Healthcare Industry News: bone graft
News Release - April 4, 2011
Alphatec Spine Receives 510(k) Clearance for Its Solus(TM) Anterior Lumbar Interbody Fusion SystemCARLSBAD, Calif., April 4, 2011 -- (Healthcare Sales & Marketing Network) -- 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 the Company has received 510(k) clearance from the FDA for its Solus Anterior Lumbar Interbody Fusion (ALIF) system.
The Solus ALIF device features an integrated fixation method based on intellectual property previously acquired by the Company. The patented fixation technology allows for enhanced segmental stability with a simplified surgical technique, while providing for substantial spacing to add bone graft.
"We are extremely pleased to announce that the Solus ALIF system is available for commercial release within the United States," said Dirk Kuyper, the Company's President and CEO. "Our exhaustive pre-clinical biomechanical testing demonstrates excellent product performance when compared to the devices currently available for sale." Mr. Kuyper also said, "We are excited to immediately commence our controlled launch strategy, with a full commercial release in the second half of 2011. In order to optimize the success of this revolutionary product, the controlled launch will be a tiered release, with an emphasis on both clinician and sales training."
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 salesforce 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.
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 the Solus system, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including the Solus system, by the surgeon community, failure to obtain or maintain FDA clearance or approval for new products, or unexpected or prolonged delays in the process, including without limitation the Solus system, 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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