CULVER CITY, Calif., September 22, 1999 -- (PRIMEZONE) CARESIDE, Inc. (AMEX:CSA; AMEX:CSA.W) announced clearance of its CARESIDE(TM) CO2 blood test from the U.S. Food and Drug Administration (FDA), after submittal just seven weeks ago. This test clearance brings the current number of cleared or exempt tests on the CARESIDE Analyzer(TM) to 36.
"We are pleased with our progress on achieving FDA clearances," said W. Vickery Stoughton, chairman and chief executive officer of CARESIDE. "These clearances are critical to our Company as we prepare for our upcoming product launch."
The Company's carbon dioxide (CO2) test measures the total CO2 concentration in anti-coagulated blood, plasma, and serum. This test aids in the diagnosis and treatment of patients with conditions such as respiratory, kidney, and metabolic disorders.
CARESIDE, Inc., a blood diagnostic company based in Culver City, California, is developing a proprietary blood testing system including its CARESIDE Analyzer(TM) 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 to the CARESIDE Analyzer in early 2000. The Company plans to manufacture and distribute the product to health care providers and will launch the CARESIDE Analyzer into the U.S. market at a cost just under $10,000.
Safe Harbor: Statements in this press release regarding CARESIDE Inc. which are not historical facts are forward-looking statements that involve risks and uncertainties. Forward-looking statements include the price of the instrument, the availability of immunochemistry tests, achieving point-of-care designation, and the distribution of the instrument. Key factors which may impact on these statements include technological hurdles, FDA clearance, 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.