CARLSBAD, Calif., Oct. 25, 2007 (PRIME NEWSWIRE) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), a medical technology company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its DYNAMO(tm) Rod System.
"Unlike a traditional rigid fusion procedure, DYNAMO(tm) is designed to allow for controlled compression, distraction, flexion and extension of vertebrae adjacent to a fusion location, which should enable the patient to have an additional range of motion during the initial healing phase following fusion surgery" stated Dirk Kuyper, President and Chief Executive Officer of Alphatec. Mr. Kuyper added, "The FDA clearance of this system enables Alphatec to provide the surgeon community with an additional solution to meet the needs of the patient and improve patient outcomes following fusion surgery."
Technical Information:
The DYNAMO(tm) Rod System contains a flexible rod that allows for 0.75 mm of compression, +/-1.75 degrees of angulation, and features a 5.5mm diameter rod that is pre-contoured for lordosis in lengths ranging from 65mm to 400mm which allows for controlled compression, distraction, flexion and extension. The DYNAMO(tm) is designed to promote load sharing between the vertebral body replacement device and the endplates while reducing stress on the screw to bone interfaces. All of the features are intended to improve and expand a surgeon's treatment options and improve patient outcomes by reducing adjacent-level disease caused by traditional fusion surgery.
Availability and Pricing:
The DYNAMO(tm) Rod System will be available in the immediate future and pricing is available on request.
About Alphatec
Alphatec Holdings, Inc. (Nasdaq:ATEC) designs, develops, manufactures and markets products for the surgical treatment of spine disorders. Alphatec's broad product portfolio and pipeline includes a variety of spinal implant products and systems focused on solutions addressing the cervical, thoracolumbar, intervertebral, minimally invasive, motion preservation, vertebral compression fractures and allograft markets. Alphatec's "surgeons' culture" emphasizes collaboration with spinal surgeons to conceptualize, design and co-develop a broad range of products. State-of-the-art in-house manufacturing capabilities provide a unique competitive advantage, enabling Alphatec to rapidly deliver customized solutions to meet surgeons' and patients' critical needs. Alphatec has 22 issued U.S. patents, six issued foreign patents and 21 pending patent applications, including 10 pending U.S. applications, six pending international applications and five pending foreign national applications. Alphatec's principal product offerings are primarily focused on the global spine fusion market, which is estimated by Alphatec to be more than $5.9 billion in 2007. In addition to its U.S. operations, Alphatec also markets a range of spine and orthopedic products in Japan through its subsidiary, Alphatec Pacific, Inc. For more information, please visit www.alphatecspine.com.
The Alphatec Holdings, Inc. logo is available at http://www.primenewswire.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's ability to successfully design, develop, manufacture and market products for the surgical treatment of spine disorders and Alphatec's expectations regarding the continued growth of the U.S. and global spine market. 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 maintain its level of previously reported sales growth, Alphatec's ability to successfully leverage upon the experience of its Scientific Advisory Board, 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 Alphatec's products, unanticipated expenses or liabilities or other adverse events affecting cash flow, Alphatec's ability to control its costs or achieve profitability, uncertainty of additional funding, failure to successfully introduce and develop new products, including products related to license agreements, including without limitation the agreement that is the subject of this press release, failure to achieve acceptance of Alphatec's products by the surgeon community, failure to obtain FDA clearance or approval for new products, the Dynamo Rod System's ability to enable the patient to have an additional range of motion as compared to a rigid fusion procedure or reduce adjacent-level disease, product liability exposure, patent infringement claims and claims related to Alphatec's intellectual property and intellectual property Alphatec licenses from third parties. Please refer to 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. Alphatec 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.