Rainier, I'll do my best at answering your good questions:
1) Novatec is an ablative laser and on their home page they mention Photorefractive Keratectomy (i.e., PRK). At WWW.Novatec-laser.com/clinical.htm they mention "Manual Epithelial Removal." That's the part of PRK where they use a brush to take off the outer tissue layer. I suspect that this is also the part of PRK that is throw-up painful. My understanding is that the removal of the epithelial tissue is also why the vision improvement comes over time and the healing response is so critical as this tissue layer grows back. Novatec's web site may be old. There are references to microkeratomes on it, so I assume that they plan to do LASIK (Flap and Zap) with it also. Hence, IMO Novatec is in the PRK and/or LASIK category.
2) Myopia is the domain of PRK and LASIK. Hyperopia is mentioned on Novatec's web site. Hyperopia has been also discussed by BEAM and Visx. I guess the dream of the designers of these wonderful machines is something that does everything. I think one of those cos. (BEAM or Visx) has abandoned their efforts with hyperopia and the other still is trying to do some testing regarding it. The correction of hyperopia requires the eye to be longer. It is difficult to make the eye longer with an ablative laser that removes cells, such as BEAM, Visx and Novatec's lasers. They have tried to do it by creating trough around the cornea. The healing response is critical with scar tissue often being a factor (which distorts the effect). It also requires a high level of skill for the opthamologist. Also, I suspect, the time required of the opthamologists with each patient would be much higher than with LTK, even it worked.
3) SNRS's core markets are hyperopia (for which it seems to be the only viable solution), presbyopia, overcorrections from LASIK and other surgeries and hopefully astigmatism (the mother-lode).
4) It appears that Novatec's core market would be myopia and probably astigmatism.
Consider also the market differences: the myopic market has probably worn glasses since they were little kids (like myself). We are used to having to wear glasses. We don't like them but we've worn them for 35 years. If we are active in sports or otherwise motivated AND have $4,500 (2 eyes) to spend we are likely candidates.
Hyperopes / Presbyopes can't see their face in the mirrors. They probably didn't wear glasses as kids. They HATE having to wear glasses (like the beautiful lady I work for, Ms. Arlene). Wearing glasses for them is a SIGN OF GETTING OLD. They are in their 40's and 50's. They have say $750 per to spend, especially if there is NO PAIN. The risk of complications (which eat up a Drs. time) is nill.
Ok marketing experts, which market do you want to be in??? I really want to hear some responses on this.
5) As a practicle point, my understanding is that the best that any patent can do is buy some time in the market. However, I've heard the CEO say that if you are shrinking collagen in the body with a holmium laser, you will be talking to our lawyers. SNRS apparently has a "Process" patent in addition to a device patent. Actually, I think there are 11 or 13 patents. Susan Largon at the Co's s/h relations dept could help you on this. A fellow in my office did find the SNRS patents on-line but I can't remember how he did it.
6) The hyperopia trials are in Phase III (the final phase). After the follow-up period, the PreMarket Approval application is submitted and the FDA looks at all the data. If successful, approval to market would then come after that. The "modernization" of the FDA, as recently legislated, may create some benefits in expediting this process, but I don't have a handle on what might be expected.
7) I don't know where Novatec is at in the process. Some parts of their web site look to be several years old.
Hope this helps, Ranier.
Regards to all.
Greg |
