Biosurface Engineering Technologies Inc announced that it will be completing the study of AMPLEX Osteo-Promotive Bone Graft System by May 2010.
AMPLEX Osteo-Promotive Bone Graft System consists of a synthetic peptide growth factor intended for advanced tissue repair. AMPLEX incorporates proprietary B2A, a BMP-2 growth factor analog, with ultra high-grade ceramic bone scaffold for use in lumbar interbody spine fusion surgery.
The pilot study is to evaulate the safety and preliminary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.
The phase II study is currently recruiting participants. The official title of the study is “A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety and Preliminary Effectiveness Of Prefix Compared To Iliac Crest Bone In Subjects With DDD Undergoing Transforaminal Lumbar Interbody Fusion”.