RegulatorySpine

Artoss, Inc. Announces FDA Clearance of NanoBone® SBX Putty for Standalone Use in Posterolateral Spinal Fusion

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.

For further information, please contact:

Artoss, Inc.

425 E Saint Germain St., Suite 106

Saint Cloud, MN 56304

PH: 320-259-4321

info@artossinc.com

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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