Healthcare Industry News: Millennium
News Release - March 12, 2013
Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus(TM) Internal Fixation Anterior Lumbar Interbody Fusion DeviceCARLSBAD, Calif., March 12, 2013 -- (Healthcare Sales & Marketing Network) -- Alphatec Holdings, Inc. (ATEC), the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell its unique and patented Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device. The device's 510(K) application was filed with the FDA during the fourth quarter of 2012.
The Alphatec Solus ALIF device features two counter-rotating titanium blades, which deploy into adjacent vertebrae on a zero-degree axis, locking the device in place. This provides four points of fixation delivered in what the Company believes is an industry leading single step. The patented device is designed to provide enhanced segmental stability with a simplified surgical technique, while providing substantial spacing to insert bone graft to help promote rapid fusion at the site. Alphatec Solus is designed to provide fast, easy and effective stabilization for a surgeon's ALIF procedures.
"We are extremely pleased to announce that the Alphatec Solus ALIF system will soon be available for commercial release within the United States," said Les Cross, Chairman and CEO of Alphatec Spine. "We launched Alphatec Solus in Europe in January this year and thus far it has been a success. Our product development programs will remain a collaborative effort between spine surgeons and our internal development group to ensure that the latest product innovations keep advancing improved patient care in the operating room."
According to Millennium Research Group, the market for internal fixation ALIF spacer devices is estimated to be approximately $129 million in 2013, representing approximately half of the total market for the ALIF spacer devices.
About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops, manufactures and markets products and solutions for the treatment of spinal disorders associated with trauma, congenital deformities, disease and degeneration. The Company's mission is to combine innovative, surgeon-inspired solutions that will help improve outcomes and patient's quality of life, with world-class customer service. To achieve its mission, the Company strives to commercialize new and innovative devices and technologies, including improved minimally invasive surgery (MIS) products and techniques and integrated biologics solutions. The Company markets its products and the products of its affiliates in the U.S. and in over 50 countries internationally via a direct sales force and independent distributors. Additional information can be found at www.alphatecspine.com.
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 commercial strategy for its Alphatec Solus ALIF device noted in this release, as well as the Company's new product development efforts in general. 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 the commercial success of the Alphatec Solus device; the uncertainty of success in licensing or developing and commercializing new products or products currently in Alphatec Spine's pipeline; failure to achieve acceptance of Alphatec Spine's products by the surgeon community, including the new Alphatec Solus device; failure to successfully implement streamlining activities to create anticipated operational savings; failure to successfully begin in-house manufacturing of certain products; failure to obtain FDA clearance or approval for new products, including the new anchored interbody device, 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 or its credit agreement; patent infringement claims and claims related to Alphatec Spine's intellectual property or products sold by Alphatec Spine. Please refer to the risks detailed from time to time in Alphatec Spine's SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2012, filed on March 5, 2013 with the Securities and Exchange Commission, 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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