Hi. You raise some good points so let me try to answer you. First of all, I am not anti-PLC or anti-TMR. I think PLC is bringing some very interesting therapy to healthcare. Unfortunately, they are about to enter a whore's business. Think of a young school girl wearing her white Confirmation dress as she walks past all the whores on 42nd street in NYC.
1. I am aware of no studies which prove similar efficacy for TMR between electrocautery and PLC's laser. But this is exactly the point. It will not stop the competitors. If laser industry history has taught us anything, it is often the company's who do good science, like PLC, who ultimately get burned and burned badly. Why? Because most older-line laser companies have FDA 510-K approval for soft tissue ablation. You can bet that Laserscope, SLT and Trimedyne (who have huge installed bases) are working on laser fibers right now that do the same thing as PLC's. They will then come up with some half-assed justification to the FDA that TMR is nothing other than soft tissue ablation and they will then try to prove what is known as "substantial equivalence" to their other fibers which are already approved. This has happened over and over again.
2. These lower-life laser companies will lurk in the shadows allowing PLC to spend millions on advertising spreading the gospel of TMR. They will then come in a year (it will take that long to navigate a 510-K through the FDA) and sell knock-off equipment at knockoff prices and pollute the market.
3. Cautery companies such as Circon, Valley Labs etc will also try to prove that their much cheaper cautery products can do the same thing at 20% of the cost. Once again they just have to get something off their shelf that already exists and which is used and approved to ablate some other organ or tissue. They will then go through the much quicker 510K process to once again prove substantial equivalence. You might be right that TMR cannot be performed with electrocautery. However, the threat of a cheaper substitute is but one of the many concerns I listed about PLC's prospects.
4. Please do not rely on the FDA to defend PLC's turf. It is not going to happen. Even if the others do not have great clincal data, the FDA, working with HCFA, has an agenda to reduce healthcare cost.
5. Regarding your comments about Dowd - I am sure he is not dumb. However, there are hundreds of failed medical products where companies overlooked the possibilities of much cheaper and equally efficacious substitute products.
6. Contrary to what we all might like to believe, my experience indicates that only about 50% of MD's make their therapy decisions based on clinical studies. The biggest single influencer of a physician's buying decision is the recommendation of another respected physician. Secondly, they always seem to gravitate toward the therapy which makes them the most money.
7. Lastly, there is many a pioneer who has died from an arrow in the back.
I hope these comments are helpful. Good luck in your investments. Just keep your eyes open. On my way to the airport. Bye for now. |
