Alphatec Spine Launches New MIS Device, the BridgePoint(TM) Spinous Process Fixation System
23 August 2012 - 12:45PM
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 it has launched
its newest Minimally Invasive Surgery (MIS) device, which is called
the BridgePoint Spinous Process Fixation System.
BridgePoint is a minimally invasive system that is designed to
enable spine surgeons to immobilize and stabilize spinal segments
without the need for pedicle screw and rod constructs. The
BridgePoint System is intended to be an adjunct to fusion of the
thoracic and lumbar spine to treat disorders resulting from
degenerative disc disease, spondylolisthesis, tumor and trauma.
"We are pleased to launch this important new product for
surgeons," said Les Cross, Alphatec Spine's Chairman and Chief
Executive Officer. "We believe BridgePoint offers unique benefits
that deliver real value to surgeons and hospitals, helping patients
who suffer chronic back pain regain their active lifestyles."
BridgePoint is designed to be implanted through a relatively
small posterior incision of approximately 5 cm in length, which
should result in less injury to muscle and tissue and less blood
loss than occurs with the implantation of traditional pedicle screw
and rod systems through a non-MIS approach. MIS procedures are
typically shorter in length, saving valuable surgeon and hospital
time and patient recovery times are typically faster and have fewer
complications.
The BridgePoint System's state-of-the-art design incorporates
telescoping plates that allow surgeons to compress or distract the
spinous processes before immobilizing the spinal segment. The
device's large contact area provides a strong anchor point to each
spinous process, facilitating compression or distraction and
optimal stability during the fusion process. BridgePoint can be
used as an adjunct to interbody fusion or posterior fusion with
decompression treatment. The large bone graft window allows
surgeons to pack additional bone graft between the spinous
processes.
BridgePoint's first implantation case was conducted in August
2012 at Cheyenne Regional Medical Center in Cheyenne, Wyoming by
Dr. Steven Beer, a board certified neurological surgeon.
"I recently had a patient with degenerative disc disease and
spinal stenosis, and BridgePoint offered a way for me to treat her
less invasively," said Dr. Beer. "BridgePoint allows me to fixate
the spine more efficiently than competitive systems and the device
makes surgery safer and faster. At the same time, it provides an
environment rich in characteristics necessary for fusion of the
spine. BridgePoint will definitely be a product I offer my
patients in the future."
The market for spinous process fixation devices is expected to
reach $206 million by 2016, growing at a compound annual growth
rate of over 24% from 2008. (Source: iData 2010)
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
products 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 affiliate, Scient'x S.A.S.,
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. In Latin America, the Company conducts its
business through its subsidiary, Cibramed Produtos Medicos. In
Japan, the Company markets its products through its subsidiary,
Alphatec Pacific, Inc. In the rest of Asia and Australia, the
Company sells its and Scient'x's products through its and
Scient'x's distributors.
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. 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.
Forward-looking statements include, with respect to the agreement
described in this press release, references to the size of the
market for spinous process fixation devices, the adoption rate of
the BridgePoint System by spinal surgeons. In addition,
forward-looking statements include the Company's ability to develop
and commercialize new products internally, and its ability to
successfully pursue and commercialize complementary acquisitions of
new products and technologies. The words "believe," "will,"
"should," "expect," "intend," "estimate" 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. 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 Alphatec Spine's pipeline; the uncertainty of success
in acquiring new products or technologies; the successful launch of
the Company's new products and the products in its development
pipeline, including the product discussed in this press release;
failure to achieve acceptance of Alphatec Spine's products by the
surgeon community; failure to successfully implement streamlining
activities to create operating cost savings; failure to
successfully begin in-house manufacturing of certain products;
failure to obtain or maintain FDA clearance or approval for
products, including the product discussed in this press release, or
unexpected or prolonged delays in the process; Alphatec Spine's
ability to develop and expand its U.S. and/or global revenues;
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; failure to
meet all financial obligations in the Cross Medical Settlement;
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 its Annual
Report Form 10-K, as well as other filings on Form 10-Q and
periodic filings on Form 8-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: Investor/Media Contact:
Mark Francois
Senior Director, Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
mfrancois@alphatecspine.com
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