HALIFAX, Sept. 24 /CNW/ - MedMira Inc., ("MedMira") (TSX Venture: MIR, NASDAQ: MMIRF), a developer and marketer of rapid diagnostic technology and solutions, announced today that the Company's rapid HIV test approval has been renewed and is now classified as medical device in China.
The regulatory license for MedMira's rapid HIV test, issued by China's State Food and Drug Administration (SFDA), was successfully renewed and re-classified as part of the ongoing healthcare reforms taking place in the country. As a regulated medical device, MedMira's rapid HIV test can be used in new and growing healthcare sectors including community diagnostic centers and mobile out-reach clinics.
"Similar to the US Food and Drug Administration's medical device regulations, this new classification allows MedMira to overcome a major hurdle in accessing the lucrative China market and we make another step forward in our long term business development plan for the Asia Pacific region," said Hermes Chan, CEO, MedMira Inc. "Local manufacturing is in place, our strategic sales and distribution partner, Triplex, is now up and running, and new markets are open to us with this new classification. With all of these favorable market conditions aligned and a shortened sales cycle we are now positioned to recognize an increase in revenue from rapid HIV tests sales in China in the coming quarters."
Classified as a drug product by the country's regulators since its initial market entry in 2004, MedMira had experienced a number of complex market barriers in selling its rapid HIV test in large volumes throughout China. The new medical device classification means greater flexibility in regulatory guidelines, making it logistically easier to sell the rapid HIV test in all regions and all healthcare sectors in China.
"We are exploring every sales opportunity for MedMira's rapid HIV test and look forward to increasing sales of this key product in the coming months," said Yiu Ming Fung, President and Chairman of Triplex International Biosciences Co., Ltd. "This newly granted approval under the medical device classification is a significant step forward in proactively promoting and selling the product in all segments of our market and is also setting the stage for the pending regulatory approvals of the five additional MedMira rapid tests we are currently adding to our product portfolio."
MedMira is a leading developer and manufacturer of flow-through rapid diagnostics. The company's tests provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The company's tests are sold under the Reveal(R), MiraWell(R), MiraCare(TM) and Multiplo(TM) brands in global markets. 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's website at www.medmira.com.
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.
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SOURCE MedMira Inc.
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