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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 22.38-4.8%Nov 14 3:59 PM EST
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To: Dixie7777 who wrote (4240)7/20/1998 12:41:00 PM
From: Peter V  Read Replies (2) of 5736
 
I don't believe that maisels left the impression you indicate that further testing is needed before the device can be relied upon.

Please don't continue the distortion of the meaning of the good doctors words.

OK, let's look at what he said in the official, company-sanctioned press release:

biz.yahoo.com

''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.''

I don't know how you can interpret those statements in any other way except that more testing needs to be done to be certain that the device can be used reliably to replace heel sticks. Maisels says he and other responsible physicians will conduct both tests to compare the new and traditional methods, and that he himself set up the protocol for additional testing of the device.

by the way there is a very solid reason for the current lack of an agreement.

Then maybe you can tell us what that reason is, and perhaps you can elaborate on the company's statement below:

"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. "

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