Alphatec Announces Commercial Launch of its First IdentiTi™ Porous Titanium Interbody System
28 Mars 2019 - 2:00PM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a
medical device company dedicated to revolutionizing the approach to
spine surgery, announced today the commercial release of its new
IdentiTi-C Porous Titanium Interbody Implant System for Anterior
Cervical Discectomy and Fusion (ACDF).
The launch of the IdentiTi-C Interbody Implant
System follows successful alpha evaluations that began in August
2018. It marks the first of six IdentiTi implant systems the
Company expects to commercially introduce in 2019.
The IdentiTi line of implant systems, with
enhanced imaging characteristics and porosity, are expected to
provide superior performance to competitive titanium implant
offerings. The IdentiTi line of implants will not only complement
the Company’s current suite of PEEK implants, but will also allow
ATEC to address the broader market of surgeons who prefer
titanium.
“With the release of its cervical IdentiTi
porous titanium interbody cage, ATEC has ushered in a new age of
excellence in cervical spine surgery,” Paul Sawin, MD, of Orlando
Neurosurgery commented. “Surgeons have had to compromise between
biology and mechanics with previous implant choices. ATEC’s
IdentiTi porous titanium has an architecture that is conducive to
new bone growth and a structural consistency that lends
predictability to its mechanical behavior. Also, because it is 60%
porous (or comprised of 60% air), the stiffness is similar to the
surrounding bone, and the imaging characteristics with x-ray, CT,
and MRI are excellent.”
“I commend the teams that collaborated to
successfully launch this innovative technology ahead of
schedule,” said Pat Miles, Chairman and Chief Executive
Officer. “The IdentiTi-C Interbody Implant System significantly
increases the sophistication of ATEC’s ACDF approach with
meaningfully differentiated technology that improves surgical
outcomes. This launch is only the beginning of the innovation
we intend to deliver in 2019, a strong demonstration of our
commitment to create value with clinical distinction.”
About the IdentiTi Porous Titanium
Interbody Systems ATEC’s IdentiTi Porous Ti Interbody
Systems offer implant options that take advantage of bone’s
affinity for titanium. Because of their porosity, IdentiTi implants
have a surface roughness that enhances stability. The
implants are also designed to provide the biological,
biomechanical, and imaging characteristics that surgeons seek in a
fusion construct.
Key features include:
- Consistent, fully interconnected porosity throughout the
implant, designed to mimic the structure and porosity of cancellous
bone;
- Pore structure (resulting in surface roughness) and an
architecture that enables both immediate and long-term
stability;
- Reduced density (60% porous), allowing enhanced intraoperative
and postoperative imaging;
- Stiffness similar to bone;
- Predictable performance associated with the subtractive
manufacturing process, creating a porous titanium material with
consistent and reproducible interconnected pore sizes; and
- Instrumentation that is intuitive, low profile, and exacting,
to optimize the surgeon experience and facilitate outstanding
patient outcomes.
About Alphatec Holdings,
Inc.Alphatec Holdings, Inc., through its wholly-owned
subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a
medical device company dedicated to revolutionizing the approach to
spine surgery. ATEC designs, develops and markets spinal
fusion technology products and solutions for the treatment of
spinal disorders associated with disease and degeneration,
congenital deformities and trauma. The Company markets its products
in the U.S. via independent sales agents and a direct sales force.
Additional information can be found at
www.atecspine.com.Forward Looking Statements This
press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainty. Such statements are based on
management's current expectations and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
The Company cautions investors that there can be no assurance that
actual results will not differ materially from those projected or
suggested in such forward-looking statements as a result of various
factors. Forward-looking statements include references to the
Company’s planned commercial launches, product introductions and
product integration, surgeon and market acceptance of Company
products, solutions and platforms, and the Company’s ability to
deliver key product features. The important factors that could
cause actual operating results to differ significantly from those
expressed or implied by such forward-looking statements include,
but are not limited to: the uncertainty of success in developing
new products or products currently in the Company’s pipeline;
failure to achieve acceptance of the Company’s products by the
surgeon community; failure to obtain FDA or other
regulatory clearance or approval for new products, or unexpected or
prolonged delays in the process; continuation of favorable third
party reimbursement for procedures performed using the Company’s
products; the Company’s ability to compete with other products and
with emerging new technologies; product liability exposure; patent
infringement claims; and claims related to the Company’s
intellectual property. The words “believe,” “will,” “should,”
“expect,” “intend,” “estimate,” “look forward” and “anticipate,”
variations of such words and similar expressions identify
forward-looking statements, but their absence does not mean that a
statement is not a forward-looking statement. A further list
and description of these and other factors, risks and uncertainties
can be found in the Company's most recent annual report, and any
subsequent quarterly and current reports, filed with
the Securities and Exchange Commission. ATEC disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, unless required by law.
Investor/Media Contact:
Tina JacobsenInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:
Jeff BlackChief Financial OfficerAlphatec
Holdings, Inc. ir@atecspine.com
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/796c523e-cd67-4229-9ba1-55469bcf16e4.
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