Xtant Medical Holdings (XTNT) Granted FDA Clearance for the Xsert Lumbar Expandable Interbody System

November 23, 2016 7:32 AM EST
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Xtant Medical Holdings, Inc. (NYSE: XTNT) announced that the U.S. Food and Drug Administration (FDA) has cleared the Xsert Lumbar Expandable Interbody System.

The Xsert System is an all titanium expandable interbody device that expands in-situ. It is available in various sizes and lordotic angulations to fit the most complex anatomical needs of patients. These spacers are designed to simplify surgeon insertion technique[s] while offering implant height adjustability. Osteointegration will be encouraged through nanotextured endplate surfaces as well as central and lateral implant graft windows. The system is intended for use at one or two contiguous levels (L2-S1 inclusive).

Xsert is also cleared to be packed with autograft or allograft bone graft. Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Xsert due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.

"We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy," stated Dr. David Kirschman, developer of Xsert and current member of the Xtant Medical Board of Directors. "With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients."

Xtant Medical estimates the U.S market for lumbar interbody devices at $1.3M and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Xsert will be available in an initial product release in mid 2017.



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