Alphatec Spine Announces Four New Product Launches in the MIS, Biologics and Thoracolumbar Market Segments at the North American
06 Oktober 2010 - 1:06AM
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, today announced that the Company has
received CE Mark approval for commercial sale in the European Union
and other jurisdictions for its HeliFix Interspinous Spacer System
and Solus ALIF System. The receipt of the CE Mark allows Alphatec
Spine to begin selling HeliFix and Solus implants in the European
Union and certain other jurisdictions that recognize the CE Mark
for commercial approval.
The HeliFix Interspinous Spacer System is a minimally invasive
non-fusion solution for lumbar spinal stenosis (LSS). Lumbar Spinal
Stenosis is a degenerative condition that affects the aging
population worldwide. It is estimated that nearly 600 million
people aged 60 years or older are diagnosed with LSS. The 2009
market size in Europe for interspinous devices was approximately
$50 million with estimated growth of 12%. The HeliFix implant
acts as an extension blocker at the affected vertebral levels and
relieves symptoms associated with LSS. The HeliFix System is
an innovative concept that features an implant with a
self-distracting helical tip. HeliFix is not available for sale in
the U.S.
The Solus ALIF System is a zero-profile, single-action locking
implant that is used in anterior lumbar interbody fusion (ALIF)
procedures. Unlike other products that are currently on the
market, which require screws or complicated locking mechanisms, the
Solus implant can be secured into position in a single
step. This single-step mechanism is a significant improvement
over similar devices. The 2009 market size for anterior
degenerative thoracolumbar fixation in Europe was approximately $45
million. The Solus ALIF System is under FDA review for 510(k)
clearance and is currently not available for sale in the U.S.
Additionally, Alphatec Spine announces two new product releases
in the U.S. market, the Aspida™ Anterior Lumbar Plating System and
the PureGen™ Osteoprogenitor Cell Allograft. The ASPIDA System
has a 510(k) clearance and features a slim profile, a single-action
self-locking mechanism and a dual-lead threaded screw, all of which
are designed to minimize the disruption of tissue near the implant
and reduce operating time for the surgeon. PureGen, the
release of which was announced earlier this week, is a highly
concentrated, pure population of adult stem cells that originates
in bone marrow and is collected from live, healthy donors for
optimal cell functionality. Unlike stem cell products that are
currently commercially available, which have an unknown population
of mesenchymal stem cells (MSCs) and are harvested from cadaveric
donor tissue, PureGen delivers a similar potency of pure adult MSCs
without the need for cultural expansion. PureGen is the first
pure adult stem cell to be released in the spinal market.
The HeliFix Interspinous Spacer System, Solus ALIF System,
Aspida Anterior Plating System and PureGen Osteprogenitor Cell
Allograft will be on display at the North American Spine Society
(NASS) Annual Meeting, which is being held from October 6th through
October 9th in Orlando, Florida.
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 sales force 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.
Also visit the Aging Spine Center, www.agingspinecenter.com, a
web-based information portal for healthcare providers and patients
regarding aging spine disorders and their treatment. Alphatec
Spine is working with the National Osteoporosis Foundation as well
as other clinical portals that provide peer-reviewed content, to
populate the Aging Spine Center. The interactive website will
enable patients to review pertinent information about all the key
disorders that affect the aging spine in an easy-to-understand
format that includes videos, graphics and questions that should be
asked of caregivers. Medical information will include published
abstracts regarding the aging spine.
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 Alphatec Spine's HeliFix,
Solus, ASPIDA and PureGen products, and those products that are
intended to treat disorders prevalent in aging patients, failure to
achieve acceptance of Alphatec Spine's products, including HeliFix,
Solus, ASPIDA and PureGen products, by the surgeon community,
failure to obtain FDA clearance or approval for new products, or
unexpected or prolonged delays in the process, including without
limitation HeliFix, Solus, ASPIDA and PureGen products, 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: Alphatec Spine, Inc.
Peter C. Wulff, Chief Financial Officer
(760) 494-6746
investorrelations@alphatecspine.com
Westwicke Partners
Lynn C. Pieper
(415) 202-5678
lynn.pieper@westwicke.com
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