Initiates European Commercial Training Program of Alphatec Spine’s OsseoFix Fracture Reduction System for Treating Vertebra...
17 Dezember 2008 - 2:30PM
Business Wire
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 on Friday,
December 12, 2008, the Company held its first medical training for
commercial use in Vienna, Austria for the OsseoFix� Spinal Fracture
Reduction System, the Company�s innovative product for the
treatment of vertebral compression fractures. Over 30 participants
including physicians and selected distributors were in attendance
at the University of Vienna in Austria where they received hands-on
cadaver lab training on the safe and effective use of the OsseoFix
system. These physicians and distributors represented several
countries in Europe, including The Benelux, Denmark, Greece, Italy,
and Turkey. �The strong participation and positive feedback
received is a great indicator of the interest level for this novel
technology for treating vertebral compression fractures,� said Dirk
Kuyper, Alphatec Spine�s President and Chief Executive Officer.
�These medical training sessions, which will be held regularly,
will provide the foundation to accelerate the commercial use of
OsseoFix in leading spine surgery centers in Europe. We are also
pleased to see that our European distributors are excited about the
market opportunity and are currently placing orders for the
OsseoFix system.� In October 2008, the Company received a European
CE Mark for the OsseoFix Spinal Fracture Reduction System, which
allows the Company to market the OsseoFix system in the European
Union for treatment of spinal compression fractures. The Company
continues the expansion of sales in Europe with both current and
new distribution partners for its core line of spinal products.
OsseoFix is not yet approved for sale in the United States and is
currently under 510(k) review with the U.S. Food and Drug
Administration (FDA). About Vertebral Compression Fractures and the
OsseoFix Spinal Fracture Reduction System According to the National
Osteoporosis Foundation there were 700,000 osteoporotic vertebral
compression fractures in the U.S., of which only one-third are
estimated to be diagnosed. Common causes of vertebral compression
fractures include osteoporosis, trauma, or a pre-existing disease
at the fracture site. Currently, the two most common procedures
used to treat vertebral compression fractures are kyphoplasty and
vertebroplasty. A kyphoplasty procedure involves injecting a
balloon through a catheter into the damaged vertebra, inflating the
balloon to restore height, and reinforcing the resultant space made
by the balloon with bone cement. A vertebroplasty procedure
involves injecting bone cement directly into the compressed
vertebral body under high pressure, with the goal of stabilizing
the fracture. Alphatec Spine designed and developed OsseoFix to
expand the market for surgical solutions for vertebral compression
fractures, with what it believes to be an improvement over the most
common procedures being used today. OsseoFix is designed to allow
for improved fracture reduction and designed to use less cement
during a surgical procedure, both of which Alphatec believes
reduces the risk of cement extravasation, reduces surgical
complications and increases clinical efficacy. 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 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 spine products in Europe. In Asia, the Company markets
a broad line of spine and orthopedic products through its
subsidiary, Alphatec Pacific, Inc. For more information, please
visit www.alphatecspine.com. 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. The Company 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 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. 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 revenue
projections, 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 those products that are intended to treat disorders
prevalent in aging patients, including the OsseoFix, failure to
achieve acceptance of Alphatec Spine's products, including the
OsseoFix, by the surgeon community, failure to obtain FDA clearance
or approval for new products, including the OsseoFix, or unexpected
or prolonged delays in the process, 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.
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