CARLSBAD, Calif., Oct. 5, 2010 (GLOBE NEWSWIRE) -- 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 the Company has received CE Mark approval for commercial sale in the European Union and other jurisdictions for its HeliFix Interspinous Spacer System and Solus ALIF System. The receipt of the CE Mark allows Alphatec Spine to begin selling HeliFix and Solus implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval.
The HeliFix Interspinous Spacer System is a minimally invasive non-fusion solution for lumbar spinal stenosis (LSS). Lumbar Spinal Stenosis is a degenerative condition that affects the aging population worldwide. It is estimated that nearly 600 million people aged 60 years or older are diagnosed with LSS. The 2009 market size in Europe for interspinous devices was approximately $50 million with estimated growth of 12%. The HeliFix implant acts as an extension blocker at the affected vertebral levels and relieves symptoms associated with LSS. The HeliFix System is an innovative concept that features an implant with a self-distracting helical tip. HeliFix is not available for sale in the U.S.
The Solus ALIF System is a zero-profile, single-action locking implant that is used in anterior lumbar interbody fusion (ALIF) procedures. Unlike other products that are currently on the market, which require screws or complicated locking mechanisms, the Solus implant can be secured into position in a single step. This single-step mechanism is a significant improvement over similar devices. The 2009 market size for anterior degenerative thoracolumbar fixation in Europe was approximately $45 million. The Solus ALIF System is under FDA review for 510(k) clearance and is currently not available for sale in the U.S.
Additionally, Alphatec Spine announces two new product releases in the U.S. market, the Aspida™ Anterior Lumbar Plating System and the PureGen™ Osteoprogenitor Cell Allograft. The ASPIDA System has a 510(k) clearance and features a slim profile, a single-action self-locking mechanism and a dual-lead threaded screw, all of which are designed to minimize the disruption of tissue near the implant and reduce operating time for the surgeon. PureGen, the release of which was announced earlier this week, 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 pure adult MSCs without the need for cultural expansion. PureGen is the first pure adult stem cell to be released in the spinal market.
The HeliFix Interspinous Spacer System, Solus ALIF System, Aspida Anterior Plating System and PureGen Osteprogenitor Cell Allograft will be on display at the North American Spine Society (NASS) Annual Meeting, which is being held from October 6th through October 9th in Orlando, Florida.
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, , 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
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 Alphatec Spine's HeliFix, Solus, ASPIDA and PureGen products, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including HeliFix, Solus, ASPIDA and PureGen 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 HeliFix, Solus, ASPIDA and PureGen 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.
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