K.Alghazali, M. Srivatsan, S. Trigwell, D. Bumpass, E. Mannen, R. McCarthy, D.E Anderson, A.S. Biris, S. Ballard
NuShores Biosciences LLC, United States
Keywords: spinal fusion, bone filler, bone regenerationSpinal fusion is the surgical standard for treating arthritic back pain, stabilizing the vertebral column after trauma, and correcting spinal deformities. Low back pain costs billions annually and nearly half a million spinal fusion surgeries are performed per year in US. Unfortunately, spinal fusion treatment has a 10-40% failure/non-union rate. Clearly, new treatment options are needed. NuShores Biosciences LLC has recently demonstrated that NuCress™ scaffolds hold promise as a new standard for spine fusion. In a recent NuShores-funded GLP study of posterolateral fusion in rabbit vertebrae the scaffold’s flexibility to shape for placement as a graft was compared to a leading bone graft substitute chronOS® by implanting at decorticated lateral processes of L4-L5 vertebrae. The study demonstrated that NuCress™ scaffold shows early bone formation within 6 weeks; at 12 weeks it appears to be a safe and superior implant for posterolateral lumbar spinal fusion – we compare our devices to the predicate through morphological assessment, radiographs, micro-CT, and histomorphometry analyses.