Alphatec Spine, Inc. Comments on Untitled Letter Related to PureGen Osteoprogenitor Cell Allograft
CARLSBAD, Calif., Jul 25, 2011 (GlobeNewswire via COMTEX) — Alphatec Holdings, Inc. ATEC -0.31% , 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, today commented on the United States Food and Drug Administration’s (FDA) untitled letter dated June 23, 2011 that was sent to Parcell Laboratories, LLC regarding Alphatec Spine’s PureGen Osteoprogenitor Cell Allograft product.
In the letter, the FDA raised questions in connection with Parcell’s position that the PureGen product is within the classification of human cell, tissue, and cellular or tissue-based products regulated solely under Section 361 of 21 C.F.R. Part 1271. Parcell Laboratories has responded to the FDA’s letter on July 21, 2011 with more complete information of the function of PureGen and how the product meets all of the criteria for being marketed under Section 361.
Dirk Kuyper, Alphatec Spine’s President and CEO, stated, “Both Alphatec Spine and Parcell Laboratories are fully committed to work closely and collaboratively with the FDA to address the questions related to the PureGen product. We look forward to discussing the PureGen product with the FDA and sharing our clinical outcomes to date.”
The PureGen Osteoprogenitor Cell Allograft has been successfully implanted in over 500 patients with no reported adverse events, complications or complaints. The product is used primarily in spinal fusion procedures for both cervical and lumbar spine. There are three controlled prospective studies currently underway to further establish the performance of the product by both academic and community-based spine surgeons.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. ATEC -0.31% . 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.S., 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.
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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 and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine’s products, including the PureGen Osteoprogenitor Cell Allograft, by the surgeon community, failure to obtain or maintain the right from the FDA to market and sell products, including the PureGen Osteoprogenitor Cell Allograft, or unexpected or prolonged delays in the process 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.
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SOURCE: Alphatec Holdings, Inc.
