CULVER CITY, Calif. November 2, 1999 (PRIMEZONE) -- CARESIDE, Inc. (AMEX:CSA) (AMEX:CSA.W) announced its filing of a premarket notification to the U.S. Food and Drug Administration (FDA) to add the point-of-care testing clearance to the CARESIDE Analyzer. The addition of the point-of-care testing clearance will enable properly trained non-lab personnel to also use the CARESIDE System.
While the CARESIDE Analyzer and its thirty-six tests have FDA clearance or are exempt and currently may be used by trained personnel in any licensed laboratory, the point of care designation will extend CARESIDE's ability to market its blood-testing system to physician office laboratories, nursing homes, urgent care centers and a variety of other sites currently underserved by traditional centralized laboratory services.
The point of care study was performed at a cross-section of actual healthcare sites over a two-month study period. More than 5000 CARESIDE cartridges were tested by healthcare workers using multiple CARESIDE Analyzers located at four different sites. The studies provided important data to validate the user-friendly design of the CARESIDE Analyzer and CARESIDE Cartridges. Clinical studies were performed according to a protocol that had undergone review and comment from the FDA.
"We are excited that we may soon be able to market the CARESIDE System as the only comprehensive point-of-care testing product available to healthcare practitioners" said W. Vickery Stoughton, chairman and chief executive officer of CARESIDE. "This clearance will be extremely beneficial to our Company as we prepare for our upcoming product launch."
CARESIDE, Inc., based in Culver City, California, is developing a proprietary blood testing system including its CARESIDE Analyzer(TM) a blood diagnostic device, and accompanying record management software. The Company plans to manufacture and distribute the product to health care providers in the U.S and abroad. CARESIDE expects to launch its product in the fourth quarter of this year.
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, and the date of FDA clearance. Key factors which may impact on these statements include technological hurdles, FDA approval process, 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.