Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A

Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A

BELGRADE, Mont., Sep. 12, 2017 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader

in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration

(FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three

additional size configurations for an expanded market opportunity, and importantly, for use with allograft. This clearance

is the second received during this quarter, and continues to strengthen Xtant Medical's focus in providing a more comprehensive

portfolio focused on regenerative care for the patient.

Xtant Medical's Irix-A is a standalone interbody device used in anterior lumber interbody fusions. The

current product line offers a Titanium and PEEK composite implant, with the additional option of a titanium plasma coating for

improved osseointegration with the spinal endplate, all with 8 or 12 of lordosis for alignment with the curvature of

the spine. This new 510k clearance adds three additional degrees of lordosis, specifically 16 , 20 , and 24 ,

providing the surgeon with a wider variety of choices to correct the patient's loss of lordosis and to improve sagittal balance.

The FDA clearance also expands the indications of use to include use with allograft, such as Xtant Medical's patented OsteoSponge,

proprietary 3Demin, or OsteoVive viable cell allograft.

"The clearance of the additional footprints, including hyperlordotic options, further enhances our lumbar

product portfolio in response to our customer's needs' said Gregory Juda, Chief Scientific Officer. "We continue to

execute on our focus of combining our hardware and biologics technologies, strengthening our position as a comprehensive supplier

for spine surgeons and their patients."

The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer

PEEK ring and three screws. It is intended for anterior spinal fusion procedures at one or two contiguous levels of the lumbosacral

spine (L2-S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.

Xtant Medical estimates the US market for standalone anterior lumbar interbody fusion market to be approximately

$230 million and growing. The US market for Demineralized Bone Matrix (DBM) is estimated at $410M. The additional Irix-A

interbody implants are intended to be available to customers later this year.

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading 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.

Important Cautions Regarding Forward-looking

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 comply

with covenants in the Company's senior credit facility and to make deferred interest payments; the ability to maintain sufficient

liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms;

the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund

operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to

innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified

technical personnel and members of the Company's management team; the availability of Company facilities; government and

third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully

integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset

future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax

purposes; the ability to service Company debt; 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 remain accredited with the American Association

of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other

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." 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.

Medical Holdings, Inc.