To all, Am fully prepared to be flamed and accused but I wanted to explain why I didn't invest in CCSI 6 months ago and why I am not today. I am a practicing MD involved in the y2k and many of you have seen my posts on TAVA and Year 2000 etc. I am not short and am not an MM(reference CK Houston if you wish to do DD) .
Background, I trained in Boston and Rochester NY and have contacts there and in many centers here in Virginia. I have delivered over 1000 babies in my career, have provided pediatric coverage for three times that amount and continue to practice. I am on a Board of a 2000 person IPA(doctor's association) which deals with a large metropolitan area of over 1.5 million including a level III Neonatal ICU.
Facts: The Companies approval from the FDA states that out of 1300 or so neonates that were in the study only 10 % had hyperbilirubinemia and thus only 130 or so were in the study. Of those 90% had correlation with serum bilirubin so 13 infants did not. That was more favorable than visual inspection but all were found to be in a range of 8-14. Reference the Cedar Sanai material here on the thread and we learn that physiologic jaundice is becoming a nonentity, that perhaps we are not even going to be treating it in the future. Perhaps not, only what I read and know from my own medical search.
The statistics in my community and in Pediatric literature is that about 10 % of neonates develop jaundice, with very little of that the kind(hemolytic) which is life threatening as your articles mention. I'm going to assume that that leaves 400,000 that have a potential to be tested, assuming we see all of them in the office or at home during those 3-5 days that this occurs after birth.
Hospitals, absolutely will consider this if financially feasible. However, only 5% or so of Hospitals have neonatal ICUs and this is where most of this work will be done. Discharge from the rest of our hospitals is usually within 24-36 hours that we're never going to see these kids in our normal hospital stays. Home Health, may be charged with testing at risk infants but I doubt every kid born(No resources and I doubt no reimbursement).
Those with the most severe forms of jaundice and those preemies in the neonatal units frequently require monitoring of other tests such as hematocrit(cell count), white cells, electrolytes, and therapeutic drugs given so I don't know whether we can sell ourselves on the decrease blood test thing.
As to pediatrician offices I have seen some unbelievably wild estimates of 20 tests per month (based on 3 pediatricians to an office). That would mean that EVERY kid born will be tested at least once and we already know that this problem only affects 10%. So even taking 20% tested twice per child you get 32 tests per pediatrician per year(that's a lot of tests). Now three peds in one office would be 96 tests(still every one of 20% tested twice) per year. Reimbursement for these are about 10 bucks so we come up with $960 per year. Now do you think a business person would buy a $10000 piece of equipment and devices and such for $960 per year? I know my answer and these scenarios are at least four times what I see as the need.
Any pediatricians or neonatologists out there please refute me immediately and I'll buy CCSI but I think it's going to be hard. I again have no knowledge of the other colorimetric applications in dentistry and fashion, soil etc. so this still might be a great company. But to wildly project a machine in every office and home health center and hospital is craziness. I see this product very useful but I see perhaps a 5- 7.5 Million total market for this machine due to the above reasons.
In conclusion, don't let the anticipation and wild desires of some to have a successful product lead you into a decision without all the facts. I think this is a good company but I don't believe the bilirubin market or the phototherapy market will be supported as projected by the company or those most exuberant on this board. I hope I'm wrong but I doubt it. Good Investing, Stephen |