Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications
August 09 2017 - 7:30AM
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 Calix-C family of
cervical interbody cages. The clearance provides for the
addition of two larger footprints and importantly, for use with
allograft. This clearance strengthens Xtant Medical’s focus
in regenerative technologies, providing a more comprehensive.
integrated cervical treatment option for surgeons and their
patients.
In Xtant’s continued effort to combine our hardware and
biologics products to provide total solutions for our customers,
the Calix-C indication now includes use with allograft comprised of
cancellous and/or corticocancellous bone graft in addition to the
current use with autograft. Xtant Medical’s 3Demin and
patented OsteoSponge technology are ideal allografts to use with
Calix-C due to their ability to compress, fill and expand within
the interbody's graft chamber, allowing for ideal bone contact with
the vertebral plates and fusion. OsteoVive, a cellular allograft,
can also be used in conjunction with Calix-C. The additional,
larger footprints of Calix-C are designed for increased stability
against the vertebral endplates, and allow for a larger lumen for
bone graft, making it a better surgical option for a greater number
of patients. The addition of the allograft indication and the
larger sizes will all be available in PEEK and Titanium plasma
coated PEEK.
"This new FDA clearance allows Xtant Medical to leverage the
clinical effectiveness of our established allograft product
offerings for use with our now expanded line of interbody devices
in cervical discectomy and fusion procedures" stated Dr. Gregory
Juda, CSO and GM of Xtant Medical. "We expect that the use of these
products as a combined spinal fusion solution will result in
positive patient outcomes."
The Calix‐C™ Cervical Interbody Spacer is intended for spinal
fusion procedures at one level (C2 – T1 inclusive) in skeletally
mature patients and is intended to be used with supplemental spinal
fixation systems such as Xtant Medical’s Spider Cervical Plating
and Certex Spinal Fixation Systems.
Xtant Medical estimates the worldwide market for cervical fusion
devices at $1.3B and growing. The worldwide market for
Demineralized Bone Matrix (DBM) is estimated at $485M. The Company
has initiated collaborative marketing efforts for the current
Calix-C offering with the surgeon's preferred Xtant Medical
allograft, and is preparing for the alpha launch of the new Calix-C
sizes later this year.
About Xtant Medical
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.
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Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital
Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com