Alphatec Spine, Inc. Initiates European Commercial Training Program of Alphatec Spine's OsseoFix Fracture Reduction System for Treating Vertebral Compression Fractures
BY EDITOR, DECEMBER 17, 2008
Alphatec Holdings, Inc., 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 on Friday, December 12, 2008, the Company held its first medical training for commercial use in Vienna, Austria for the OsseoFix(TM) Spinal Fracture Reduction System, the Company's innovative product for the treatment of vertebral compression fractures.
Over 30 participants including physicians and selected distributors were in attendance at the University of Vienna in Austria where they received hands-on cadaver lab training on the safe and effective use of the OsseoFix system. These physicians and distributors represented several countries in Europe, including The Benelux, Denmark, Greece, Italy, and Turkey.
"The strong participation and positive feedback received is a great indicator of the interest level for this novel technology for treating vertebral compression fractures," said Dirk Kuyper, Alphatec Spine's President and Chief Executive Officer. "These medical training sessions, which will be held regularly, will provide the foundation to accelerate the commercial use of OsseoFix in leading spine surgery centers in Europe. We are also pleased to see that our European distributors are excited about the market opportunity and are currently placing orders for the OsseoFix system."
In October 2008, the Company received a European CE Mark for the OsseoFix Spinal Fracture Reduction System, which allows the Company to market the OsseoFix system in the European Union for treatment of spinal compression fractures.
The Company continues the expansion of sales in Europe with both current and new distribution partners for its core line of spinal products.
OsseoFix 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 (FDA).
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 OsseoFix 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.
