Alphatec Spine Receives 510(k) Clearance for Its Solus(TM) Anterior Lumbar Interbody Fusion System
04 April 2011 - 3:10PM
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of
Alphatec Spine, Inc., a medical device company that designs,
develops, manufactures and markets products for the surgical
treatment of spine disorders, with a focus on treating conditions
related to the aging spine, announced today that the Company has
received 510(k) clearance from the FDA for its Solus Anterior
Lumbar Interbody Fusion (ALIF) system.
The Solus ALIF device features an integrated fixation method
based on intellectual property previously acquired by the Company.
The patented fixation technology allows for enhanced segmental
stability with a simplified surgical technique, while providing for
substantial spacing to add bone graft.
"We are extremely pleased to announce that the Solus ALIF system
is available for commercial release within the United States," said
Dirk Kuyper, the Company's President and CEO. "Our exhaustive
pre-clinical biomechanical testing demonstrates excellent product
performance when compared to the devices currently available for
sale." Mr. Kuyper also said, "We are excited to immediately
commence our controlled launch strategy, with a full commercial
release in the second half of 2011. In order to optimize the
success of this revolutionary product, the controlled launch will
be a tiered release, with an emphasis on both clinician and sales
training."
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec
Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device
company that designs, develops, manufactures and markets products
for the surgical treatment of spine disorders, primarily focused on
the aging spine. The Company's mission is to combine
world-class customer service with innovative, surgeon-driven design
that will help improve the aging patient's quality of
life. The Company is poised to achieve its goal through new
solutions for patients with osteoporosis, stenosis and other aging
spine deformities, improved minimally invasive products and
techniques and integrated biologics solutions. In addition to
its U.S. operations, the Company also markets its products in over
50 international markets through its subsidiary, Scient'x S.A., via
a direct salesforce in France, Italy and the United Kingdom and via
independent distributors in the rest of Europe, the Middle East and
Africa, South America and Latin America. In Asia and
Australia, the Company markets its products through its subsidiary,
Alphatec Pacific, Inc., and through Scient'x's distributors in
China, Korea and Australia.
The Alphatec Holdings, Inc. logo is available
at http://www.globenewswire.com/newsroom/prs/?pkgid=3520 |
Forward Looking Statements
This press release may contain "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. These forward-looking statements include, but are not
limited to: Alphatec Spine's ability to accelerate new product
momentum, bring to market differentiated products and commercialize
its product pipeline. Alphatec Spine cautions investors that there
can be no assurance that actual results or business conditions will
not differ materially from those projected or suggested in such
forward-looking statements as a result of various factors,
including, but not limited to, the following: Alphatec Spine's
ability to meet its financial guidance, the growth rate of the
spine market related to aging and elderly patients, uncertainty of
success in developing new products or products currently in
Alphatec Spine's pipeline, including the Solus system, and those
products that are intended to treat disorders prevalent in aging
patients, failure to achieve acceptance of Alphatec Spine's
products, including the Solus system, by the surgeon community,
failure to obtain or maintain FDA clearance or approval for new
products, or unexpected or prolonged delays in the process,
including without limitation the Solus system, Alphatec Spine's
ability to develop and expand its business in the United States,
Asia and Europe , continuation of favorable third party payor
reimbursement for procedures performed using Alphatec Spine's
products, unanticipated expenses or liabilities or other adverse
events affecting cash flow or Alphatec Spine's ability to
successfully control its costs or achieve profitability,
uncertainty of additional funding, Alphatec Spine's ability to
compete with other competing products and with emerging new
technologies, product liability exposure, patent infringement
claims and claims related to Alphatec Spine's intellectual
property. Please refer to the risks detailed from time to time in
Alphatec Spine's SEC reports, including quarterly reports on Form
10-Q, reports on Form 8-K and annual reports on Form 10-K. Alphatec
Spine 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.
CONTACT: Michael O'Neill
Chief Financial Officer
Alphatec Spine, Inc.
(760) 494-6746
investorrelations@alphatecspine.com
Westwicke Partners
Lynn C. Pieper
(415) 202-5678
lynn.pieper@westwicke.com
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