Healthcare Industry News: osteoporosis
News Release - July 7, 2009
Alphatec Spine, Inc. Enters Agreement with International Spinal Innovations, LLCCARLSBAD, Calif.--(HSMN NewsFeed)--Alphatec Holdings, Inc. (Nasdaq: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, announced today that it has entered into an agreement with International Spinal Innovations, LLC, pursuant to which International Spinal Innovations will provide Alphatec Spine worldwide license rights to intellectual property related to a stand-alone anterior lumbar interbody fusion (ALIF) device.
The International Spinal Innovations license, combined with intellectual property previously acquired from SpineVision S.A., will allow Alphatec Spine to develop and commercialize a zero-profile, self-locking interbody device for both ALIF and cervical procedures. Alphatec Spine expects to submit its stand-alone ALIF device to the U.S. Food and Drug Administration (FDA) for a 510k clearance in the first half of 2010. In addition, the Company anticipates launching the stand-alone ALIF product initially in Europe under a CE mark in the first half of 2010.
The 2009 interbody fusion market in the U.S. is estimated to be more than $950 million. The 2009 ALIF market represents the largest interbody segment in the U.S. with an estimated market in 2009 exceeding $350 million.
"We are extremely pleased to have acquired this unique concept for stand-alone interbody devices," said Dirk Kuyper, the Company’s President and CEO. Mr. Kuyper added, "The zero-profile, single-action locking implant is a substantial improvement over devices requiring screws or additional steps." Mr. Kuyper continued, "This new technology license, combined with intellectual property previously acquired from SpineVision S.A., will enable Alphatec Spine to leverage a strong proprietary position in the largest segment of the interbody market. Both hospitals and surgeons are attempting to reduce procedure time and cost, and stand-alone implants that do not require supplemental posterior fixation are a logical progression in providing more cost-effective alternatives for patients, surgeons and hospitals."
"This stand-alone device will be unique in that it will be designed to be inserted and locked into the superior and inferior vertebral endplates in a single step," said J.P. Timm, the Company’s Vice President of Research & Development. Mr. Timm continued, "The simple insertion and fixation will result in a quicker procedure that should reduce the risk to the patient and cost to the hospital."
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq: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 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 spine products in Europe. In Asia, the Company markets a broad line of spine and orthopedic products through its subsidiary, Alphatec Pacific, Inc.
Also visit the Aging Spine Center, www.agingspinecenter.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. The Company is working with the National osteoporosis Foundation as well as other clinical portals that provide peer-reviewed content, to populate the Aging Spine Center. The interactive website will enable patients to review pertinent information about disorders that affect the aging spine in an easy-to-understand format that includes videos, graphics and questions that should be asked of caregivers. Medical information will include published abstracts regarding the aging spine.
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 2009 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, including stand-alone ALIF products, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including stand-alone ALIF products, by the surgeon community, failure to obtain FDA clearance or approval for new products, or unexpected or prolonged delays in the process, including without limitation stand-alone ALIF products, 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.
Source: Alphatec Spine
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