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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) September 15, 1997
CHROMATICS COLOR SCIENCES INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
New York
(State or other jurisdiction of incorporation)
0-21168 13-3253392
(Commission File Number) (IRS Employer Identification Number)
5 East 80th Street, New York, New York 10021
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (212) 717-6544
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Page 1 of 7 pages
Exhibit Index located on page 5
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ITEM 5. OTHER EVENTS
Chromatics Color Sciences International, Inc. (the "Company") announced on
September 15, 1997 that it has completed its analysis of the existing market for
bilirubin tests on newborn infants in the United States, and the approximate
size of that market in the developed countries of Europe, South America and
Canada combined, and Asia.
The World Health Organization has published the current annual birthrate of
approximately 4,000,000 births in the United States, with approximately 10% of
these births being premature infants. The Company estimates that individual
bilirubin blood tests on newborn infants (heelsticks), which are not part of a
general panel blood test, total approximately 15,000,000 tests performed
annually in the United States, based on data made available by the World Health
Organization, the American Academy of Pediatrics, independent market studies
commissioned by the Company and business proposals from potential marketing
partners.
The Company believes that published reimbursement amounts by third party
insurance carriers for heelstick bilirubin blood tests, not part of a panel
test, range between $22-$34 per test in the United States. Assuming a $22 fee,
the Company estimates that approximately $330 million in spent annually on
monitoring bilirubin infant jaundice in the United States.
Internationally, using the World Health Organization birth rates,
independent market studies and research obtained from companies currently
marketing neonatal medical devices in foreign countries, the Company estimates
that the current European market for infant bilirubin tests is approximately the
same size as the U.S.; South America and Canada combined represent approximately
25% of the U.S. market size and the Southern Chinese and entire Japanese markets
combined represent approximately the same size of market as the United States.
Since recently receiving FDA marketing clearance in the U.S., the Company
is currently undertaking the procedures to obtain required international
regulatory clearances for its noninvasive bilirubin monitoring device and
technology. The Company has also begun the process of establishing third party
reimbursement for its noninvasive bilirubin testing which will be an important
factor in its pricing structure in the United States.
Certain of the matters discussed in the announcement contain 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
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report on form 10-KSB for the year ended December 31, 1996 and its quarterly
report on Form 10-QSB for the period ended June 30, 1997.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) Exhibits:
1. Chromatics Color Sciences International, Inc. Press Release,
dated September 15, 1997.
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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/ Leslie Foglesong
Name: Leslie Foglesong
Title: Secretary
Date: September 18, 1997
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EXHIBIT INDEX
Document Page Number
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1. Chromatics Color Sciences International, Inc. 6
Press Release, dated September 15, 1997.
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CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
Contact: Darby S. Macfarlane
Telephone: 212-717-6544
Fax: 212-717-6675
FOR IMMEDIATE RELEASE
September 15, 1997
CHROMATICS ANNOUNCES ANALYSIS OF EXISTING MARKET
FOR NEWBORN BILIRUBIN TESTING
Chromatics Color Sciences International, Inc. (NASDAQ: CCSI) today announced
that it has completed its analysis of the existing market for bilirubin tests on
newborn infants in the United States, and the approximate size of that market in
the developed countries of Europe, South America and Canada combined, and Asia.
The World Health Organization has published the current annual birthrate of
approximately 4,000,000 births in the United States, with approximately 10% of
these births being premature infants. The Company estimates that individual
bilirubin blood tests on newborn infants (heelsticks), which are not part of a
general panel blood test, total approximately 15,000,000 tests performed
annually in the United States, based on data made available by the World Health
Organization, the American Academy of Pediatrics, independent market studies
commissioned by the Company and business proposals from potential marketing
partners.
The Company believes that published reimbursement amounts by third party
insurance carriers for heelstick bilirubin blood tests, not part of a panel
test, range between $22-$34 per test in the United States. Assuming a $22 fee,
the Company estimates that approximately $330 million in spent annually on
monitoring bilirubin infant jaundice in the United States.
Internationally, using the World Health Organization birth rates, independent
market studies and research obtained from companies currently marketing neonatal
medical devices in foreign countries, the Company estimates that the current
European market for infant bilirubin tests is approximately the same size as the
U.S.; South America and Canada combined represent approximately 25% of the U.S.
market size and the Southern Chinese and entire Japanese markets combined
represent approximately the same size of market as the United States.
Since recently receiving FDA marketing clearance in the U.S., the Company is
currently undertaking the procedures to obtain required international regulatory
clearances for its noninvasive bilirubin monitoring device and technology. The
Company has also begun the
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process of establishing third party reimbursement for its noninvasive bilirubin
testing which will be an important factor in its pricing structure in the United
States.
Based on the Company's initial business discussions with International Medical
Device Companies interested in global distribution rights for the Company's
noninvasive bilirubin monitoring medical device for newborns, significant market
penetration in the U.S. and International markets would require 3-4 years from
the start of commercial distribution.
The Company also stated that it could not at this time disclose the pricing
structure and business models currently being discussed with different potential
distribution partners, including any increased market potential for noninvasive
testing. In this regard, the Company has recently retained the services of two
business advisors to assist in current discussions, analysis and execution of
its long range marketing and distribution plan.
The Company is engaged in the business of color science and has developed
technologies with potential medical applications involving the detection and
monitoring of certain chromogenic diseases. These technologies also have other
applications 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.
The Company's common stock and warrants are traded on NASDAQ under the symbols
"CCSI" and "CCSIW" respectively.
Certain of the matters discussed in this announcement contain 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 for the year ended
December 31, 1996 and its quarterly report on Form 10-QSB for the period ended
June 30, 1997.
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