Clinical Trials to get Underway with Multiplo(R) Complete Syphilis (TP/nTP) Antibody Test - A Potential Game Changer to Address Syphilis Health Crisis in Canada

HALIFAX, NS / ACCESSWIRE / August 13, 2024 / Today, MedMira Inc. (MedMira) (TSXV:MIR) announces it will conduct full clinical trials for its unique Multiplo^® Complete Syphilis (TP/nTP) Antibody Test (Multiplo^® TP/nTP) with the goal of getting it licensed in Canada. The new Multiplo^® TP/nTP will provide a complete system which combines screening and confirmation in one test. Just announced by Health Minister Mark Holland, the clinical trial is happening in partnership with REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions with funding from the Canadian Institute of Health Research (CIHR).

This significant achievement is a major milestone in the fight against the rising growth of syphilis. MedMira's unique and patented Multiplo^® TP/nTP provides a high-quality rapid point-of-care (POC) test to screen and confirm instantly while supporting the health care system with the fastest and most cost-effective testing solution. By utilizing its unique and patented RVF technology, MedMira offers the only commercially available combined screening and confirmation test which takes less than 3 minutes (from sample collection to easy-to-read results) for the detection of active syphilis infection with immediate results.

"With the tremendous support of REACH Nexus at MAP, we have been able to demonstrate our superior technology and with it our products high quality and flexibility. This led to the most recent award and enables MedMira to bring this very much needed product to the Canadian market. Without scientists and their team at MAP and the funding from CIHR, Canadians would not have been able to benefit from this essential test. Hence, we are grateful for the support and believe in our technology and products" says Hermes Chan, CEO of MedMira." Our Multiplo^® TP/nTP is unique in every way 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."

The Multiplo® TP/nTP test integrates the detection of both treponemal (TP) and non-treponemal (nTP) antibodies into a single diagnostic tool. By targeting biomarkers associated with both active and past infections, this test offers a comprehensive solution that combines the screening and confirmation phases used in global testing protocols. Unlike traditional syphilis tests, our innovative, user-friendly, and durable diagnostic tool addresses the increasing need for flexible, accurate, and cost-effective detection of active syphilis infection. The Multiplo® TP/nTP not only detects exposure to TP but also determines an active infection status by simultaneously identifying both non-treponemal and treponemal antibodies.

"We need more rapid point-of-care (POC) testing options approved in Canada to reach the undiagnosed with HIV, syphilis and other blood-borne infections and sexually transmitted infections (STBBIs)" said Dr. Sean B. Rourke, director of REACH and MAP scientist at St. Michael's Hospital (Unity Health Toronto). "We are very excited about the partnership and implementation science work we are doing with MedMira that will have real-life impacts for Canadians, and for people around the world.

With funding from the Canadian Institutes of Health Research (CIHR), Dr. Rourke and his team at REACH Nexus is leading efforts to address these epidemics 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.

"The approach we are taking to addressing the rising number of STBBIs are game-changers for Canada," says Dr. Rourke. "Not everyone has access to the testing they need for STBBIs because of health inequities, stigma and various forms of discrimination. We need to democratize rapid testing - get more POC and self-testing (for use at home) approved by Health Canada - so that all Canadians have access to the testing they need to make decisions about their health and wellbeing, when and where it's best for them."

MedMira along with their partners from REACH Nexus and MAP have identified clinical and community sites in the Western part of Canada as an ideal location for this next "test, treat and connect" clinical trial and implementation science study, subject to Health Canada's authorization.

MedMira's focus on syphilis is based on the tremendous impact of this sexually transmitted disease on global health. In 2018 alone, the European CDC reported about 34,000 new confirmed cases of syphilis with a 70% increase in the notification rate in 2017 compared to 2010. They also concluded that for the first time since the early 2000s EU/EEA countries reported more syphilis cases than HIV. Since treatments that can prevent the progression of syphilis are available, rapid diagnosis and treatment of infected individuals along with the rapid identification of sexual contacts is a high priority.

About REACH Nexus at St. Michael's Hospital's MAP Centre for Urban Health Solutions (Unity Health Toronto network)

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 more on LinkedIn and Twitter.

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 and medmira.ca. 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

Unity Health Toronto contact

Communications@unityhealth.to

SOURCE: MedMira, Inc.