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Posted by on in Clinical Studies

anulex.pngOn 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. 

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