MedMira Increases Product Registrations Internationally
16 Agosto 2005 - 12:17PM
PR Newswire (US)
Rapid HIV and Hepatitis C Test Evaluations Underway in 24 Countries
HALIFAX, Aug. 16 /PRNewswire-FirstCall/ -- MedMira Inc.,
("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF) the global market
leader in rapid flow through diagnostic technology, announced today
that it is registering its rapid HIV and combination HIV/hepatitis
C (HCV) tests in an additional 24 markets around the world. These
new registrations will significantly boost the company's market
presence and add new revenue streams. MedMira is currently
registered and actively selling products in over a dozen major
markets including the United States, China, South Africa, and
Canada. In conjunction with product registrations, MedMira has
established a network of qualified distributors or agents in each
country. Registrations vary in complexity and length depending on
the requirements in each country or region. MedMira has targeted
countries where HIV and HCV prevalence is high and there is demand
for rapid diagnostics. Once registrations are completed, MedMira
and its distributors can participate in national tenders. "For the
past 12 months we have been building relationships with highly
qualified distributors and assisting them throughout the intricate
regulatory and evaluation processes in their territories," said
Giles Crouch, vice president sales and marketing with MedMira. "In
countries where our MiraWell(R) rapid HIV and combination HIV/HCV
tests have been evaluated, we have placed first for technical
performance every time. As registrations become finalized, our
distributors are fully enabled to go to market with MedMira's high
quality rapid tests and participate in large national tender bids
within their territories." With CE approval of the MiraCare(TM)
rapid HIV whole blood and serum/plasma test expected later this
year, MedMira will further increase market coverage to include 25
European Union countries. New registrations are also in progress
for whole blood rapid tests in China, and in Africa, Latin America
and Eastern Europe. While many African and Latin American countries
do not have formal regulatory bodies, they require evaluations and
small clinical trials within national virology labs and hospitals.
Mr. Crouch continues, "In order to achieve sales, two critical
elements must occur; establishment of qualified regional
distributors and subsequent product registration. Our objective was
to increase efforts on building a strong international distribution
network and gaining these registrations, an enormous task that
takes time, and is now approaching fruition." MedMira has been
transitioning from a research and development focused company with
proven technology, to a fully commercial venture targeting sales
efforts in global markets. MedMira gained key international
regulatory approvals starting with Health Canada in 1998, followed
by the United States Food and Drug Administration (FDA) and China's
State Food and Drug Administration (SFDA) in 2003. With the
anticipated CE mark coming later this year, MedMira will be the
only rapid HIV test manufacturer in the world with these four
highly regarded approvals, critical to facilitating faster
registrations in developing nations where national HIV programs
regularly purchase large quantities of rapid tests. "We committed
to a defined strategy for the past year to advance MedMira into a
commercial operation with a focus of delivering our innovative
solutions, built on leading edge diagnostics research and
development, to end-users," said Hermes Chan, president and COO of
MedMira. "This plan is working and we look forward to positive
gains and taking MedMira to the next level of success in the coming
months." About MedMira MedMira is the leading global manufacturer
and marketer of in vitro flow-through rapid diagnostic tests.
MedMira's tests provide 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 and hepatitis C. The United
States FDA and the SFDA in the People's Republic of China have
approved MedMira's Reveal(TM) G2 and MiraWell(R) rapid HIV tests,
respectively. MedMira's Reveal(TM) G2 and MiraWell(R) rapid HIV
tests are currently used in clinical laboratories, hospitals, and
clinics where professional counselling and patient treatment are
immediately available. The MiraCare(TM) Rapid HIV Antibody Test,
MedMira's over-the-counter (OTC) product, is available in
pharmacies throughout Hong Kong and Macao Special Administrative
Regions, in the People's Republic of China. MedMira delivers rapid
diagnostic solutions to healthcare communities around the globe.
Its corporate offices and manufacturing facilities are located in
Halifax, Nova Scotia, Canada with a representative office in
Beijing, China. This news release contains forward-looking
statements, which involve risk 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. For
more information visit MedMira's website at
http://www.medmira.com/. DATASOURCE: MedMira Inc. CONTACT: Dr.
James Smith, Investor Relations, Tel: (902) 450-1588, E-mail: ;
Andrea Young, Corporate Communications, Tel. (902) 450-1588, Email:
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