CARLSBAD, Calif., May 15, 2007 (PrimeNewswire via COMTEX News Network) -- Alphatec Holdings, Inc. (Nasdaq:ATEC), a leading medical device company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, announced today the release of the CONNECT® II Cervical Structural Allograft spacer. The CONNECT II product is integrated with Alphatec's proprietary cervical fusion instrumentation for maximum ease of use, procedural efficiency and further completes Alphatec's cervical fusion product line.
"Allografts have a very strong following in the surgeon community due to their high success rates and ease of use and our CONNECT II product provides an excellent matrix for rapid perfusion leading to successful patient outcomes and we believe that it will become the allograft of choice for many surgeons," stated M. Ross Simmonds, Senior Vice President and Chief Operating Officer of Alphatec.
Simmonds added, "The CONNECT II product complements our current DELTALOC® and DELTALOC® REVEAL anterior cervical plates, as well as our soon to be released anterior cervical plate that just received a 510(k) clearance from the FDA. This new product is one more example of our commitment to providing solutions targeted at serving the needs of the spinal disorder marketplace and enabling our surgeon customers to have additional technology options while utilizing Alphatec as their trusted spinal medical device partner."
Technical Information
CONNECT II Cervical Structural Allograft is produced from dense cancellous bone with a thick anterior cortical face to maximize compressive strength for optimal fusion. It is machined from the femoral head and other non-vertebral bone sources. The rapid perfusion and the CONNECT II cancellous matrix provides the structural and biological conditions necessary for optimal healing.
The dimensions of CONNECT II are 14 millimeters in width, 14 millimeters in length, and the heights vary from 5 millimeters to 10 millimeters. All CONNECT II product sizes utilize a 7* lordotic angulation that re-establishes sagittal alignment and provides for maximum graft-to-host bone surface area. The range of sizes and versatile design provides optimal distraction and permits customization for a perfect fit for various patient specific needs, while the maximum graft-to-host bone surface contact area promotes excellent healing ability.
CONNECT II is processed aseptically, freeze-dried, and shipped in a peel-pack. Some of the advantages of the freeze-dried packaging are that the product can be held at room temperature and eliminates the need for a freezer, dry ice or coolers. Although no thawing time is required, the product does require reconstitution in sterile saline. CONNECT II has a five year shelf life.
Availability and Pricing
The CONNECT II is now available for shipping and pricing is available on request.
About Alphatec
Alphatec (Nasdaq:ATEC) designs, develops, in-licenses, manufactures and markets innovative products for the surgical treatment of spine disorders. The company's broad product portfolio includes a variety of spinal implant products and systems focused on solutions addressing the cervical, thoracolumbar, intervertibral, minimally invasive, allograft, and motion preservation markets. The company'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 the company to rapidly deliver customized solutions to meet surgeons' and patients' critical needs. Alphatec has 18 issued U.S. patents, one issued foreign patent and 24 pending patent applications, including sixteen pending U.S. applications, four pending international applications and four pending foreign national applications. Alphatec's principal product offerings are primarily focused on the U.S. spine fusion market, which is estimated to approach $5.9 billion in 2007. In addition to its U.S. operations, the company 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.
Forward Looking Statements
This press release may contain forward-looking statements 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. 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 develop and expand its spine fusion business in the United States and Japan, the surgeon community's continued acceptance of allograft products, including CONNECT II, 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 achieve acceptance of our products by the surgeon community, including CONNECT II, failure to obtain FDA clearance or approval for new products, Alphatec's ability to compete with other competing products and with emerging new technologies within and outside of spinal fusion, product liability exposure, patent infringement claims and claims related to our intellectual property. 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. 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.
SOURCE: Alphatec Holdings, Inc.
Alphatec Holdings, Inc.
Gordon C. Bigler, Vice President, Investor Relations & Corp. Communications
760.431.9286 x 402
gbigler@alphatecspine.com
