think you're off, dude! Trials may start in 2013. Never seen clearance take less than a year or more with these deals. Has FDA approved trials at all yet? From what I see since my post, looks like not even close. Done well with the penny stuff from time to time. Got my wallet chopped in half too. Just being cautious! Thanks
Sorry, I wasn't paying attention... you are the original poster. They are utilizing the HUD/HDE pathway which can get them to low volume revenues doing the procedure on a limited scale and conceivably in less than a year. If these procedures go without a hitch safety-wise and there is demonstrated efficacy, then it would be expanded to full status and they can ramp up revenues considerably. They also have additional products in the pipeline that will likely follow the same streamlined pathway to the market. This is a 5 year investment horizon to an outcome that could have massive upside.
Hi dblank, I guess it is in the interpretation of what the OP meant by "clearance" as I had assumed (probably mistakenly) that they meant clearance to begin the human studies. If it is final clearance to market the medical device, it doesn't move as slowly as a pharma and conceivably it could occur by year end 2013 as it is on a fast track pathway.