First Spine Patient For Alphatec NEXoss™ Synthetic Bone Graft Matrix

“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.”

In short

The first clinical use of Alphatec Spine’s NEXoss,™ synthetic bone graft has been announced. The material is indicated for use in posterolateral spine fusions in conjunction with bone marrow aspirate, autograft bone and appropriate hardware.

Background

Many surgical procedures of the spine require bone grafts to regenerate bone that has been removed or damaged due to disease or trauma. Synthetic grafts are increasingly challenging autologous or allograft alternatives for the perhaps obvious reasons that they avoid the harvesting procedure and some of the other potential complications associated with these solutions. Indeed the market for synthetics is fast growing and reportedly projected to maintain a 10% annual growth rate over the next five years.

Alphatec Spine, Inc. designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine. Alphatec NEXoss is composed of two unique patented technologies. The first is an engineered extracellular collagen bioscaffold that provides a physical structure for cell infiltration and attachment. The second is osteoconductive nano-structured bone crystals that have similar composition, structure and size as human bone.

These two technologies function together to provide what the company claims is an ideal environment for a natural bone growth solution. Alphatec NEXoss is supported by in vitro and in vivo clinical data.

Last month, Alphatec announced the acquisition of exclusive U.S. distribution rights to market the product under its own brand name called Alphatec NEXoss.

The case

The three-level posterior lumbar fusion procedure was performed by Joseph Stern, M.D., a neurosurgeon in private practice in Greensboro, NC. The patient was treated 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.

Dr. Stern 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,” said Dr. Stern. “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.”

Company comments

“Alphatec NEXoss is an excellent product and an important addition that strengthens our biologics portfolio with a synthetic bone matrix offering,” said Les Cross, Alphatec Spine’s Chairman and Chief Executive Officer. “What makes NEXoss effective is that its patented structure is nearly identical in composition to natural human bone.

“Having a synthetic bone graft solution enables Alphatec Spine to offer one of the most comprehensive biologics portfolios in the industry, which includes structural allografts, DBMs, scar barriers, a stem cell allograft and now synthetic bone grafts. In addition to the many internal new product development programs we have underway, this supply agreement is representative of the many opportunities available in the marketplace today that will help the Company maintain a continuous flow of new products.”

Regulatory status

Alphatec NEXoss is FDA-cleared for commercial sale.

Source: Alphatec Holdings, Inc., Globe Newswire