MedMira Inc. / CA58501R1029

Halifax, Nova Scotia, August 26, 2025 – MedMira Inc. (MedMira) (TSXV: MIR) announced today that it has received approval from Health Canada for its Reveal® TP (Syphilis) Antibody Test (Reveal® TP) – the fastest stand-alone screening device for syphilis in Canada.
Reveal® TP is an essential point-of-care tool for healthcare professionals and represents a critical advance in improving access to syphilis testing across Canada – particularly in the Prairie provinces, where rates of infection and congenital syphilis are rapidly increasing.
The test detects syphilis antibodies using a single fingerstick blood sample and provides immediate, persistent results. It is the fastest syphilis test approved in Canada and utilizes Rapid Vertical Flow (RVF) technology developed by MedMira.
Health Canada's approval of the device is based on the results of several clinical trials involving a total of 1,760 people in Alberta and Saskatchewan, conducted by Dr. Sean B. Rourke, director of REACH Nexus and a research scientist at the MAP Centre for Urban Health Solutions at St. Michael's Hospital (Unity Health Toronto), with funding from the Canadian Institutes of Health Research (CIHR). One of these trials, the "Test, Treat, and Connect" study, was led by Dr. Stuart Skinner of the University of Saskatchewan and Nikki Williamson of the Wellness Wheel Medical Clinic in Regina, a non-profit organization that provides culturally responsive treatment for HIV and sexually transmitted and bloodborne infections (STBBI) in First Nations communities.
This accurate, easy-to-use test can be used in a wide range of healthcare settings, from hospitals and doctor's offices to community health clinics and non-profit community organizations. It offers an important new way to identify syphilis cases in Canada and provide timely treatment and care for those affected.
"We are proud to add a solution to Canada's diagnostic toolbox that meets the demands of speed, reliability, and scalability," said Hermes Chan, CEO of MedMira. "This approval reflects our commitment to developing technologies that address urgent public health challenges while improving access to care."
Canada has seen a dramatic increase in syphilis cases in recent years. Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum . It can lead to painless ulcers or, in more advanced cases, severe organ damage. Congenital syphilis, which occurs when an untreated or inadequately treated pregnant woman transmits the infection to her baby, can result in stillbirth or other serious consequences.
According to the latest data from the Public Health Agency of Canada, syphilis cases have nearly doubled from 6,371 in 2018 to 12,135 in 2023. Congenital syphilis has also increased sharply, from 17 cases in 2018 to 53 cases in 2023—a 220% increase.
"Infectious syphilis is a public health emergency in Canada, affecting entire communities—particularly in Alberta, Saskatchewan, and Manitoba," said Dr. Sean B. Rourke, director of REACH and a MAP scientist at St. Michael's Hospital. "Another rapid point-of-care test for syphilis is critical to help people get tested quickly and receive culturally appropriate care. The more people we diagnose and treat, the faster we can help end this tragic health crisis."
With funding from the CIHR, Dr. Rourke and his team at REACH Nexus conducted a study to evaluate MedMira's trial at 20 sites in Saskatchewan, including First Nations communities, remote areas, community health facilities, and a federal correctional facility.
"This stand-alone rapid syphilis test is an important step toward providing Indigenous communities—especially in rural and remote areas—with more accessible STBBI testing options," said Williamson, a registered nurse. "This is critical to developing culturally informed and self-directed testing strategies that promote prevention, early detection, and linkage to care, all with the goal of eradicating syphilis."
Reveal® TP complements MedMira’s growing portfolio of approved rapid tests, including the Multiplo® The Rapid TP/HIV Antibody Test and the Reveal® G4 Rapid HIV-1/2 Antibody Test, both approved by Health Canada in December 2024 and January 2025, respectively. All MedMira tests are developed and manufactured in Halifax, Nova Scotia.
About REACH Nexus at the MAP Centre for Urban Health Solutions at St. Michael's Hospital
REACH Nexus is an ambitious national research group working to combat HIV, hepatitis C, and other sexually transmitted and bloodborne infections in Canada. Its focus is on reaching undiagnosed cases, implementing and expanding new testing options, strengthening linkages to care, improving access to prevention options (PrEP and PEP), and ending stigma. We work in collaboration and partnership with people living with HIV, community-based organizations, frontline providers, health-care providers and policymakers, public health authorities, researchers, business leaders, industry partners, and federal, provincial, and regional policymakers. Follow us on Twitter, Instagram, and Facebook.
About MedMira
MedMira is a leading developer and manufacturer of Rapid Vertical Flow diagnostics ( ® ). The company's tests enable hospitals, laboratories, clinics, and individuals to instantly diagnose diseases such as HIV, syphilis, hepatitis, and SARS-CoV-2 in just three simple steps. The company's tests are sold globally under the brands REVEAL ® , REVEALCOVID-19 ® , Multiplo ® , and Miriad ® . Based on its patented Rapid Vertical Flow ® technology, MedMira's rapid HIV test is the only one in the world with regulatory approval in Canada, the United States, China, and the European Union. MedMira's corporate headquarters and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information, please visit medmira.com. Follow us on Twitter and LinkedIn.
This press release contains forward-looking statements that involve risks and uncertainties and reflect the Company's current expectations regarding future events, including statements regarding potential regulatory approvals, product launches, future growth, and new business opportunities. Actual events could differ materially from those projected herein and depend on a number of factors, including, but not limited to, changing market conditions, the successful and timely completion of clinical trials, uncertainties related to the regulatory approval process, the establishment of corporate alliances, and other risks detailed from time to time in the Company's quarterly reports.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
MedMira Contact
Markus Mile
Chief Financial Officer
MedMira Inc.
Phone 902-450-1588
REACH Nexus Contact
Andrew Russell
Senior Communications Specialist
REACH Nexus – MAP Center for Urban Health Solutions
Phone 416-268-7642
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