Alphatec Spine, Inc. Enters Agreement with International Spinal Innovations, LLC
07 Juli 2009 - 10:05PM
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, announced today that it has entered
into an agreement with International Spinal Innovations, LLC,
pursuant to which International Spinal Innovations will provide
Alphatec Spine worldwide license rights to intellectual property
related to a stand-alone anterior lumbar interbody fusion (ALIF)
device.
The International Spinal Innovations license, combined with
intellectual property previously acquired from SpineVision S.A.,
will allow Alphatec Spine to develop and commercialize a
zero-profile, self-locking interbody device for both ALIF and
cervical procedures. Alphatec Spine expects to submit its
stand-alone ALIF device to the U.S. Food and Drug Administration
(FDA) for a 510k clearance in the first half of 2010. In addition,
the Company anticipates launching the stand-alone ALIF product
initially in Europe under a CE mark in the first half of 2010.
The 2009 interbody fusion market in the U.S. is estimated to be
more than $950 million. The 2009 ALIF market represents the largest
interbody segment in the U.S. with an estimated market in 2009
exceeding $350 million.
"We are extremely pleased to have acquired this unique concept
for stand-alone interbody devices," said Dirk Kuyper, the Company�s
President and CEO. Mr. Kuyper added, "The zero-profile,
single-action locking implant is a substantial improvement over
devices requiring screws or additional steps." Mr. Kuyper
continued, "This new technology license, combined with intellectual
property previously acquired from SpineVision S.A., will enable
Alphatec Spine to leverage a strong proprietary position in the
largest segment of the interbody market. Both hospitals and
surgeons are attempting to reduce procedure time and cost, and
stand-alone implants that do not require supplemental posterior
fixation are a logical progression in providing more cost-effective
alternatives for patients, surgeons and hospitals."
"This stand-alone device will be unique in that it will be
designed to be inserted and locked into the superior and inferior
vertebral endplates in a single step," said J.P. Timm, the
Company�s Vice President of Research & Development. Mr. Timm
continued, "The simple insertion and fixation will result in a
quicker procedure that should reduce the risk to the patient and
cost to the hospital."
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 spine products in Europe. In Asia, the Company markets
a broad line of spine and orthopedic products through its
subsidiary, Alphatec Pacific, Inc.
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 2009 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 stand-alone ALIF products, and
those products that are intended to treat disorders prevalent in
aging patients, failure to achieve acceptance of Alphatec Spine's
products, including stand-alone ALIF 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 stand-alone ALIF 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.
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