XTNT HUGE FDA News Xtant Medical Announces FDA Clearance of the Xspan(TM) Laminoplasty Fixation System
7:30 AM ET 3/30/16 | GlobeNewswire
Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, X-spine Systems, received FDA clearance of the Xspan(TM) Laminoplasty Fixation System.
About the Xspan(TM) Laminoplasty Fixation System
The Xspan(TM) System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord. Unlike a laminectomy, where the entire lamina is removed, only an opening or window is made on one side of the lamina to alleviate the compression of the spinal cord. The lamina is then restructured by a small plate which allows the spinal canal to increase in size without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.
The Xspan(TM) Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3). "We are very pleased to have received clearance for Xspan," stated Dr. David Kirschman, CSO, EVP, and Director of Xtant Medical. "This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners."
Xtant Medical estimates the world wide market for laminoplasty at $110M and growing. Xspan will be available to a limited number of key surgeons in the second fiscal quarter of 2016, with a larger general release to follow later in 2016.
About Xtant Medical Holdings
Xtant Medical Holdings, Inc. (NYSE 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.
