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CMED Announces Receipt of SFDA Quality Testing Certificate
Mar 25, 09 03:00AM
BEIJING, March 25 /PRNewswire-Asia-FirstCall/ -- China Medical Technologies, Inc. (the ''Company'') (Nasdaq: CMED - News), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company received quality testing certificate (the ''Certificate'') for its SPR-based Analysis System (the ''SPR System'') from one of the State Food and Drug Administration (the ''SFDA'') Quality Supervision and Testing Centres yesterday. To receive the Certificate, the Company's SPR System has passed all the safety and performance parameters required by the SFDA.
''The receipt of the Certificate marks an important milestone during the SFDA approval process for our SPR System,'' said Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company. ''We will continue to work on the approval process which includes the commencement of 120 clinical trial samples by three SFDA authorized Tier-1 hospitals and subsequent administrative procedures by the SFDA before its approval. Meanwhile, we have commenced the clinical trial for our HPV-DNA Biosensor Chip. Another three SFDA authorized Tier-1 hospitals have collected over 1,000 clinical samples required by the SFDA to conduct the testing for our HPV Chip. They have processed about one- third of the samples and will continue to finish the remaining samples to submit the results for our SFDA approval process for our HPV Chip. We expect to receive the respective SFDA approval for our SPR System and HPV Chip before the end of 2009, which is in-line with our previous expectations. We will make announcement for each important milestone upon achievement during the SFDA approval process for both our SPR System and HPV Chip.''
About China Medical Technologies, Inc.
China Medical Technologies is a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic (IVD) products using Enhanced Chemiluminescence (ECLIA) technology, Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology to detect and monitor various diseases and disorders. For more information, please visit http://www.chinameditech.com .
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute ''forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as ''will,'' ''expects,'' ''anticipates,'' ''future,'' ''intends,'' ''plans,'' ''believes,'' ''estimates'' and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in the Company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.