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MedMira has received the CE mark for Reveal® TP (syphilis) and has begun clinical trials in Canada. CanadianBusinessJournal

Halifax, Nova Scotia, March 9, 2022 (GLOBE NEWSWIRE) — Today, MedMira Inc. (MedMira) (TSXV: MIR) launches Reveal® TP (Syphilis) products in Europe and begins clinical trials in Canada Did. We have obtained the CE mark today and are currently available in Europe and all countries that have approved the CE mark. In addition, with the support and partnership of REACHFexus (www.reachnexus.ca) of the MAP Center for Urban Health Solutions, we will continue to work on the Clinical Trials Application (ITA), a clinical trial planned in Canada that will begin in the spring. I am. (Www.maphealth.ca), housed at St. Michael’s Hospital in Unity Health Toronto.

Syphilis is a sexually transmitted disease (STBBI) caused by bacteria. Treponema pallidum.. If left untreated, syphilis progresses to the third stage, causing lesion recurrence and more serious symptoms of syphilis such as severe multi-organ infections, blood vessels, and neurological damage. Congenital syphilis occurs when a mother infected with syphilis transfers the infection to her baby during pregnancy. This can lead to stillbirth, miscarriage, premature babies, bone deformities, brain and nerve problems in the baby.

Based on an increasing epidemic of syphilis, increased damage to public health, and a new focus on syphilis diagnosis and treatment, market analysts have the highest predicted compound annual growth rate (CAGR) of around 3%. Placed a high syphilis diagnosis. In the infectious disease market, the market size of the syphilis rapid test kit in 2022 is US $ 606.4 million. In addition, a recent study by researchers at Columbia University reported that 1.2 million syphilis diagnostic tests were used at only 81 state and local public health laboratories (PHL in the United States in 2016), and therefore high. Shows market demand.

“Med Mira’s team has a big focus on REVEAL COVID-19,® And VYRA® The product line continued to develop infectious disease products with a focus on three major markets: HIV, HCV and TP. Despite the world’s attention to the situation of COVID-19, other illnesses are constant and we are committed to helping people know … ®. Therefore, we are pleased to be able to obtain the CE mark for Point of Care settings to provide more access to end users, “said Hermes Chan, CEO of Med Mira. “In addition, to support healthcare systems with high-quality, cost-effective solutions, there is a great need for rapid and reliable testing procedures in Canada. REACH Nexus Dr. Sean Rourke and his team. We are pleased to have the opportunity to work with you to initiate the regulatory process and are confident that Reveal® TP will be available in Canada shortly. “

The World Health Organization (WHO) points out an unacceptably high prevalence of syphilis in 2021 and needs to efficiently advance its goal of eliminating syphilis as a public hygiene threat by 2030. Was emphasized. The need for an effective strategy to combat the rate of increase in syphilis. Canada reported an incidence of 24.7 per 100,000 in 2020, up from 5.1 per 100,000 in 2011. In 2018 alone, the European CDC (ecdc) reported about 34,000 new confirmed cases of syphilis. Prompt diagnosis and treatment of infected individuals should be prioritized, as well as rapid identification and treatment of sexual contact, as treatment options that can prevent the progression of syphilis are available.

“To reach people who have not been diagnosed with HIV, syphilis, or other blood or sexually transmitted diseases (STBBI), we need a faster Point of Care (POC) testing option approved in Canada.” Director Dr. Sean B. Rourke said. REACH Nexus and Scientists at the MAP Center for Urban Health Solutions at St. Michael’s Hospital in Unity Health Toronto. “We are very excited about our partnership with MedMira and the work of implementation science, which has a real impact on Canadians and people around the world. The approach we are taking to deal with the growing STBBI. Is a “game changer” for Canada. Not everyone has access to the tests required for STBBI due to health injustice, prejudice, and various forms of discrimination. Rapid testing needs to be democratized to increase POC and self-testing (used at home) approved by Health Canada. This gives all Canadians access to the tests they need to determine when, where and best. For them. “

Funded by the Canadian Institute of Health (CIHR), Dr. Rourke of REACH Nexus and his team are working with Canadians to lead efforts to combat these epidemics. in vitro diagnosis Developers, healthcare providers, community stakeholders, and experienced people, researchers, the Ministry of Health, and public health are bringing new POC tests here to the market here in Canada, while at the same time these epidemics against Canadians. Deal with the burden. Using this new implementation science approach, under the leadership of Dr. Ameeta Singh of the University of Alberta, the work of “testing and treating” HIV and syphilis is proceeding smoothly in northern Alberta while assessing the performance of Multiplo. is.®HIV and syphilis POC tests performed by MedMira. And later this spring, Med Mira applied for a license in Saskatchewan while conducting another “test and treatment” implementation scientific study to address the outbreak of syphilis using Reveal® TP products. Work begins to collect the performance data you want to use. Health Canada.

MedMira, along with REACH Nexus partners, has identified the Western Canada clinical / community site as an ideal location for this upcoming “Test and Treatment” clinical trials and scientific research, subject to Health Canada approval. ..

About REACH Nexus at MAP Center for Urban Health Solutions

REACH Nexus is an ambitious national research group working on ways to combat HIV, hepatitis C, and other sexually transmitted and blood-borne diseases (STBBI) in Canada. Their focus is to reach undiagnosed, implement and scale up new test options, strengthen connectivity to care, improve access to preventive options (PrEP and PEP), and stigma. Is to end. We work with people who live with HIV to build partnerships. A community-based organization. Frontline service provider. Health providers and decision makers. Public health agencies; researchers; business leaders; industry partners, and federal, state, and regional policy makers. Follow us on Twitter, Instagram and Facebook.

About Med Mira

MedMira is a leading developer and manufacturer of Rapid Vertical Flow.® diagnose. The company’s tests provide hospitals, laboratories, clinics and individuals with the diagnosis of diseases such as HIV, syphilis, hepatitis and SARS-CoV-2 in just three easy steps.Our tests are sold globally under REVEAL®REVEALCOVID-19®, Multiplo® And myriad® brand.Based on the patented Rapid Vertical Flow® Technology, MedMira’s rapid HIV testing is the only one in the world that has received regulatory approval in Canada, the United States, China, and the European Union. MedMira’s 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 news release contains forwardsA visual statement that reflects our current expectations of future events, including risks and uncertainties. This includes statements regarding regulatory approvals, product launches, future growth, and new business opportunities. Actual events can differ materially from those predicted here, including changes in market conditions, successful and timely completion of clinical trials, uncertainties associated with the regulatory approval process, and establishment of business alliances. Depends on many factors, including but not limited to, and other risks. Details can be found at any time in the company’s quarterly report.

Neither the TSX Venture Exchange nor its regulatory service provider (the term is defined in the TSX Venture Exchange Policy) is responsible for the validity or accuracy of this release.

MedMira Contact
Markus Meil
CFO
MedMira Inc.
ir@medmira.com

Contact for St. Michael’s Hospital
Communications@unityhealth.to


CBJ News Maker

MedMira has received the CE mark for Reveal® TP (syphilis) and has begun clinical trials in Canada. CanadianBusinessJournal

Source link MedMira has received the CE mark for Reveal® TP (syphilis) and has begun clinical trials in Canada. CanadianBusinessJournal

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