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Press Release

Xtant Medical Announces First Surgical Cases of Xspan™ Laminoplasty Fixation System


Posted on: 14 Nov 16

BELGRADE, Mont., Nov. 14, 2016 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the first surgical cases of the Xspan Laminoplasty Fixation System.

The first two cases were performed by Dr. Francisco Vaz-Guimaraes at the Michael E. DeBakey VA Medical Center in Houston. The open door laminoplasty procedure was performed to treat spinal stenosis without fusing the vertebrae. "The Xspan system is easy to put in, final construct was rock solid. Both patients were discharged shortly after the procedure," stated Dr. Vaz-Guimaraes. Dr. Vaz-Guimaraes is a Neurosurgeon and faculty member at Baylor College of Medicine, and contracted with the Michael E. DeBakey VA Medical Center in Houston.

Dr. Fuentes and Dr. Ehni, both of the VA Medical Center in Houston, advised from concept to final implant, ensuring Xspan was designed utilizing the expertise of surgeons who routinely perform laminoplasty procedures with the expertise of Xtant Medical engineers. "The Xspan Laminoplasty System has been designed to make the open door laminoplasty technique safer, more adaptable to spondylotic variations in the dorsal element anatomy, and simpler to perform," said Dr. Ehni.

Dr. David Kirschman, developer of Xspan and member of the Xtant Medical Board of Directors, states, "The Xspan system is a comprehensive set of implants and instruments to perform the cervical laminoplasty procedure. This procedure allows for direct decompression of the cervical spine, with minimum disruption to patient anatomy. This system is emblematic of Xtant's vision to maximize outcomes while minimizing patient impact."

The Xspan 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 and often is performed in conjunction with spinal fusion, laminoplasty involves only an opening or window 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 for an expansion of the spinal canal without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.

Xtant Medical estimates the worldwide market for laminoplasty at $128M and growing. Xspan is currently available to a limited number of key surgeons with a larger general release to follow later in 2017.

About Xtant Medical Holdings

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical 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 Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

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. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading "Risk Factors." You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

GlobeNewswire
globenewswire.com

Last updated on: 14/11/2016

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