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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 30, 1997
CHROMATICS COLOR SCIENCES INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
New York
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(State or other jurisdiction of incorporation)
0-21168 13-3253392
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(Commission File Number) (IRS Employer Identification Number)
5 East 80th Street, New York, New York 10021
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (212) 717-6544
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Page 1 of 5 pages
Exhibit Index located on page 4
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ITEM 5. OTHER EVENTS
On July 30, 1997, Chromatics Color Sciences International, Inc. (the
"Company") 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
the Company 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 the Company's premarket
notification (510(k)) submission requesting marketing clearance for the device
from the agency. The "substantial equivalence" order states that the Company
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." The Company intends to comply with any applicable "general
controls" and "special controls" for purposes of commercial distribution.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION
AND EXHIBITS
(c) Exhibits:
1. Chromatics Color Sciences International, Inc. Press Release,
dated July 30, 1997.
2
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
By: /s/ Darby S. Macfarlane
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Name: Darby S. Macfarlane
Title: Chief Executive Officer
Date: August 4, 1997
3
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EXHIBIT INDEX
Document Page Number
1. Chromatics Color Sciences International, Inc. 5
Press Release, dated July 30, 1997.
4
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CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
Contact: Darby S. Macfarlane
Telephone: (212) 717-8544
Fax: (212) 717-6675
FOR IMMEDIATE RELEASE
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 its annual report on Form 10-KSB.
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