Alphatec Spine Reaches Milestone of OsseoFix Adoption
19 Juni 2009 - 2:05PM
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, as of June 1,
2009, over 115 patients in eight European countries have been
treated with the OsseoFix� Spinal Fracture Reduction System, the
Company�s innovative product for the treatment of vertebral
compression fractures. The first European training session was held
at the University of Vienna in mid-December 2008. The first
shipments of OsseoFix products into Europe occurred at the end of
December 2008.
�We are pleased with the significant surgeon adoption of
OsseoFix across Europe. Surgeons who are using the OsseoFix system
benefit from the potential to improve patient outcomes by providing
an enhanced ability for vertebral height maintenance while using
less cement as a result of the permanent titanium implant. As this
product represents our initial launch into the aging spine market,
we are particularly pleased with the manner in which the adoption
of OsseoFix appears to be accelerating. Over 60 patients were
treated in May alone,� said Dirk Kuyper, Alphatec Spine�s President
and Chief Executive Officer. Mr. Kuyper added, �Our next training
lab, which will be held in July in Vienna, is oversubscribed, with
50 surgeons and over 70 total participants already enrolled in what
will be our third training session.�
The OsseoFix system 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.
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 the OsseoFix system 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
disorders affecting 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 biologic 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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