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

To: Susan S. who wrote (3929)	7/3/1998 10:27:00 AM
From: JanyBlueEyes	Read Replies (1) \| Respond to of 5736

You must not have taken the time to read: Message 5082385 - Dr. Jeffrey Maisels Clarifies Misstatements by TheStreet.com Regarding Chromatics Color Sciences' TLc-BiliTest(TM) ---------- <<Folks, unless he is the humanitarian of the decade (doing studies for CCSI in his free time), that is too little money to pay a physician to do a thorough medical research project.>> Dr. Maisels' is one of the most highly regarded medical experts with regards to bilirubin infant jaundice. He has written extensively on the subject. His credentials speak for themselves. No prominent physician would let his name be associated with something that did not have potential in the marketplace.See: Message 3033819 and ncbi.nlm.nih.gov Quote from Dr. Maisels: "...I am confident that the Colormate(TM) TLc-BiliTest(TM) will replace the overwhelming majority of heel sticks." ---------- <<He's NOT using the Colormate in his hospital. This speaks volumes.>> <<All drugs and medical devices have a few drawbacks, even if minor. Why isn't Dr. Maisel objective enough to point out both the pros and cons? After all, his journal readers (physicians) are known to be savvy and skeptical about prescribing new products..>> Quote from Dr. Maisels: "...Other studies conducted in smaller patient populations, including those conducted under my supervision at William Beaumont Hospital in Royal Oak, Michigan, support these results." "...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...." ---------- <<For the first time he mentions that more studies need to be done. I agree with this, but why did it take so long to bring this up? It seems that CCSI has been promising a big manufacturing deal based on the results of only two studies.>> <<Physicians are not going to rush out and order a product based on just two studies (one of which had only 43 patients), unless of course the product is truly revolutionary, which the Colormate is not.>> Quote from Dr. Maisels: "...This is evidenced by the very impressive data in studies conducted by Dr. Ian Holzman - Mt. Sinai Hospital, Division of Newborn Medicine in New York, of large patient populations of various races, different gestations and babies under phototherapy. This body of testing is impressive by any standard...." "..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 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.'' ---------- <<Finally, now that CCSI has stated they plan to do further multicenter studies, they will not be entering into any deals until these are completed.>> This statement is absolutely incorrect. ---------- <<These kinds of studies take months to complete, even with the involvement of experienced CRO's (clinical research organizations that help companies test products). Therefore, no way can the product be rolled out at the end of summer as Darcy just stated recently.>> CCSI has stated these studies are being conducted at this time and will be done by the end of August. These studies are routinely done to help support the data that was previously collected to aid the physician with his/her decision to use the device. These studies have nothing to do with a distribution deal, manufacturing or product rollout.