Frost & Sullivan Lauds X-Spine Systems’ Unique and Innovative Spinal Implant Product
Palo Alto, Calif. — March 4, 2008 —Frost & Sullivan recognizes X-Spine Systems, Inc. with the 2008 North American Frost & Sullivan Award for Product Innovation in the field of advanced spinal implantation systems for developing the Capless LI Pedicle Screw system.
This product employs the company’s proprietary Capless screw locking technology that simplifies screw placement by reducing the number of steps during spinal stabilization surgery. It also provides several less invasive options for screw placement and reduces operating and recovery time.
The significance of the Capless LI Pedicle Screw system lies in its unique rotary locking mechanism. “The proprietary rotary locking mechanism incorporated in the screw allows the direct fixation of rod in place, thus doing away with the need for a separate cap or setscrew,” says Frost & Sullivan Research Analyst Prasanna Vadhana Kannan. “In addition to functional benefits for the surgeon, this design results in fewer parts to stock and inventory, in turn leading to significant cost-savings.“
Having been subjected to extensive biomechanical testing, the Capless screw technology offers improved performance over conventional technologies. It is designed to provide a large surface contact area between rod and locking mechanism for greater locking strength. It also includes a flexible crossbar stabilizer that employs a proprietary floating ring that simultaneously locks onto the rod and cross bar, offering improved stability of the overall screw construct. This design also eliminates the possibility for undesired cap loosening, cap loss or difficulties in cap placement.
Since receiving clearance from the FDA in September 2007, the Capless LI Pedicle Screw system has undergone over 200 implantations. The company hopes to build upon the successful Capless product platform to increase indications and exposure in the minimally invasive, deformity, and dynamic fixation markets.
“The company is also investing in the development of a disk augmentation system, which will improve the function and reduce the pain associated with degenerative disk disease of the lumbar spine, without destruction of underlying anatomy,” notes Prasanna. “Recently, X-Spine received FDA clearance for the Butrex buttress plating system, which provides an implant option for the front of the spine and is intended to be used along with the Capless LI Pedicle Screw system.”
Apart from the two issued patents and multiple patents pending in the spinal fixation market, X-Spine Systems has five FDA-approved products in the United States and two with CE mark for Europe. The company has also granted several licensing and/or distribution agreements for its proprietary technology to other important market participants.
Each year Frost & Sullivan presents this Award to the company that has demonstrated excellence in new products and technologies within its industry. The recipient company has shown innovation by launching a broad line of emerging products and technologies.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
About X-Spine Systems, Inc.
Based in Ohio, X-Spine Systems, Inc. is a privately-held corporation dedicated to developing next-generation spinal implants that improve spinal surgery outcomes and optimize surgeon experience.
About Frost & Sullivan
Frost & Sullivan, the Global Growth Consulting Company, partners with clients to accelerate their growth. The company's Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth-focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information, visit http://www.awards.frost.com.
X-spine Announces FDA Clearance for New Spinal System
January 30, 2008--X-spine Systems, Inc., a leading developer and manufacturer of spinal implant systems, announced today that it had obtained FDA clearance to market its new BUTREX™ Buttress Plating System. The system builds upon X-spine’s growing lineup of spinal fixation technology by offering a compact titanium alloy plate for the buttressing of an anterior lumbosacral intervertebral bone graft. The BUTREX™ utilizes X-spine’s patented resilient-arm screw locking technology to prevent screw dislodgement from the buttress plate. “The BUTREX™ brings additional confidence to ALIF procedures by significantly reducing the potential for anterior expulsion of the interbody bone graft.” states David Kirschman, M.D., Chief Medical Officer of X-spine. “When used with supplemental posterior instrumentation, such as the X-spine CAPLESS® pedicle screw systems, the BUTREX™ adds stability and security to ALIF procedures.” The BUTREX™ system includes a comprehensive set of placement instrumentation designed for the unique exposure challenges of the anterior lumbosacral spine. Based in Miamisburg, Ohio, privately-held X-spine Systems, Inc. is an emerging leader in the development of propriety technology for the international spinal surgery industry.
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