Chromatics Color Sciences International. Inc; CCSI Message Board

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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 29.77

+3.7%

Nov 5 3:59 PM EST

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To: CatLady who wrote (3078)	6/13/1998 12:56:00 AM
From: CatLady	Read Replies (1) of 5736

Found something in the 10K, Clayleas was right on 'hand-held' vs. LED device approval. "The FDA-cleared device includes the Colormate(TM) device for monitoring bilirubin infant jaundice when operated using external power sources with a computer and printer, and when operated as a battery-operated hand-held, optional computer assisted device (collectively, with the Company's disposable calibration components, hereinafter referred to as the "Colormate(TM) Bilirubin Device"). The Colormate(TM) Bilirubin Device is a proprietary color measurement instrument containing a light source and optical filters. Color measurements are obtained from an infant by placing the Colormate(TM) Bilirubin Device on different physical sites of the newborn for 5-10 seconds. Accuracy of the color measurements are ensured by a proprietary disposable color-calibration and verification standard used prior to each baby's measurement. Each color measurement of the skin is analyzed by the Company's proprietary technology to provide an estimate in mg./dl. correlating to the newborn's serum bilirubin concentration within a clinically useful range. The Company also has recently completed development of the working prototype for a less expensive hand-held, LED version of the Colormate(TM) Bilirubin Device (the "Bilirubin LED Device") that could be used for monitoring bilirubin infant jaundice, subject to additional clinical testing and further FDA review and clearances. The Company recently received approval from Mt. Sinai Hospital (New York City), Elmhurst Hospital (New York City) and William Beaumont Hospital (Detroit) to commence such clinical trials of the Bilirubin LED Device. The Company intends to begin the clinical testing of the Bilirubin LED Device in the second quarter of 1998."

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