David,
<<Contrary to "Negative Ted's 100 worst posts", Palomar Medical can now claim "Permanent Hair Removal". This was Ted's most frequently mentioned slam against laser treatments. Now the FDA agrees with Palomar.>>
FDA has NOT allowed Palomar to claim "permanent hair removal", only "permanent hair reduction."
FDA has defined permanent hair reduction as "a long-term stable reduction in the number of hairs regrowing after treatment regimen."
In other words, not permanent!
The new label might mean something if nearly all of the hair had not grown back after, say, a couple of years, but based on what little data Palomar has released, regrowth averages about 70 to 80 percent after one year. Many patients will have nearly 100 percent regrowth, while a few may have about 50 percent, still a marginal result result, at best. Moreover, I doubt that there is any way for a physician to accurately predict the treatment outcome for each patient.
So, I believe that the actual treatment results are as poor as ever, given the high price of treatment.
<<Laser sales should grow faster, now,>>
You really want them to sell MORE Epilasers???
<<but more immediately it should really help with their treatment centers now that they can advertise the "permanent" feature, exclusively.>>
What centers? Do you know where they are? Remember how PMTI used to state how many there were in their PR, and even named their locations in SEC filings? Well, they haven't done so in quite a while, have they? And they say little about them in conference calls. I wonder why?
In any case, all Epilaser clinics will have to be very careful about advertising permanence, since almost all of the hair regrows. And FDA insisted that Palomar expand its product labeling to include detailed tabulations of its clinical results.
Labeling is FDA jargon for all documentation that ships with the product, such as user/training manuals, stickers affixed to the product, and promotional materials. Strictly speaking, FDA enforces Palomar's adherence to the labeling in the sale of the device.
Physicians can use the product as they see fit, including making any treatment claims they wish; however, going far beyond the claims supported by the product labeling leaves them more vulnerable to lawsuits by patients who expected better treatment outcomes.
So I suspect the use of the word permanent may prove to be more of a liability than a blessing.
<<Of course if I was a physician looking for this tool, I'd certainly go with the ONLY company that can claim "permanent" hair removal. So sales should pick up nicely there, too.>>
You seriously want them to sell more Epilasers????
<<At the current stock price, could be a nice investment.>>
Would you care to favour us with an estimate of revenue, GP, OP, EPS and PE, based purely on fundamentals? |
