Healthcare Industry News: bone cement
News Release - June 19, 2009
Alphatec Spine Reaches Milestone of OsseoFix AdoptionOver 100 Patients in Europe Treated with the OsseoFix Spinal Fracture Reduction System for Vertebral Compression Fractures
Over 40 Surgeons Trained in Europe with Next Training Session Oversubscribed
CARLSBAD, 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, today announced that, as of June 1, 2009, over 115 patients in eight European countries have been treated with the OsseoFix(TM) Spinal Fracture Reduction System, the Company’s innovative product for the treatment of vertebral compression fractures. The first European training session was held at the University of Vienna in mid-December 2008. The first shipments of OsseoFix products into Europe occurred at the end of December 2008.
“We are pleased with the significant surgeon adoption of OsseoFix across Europe. Surgeons who are using the OsseoFix system benefit from the potential to improve patient outcomes by providing an enhanced ability for vertebral height maintenance while using less cement as a result of the permanent titanium implant. As this product represents our initial launch into the aging spine market, we are particularly pleased with the manner in which the adoption of OsseoFix appears to be accelerating. Over 60 patients were treated in May alone,” said Dirk Kuyper, Alphatec Spine’s President and Chief Executive Officer. Mr. Kuyper added, “Our next training lab, which will be held in July in Vienna, is oversubscribed, with 50 surgeons and over 70 total participants already enrolled in what will be our third training session.”
The OsseoFix system is not yet approved for sale in the United States and is currently under 510(K) review with the U.S. Food and Drug Administration.
About Vertebral Compression Fractures and the OsseoFix Spinal Fracture Reduction System
According to the National Osteoporosis Foundation there were 700,000 osteoporotic vertebral compression fractures in the U.S., of which only one-third are estimated to be diagnosed. Common causes of vertebral compression fractures include osteoporosis, trauma, or a pre-existing disease at the fracture site.
Currently, the two most common procedures used to treat vertebral compression fractures are kyphoplasty and vertebroplasty. A kyphoplasty procedure involves injecting a balloon through a catheter into the damaged vertebra, inflating the balloon to restore height, and reinforcing the resultant space made by the balloon with bone cement. A vertebroplasty procedure involves injecting bone cement directly into the compressed vertebral body under high pressure, with the goal of stabilizing the fracture.
Alphatec Spine designed and developed the OsseoFix system to expand the market for surgical solutions for vertebral compression fractures with what it believes to be an improvement over the most common procedures being used today. OsseoFix is designed to allow for improved fracture reduction and designed to use less cement during a surgical procedure, both of which Alphatec believes reduces the risk of cement extravasation, reduces surgical complications and increases clinical efficacy.
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.
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 revenue projections, 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 those products that are intended to treat disorders prevalent in aging patients, including the OsseoFix, failure to achieve acceptance of Alphatec Spine's products, including the OsseoFix, by the surgeon community, failure to obtain FDA clearance or approval for new products, including the OsseoFix, 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.
Source: Alphatec Spine
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