Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., announced the first clinical use of Alphatec NEXoss, a next generation synthetic bone graft indicated for use in posterolateral spine fusions in conjunction with bone marrow aspirate, autograft bone and appropriate hardware.
Trial for NEXoss, Synthetic Bone Graft
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NEXoss is composed of two patented technologies. One is an engineered extracellular collagen bioscaffold that provides a physical structure for cell infiltration and attachment. The other is osteoconductive nano-structured bone crystals that have similar composition, structure and size as human bone. These two technologies function together to provide an environment for a natural bone growth solution.
Alphatec NEXoss is supported by in vitro and in vivo clinical data. Alphatec acquired the exclusive U.S. distribution rights to market Alphatec NEXoss under its own brand name. The product has been FDA-cleared for commercial sale.
Joseph Stern, M.D., a neurosurgeon in private practice in Greensboro, North Carolina, performed the three-level posterior lumbar fusion procedure. He treated the patient for progressive worsening of spondylolisthesis of L3-4 and L5-S1 with spinal stenosis and degenerative changes at L3-4, L4-5, and L5-S1 levels.
Stern said that he chose Alphatec NEXoss as the fusion graft material based on the proven safety and effectiveness of the product technology. “I am very pleased with the excellent handling properties of Alphatec NEXoss, ” he said. “The mixing and delivery system has been designed with the surgeon in mind and provides a very easy and effective way to deliver the graft both in open and MIS cases.”
Les Cross, Alphatec Spine’s chairman and chief executive officer, said in the September 18 press releas, “Alphatec NEXoss is an important addition that strengthens our biologics portfolio with a synthetic bone matrix offering. What makes NEXoss effective is that its patented structure is nearly identical in composition to natural human bone.”
Alphatec Spine’s management estimates the spinal orthobiologics market to be approximately $2 billion annually in the U.S. They believe that synthetics are one of the fastest growing areas in the spinal orthobiologics space and management expects it to grow at a compound annual growth rate of approximately 10% over the next five years.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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