FDA reviews proposed device under 510(k) procedure.NEW YORK--(BUSINESS WIRE)--Dec. 4, 1996--Chromatics Color Sciences International Inc.(NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CCSI CCSI Computer & Control Solutions, Inc CCSI Cisco Certified Systems Instructor (training qualification) CCSI Canadian Centre for Swine Improvement CCSI Contemporary Control Systems, Inc CCSI Channel Coding with Side Information ) announced that on Nov. 18, 1996 the Federal Food and Drug Administration determined to accept for review under its 510(k) notification procedures the company's request to market its Colormate III(TM), a transcutaneous transcutaneous /trans·cu·ta·ne·ous/ (-ku-ta´ne-us) transdermal. trans·cu·ta·ne·ous adj. Transdermal. bilirubinometer. The company is seeking FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. marketing clearance for use of the Colormate III(TM) in the noninvasive monitoring of bilirubinemia in newborn babies. The company's clinical trials of the Colormate III(TM), which, in the company's opinion, demonstrate a statistically significant correlation between the Colormate III(TM)'s results and serum bilirubin Bilirubin The predominant orange pigment of bile. It is the major metabolic breakdown product of heme, the prosthetic group of hemoglobin in red blood cells, and other chromoproteins such as myoglobin, cytochrome, and catalase. concentration levels and superior sensitivity at clinical decision levels to that of visual estimates, have been submitted to the FDA in support of the 510(k) notification. Because the Colormate III(TM) is noninvasive, the company believes the device has the ability to provide more frequent, enhanced clinical decision assistance without subjecting neonates to traumatic invasive procedures. While the company believes that the FDA will issue marketing rights to the Colormate III(TM) pursuant to its 510(k) notification, there can be no assurance that such marketing rights will be granted by the FDA or that the company will be successful in its marketing efforts for the Colormate III(TM). Chromatics chro·mat·ics n. (used with a sing. verb) The scientific study of color. chro  ma·tist n. Color Sciences International Inc. is engaged in the business of color not of the white race; - commonly meaning, esp. in the United States, of negro blood, pure or mixed.See also: Color science, including the scientific color measurement and classification of human skin, certain color-sensitive consumer products, and in determining the color compatibility of such skin and product color classification for use in a variety of industries including the cosmetic, beauty aid and fashion industries, as well as technology development for potential medical applications involving the detection and monitoring of certain chromogenic chro·mo·gen·ic adj. Of or relating to a chromogen or to chromogenesis. chromogenic (krō´mōjen´ik), adj pertaining to color production. diseases. The company's common stock and warrants are traded on NASDAQ under the symbols "CCSI" and "CCSIW", respectively. Except for the historical information contained herein, certain of the matters discussed are forward-looking statements that involve material risks to and uncertainties in the company's business which may cause actual results to differ materially from those anticpated by the statements made herein. Such risks and uncertainties include, among other things, the availability of any needed financing, the company's ability to implement its long range business plan for various applications for its technologies, the impact of competition, the obtaining of and compliance with regulatory approvals applicable to proposed application of the company's technology, the management of growth, and other risks and uncertainties that may be detailed from time to time in the company's reports filed with the Securities and Exchange Commission, including those set forth in the Form 10-KSB. CONTACT: Darby Macfarlane MacFarlane or Macfarlane is a surname shared by:
212/717-6544 fax, 212/717-6672 |
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