
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.
X-spine Announces CE Marking of Spinal Fixation Systems
Oct 15 2007- X-spine Systems, Inc. , an Ohio, USA, based developer of spinal implant systems announced the CE mark approval for its Capless™ and Spider Cervical™ spinal implant products for distribution in the European community. X-spine concurrently announced an agreement with Highland Medical Ltd. of Oxfordshire, UK to be the designated distributor for X-spine products in the United Kingdom.
“We are thrilled to be bringing the Capless and Spider systems to Europe. These products incorporate technologies not currently available to European surgeons, so we feel that there is a great opportunity to build X-spine’s presence,” states David Kirschman, MD, X-spine president. X-spine products are currently being distributed throughout the USA and in South Africa.
The Capless™ Pedicle Screw System incorporates a proprietary rotary locking mechanism which affixes the rod in place without a separate cap or setscrew. Elimination of the locking cap allows for faster surgeries, without the possibility of cap loosening, cap loss, or cross threading which is endemic to traditional screw systems. It also means fewer parts to stock and inventory, which results in cost-savings.
The Spider Cervical™ Plating System consists of a cervical fixation plate with a patented “resilient arm" locking mechanism to prevent screw back-out. The Spider Cervical plating system eliminates false screw locking by providing positive auditory, tactile and visual feedback to the surgeon. These factors confirm screw locking without requiring any additional locking steps.
Based in Miamisburg, Ohio, privately-held X-spine Systems, Inc. is an emerging leader in the development of propriety technology for the spinal surgery industry. www.x-spine.com
CONTACTS:
X-SPINE SYSTEMS, INC.
Bryan Hake
National Sales Manager
X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342
800-903-0640
HIGHLAND MEDICAL LTD
Spike Menegaldo
Hilliard House
Lester Way
Wallingford
Oxon, UK
OX10 9TA
+44 (0) 1491 827514
X-spine Announces FDA Clearance for New Spinal System
Sept 17, 2007--X-spine Systems, Inc., a developer and manufacturer of spinal implant systems, announced today that it had obtained FDA clearance to market its new Capless LI ™ Pedicle Screw System. The system builds upon X-spine’s proprietary Capless ™ polyaxial screw locking technology by offering a more compact screw unit, increased screw angulation, screw cannulation and tissue sparing retraction.
“The Capless LI ™ effectively addresses the increasing need for reduced tissue disruption during spinal fixation procedures. It allows for several less invasive options for screw placement, including over-wire, mini-open and muscle-sparing approaches. Of course, it includes all the benefits of the Capless™ locking technology, which allows for screw locking without the problems endemic to separate locking caps or setscrews” states David Kirschman, M.D., president of X-spine. X-spine made the announcement of approval while exhibiting at the Congress of Neurological Surgeons annual meeting in San Diego, CA. The Capless LI ™ Pedicle Screw System is a key component of X-spine’s growing lineup of unique products for spinal surgery. Based in Miamisburg, Ohio, privately-held X-spine Systems, Inc. is an emerging leader in the development of propriety technology for the spinal surgery industry. www.x-spine.com
Contact:
Bryan Hake
National Sales Manager
X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342
800-903-0640
X-spine awarded key patent for spinal systems.
Feb 27, 2007. X-spine Systems was awarded U.S. patent 7182782 for key technology in dynamic spinal fixation systems. “The award of this patent, with over 170 claims, builds upon X-spine’s most critical asset-- intellectual property,” states surgeon-inventor Dr. David Kirschman. “This technology serves to bridge the gap between traditional fusion and dynamic devices, and gives spine surgeons the most flexible tools for the treatment of their patients.” Some of the patent’s technology can be seen in the Spider Cervical plating system, while other technologies will be found in forthcoming product platforms.
X-spine receives FDA approval to market new spine system.
Dec.13, 2005--X-spine Systems, Inc., a developer and manufacturer of spinal implant products, announced today that it received FDA approval to market its new Capless(TM) polyaxial pedicle screw system. The screw design incorporates a proprietary rotary locking mechanism which affixes the rod in place without a separate cap or setscrew. "Elimination of the locking cap is the first major advance in multi-axial screw technology in over fifteen years," states David Kirschman, M.D., president of X-spine. "This allows for faster surgeries, without the possibility of cap loosening, cap loss, or cross threading which is endemic to traditional screw systems. It also means fewer parts to stock and inventory, which results in cost-savings." Extensive biomechanical testing has been performed on the Capless screw system demonstrating equivalent or superior performance compared to established screw systems.
X-spine receives FDA approval to market new cervical plating system.
Oct. 24, 2005--X-spine Systems, Inc., a developer and manufacturer of spinal implant products, announced today that it had obtained FDA clearance to market its new Spider Cervical plating system. The system consists of an cervical fixation plate with a proprietary "resilient arm" locking mechanism to prevent screw backout. "The Spider Cervical effectively addresses the number one problem with locking cervical plates, which is false locking," states David Kirschman, M.D., president of X-spine." "I feel that in many cases of inadvertent screw backout, the screw was never properly locked in the first place, since the surgeon didn't get adequate feedback from the locking mechanism." The Spider Cervical plating system provides positive auditory, tactile and visual feedback to the surgeon to indicate screw locking, while not requiring any additional locking steps. The Spider Cervical plating system joins the forthcoming Capless pedicle screw system in X-spine's growing portfolio of surgeon-centric spinal products.
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