Healthcare Industry News: Fixation System
News Release - September 25, 2008
Alphatec Spine Announces 510(k) Clearance for Its Novel Cervical Interbody Implant
CARLSBAD, Calif., Sept. 25, 2008 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (NasdaqGM:ATEC ), the parent company of Alphatec Spine, Inc., a leading medical technology company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that it received U.S. Food and Drug Administration (FDA) 510(k) market clearance for its Novel(r) Cervical Interbody implant. The Novel Cervical Interbody implant is the latest product in Alphatec Spine's pipeline that provides solutions for disorders affecting the cervical spine.The Novel Cervical Interbody is offered in three footprints in both PEEK and titanium. The implant is designed to optimize endplate contact and has windows that increase the surgeon's ability to insert grafting material into the implant. The Novel Cervical Interbody has been cleared by the FDA as a cervical interbody device, complementing existing Alphatec Spine products, including the Trestle(tm) Anterior Cervical Plating System, the Solanas(tm) Posterior Cervico-Thoracic Fixation System, and the AlphaGRAFT ProFUSE(tm) demineralized bone scaffolds.
``We are very pleased to be one of the few companies to have an implant receive FDA clearance as a cervical interbody device,'' said Dirk Kuyper, President and Chief Executive Officer of Alphatec Spine. ``The addition of the new Novel Cervical Interbody implant to our product portfolio is an extremely positive step in our company's commitment to bringing a full-line of spinal solutions to the surgeon community.''
The Novel Cervical Interbody implant is used when performing an anterior cervical discectomy and fusion (ACDF) procedure. This procedure is used to treat a damaged disc in the cervical region due to either a bulging or herniated disc, or due to degenerative disc disease.
The total interbody market in the U.S. is estimated to be valued at more than $930 million in 2008, and forecasted to approach $1 billion by 2010. In 2008, cervical interbody procedures in the U.S. are estimated to account for 49% of all the interbody procedures performed.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (NasdaqGM:ATEC ). Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions 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 and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, Alphatec Spine 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 http://www.alphatecspine.com.
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: 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 the successful launch of the Novel Cervical Interbody implant, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including the Novel Cervical Interbody implant, by the surgeon community, failure to obtain FDA clearance or approval for new 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.
Source: Alphatec Holdings
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