Ann: Hernia Product Update, page-73

At least initially it was thought that BTM, with a few minor modifications, would be the new hernia product
this in turn meant that all the BTM safety and efficacy data applied
however, as time passed it became apparent that the hernia product was an entirely different beast - in effect something entirely new with a whole new suite of IP
unfortunately this has meant that the BTM safety / efficacy data no longer apply .. hence new studies and the inevitable time it takes to complete these studies
I would put it to you that these are actually not delays but simply cutting edge science in action
in the meantime BTM will continue to grow (even now it has only a small market share) and there is also the ulcer treatment product coming onboard to fund SP growth for the next 18 months