Today, MedMira Inc. (MedMira) (TSXV: MIR) launches its Reveal® TP
(Syphilis) product in Europe and gets clinical trials underway in
Canada. The Company received the CE mark today and is now available
in Europe and any countries accepting the CE mark. Furthermore, the
Company continues their work on the Investigational Testing
Application (ITA) for the planned clinical trial in Canada to start
in the spring with the support and partnership of REACH Nexus
(www.reachnexus.ca) at the MAP Centre for Urban Health Solutions
(www.maphealth.ca), housed at St. Michael’s Hospital of Unity
Health Toronto.
Syphilis is a sexually transmitted blood-borne
infections (STBBIs) caused by the bacterium Treponema pallidum.
When left untreated syphilis moves to the tertiary stage causing
the re-occurrence of lesions and more severe symptoms of syphilis
such as serious multi-organ infections, vascular, and neurological
damage. Congenital syphilis occurs when a syphilis-infected mother
passes the infection onto her baby during pregnancy which can lead
to stillbirth or death shortly after birth, miscarriage,
prematurity, deformed bones, brain and nerve problems of the
baby.
Based on the increasing prevalence of syphilis,
its increased toll on public health, and the renewed focus on the
diagnosis and treatment of syphilis, market analysts have placed
syphilis diagnostics with the projected compounded annual growth
rate (CAGR) of about 3%, the highest amongst infectious diseases
market, and the market size for syphilis rapid test kits at 606.4
million USD in 2022. Additionally, a recent study by researchers at
Columbia University reported the use of 1.2 million syphilis
diagnostic tests in just 81 state and local Public Health Labs
(PHLs) in the US during 2016, thus showing the high market
demand.
“While MedMira’s team has placed a major focus
in our REVEALCOVID-19® and VYRA® product lines, we continued
working on the infectious diseases products with emphasis on the
three major markets: HIV, HCV and TP. Despite the world’s attention
to the COVID-19 situation, other diseases do not take a break and
we are firmly committed to helping people know…®. Therefore, we are
pleased to receive the CE mark for the Point-of Care settings to
provide greater access to the end-users,” says Hermes Chan, CEO of
MedMira. “Furthermore, we see a tremendous need for fast and
reliable testing procedures in Canada in order to assist the health
care system with a high quality and cost-efficient solution. We are
excited to have the opportunity to work with Dr. Sean Rourke and
his team at REACH Nexus to initiate the regulatory process, and
confident that Reveal® TP will soon be made available in
Canada.”
The World Health Organization (WHO), in 2021,
noted the unacceptably high prevalence of syphilis and highlighted
the need to efficiently advance the goal of eliminating syphilis as
a public health threat by 2030. Recent data from both the European
Union and Canada further support the need for effective strategies
to combat the increasing rates of syphilis. Canada reported an
incidence rate of 24.7 per 100,000 in 2020, up from 5.1 per 100,000
in 2011. While in 2018 alone, the European CDC (ecdc) reported
about 34,000 new confirmed cases of syphilis. Since treatment
options that can prevent the progression of syphilis are available,
rapid diagnosis and treatment of infected individuals along with
the rapid identification and treatment of sexual contacts should be
a high priority.
“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
Nexus and scientist at MAP Centre for Urban Health Solutions at St.
Michael’s Hospital of 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
people around the world. The approach we are taking to addressing
the rising number of STBBIs are “game-changers” for Canada. 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.”
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. Using this novel implementation science approach, the work is
progressing well in northern Alberta under the leadership of Dr.
Ameeta Singh at the University of Alberta to “test and treat” for
HIV and syphilis while evaluating the performance of the Multiplo®,
HIV and syphilis POC test made by MedMira. And later this spring,
work will get underway in Saskatchewan to conduct another “test and
treat” implementation science study to address the syphilis
outbreaks there using the Reveal® TP (Syphilis) Product while also
collecting performance data MedMira will use for their licensing
application to Health Canada.
MedMira along with their partners from REACH
Nexus have identified clinical /community sites in the Western part
of Canada as an ideal location for this next “test and treat”
clinical trial and implementation science study, subject to Health
Canada’s authorization.
About REACH Nexus at 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, Instragram 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.
Neither 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 ContactMarkus MeileChief
Financial Officer MedMira Inc.ir@medmira.com
St. Michael’s Hospital
Contactcommunications@unityhealth.to
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