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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 28.92+3.1%11:07 AM EDT

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To: Gurupup who wrote (3269)6/18/1998 3:44:00 PM
From: JanyBlueEyes  Read Replies (5) of 5736
 
LED vs HAND-HELD

From the most recent 10K dated 3/31/98
205.185.55.25

HAND-HELD

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......

LED

The Company has conducted research and development and developed engineering specifications regarding a hand-held LED version of the Colormate(TM) System. This version may be marketed for medical use after conducting further clinical testing and is subject to FDA clearance for this Bilirubin LED Device. The Company recently received approval from Mt. Sinai Hospital, Elmhurst Hospital and William Beaumont Hospital to commence clinical trials of the Bilirubin LED Device.

For non-medical applications, the Colormate(TM) LED Device may be marketed in various industries including the dental, beauty aid and fashion industries and also may be marketed directly to consumers for home and personal use. The Company expects the new LED versions will also be capable of being manufactured at a cost substantially less than the cost incurred in manufacturing the Company's existing Colormate(TM) units.
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Note: FDA clearance is not needed for non-medical applications.
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