I am long CSII and not a medical person. However, when I realized they had a device that could basically go in and Roter Rooter blockages out of my heart artery, I was all in. This is incredible. If I had to get a stent that was simply going to try and squish that plaque to the side or had the option of having it removed first and then a stent put in...well, it's a no brainer. There are millions of people who will need this procedure. Someone on this board said CSII is worth over $100/share because of this technology. I mean it may not be a cure for cancer but it is addressing a huge, needed medical issue. I would appreciate some informed opinions from the more knowlegeable medical people on this board on how much CSII is now worth with the terrific results of their clinical trials and the fact they seem to be on track for FDA approval of using their device in the heart area. Thank you for your opinions. jf
San Francisco, CA - Rotational atherectomy prior to the implantation of a drug-eluting stent (DES) failed to have any impact on in-stent late lumen loss in elderly patients with calcified lesions, according to the results of a new study.
Dr Gert Richardt
Presenting the results of ROTAXUS today at TCT 2011, lead investigator Dr Gert Richardt (Segeberger Kliniken, Germany) noted the results of the study "went the other way around," with patients treated with the paclitaxel-eluting stent (Taxus, Boston Scientific) alone having less in-stent late lumen loss than those treated with atherectomy prior to receiving the paclitaxel stent. Although he concluded by stating that rotational atherectomy does not increase the efficacy of drug-eluting stents in calcified lesions, he, as well as others, stressed that provisional atherectomy still has a role in patients with complex, calcified lesions and remains useful as a bailout strategy for lesions that cannot be crossed or dilated.
"We did not include the most complex patients [in ROTAXUS]," said Richardt during a morning press conference announcing the results. "Maybe if we treated a group of patients even more complex than in this study we would show a benefit of the rotablator."
Dr Roxana Mehran
The ROTAXUS study included 240 patients with stable or unstable angina and coronary artery disease. The primary angiographic inclusion criteria included treatment of a lesion in a native coronary artery with moderate to severe calcification. The primary end point of the study—in-stent late lumen loss at nine months—was 0.44 mm in the atherectomy/paclitaxel-stent arm and 0.31 mm in patients who received the paclitaxel-eluting stent alone. There was no difference in any clinical end points at nine months.
Despite the negative results, Dr Roxana Mehran (Mount Sinai School of Medicine, New York), who was not involved in the trial, stressed that rotational atherectomy still plays a role in clinical practice. "It's important to note that rotational atherectomy still does have a place in our armamentarium, but it would be in the very severely calcified lesions or complex morphologies that would make our procedures easier."
I am not a medical person--but I have owned the stock since before it went public--and have studied the market quite a bit. Typical buyouts for medical companies like this average 5 times sales--but this one will go for much more than that because it was originally designed for the coronary market--and it would seem, based on the trial results that they should get FDA approval in that market--that will still take around 6 months or more unless the FDA gives them quick approval because the results were so good and the safety is excellent. Assuming continual growth rate in PAD--their sales run rate could be 110-120-mil projected forward before they even get coronary approval. If they waited long enough I am sure that the stock will be worth 70-100 dollars---but I think the buyout will come this year--probably just before or after FDA approval. I like Abbott--with their dissolving stent the two technologies go hand in hand. Abbot is selling for 34/share--I think a 1 for 1 stock swap would be great. The sales price is closely related to timing and what the company is selling at when the deal is made--there could be a bidding war if a couple of the big medical firms want the tech---I gutsy CEO would buy them now before they get too expensive---but most of them would want to see that FDA approval first. This company needs to go Global to reach anywhere near its potential--one of the big guys will want to add them to their portfolio--that is how the medical business works these days. I am guessing 30-35--but I would love to see $50---JMO Good luck
I wonder with all the good news if CSII will keep going up to about $30 and base there and then really take off when the buyout rumors start or the FDA approval comes through. Obviously a lot of people have been buying in the at $18-$20 in the past few days.