Ann: Hernia Product Update, page-70

My understanding was and remains that the hernia device was always entirely resorbable. There isn’t a positive spin possible here. We are being told of an accelerating delay, i.e., time to market has stretched out by two years over the course of one year. It may be that the FDA is requiring additional clinical data. Reading between the lines, there may be an abandonment of the woven material previouly indicated. But whatever the reasons might be, this kind of delay to market won’t please the market. The share price over the next year or so will have to be driven almost entirely by BTM sales. Let’s hope for good news on that front. There isn’t any good news here.