April 24, 2019
Artoss, Inc. is pleased to announce that the US Food & Drug Administration has cleared NanoBone SBX Putty for standalone use in posterolateral spinal fusion. NanoBone was tested alone (without addition of autograft or bone marrow aspirate) in the ASTM International standardized animal model and found to be equivalent to the “gold standard” autograft in fusion rate.
James J. Cassidy, Ph.D., Managing Director of Artoss, Inc., the exclusive North American distributors for NanoBone in orthopaedic surgery, said, “The ASTM standard animal model for lumbar intertransverse process spinal fusion is a very challenging model designed to replicate clinically relevant fusion rates for iliac crest autograft in the posterolateral spine. A majority of bone void fillers must be mixed with autograft in order to achieve equivalent fusion rates to autograft alone. We’re pleased to offer surgeons a synthetic alternative to autograft that does not require mixing with autograft or bone marrow. Using a synthetic bone void filler alone offers significant cost savings to hospitals. NanoBone stands alone.”
“NanoBone Bone Graft used as a standalone in posterolateral spinal fusion represents a significant advancement in patient care.” said J. Eric Gee, M.D. “Eliminating the need to mix synthetic graft with autograft or to harvest and concentrate bone marrow aspirate will save time and money as well as streamline operating room procedures.”
NanoBone Bone Graft products have been used in Europe and the US for more than ten years in more than 100,000 clinical cases across all indications. They have been available in the United States through Artoss, Inc. since 2015.
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