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%

3:59 PM EST

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To: Quad Sevens who wrote (2919)	6/11/1998 6:06:00 PM
From: jpbrody	Read Replies (2) of 5736

To the FDA "substantial equivalence" refers to the test results. To get 501k approval, you must prove that your device's test results are "substantially equivalent" (or better) to devices already on the market. It doesn't say anything about the method of achieving the results. Invasive/non-invasive whatever, as long as the results are as good as what's out there you can get approved. There's an alternative process to get something approved that does not exist on the market now. PMA (pre-market approval) that is much more involved. I think Asensio mauled the substantial equivalence part of his argument, and I'm short. What I find troubling is CCSI's reply on the market size: SIZE OF MARKET ALLEGATION: Asensio & Co. states that ''CCSI claims that U.S. Hospitals spend approximately $330 million to $510 million per year on monitoring infant jaundice.'' CCSI's publicly released estimates of the existing size of market stated that 15,000,000 individual laboratory serum bilirubin tests were conducted in the United States annually for monitoring bilirubin infant jaundice . . . The Company additionally stated that the hospitals charged between $22-$34 per test in the United States for reimbursement by third party insurance carriers. His point is not that 15,000,000 x $22 is not equal to $330 million, but that it's false and misleading to imply that is the potential market for CCSI's bilirubin testing. Here's a business plan. Why don't they sell Tylenol to hospitals for $1 per tablet. I can prove that the average amount spent per tablet of Tylenol in a hospital is $3.

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