Culver City, Calif., Dec. 13, 1999 (PRIMEZONE) -- CARESIDE, Inc., (AMEX:CSA) (AMEX:CSA.W) announced today that the Company's CARESIDE Analyzer(tm) blood-testing system, already cleared by the U.S. Food and Drug Administration for licensed laboratory use, has received additional FDA clearance for point-of-care use. This enables patients to have their blood drawn and tested at their "point-of-care" - whether they are at a nursing home, a physician's office, a health clinic or any other healthcare facility.
This point-of-care FDA clearance means that healthcare practitioners can use the CARESIDE Analyzer(tm) to obtain blood test results and report them to their patients within 15 minutes of drawing a blood sample from the patient. Practitioners who equip their offices with the CARESIDE Analyzer no longer will be forced to send patients - or their blood samples - to outside laboratories and wait days for results.
This clearance also means that properly trained non-technical personnel can operate the CARESIDE Analyzer, eliminating the need for a lab specialist to oversee each test. Thus, the CARESIDE Analyzer increases efficiency of medical offices.
"The FDA point-of-care clearance extends CARESIDE's ability to market its blood-testing system to physician offices, nursing homes, urgent care centers and a variety of other sites currently underserved by traditional centralized laboratory services," said Chairman and Chief Executive Officer W. Vickery Stoughton. "We also believe the CARESIDE Analyzer offers the medical community an opportunity to provide more timely and precise care because results can be instantly used for patient diagnosis and treatment. The CARESIDE Analyzer is the only point-of-care blood testing system able to deliver to the healthcare practitioner a comprehensive menu of routine blood tests."
The clearance was based upon a demonstration that both licensed lab personnel and non-technical personnel were capable of obtaining equivalent results after receiving appropriate training. CARESIDE provides the training, which usually takes a few hours, to its clients.
The CARESIDE Analyzer currently has FDA clearance for 36 tests in the categories of chemistry, electrochemistry and coagulation. Immunochemistry testing is expected to be available in 2000. The company expects to launch its desktop device into the U.S. market in the last quarter of 1999 at a price just under $10,000.
CARESIDE, Inc., based in Culver City, CA, has developed a proprietary blood testing system, including its CARESIDE Analyzer 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 point of patient care by producing accurate test results within 15 minutes. CARESIDE will also market a companion hematology system capable of performing a 16-parameter complete blood count with three-part white blood cell differential. The company plans to manufacture both the CARESIDE Analyzer and the CARESIDE hematology product and distribute each 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.