TheStreet.comRegarding Chromatics Color Sciences' TLc-BiliTest(TM)
NEW YORK, July 2 /PRNewswire/ -- Chromatics Color Sciences International, Inc. (Nasdaq: CCSI) today issued the following statement by Dr. Jeffrey Maisels, Chairman Dept. of Pediatrics William Beaumont Hospital, Clinical Professor of Pediatrics, Wayne State University School of Medicine and Clinical Professor of Pediatrics and Communicable Diseases, University of Michigan Medical School:
"The statements attributed to me by TheStreet.com were not stated in their complete context. What is clear to me, is that the TLc-BiliTest(TM) is a very important recent advance and will assist the medical community in providing better care for the jaundiced newborn infant, while at the same time helping parents and their babies by using a non-invasive test. This is evidenced by the very impressive data in studies conducted by Dr. Ian Holzman - Mt. Sinai Hospital, Division of Newborn Medicine in New York, of large patient populations of various races, different gestations and babies under phototherapy. This body of testing is impressive by any standard. Other studies conducted in smaller patient populations, including those conducted under my supervision at William Beaumont Hospital in Royal Oak, Michigan, support these results.
"In response to the question asked as to whether I would use the TLc-BiliTest(TM) to replace blood serum now, I believe that routine medical practice dictates that any new device on the market needs to be initially applied in parallel with other known measurements. The TLc-BiliTest(TM) is no exception to this rule, although depending on circumstances you could initially use Colormate and not a blood test in many cases. I will certainly use the device and benchmark results against blood sample testing for some period of time, as would any responsible physician until comfortable replacing old technology with new. I am confident that the Colormate(TM) TLc-BiliTest(TM) will replace the overwhelming majority of heel sticks.
"I have advised Chromatics Color Sciences that to expedite this process, multi-center studies are routinely done for new medical products on the market such as those done with the non-invasive Nellcor Pulse-Oximeter. In this regard, I have written the protocol now being used by Chromatics for such studies being conducted."
As far as statements attributable to Ms. Macfarlane with regard to orders, shipping schedules and distribution, the Company stated that although this has been its business plan, there can be no assurances as to timing or consummation of sales.
Chromatics Color Sciences is in the business of color science and has developed technologies and intellectual properties which it believes have medical applications involving the detection and monitoring of certain chromogenic diseases or disorders such as bilirubin infant jaundice. The Company defines chromogenic diseases or disorders as those diagnosed or monitored by the coloration of the human skin, tissue or fluid being affected. In this regard, the Company has received Food and Drug Administration (FDA) clearance for commercial marketing of its medical device for detection and monitoring of bilirubin infant jaundice.
Other medical applications will require additional clinical trials and FDA clearance. The Company's technologies and intellectual properties 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.
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, 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-K for the year ended December 31, 1997.
SOURCE Chromatics Color Sciences International, Inc.
CO: Chromatics Color Sciences International, Inc.; TheStreet.com
ST: New York
IN: MTC FIN
SU: LAW
07/02/98 08:50 EDT prnewswire.com
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