MedMira Receives Investigational Testing Authorization for its Multiplo(R) Complete Syphilis (TP/nTP) Antibody Test

HALIFAX, NS / ACCESSWIRE / January 9, 2025 / Today, MedMira Inc. (MedMira) (TSXV:MIR) announced that its received investigational testing authorization (ITA) from Health Canada to begin clinical trials for its Multiplo^® Complete Syphilis (TP/nTP) Antibody Test (Multiplo^® TP/nTP), a cutting edge device that can determine active and non-active syphilis.

The upcoming trials will be led by REACH Nexus at the MAP Centre for Urban Health Solutions at St. Michael's Hospital (Unity Health Toronto) with funding from the Canadian Institute of Health Research (CIHR) and Indigenous Services Canada (ISC).

The approval of the ITA is an important step towards getting the Multiplo^® Complete Syphilis (TP/nTP) Antibody Test licensed and into the Canadian market. MedMira offers the only commercially available combined screening and confirmation test which takes less than 3 minutes (from finger prick sample to easy-to-read results) for the detection of active syphilis. The Multiplo® TP/nTP test detects both treponemal (TP) and non-treponemal (nTP) syphilis antibodies in a single diagnostic tool that targets biomarkers associated with both active and past cases of syphilis.

Unlike traditional syphilis tests, the Multiplo^® Complete Syphilis (TP/nTP) Antibody Test is a user-friendly and durable diagnostic tool that addresses an urgent need for more accurate and cost-effective options to help healthcare providers to test and treat syphilis.

"Previous studies by REACH Nexus at MAP demonstrated our products high quality and flexibility. This led to the most recent testing authorization and enables MedMira to bring this much needed product closer to entering the Canadian market. Without the research team at MAP and the funding from CIHR, Canadians would not be able to benefit from this essential test. We are grateful for the support and believe in our technology and products," said Hermes Chan, CEO of MedMira. "Our Multiplo^® TP/nTP is unique and there is no comparable testing solution that can provide our speed, quality and cost-effectiveness. We truly feel this is a wonderful addition to the Canadian health care sector and will enable for health care providers to act swiftly in cases of active syphilis infections while unburden the financial strain on the overall system."

This approval to begin clinical trials comes at urgent time in Canada, where rates of syphilis have skyrocketed in recent years. In 2022, there were 13,953 reported syphilis cases, with rates increasing by 109% compared to 2018, according to the latest numbers from the Public Health Agency of Canada. Congenital syphilis cases saw a 7% increase from 2021 and a 599% increase from 2018.

Amid these soaring cases, particularly in underserved and remote communities, the Multiplo^® TP/nTP provides an essential testing device to help reach the undiagnosed living with syphilis.

"With the serious health crisis underway, we are doing everything we can to make sure these tests get to those who need them most, and help connect people to culturally appropriate treatment and care," said Dr. Sean B. Rourke, director of REACH and MAP scientist at St. Michael's Hospital. "This is a significant Canadian success story of how the private and public health sectors need to be working together to address health inequities."

With funding from the Canadian Institutes of Health Research (CIHR), Dr. Rourke and his team at REACH Nexus are leading efforts to address the syphilis epidemic by working collaboratively with Canadian in vitro diagnostic developers, health care providers, community stakeholders and people with lived experience, researchers, health ministries and public health to bring new POC tests to market here in Canada - while also addressing the burden of these epidemics to Canadians at the same time.

Dr. Rourke and his team at REACH Nexus have identified clinical/community sites in Alberta, Saskatchewan and Manitoba as ideal locations for this next "test, treat and connect" clinical trial and implementation science study.

About REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions

REACH Nexus is an ambitious national research group working on how to address HIV, Hepatitis C, and other sexually transmitted and blood-borne infections (STBBIs) in Canada. Their focus is on reaching the undiagnosed, implementing and scaling up new testing options, strengthening connections to care, improving access to options for prevention (PrEP and PEP) and ending stigma. We work in collaboration and partnership with people living with HIV; community-based organizations; front-line service providers; healthcare providers and decision makers; public health agencies; 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 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 medmira.com. 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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MedMira Contact

Markus Meile
Chief Financial Officer
MedMira Inc.
ir@medmira.com
Phone 902-450-1588

REACH Nexus Contact

Andrew Russell
Senior Communications Specialist
REACH Nexus - MAP Centre for Urban Health Solutions
andrew.russell@unityhealth.to
Phone 647-237-2912

SOURCE: MedMira, Inc.