NZ company - tissue repair product, page-16

point of note: the mesenthes product Endoform is a 510k device and they was not required to do clinical studies as they had many predicate devices. Vitrogro is different - biologic not device, no predicate, will require statistically powered clinical trial. CE is often the faster approach. Is not fair or correct to blame management for that decision. My criticising of management is that they have not started controlled trials without which they will not get reimbursement. yes, I bang on this drum.