Healthcare Industry News: Alphatec Spine
News Release - July 18, 2006
Alphatec Holdings, Inc. Announces FDA Clearance for Its Adjustable Bridge ProductCARLSBAD, Calif., July 18 (HSMN NewsFeed) -- Alphatec Holdings, Inc. (Nasdaq: ATEC ), a medical device company that provides customized spinal products and a broad suite of spine fusion solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") allowing it to market its adjustable bridge product. As previously disclosed in Company filings, Alphatec entered in to a private label distribution agreement with Sea Spine, Inc. for the sale of Sea Spine's Cross LinkŪ adjustable bridge product under Alphatec's private label. This FDA clearance will allow Alphatec to begin the immediate commercial sale of its private label adjustable bridge, which will be used in combination with the Company's ZodiacŪ line of polyaxial pedicle screws.
Alphatec is a medical device company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders. Alphatec's principal product offerings are primarily focused on the U.S. spine fusion market, which is estimated to approach $3 billion in 2007, through its wholly-owned subsidiary, Alphatec Spine, Inc., and include a variety of spinal implant products and systems comprised of components such as spine screws, spinal spacers, and plates that offer multiple solutions to address patients' needs. In addition to Alphatec's U.S. presence, it also participates in the Japanese spine fusion and orthopedic trauma markets through its subsidiary, Alphatec Pacific, Inc. Our mission is to be a value based leader in the spinal market by providing unmatched service to and taking scientific direction from our physician customers. We do so through our unique in-house manufacturing facility in Carlsbad, California that allows us to respond quickly and to customize innovative products needed for spine fusion surgery.
Forward Looking Statements
This press release may contain forward-looking statements that involve risks and uncertainty, including statements that Alphatec's commercial sale of such private label adjustable bridge products will occur in the time periods planned, that many of Alphatec's multi-level fusion surgeries are candidates for use with an adjustable bridge product, that surgeons will adopt our private label adjustable bridge product, and that our private label adjustable bridge product will provide complementary revenues by increasing our revenue per surgery. 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. Alphatec 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's ability to develop and expand its spine fusion business in the United States and Japan, Alphatec's ability to expand and maintain a successful sales and marketing organization, continuation of favorable third party payor reimbursement for procedures performed using our products, unanticipated expenses or liabilities or other adverse events affecting cash flow or Alphatec's ability to achieve profitability, uncertainty of additional funding, uncertainty of success in developing any new products, failure to successfully introduce and develop new products, including products related to license agreements, failure to obtain FDA clearance or approval for particular devices, Alphatec's ability to compete with other competing products and with emerging new technologies within and outside of spinal fusion, product liability exposure and patent infringement claims. Please refer to the risks detailed in Alphatec's Form S-1 on file with the SEC, as well as the risks detailed from time to time in Alphatec's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. We disclaim 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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