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 porous
titanium line of IdentiTi™ implants for lateral interbody
fusion (LIF) procedures. The launch of the IdentiTi LIF Interbody
Implant Systems follows successful alpha evaluations that began in
January 2019. The Company has successfully commercialized all of
the six IdentiTi Implant Systems slated for release in 2019.
The Company also announced the commercial
release of the AMP™ Lateral Anti-Migration Plate, as well as
the re-design and reconfiguration of its PEEK lateral interbody
implant offering, Transcend™.
With the expected launch of SafeOp
neuromonitoring next month, in November 2019, ATEC is on track to
launch all 12 of its planned commercial launches for 2019,
executing on its commitment to accelerate growth through clinical
distinction.
“Each of these products has been purposefully
designed to improve lateral spine surgery by the team that
developed and pioneered the lateral approach years ago,” said Pat
Miles, Chairman and Chief Executive Officer. “Along with the
automated objective information that our SafeOp technology will
afford when it launches in November, we are bringing meaningful
improvement to lateral surgery outcomes. While we are proud of this
year’s accomplishments, we know we are only just beginning to
demonstrate the prowess of spine’s new Organic Innovation
Machine.”
Dr. Luiz Pimenta, ATEC’s Chief Medical Officer
and the spine surgeon widely recognized as the pioneer of the
lateral approach said, “With the release of the IdentiTi LIF
line, surgeons now have access to porous metal implants that
more precisely mimic bone architecture and function. These new
lateral solutions are representative of the sophistication ATEC is
engineering to establish new standards for spine surgery,
regardless of the surgical approach.”
The IdentiTi LIF and IdentiTi LIF-HL
Porous Titanium Interbody Implant Systems
“Preclinical studies1 have shown that
IdentiTi LIF’s porous surface provides enhanced initial stability,
conforms to the vertebral endplates, and results in bony in-growth
and osseointegration, factors critical
to improved short and long-term outcomes,” affirmed Dr.
Antoine G. Tohmeh, Director of Minimally Invasive Spine Surgery at
Multicare Neuroscience Institute in Spokane, Washington. “ATEC’s
IdentiTi LIF Implant Systems offer customizable treatment
with a myriad of footprints and lordotic options, including 0,
10, 15, 20, and 30 degree hyperlordotic
implants.”______________________1Data on file; ATEC Spine.
A photo accompanying this announcement is available
at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a1996d2f-6cef-4141-8771-8c04edc796ef
Key Features of the IdentiTi Porous
Titanium Implant Systems
ATEC’s IdentiTi Implant Systems are designed to
provide the biological, biomechanical, and imaging characteristics
that surgeons seek in a fusion construct. The subtractive process
used to manufacture each IdentiTi Implant System results in more
predictable mechanical performance and enhanced imaging
characteristics. IdentiTi implants take advantage of bone’s
affinity for titanium and, because of their porosity, have a
surface roughness that enhances stability. ATEC IdentiTi implants
not only complement the Company’s current suite of PEEK implants,
but also allow ATEC to address the broader market of surgeons who
prefer titanium.
Key features of IdentiTi Implant Systems
include:
- Subtractive manufacturing process creates a consistent porous
titanium material that mimics the structure of cancellous bone and
furthers product performance predictability with consistent and
reproducible interconnected pore sizes;
- Proprietary pore structure designed to create surface roughness
that facilitates immediate implant stability and surface
adhesion;
- Reduced density (60% porous) enhances intraoperative and
postoperative imaging;
- Stiffness similar to bone; and
- Intuitive, low profile, and exacting instruments designed to
optimize the surgeon experience and facilitate outstanding patient
outcomes.
The AMP Anti-Migration
Plate
ATEC’s AMP Lateral Anti-Migration Plate is a
modular lateral plate thoughtfully designed to embody simplicity
with a zero-step screw locking feature that provides audible,
tactile, and visible indicators of screw locking. Engineered with a
lean profile and one and two-screw plate options, AMP is capable of
unprecedented screw angulation and is fully compatible with
IdentiTi LIF, IdentiTi LIF-HL, and Transcend Lateral Interbody
Implants.
Dr. William Taylor, Professor of Neurosurgery at
UC San Diego, said, “The AMP system is the perfect solution for
when the anterior longitudinal ligament is released, whether
intentionally in an anterior column realignment, or
unintentionally. It seamlessly attaches in situ to any of ATEC’s
lateral interbody implants.”
The Transcend Lateral Interbody
Spacer
Transcend Lateral marks the first release out of
ATEC’s new PEEK interbody implant portfolio. Transcend Lateral has
been redesigned to better meet the needs of surgeons by providing
continuity in lordotic options and a more refined distal tip that
enhances insertion into the disc space. The chevron pattern on
Transcend Lateral interbody implants provides anti-migration
support for initial stability. Transcend and IdentiTi Lateral are
designed to function with the same instrumentation, enabling
surgeons to use either implant material without requiring
proprietary instrumentation.
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:
Josh BergInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:
Jeff BlackChief Financial OfficerAlphatec
Holdings, Inc. ir@atecspine.com
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