Great News! Time for CCSI to move from the "Five Dollars and under" room, eh?
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NEW YORK--(BUSINESS WIRE)--July 30, 1997--On July 30, 1997,
Chromatics Color Sciences International Inc. received a "substantial
equivalence" determination order, in the form of a letter dated July
24, 1997 from the Center for Devices and Radiological Health (CDRH),
Food and Drug Administration (FDA), authorizing Chromatics to
commercially distribute its Colormate(TM) device for non-invasive
monitoring of Bilirubin infant jaundice in the United States. The
"substantial equivalence" order was in response to Chromatics'
premarket notification (510(k)) submission requesting marketing
clearance for the device from the agency. The "substantial
equivalence" order states that Chromatics must comply with the
medical device "general controls," e.g., device establishment
registration, medical device listing, good manufacturing practices
(quality system regulation), labeling, and the statutory
prohibitions against adulteration and misbranding. The order also
states that the Colormate(TM) device is a Class II device which may
be subject to additional "special controls." Chromatics intends to
comply with any applicable "general controls" and "special controls"
for purposes of commercial distribution.
The company is engaged in the business of 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 diseases. The
company's common stock and warrants are traded on NASDAQ under the
symbols "CCSI" and "CCSIW", respectively.
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 anticipated 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 further regulatory clearances
applicable to proposed new applications of the company's technology,
the maintenance of existing and any future regulatory clearances, 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 it's
annual report on Form 10-KSB.
CONTACT: Chromatics Color Sciences International Inc., New York
Darby S. Macfarlane, 212/717-6544
Fax: 212/717-6675
KEYWORD: NEW YORK
INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY MEDICINE
BANKING
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