP/HIV SELF-TEST IN CANADA

A clinical trial has officially started earlier than anticipated to evaluate Medmira Inc.'s Multiplo TP/HIV rapid test for use as a self-test in Canada.

Medmira has been able to move forward with this label claim and avoid additional testing requirements (for example, by non-health care professions) with agreement from Health Canada.

The first participants have been enrolled at the Cool Aid Community Health Centre in Victoria, B.C., and at Women's Health In Women's Hands Community Health Clinic in Toronto, marking a critical step in bringing this dual HIV and syphilis self-test to communities that need it most.

This trial -- financed by the Canadian Institutes of Health Research and led by Reach Nexus at the MAP Centre for Urban Health Solutions at St. Michael's Hospital (Unity Health Toronto) -- is designed to support a new label claim application for self-testing.

"We're focusing all our efforts on the self-test because we know it will have the broadest reach of people who critically need it and the greatest public health impact on reducing new cases," said Dr. Sean B. Rourke, director of Reach Nexus and scientist at MAP. "It also puts the power directly in people's hands -- giving them privacy, control and the ability to act on their health when and where it works for them."

Typically, regulatory pathways require obtaining approval for professional or non-professional use before a self-testing label claim can be pursued. Professional use refers to the test being administered by health care practitioners, and non-professional use refers to testing performed by lay users under supervision, whereas self-testing allows individuals themselves to perform the test on their own at home.

However, following further discussions with Health Canada and the submission of previously collected clinical trial data, Medmira received confirmation to bypass the non-professional use step and proceed directly with the self-testing application.

"This is a critical next step in making our Multiplo TP/HIV test available for self-testing in Canada," said Hermes Chan, chief executive officer of Medmira. "We're committed to providing a fast, accurate and easy-to-use self-test that can deliver immediate results, helping people to know their status in the privacy of their homes and get connected to care. We believe this is the most direct and effective path to having an immediate impact on the HIV and syphilis epidemics."

Recent data from the Public Health Agency of Canada show alarming increases in both HIV and syphilis:

• New HIV diagnoses in Canada surged by over 35 per cent from 2022 to 2023, with a greater-than-40-per-cent spike in Manitoba.
• Saskatchewan reported 19.4 new HIV diagnoses per 100,000 people, more than triple the national average.
• Syphilis cases nearly doubled from 2018 to 2023 from 6,371 cases to 12,135 cases.
• Congenital syphilis cases have also increased, rising from 17 cases in 2018 to 53 cases in 2023 -- a 220-per-cent increase since 2018.

The Multiplo TP/HIV rapid self-test provides immediate results from a simple finger-prick blood sample. A positive result can then be confirmed through lab testing, enabling people to quickly access culturally safe treatment and care.

Clinical trial implementation is under way across multiple provinces, with the first participants enrolled in Victoria, B.C., and Toronto, Ont. Additional sites will launch in the coming weeks in Ontario and Nova Scotia, in partnership with trusted community organizations, including the Hassle Free Clinic in Toronto and the Halifax Sexual Health Clinic.

About Medmira Inc.

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, 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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