Alphatec Announces Commercial Launch of TLIF IdentiTi™ Posterior Curved Porous Titanium Interbody Implant System
May 30 2019 - 9:00AM
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
IdentiTi-PC Porous Titanium Interbody Implant System for
Transforaminal Lumbar Interbody Fusion Procedures (TLIF).
“The commercial launch of IdentiTi-PC
demonstrates continued solid progress against our commitment to
accelerate growth by compelling the spine market and engaging
surgeons with clinical distinction,” said Pat Miles, Chairman and
Chief Executive Officer. “This marks the fourth of twelve new
product launches planned for 2019, an extraordinary level of
development by any measure. We have built the spine market’s
new organic innovation machine.”
TLIF IdentiTi-PC Porous Titanium
Interbody Implant System
The launch of the IdentiTi-PC Interbody Implant
System follows successful alpha evaluations that began in August
2018. It marks the third of six IdentiTi implant systems the
Company expects to commercially introduce in 2019.
The IdentiTi line of implant systems are
manufactured using a subtractive process, which begets more
predictable, proprietary porosity and results in enhanced imaging
characteristics. The implants are expected to perform better
than 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.
“The IdentiTi-PC proprietary pore structure is similar to that
of cancellous bone. The porosity creates a roughness that improves
initial stability through surface adhesion and facilitates bone
apposition,” remarked Geoffrey Cronen, MD, of Florida Medical
Clinic Orthopaedic Surgery. “ATEC’s product development machine has
surpassed all expectations with its speed to market while holding
the highest standards. It has been remarkable to
observe.”
Key Features of 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;
- Proprietary pore structure designed to create surface roughness
that enhances immediate implant stability and facilitates surface
adhesion;
- Reduced density (60% porous) enhances intraoperative and
postoperative imaging;
- Stiffness similar to bone;
- Subtractive manufacturing process creates a consistent porous
titanium material that furthers product performance predictability
with consistent and reproducible interconnected pore sizes across
the IdentiTi family of implants; and
- Intuitive, low profile, and exacting instruments designed 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
https://www.globenewswire.com/NewsRoom/AttachmentNg/0376c9aa-425e-4f9e-9293-12cf56fcc41b
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