Healthcare Industry News: Scient'x
News Release - January 3, 2013
Alphatec Spine Receives U.S. FDA 510(K) Market Clearance for Two New Products and Receives Japanese Shonin Approval to Begin Marketing Its Novel(R) Peek Lumbar Spinal SpacersCARLSBAD, Calif., Jan. 3, 2013 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (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, today provided an update related to its product commercialization efforts.
The Company announced that it has recently received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for two new products in the Company's new product pipeline:
An anchored, anterior cervical interbody device, called Pegasus(TM), which offers single-step deployment of the anchoring blades without the need for impaction; and,
A new MIS system, called ILLICO(R) FS Facet Fixation System, which enables spine surgeons to immobilize and stabilize spinal segments without the need for pedicle screw and rod constructs.
Additionally, the Company said that it has received Shonin approval in Japan from the Pharmaceuticals and Medical Devices Agency to market and sell three lines of the Company's Novel PEEK Spinal Spacers, including the Novel SD, the Novel LCC and the Novel TL, which are used in posterior spine fusion procedures. PEEK, or polyetheretherketone, is a radiolucent material containing radiographic markers, which enhance interbody visualization and alignment during the fusion process.
"I am pleased to announce these important new developments related to our new product commercialization strategy at Alphatec Spine," said Les Cross, Chairman and CEO of Alphatec Spine. Our initiatives to strengthen the top-line growth of the Company through robust internal product development, acquisitions and license arrangements, and continued global expansion are gaining momentum. Our new Pegasus anchored cervical interbody device and ILLICO FS system represent key additions to our cervical and MIS offerings in the U.S., respectively.
"In Japan, product registration has been a long and complex process and we are pleased to have achieved that significant milestone for our Novel PEEK Spinal Spacer Systems, complementing the strong sales presence we have already established there."
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (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 products 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 affiliate, Scient'x S.A.S., via a direct sales force in France, Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In Latin America, the Company conducts its business through its subsidiary, Cibramed Produtos Medicos. In Japan, the Company markets its products through its subsidiary, Alphatec Pacific, Inc. In the rest of Asia and Australia, the Company sells its and Scient'x's products through its and Scient'x's distributors.
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. 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. Forward-looking statements include references to the Company's ability to develop and commercialize new products targeted for U.S. and international markets. The words "believe," "will," "should," "expect," "intend," "estimate" and "anticipate," variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to; the uncertainty of success in developing new products or products currently in Alphatec Spine's pipeline; the uncertainty of success in acquiring new products or technologies; the successful launch of the Company's new products and the products in its development pipeline, including the products discussed in this press release; failure to achieve acceptance of Alphatec Spine's products by the surgeon community, including the products discussed in this press release; failure to successfully implement streamlining activities to create operating cost savings; failure to successfully begin in-house manufacturing of certain products; failure to obtain or maintain regulatory clearance or approval for products, including the products discussed in this press release, or unexpected or prolonged delays in the process; Alphatec Spine's ability to develop and expand its U.S. and/or global revenues; 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; failure to meet all financial obligations in the Cross Medical Settlement; 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 its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-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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