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Newton, MA, August 8, 2005. Clinical Data, Inc.,(NASDAQ:CLDA) announced today that the Company has received FDA 510K clearance for a new hematology analyzer, the Excyte Pro-Diff 5. Clinical Data will be distributing the analyzer and consumables under an exclusive distribution agreement for North America with Melet Schloesing Laboratoires International, S.A. of Cergy-Pontoise, France, the developer of the instrument. Clinical Data also announced that product launch will begin immediately.
Differential cell counting is used to diagnose such conditions as anemia, infections, allergic reactions and platelet disorders. Millions of such tests are performed daily in hospitals and doctors' offices worldwide. Clinical Data estimates the annual market for hematology analyzers to be over $670 million in the U.S. and over $1.7 billion globally.
The Excyte Pro-Diff 5 is a fully-automated device used to count red blood cells, white blood cells, platelets, measure hemoglobin and calculate or measure several red cell indices, including erythrocyte mean corpuscular volume, mean corpuscular hemoglobin, and the mean corpuscular hemoglobin concentration. The analyzer performs a differential cell count by classifying the individual white cell components into subpopulations of lymphocytes, granulocytes, eosinophils, basophils, and monocytes through electronic sizing. The uniqueness of Melet Schloesing's proprietary technology is that it allows a 5-part differential cell count to be measured for the same cost as conventional 3-part differential analyzers in use today. The analyzer and consumables are to be distributed under the Clinical Data brand name.
Jim Mulry, Director of Hematology Marketing at Clinical Data, commented, "The competitively priced Excyte Pro-Diff 5 Analyzer, with sample auto-loading capability, is designed to meet the needs of the clinical laboratory in providing a complete blood count and a quantitative five-part leukocyte analysis. It is particularly well suited for the physician's office lab. This new hematology analyzer complements the family of diagnostic products now offered by our Clinical Data"
Francois Melet, Founder and President of Melet Schloesing Laboratoires International, S.A. stated, "We are very pleased to have obtained FDA clearance for our technology which we believe has a marked competitive advantage. We look forward to working closely with Clinical Data to insure the success of this collaborative venture."
Clinical Data, through its domestic and foreign subsidiaries, focuses on the needs of physician offices and smaller clinical laboratories. The Company promotes a complete range of products and services for the growing physician office laboratory market including blood chemistry and diagnostic assays to clinics and hospitals throughout the world.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information about Clinical Data that are intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are further urged to review Clinical Data's various SEC reports, including but not limited to our Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and the Company's 2004 and 2005 quarterly reports on Form 10-QSB.