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 releases of its PLIF
IdentiTi-PS Porous Titanium Interbody Implant System for Posterior
Lumbar Interbody Fusion Procedures (PLIFs) and its AlphaGRAFT
Demineralized Bone Matrix (DBM) Fiber.
“These new product launches are a direct
reflection of the unmatched spine expertise we have amassed at
ATEC,” said Pat Miles, Chairman and Chief Executive Officer. “Our
teams are rapidly architecting technology that improves surgical
outcomes. The ATEC innovation machine will launch 12 new products
in 2019, including these offerings – an exceptional number by any
industry standard.”
IdentiTi-PS Porous Titanium Interbody
Implant System
The launch of the IdentiTi-PS Interbody Implant
System follows successful alpha evaluations that began in June
2018. It marks the second 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 performance that is superior 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.
“The IdentiTi-PS implant represents the next
evolution in porous titanium interbody implants,” added David G.
Schwartz, MD, MBA, of OrthoIndy and Indiana University School of
Medicine. “IdentiTi implants have a porosity and stiffness similar
to bone, properties conducive to new bone growth, with minimal
imaging scatter across all radiographic modalities.”
“Achieving sagittal balance from a posterior
approach can be challenging with most traditional implant options,”
commented David S. Jones, MD, of Carolina Neurosurgery and Spine
Associates. “IdentiTi-PS implants were designed to insert the
implant on its side and then rotate up, which is a powerful
lordosis-inducing maneuver with 15- and 20-degree implant
options.”
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), which enhances intraoperative and
postoperative imaging;
- Stiffness similar to bone;
- Subtractive manufacturing process, creating consistent and
reproducible interconnected pore sizes, which leads to predictable
performance across the IdentiTi family of implants; and
- Intuitive, low profile, and exacting instruments designed to
optimize the surgeon experience and facilitate outstanding patient
outcomes.
AlphaGRAFT DBM Fiber
Technology
Demineralized Bone Matrix (“DBM”) is a standard
in the market for bone graft substitutes, or “biologics” products,
which are used as an alternative to the patient’s own bone
(autograft) in spine fusion procedures. ATEC designed AlphaGRAFT
DBM Fiber to combine the regenerative capacity of interconnected
fibers with the maximum availability of growth factors endogenous
to bone. Composed entirely of demineralized fibers, AlphaGRAFT DBM
offers a unique, moldable allograft with cohesive handling
characteristics and an osteoconductive scaffold for the delivery of
autologous stem cells.
“The AlphaGRAFT DBM Fiber is my new go-to biologic for all my
MIS interbody fusions. There is no required defrost or decanting
time, it is easily rehydrated with local blood, bone marrow or
venous drawn blood, and if I need more, we just peel open another
package,” remarked Ray Oshtory, MD, of Pacific Heights Spine Center
in San Francisco, California. “In the past, I was wary of letting
the scrub tech prepare the biologic as I wanted to make sure I
liked the mixture of chips, putty, cellular, etc.; but with the
fibers, they are so easily moldable and cohesive, I can prepare the
endplates while the scrub tech prepares the biologic and implant,
saving time and frustration. I feel more confident in the fusion
because the demineralization exposes osteoinductive growth factors
within the osteoconductive fiber network.”
Key Features of AlphaGRAFT DBM Fiber
Technology
- Optimized handling, enabling combination with allograft or
autograft for use in spinal fusion procedures;
- Engineering that enhances regenerative capacity compared to
particulate DBM;
- 100% demineralized fibers, to expose innate osteoinductive
growth factors;
- Delivery of osteogenic cells, when hydrated with the patient’s
bone marrow aspirate; and
- Proven regenerative capacity, exhibiting all five elements of
new bone formation in validated animal models.
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
Photos accompanying this announcement are available
at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/09247341-40a9-4224-bd5e-500ec4ff756f
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