Full Press Release Details
Xtant Medical Receives FDA
510(k) Clearance for InTice -C Porous Titanium Cervical Interbody System
BELGRADE, MT., May. 21, 2018 -- Xtant
Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development of regenerative medicine products and medical devices,
announces U.S. Food and Drug Administration (FDA) 510(k) clearance for InTice -C
Porous Titanium Cervical Interbody System.
InTice-C is designed using OsteoSync Ti,
a best-in-class, cost-effective, highly porous titanium scaffold material for improved implant fixation. The material more closely
resembles the bioscaffold of cancellous bone, and further combines Xtant Medical's hardware and biologic portfolios. In addition
to InTice-C serving as a bioactive scaffold, it is also cleared for use with Xtant's proprietary allograft lines, including
OsteoSponge , 3Demin Cortical Fibers, and OsteoVive viable cell allograft.
"InTice-C represents Xtant's latest addition to our
spinal implant portfolio and is our first spinal implant to be engineered using a best-in-class porous titanium material"
stated Dr. Gregory Juda, Chief Scientific Officer and General Manager of Xtant Medical. "The porous architecture of the titanium
was designed to improve implant fixation, both prior and post fusion. We expect a positive reception of this technology from our
surgeon customers in the cervical spine market."
The InTice-C Is designed to provide cervical intervertebral
body fusion options for each patient's varied anatomy. It is offered in multiple footprint, height and endplate options.
The commercial pure titanium structure offers continuous pore interconnectivity from the top to the bottom as well as from the
outer perimeter to the large central graft cavity of the implant. This optimizes vascularization to the fusion site allowing the
implant to be a participant in the fusion process. The implant utilizes machined endplate structures in conjunction with the inherent
texture of the porous titanium to provide migration resistance. The implant is offered in individual sterile packages. InTice-C
was developed in collaboration with Sites Medical.
InTice-C will help the Company further penetrate the $285 million
dollar cervical spine market. Xtant's other cervical interbody options include Calix -C, Calix-C PC, Atrix-C ,
and Irix -C, which offer PEEK, PEEK with a plasma-coated titanium, a structural biologic solution, and a standalone
cervical option, respectively.
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: the ability to increase revenue; the ability to achieve
expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and
retain qualified technical personnel and members of the Company's management team; influence by Company management; the security
of our technology systems; government and third-party coverage and reimbursement for Company products; the ability to obtain donors
to support the biologic portfolio; the availability of Company facilities; the ability to remain accredited with the American
Association of Tissue Banks; the ability to obtain regulatory approvals; government regulations; product liability claims and
other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability
to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property;
the ability to use net operating loss carry-forwards to offset future taxable income; the ability to service Company debt; the
ability to comply with covenants in the Company's senior credit facility; the ability to raise additional financing and other
factors. Additional risk factors are listed in the Company's Annual Report on Form 10-K for the year ended December 31, 2017 filed
with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without
limitation its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. Investors are encouraged to read the Company's
filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Investors should
not place considerable reliance on the forward-looking statements contained in this release. 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. The Company's business is subject to substantial
risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration
to these risks and uncertainties. All forward-looking statements attributable to us or persons acting on our behalf
are expressly qualified in their entirety by this cautionary statement.
Xtant Medical Holdings, Inc.