On February 11, 2011, the company doors of Anulex Technologies, Inc. began to close. On this day, they were informed by FDA via a Anulex Warning Letter that there regulatory strategy/execution was severely defective. The company decided early in their history that they could obtain a 510(k) clearance for soft tissue approximation (suture) for procedures such as general and orthopedic surgery. After such a clearance they could proceed and conduct prospective phase III clinical studies for spinal annular repair (as part of a spinal discectomy procedure. This was the real marketing objective) without FDA approval (Investigational Device Exemption). It is clearly understood by most that this is a more specific patient population with a very different goal; to repair a spinal disc to allow continued functioning of that anatomical structure (an anatomical part that is avascular and doesn’t have a significant repair mechanism like skin). In addition, the adverse event profile for such an indication is much more significant (proximity to the cauda equina) than closing a surgical incision. All of these differences should have clearly identified their regulatory strategy as fraught with problems.