Xtant Medical and Pinnacle Spine Group Announce Distribution Agreement, Expanding the Availability of Innovative InFill® Lateral Fusion System
BELGRADE, Mont. and DALLAS, June 08, 2016 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices and Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions, today announced a joint agreement to expand distribution of Pinnacle's InFill® Lateral Lumbar Interbody Fusion System. Through this agreement, Xtant enters the lateral lumbar interbody fusion market, expanding its spinal hardware portfolio.
The foundation of Pinnacle Spine Group's complete InFill fusion systems is its patented ability to deliver bone graft material to the fusion device in situ. The unique features of the InFill Lateral Fusion device combined with the InFill Graft Delivery System provide the opportunity for a more robust fusion column and maximized bone graft-to-endplate contact. The InFill Lateral Lumbar Interbody Fusion system is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1.
"We are excited to partner with Xtant Medical, a recognized industry leader, to bring new and innovative solutions to spine surgeons," said Zach Sowell, President of Pinnacle Spine Group. "Our patented innovative technology offers a terrific platform for Xtant and Pinnacle to grow their core competencies and expand their scope in the spinal fusion segment."
"It is a very exciting time for Xtant Medical as we continue to broaden our portfolio. This system will allow Xtant Medical to meet the needs of orthopedic and neuro spine surgeons who currently practice minimally invasive spine surgery or looking to expand their procedural options," stated Dr. David Kirschman, Executive Vice President and Chief Scientific Officer.
According to iData Research, it is estimated that the US market for lateral lumber interbody fusion in 2015 was nearly $254M and is expected to be close to $309M in 2020.
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.
About Pinnacle Spine Group, LLC
Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff. Backed by the pioneering private equity firm Sowell & Co., Pinnacle is dedicated to developing advanced technologies that offer greater opportunities for positive patient outcomes. The team applies innovative thinking to deliver implants and instrumentation that simplify and enhance the surgical procedure.
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.