Healthcare Industry News: intervertebral body fusion
News Release - February 2, 2010
Alphatec Spine Receives CE Mark for its OsseoScrew(TM) Spinal Fixation System and Its GLIF/ ARC(TM) Portal Access SystemEU Market Release of OsseoScrew in 1Q 2010 and GLIF in the Second Half of 2010
CARLSBAD, Calif., Feb. 2, 2010 -- (Healthcare Sales & Marketing Network) -- 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, today announced that the Company has received the CE Mark for commercial sale in the European Union and other jurisdictions for its OsseoScrew Spinal Fixation System and its Guided Lumbar Interbody Fusion (GLIF) System / Arc Portal System. The receipt of the CE Mark allows Alphatec Spine to begin selling these implants in the European Union and certain other jurisdictions that recognize the CE Mark for commercial approval.
The OsseoScrew Spinal Fixation System is an innovative concept in pedicle screw fixation. The OsseoScrew provides three points of fixation; the pedicle, the transverse/superior facet, and the junction of the anterior pedicle and vertebral body. This is in contrast to a standard pedicle screw that only has one point of fixation the pedicle itself. The OsseoScrew implant is an expandable pedicle screw that addresses the challenges of demanding spinal fusion constructs in which there is a need for fixation with clinically proven technology that enhances the fixation in the bone-implant interface by 30%.
"We are pleased to announce that the second product from our Aging Spine development pipeline is available for commercial release in the European Union. The OsseoScrew Spinal Fixation System is the only available option for patients that adequately addresses the challenging spinal fusion constructs that need an increased level of fixation," said Dirk Kuyper, the Company's President and CEO. Mr. Kuyper added, “The OsseoScrew has an expandable region that locks the screw into the neck of the pedicle, in a manner that is similar to how a molly bolt is used in dry wall. Our biomechanical testing has confirmed that the expanded screw provides a 30% improvement of the bone/implant interface as compared to a standard pedicle screw.“
The OsseoScrew system is scheduled for its first European clinical use in February 2010. The OsseoScrew system is not available for sale in the U.S. and the Company is in discussions with the FDA to obtain 510(k) clearance for the product.
The Guided Lumbar Interbody Fusion (GLIF) technique and ARC Portal Access System is designed to provide surgeons with trans-psoas access and direct visualization to the intervertebral disc space while allowing the patient to remain in a prone position during lumbar interbody fusion procedures.
The GLIF surgery technique is a minimally invasive extracavitary approach to the anterior spine designed for intervertebral body fusion. The GLIF system is designed to reduce intra-operative blood loss and minimize tissue disruption while decreasing the post-operative recovery time for most patients.
When augmented with posterior pedicle fixation, the GLIF system eliminates the need to reposition the patient intra-operatively, thereby reducing the overall length of the lateral lumbar fusion procedure and potentially reducing operating room costs.
The Company expects to begin a limited market release of the GLIF system in Europe during the second half of 2010.
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 disorders affecting 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 biologic 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. For more information, please visit www.alphatecspine.com.
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 the OsseoScrew System and the GLIF/ARC Access System, and those products that are intended to treat disorders prevalent in aging patients, failure to achieve acceptance of Alphatec Spine's products, including the OsseoScrew System and the GLIF/ARC Access System, 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 the OsseoScrew System and the GLIF/ARC Access System, Alphatec Spine's ability to develop and expand its business in the United States, Asia and Europe, continuation of favorable third party payer reimbursement and acceptable collections from hospitals 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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