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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?


To: poodle who wrote (1038)2/15/1998 11:32:00 PM
From: JanyBlueEyes  Respond to of 5736
 
Other Diseases/Conditions

From: exchange2000.com - AUG 12, 1997 CONFERENCE CALL - Questions from the Floor

QUESTION:First question regards any other medical applications for the product. You mentioned other diseases. Have you submitted any FDA 510(k)submissions to diagnose other diseases? Thank you.

DARBY MACFARLANE: Not at this juncture. We focused all of our attention on getting through the FDA process with bilirubin infant jaundice. We have conducted some R & D on a couple of the other diseases such as anemia and tuberculosis but we have not begun any formal clinical trials.

From exchange2000.com - CONFERENCE CALL TRANSCRIPT 9/17/97 :

To develop monitoring instruments for these (other) medical applications it would require extensive clinical trials to obtain separate FDA clearances for each monitoring system.......

From sec.gov - 1996 Annual Report 10K:

From February 1993 to June 1995, the Company conducted a feasibility study for clinical tests at Elmhurst Hospital for use of its technology in the diagnosis of tuberculosis through the measurement of skin color. The Company stopped such studies in order to focus its limited resources on the more advanced Bilirubin Project and its long-range business plan to commercialize that application. Extensive further testing will be required to evaluate the use of the Company's technology for the diagnosis of tuberculosis...