BELGRADE, Mont., Dec. 01, 2015 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, X-spine Systems, Inc. received FDA clearance of expanded indications to include ilium fixation as well as extended length screws for the Fortex® and the Xpress™ 2 Pedicle Screw System.
The extended length screws are compatible with X-spine’s current Fortex and Xpress instrument systems, offering a comprehensive pedicle screw portfolio. These dual lead, non-cannulated screws are indicated for use in posterior, non-cervical, T1-S2/Ilium pedicle spinal fixation. They are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumors, and failed previous fusion.
“Elevated biomechanical forces make long segment lumbosacral spine fixation challenging to perform,” states Dr. David Kirschman, Chief Scientific Officer of Xtant Medical and President of X-spine Systems. “Expanded indications into the ilium with extended implants will enhance fixation and enable surgeons to treat a wider variety of pathologies than sacral fixation alone.”
About Xtant Medical Holdings
Xtant Medical Holdings, Inc. (NYSE: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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This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.
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