CULVER CITY, Calif, August 9, 1999, (PRIMEZONE) -- CARESIDE, Inc. (AMEX:CSA) today announced clearance of its coagulation test CARESIDE(TM) PT by the U.S. Food and Drug Administration (FDA), bringing the company's current number of cleared or exempt blood tests to 32. With this clearance, CARESIDE(TM) believes its CARESIDE(TM) Analyzer is the first medical device capable of providing chemistry, electrochemistry, and coagulation results within one desktop instrument. The company expects to launch its device into the U.S. market in the last quarter of 1999 at a price just less than $10,000.
This coagulation test, known as Prothrombine Time (PT), measures clot formation in citrated plasma. This test aids in the monitoring of patients receiving anticoagulation therapy such as patients with heart disease, and assists in the detection of clotting disorders which may lead to strokes.
CARESIDE's coagulation cartridge combines all the necessary reagents in a simple, easy to use format that works with a few drops of whole blood. Traditional testing methods have required multiple additions of precise reagent volumes. CARESIDE's unique coagulation cartridge produces PT results equivalent to those produced by hospital and commercial labs with no additional reagent necessary.
CARESIDE(TM) PT uses a reagent co-developed by CARESIDE and International Technidyne Corporation (ITC) for which a joint patent application has been filed. CARESIDE has the exclusive right to use this technology in analyzers capable of testing multiple categories of diagnostic tests such as blood chemistry, electrochemistry and coagulation. ITC will retain the exclusive right to use the technology within a device that performs only coagulation testing.
CARESIDE, Inc., a blood diagnostic company based in Culver City, California, recently announced its initial public offering in June 1999. The Company is developing a proprietary blood testing system including its CARESIDE(TM) Analyzer, a hematology testing device, and accompanying record management software.
The CARESIDE??Analyzer will provide a cost-effective and efficient means of analyzing blood chemistry, electrochemistry, and coagulation at the same location as the patient by producing accurate test results within 15 minutes. The Company expects to add immunochemistry testing in early 2000. The CARESIDE? Analyzer System performs hematology testing through an optional connected testing device. The Company plans to manufacture and distribute the product to health care providers in the U.S and abroad.
Safe Harbor: Statements in this press release regarding CARESIDE Inc. which are not historical facts are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include the date of market launch, the price of the instrument, and the availability of immunochemistry tests. Key factors which may impact on these statements include technological hurdles and other challenges inherent in product research, development, manufacturing, marketing, and other factors discussed in the Company's prospectus. The Company undertakes no obligation to update forward-looking statements. Please see the risk factors listed from time to time in the Company's prospectus and reports on file with the SEC.