Mr. Hermes Chan reports

MEDMIRA RECEIVES INVESTIGATIONAL TESTING AUTHORIZATION FOR ITS MULTIPLO(R) COMPLETE SYPHILIS (TP/NTP) ANTIBODY TEST

Medmira Inc. has received investigational testing authorization from Health Canada to begin clinical trials for its Multiplo complete syphilis (treponemal/non-treponemal) antibody test (Multiplo TP/nTP), a cutting-edge device that can determine active and non-active syphilis.

The coming 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 and Indigenous Services Canada.

The approval of the ITA is an important step toward 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 fewer than three minutes (from finger prick sample to easy-to-read results) for the detection of active syphilis. The Multiplo TP/nTP test detects both treponemal and non-treponemal 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 health care 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, chief executive officer 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 unburdening 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 per cent compared to 2018, according to the latest numbers from the Public Health Agency of Canada. Congenital syphilis cases saw a 7-per-cent increase from 2021 and a 599-per-cent 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 under way, 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, 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 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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