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

To: THESTOCKMAN who wrote (4967)	3/20/1999 9:50:00 AM
From: Cacaito	Read Replies (1) \| Respond to of 5736

Stockman, There is no "bleaching" of skin during phototherapy. Tanning is minimal during phototherapy it depends on excess heat (not light)and this is control for in all NICUs. Reddning is more common (and minimal in most cases), not a problem for the bilicheck. The technique measures reflectance of infrared light, collagen and melanin are the major components of skin to interfere (and already accounted for) with the algorithm. 9 years? do not count on it, sprx is already developed and in the market. 3 separate sites in the US? is that a new rule for clinical trials? CCSI single study was at the Elmhurst hospital, Queens, New York City, not three separate sites. The trials are ongoing in six centers in Europe, this is a sign that they will get fast accruals and fast completion. Two hospitals in Pennsylvania will be starting trials in the US soon. Several hundreds of babies? CCSI trial has only 61 babies in phototherapy: ncbi.nlm.nih.gov FDA a year or two for a new indication in an approved device, not when all your modules are already organized. New FDA rules about "modular" applications. Sprx will only need to publish in a "peer reviewed journal" for the information of the trial to be given to physicians (just given the data, not promoting it), according to new FDA rules on off label information. Physicians will decide on their own if the data is good and they could use the device off label. Sprx primary, and almost only market, is the same as CCSI: NICUs. And it is where their promotion is mainly going.