Janybird, Thanks again for accepting my intentions and DD. The article you referenced is in the Dec. 96 issue of Clin Bioch 1996(29) 6: 581-6 if any others might want to check it out. Unless you want to pay for it from a medline search (abstract only is free) you will need access to a medical library.
I am going to summarize my arguments and include articles from Dr. Maisels also throughout the past decade to reinforce my argument that the market for this is indeed smaller than purported. Without knowing the cost of the devices and the disposables I cannot comment furhter regarding the acceptance of this by the public, the insurance companies, or the pediatricians. If this is cheap and available next to the Over the Counter items it may end up having a much greater market but less revenue. I just don't have the answer to this.
Various Pediatric textbooks give the incidence of jaundice over 12 as 6-8% and that over 8 as 20%. Others including the AAP state that at some time or another about 20% of all infants (bottle plus breast fed) will have totals over 12. For reasons of revenue projections I have to assume for my comfort that this is the population identified.(800,000 in the US). 60% of these will be normal newborns, 40% will be preemies, although the total percent of preemies is much higher.
There is no reference made in the Dec 96 article as to what percent of were tested and whether or not they used some visual or other criteria for testing.
Dr. Maisels has been very prolific in his publications re bilirubin and is indeed an expert in the field. He is a Medical Advisory Board Member and not a company spokesperson. In his article in Pediatrics in May 1992,vol89 no.6, he and Dr Newman state that the recommendations for aggressively testing and treating newborns with elevated bilirubins
is just that and they suggest new guidelines which are less aggressive and consistent.
They go on to say that for babies discharged from hospital early that a Cord Blood and Coombs be done to identify those at risk and then to follow those infants closely(less than 1% total infants) "We would advise parents of these low risk infants that the jaundice is unlikely to be a problem, but that if it extends to the baby's feet, or markedly increases in intensity, they should return to have the bilirubin checked."
They say that the overtreatment of jaundice "retains much of the unneccesary follow-up and diagnostic effort ".
In Pediatrics 1997 Maisels and Kring go on to state that followup of infants at three to five days are important in the office, but I can find no further mention of changes in their earlier recommendations.
So, our Medical has stated in numerous articles that we overtest for bilirubin. We do not know the present cost for bilirubin testing with the Colorimetric device. The Pediatric Textbooks and the AAP estimate that our most needed population (those with bili greater than 12 number only 20%). The treatment guidelines recommended by Dr. Maisels is above 20 in otherwise normal newborns. More emphasis has been placed on the proper breast feeding freuency in the latest literature including active parental teaching than with more aggressive bili testing.
The company estimates two tests for every child. I estimate two tests per 20% of children. The company states 22-34 dollars for test reimbursement, fact is $10 is about as much as we can get for this.
Janybird and all, that's all I have. I estimate the disposable market in the US to be at most $16 million total, not including the machinery. Multiply that by four and you get a reasonable recurrent disposable market of 64 million. Now if this gets approved for the over the counter market and some of the hysterics and such as appear at times on this board are used by advertisers to sell these items to worried parents then I believe the companies estimates may be true. Will the price inevitably go down under this scenario. Yes, resoundingly if they hope to hit all parents.
At a market cap of $250 million and the costs of distributing and manufactering ahead of them, I believe a realistic price for a successful marketing of this product to be somewhere in the 20's. I think medically this is indeed a great product, or I wouldn't even be here. However, the downsides of the current market and the expectations for this very small cap company is going to keep me away. Call me what you may but those are only the facts as I have gathered from my own literature. Please Private Message me if you wish to discuss further since I don't particularly enjoy responding to name calling. Thanks for your attention, Stephen |
