Alphatec Spine, Inc. Releases PureGen(TM) Osteoprogenitor Cell Allograft to Facilitate Bone Regeneration and Announces First Pat
05 Oktober 2010 - 3:10PM
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 the release of its
PureGen Osteoprogenitor Cell Allograft at the North American Spine
Society Meeting (NASS) in Orlando, FL. PureGen 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 a pure adult
MSCs without the need for cultural expansion. PureGen is the
first pure adult stem cell to be released in the spinal market.
Dr. Carl Lauryssen, a Neurosurgeon and Director of Research and
Education at Olympia Medical Center in Los Angeles, CA, completed
the first procedure using PureGen. Pablo Pazmino, M.D. assisted in
the surgery. Dr. Lauryssen has twice been awarded the Young
Investigator Award from the American Association of Neurological
Surgeons for his work on cervical disorders and stem cell
research. The patient underwent a L4-S1 posterolateral
fusion. "I believe in the promise of stem cells for treating
spinal disorders as they pose minimal inflammatory side effects and
have the capacity to repair and regenerate bone. I also
believe the PureGen cell has the potential for providing surgeons
with better clinical outcomes in spinal fusion," stated Dr.
Lauryssen.
"We are committed to developing meaningful biologics solutions
to improve surgical outcomes in the spine market, and this exciting
new stem cell product has an enormous amount of potential. The
PureGen osteoprogenitor cell is an extremely powerful cell that has
both pluripotent potential and osteogenic differentiation. Our
preclinical results underscore the ability of this cell to
differentiate to bone faster and more efficiently than either bone
marrow aspirate or mesenchymal stem cells," said Dirk Kuyper, the
Company's President and CEO. Mr. Kuyper added, "It's exciting
to add this significantly differentiated product to our
portfolio. The PureGen osteoprogenitor cell will provide
Alphatec Spine with an excellent position in the growing market of
stem cell therapies for treating disorders of the spine, and will
be a strong complement to the other innovative technologies in our
core fusion and aging spine portfolios."
The PureGen osteoprogenitor cell allograft facilitates bone
fusion, and is marketed exclusively by Alphatec Spine. PureGen is
an adult stem cell that provides cellular and growth factors needed
for osteogenesis, without the potential complications of
autograft. Applied at the site of a musculoskeletal defect,
PureGen mimics the regenerative environment of youthful tissues by
increasing the concentration of stem cells available to repair
tissue and build bone.
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.agingspine.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 stem cells or the PureGen
product, and those products that are intended to treat disorders
prevalent in aging patients, failure to achieve acceptance of
Alphatec Spine's products, including the PureGen product, 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 the PureGen product, 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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