Xtant™ Medical Announces the FDA Clearance for the Posterior Cervical Screw Indication on Certex® Spinal Fixation System
BELGRADE, Mont., May 12, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced FDA clearance for the posterior cervical screw indication on the Certex® Spinal Fixation System. The cleared indication for the posterior cervical screw expands the use of the Certex® screws into the posterior cervical spine. The Certex® Spinal Fixation System can be linked to the Fortex® Pedicle Screw System and the Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
“This extended use of Certex® screws in the cervical spine enhances stability for posterior cervical procedures allowing an opportunity to increase fixation options to promote fusion,” states Dr. David Kirschman, Executive Vice President and Chief Scientific Officer.
The Certex® Spinal Fixation System is also intended to assist in restoring the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is medically determined to be of insufficient duration to permit achievement of fusion.
The U.S. posterior cervical fixation market is approximately $408M in 2016, according to Millennium Research Group. Certex is indicated for implantation using a posterior approach at the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3).
About Xtant Medical Holdings
Xtant Medical Holdings, Inc. (NSYE MKT:XTNT) develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
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