Medmira (PK) (USOTC:MMIRF)
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Health Canada Approves New MedMira Rapid HIV Test
Achieves Second North American Regulatory Success
HALIFAX, Oct. 21 /PRNewswire-FirstCall/ -- MedMira Inc. ("MedMira") (TSX
Venture: MIR, NASDAQ:MMIRF) the global market leader in flow-through
diagnostics for infectious diseases, announced today that it has received
approval from Health Canada to market and sell its enhanced MedMira(TM) Rapid
HIV Test for detection of HIV antibodies in human serum or plasma. The new
MedMira(TM) Rapid HIV Test will be made available immediately in Canadian
clinical healthcare settings.
Health Canada's approval highlights the second major regulatory approval of
product enhancements that MedMira has applied for, and successfully obtained
this year. Production of this new Canadian product will substantially increase
MedMira's operational efficiencies and further position the Company for
expansion into new applications.
The new MedMira(TM) Rapid HIV Test contains features similar to that approved
by the United States Food and Drug Administration (June, 2004) making it
simpler to use and offering substantial time and cost-savings to the user. The
most prominent enhancement of the new test includes an on-board control line
for validation of the test result.
"MedMira strives to meet and exceed market demands by improving products to
reflect our customer's needs", said Hermes Chan, President and Chief Operating
Officer of MedMira. "With these two recent North American approvals for our
highest quality products, we have proven that we can anticipate the market
needs, and have the resources to navigate these important regulatory pathways
in a timely manner. I want to congratulate our regulatory team for such a great
achievement."
The MedMira(TM) Rapid HIV Test provides test results in just under 3-minutes
and is intended for clinical healthcare settings, emergency situations,
delivery rooms and occupational exposures.
At the end of 2003, there were approximately 56,000 adults and children in
Canada living with HIV/AIDS (with an adult prevalence rate of 0.3%). According
to 2004 UNAIDS statistics, approximately 3500 people are newly infected with
HIV in Canada each year.
About MedMira
MedMira is a leading global manufacturer and marketer of in vitro rapid
diagnostic tests for the clinical laboratory market. MedMira's tests issue
reliable, rapid diagnosis in just 3 minutes for the detection of human
antibodies in human serum, plasma or whole blood for diseases such as HIV,
hepatitis B and hepatitis C. The United States Food and Drug Administration
(FDA) and the State Food and Drug Administration (SFDA), in the People's
Republic of China, have approved MedMira's Reveal(TM) G2 and MiraWell(TM) Rapid
HIV Tests, respectively. MedMira has the only rapid diagnostic device to
receive these two prominent government approvals. For more details visit
MedMira's website at http://www.medmira.com/.
MedMira's Reveal(TM) G2 and MiraWell(TM) rapid HIV tests are currently used in
clinical laboratories and hospitals where professional counseling and patient
treatment are immediately available. MedMira markets its rapid tests worldwide
in such countries as the United States, Canada, South Africa and China. Its
corporate offices and manufacturing are located in Halifax, Nova Scotia,
Canada.
This news release contains forward-looking statements, which involves risks and
uncertainties and reflect the company's current expectation regarding future
events. 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.
The TSX Venture Exchange has not reviewed and does not accept responsibility
for the adequacy or accuracy of this statement.
DATASOURCE: MedMira Inc.
CONTACT: MedMira Contact: Dr. James Smith, (902) 450-1588 or
e-mail: