May 24, 2010 12:43 PM

X-spine Announces New FDA Clearance of Spinal Implant System

MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global manufacturer of implants and instruments for spinal surgery, announced FDA clearance of its new Fixcet ™ Spinal Facet Screw System. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, instability and trauma.

The system incorporates a novel one-piece screw design which provides active compression of the facet joint and improved apposition of the facet surfaces compared to other systems. It can also be inserted through either a traditional open approach or a minimally invasive, wireguided
approach.

“We are seeing an evolution to smaller spinal fixation procedures, including those being done on a short patient stay basis. Being a minimally invasive facet system, the Fixcet is ideal for such procedures where lumbar fusion needs to be performed with minimal tissue disruption,” states X-spine CEO Dr. David Kirschman.

The Fixcet joins X-spine’s growing portfolio of spinal implant products, including the Spider
Cervical™ plating system, the X90™ pedicle screw system, the Fortex™ pedicle screw
system, the Calix ™ interbody fixation system, and the Butrex™ buttress plating system.
About X-spine Systems, Inc.

X-spine (www.x-spine.com) is a global developer and manufacturer of novel technologies for
the treatment of spinal disease. Based in Ohio, privately-held X-spine markets spinal
implants and surgical instruments worldwide for the treatment of spinal degenerative
disease, deformity, trauma, and spinal tumors.

X-spine Announces Exclusive License with Gamma Spine for Minimally-Invasive Spinal Technology

March 8, 2010--X-spine Systems, Inc., a global manufacturer of implants and instruments for spinal surgery, announced today that it has entered into an exclusive license agreement with Gamma Spine for the development and distribution of its minimally invasive spinal fixation technology. Gamma Spine, founded by Dr. Vijay Goel, Ph.D., will participate in the development process with X-spine. "I am thrilled be working with Dr. Goel, who is one of the world's most renowned and published experts in spinal biomechanics, to develop this unique and valuable technology," stated Dr. David Kirschman, President and CEO of X-spine. The patent-pending device allows for the fixation of adjacent vertebral segments with minimal tissue disruption while attaining the biomechanical advantages of a traditional full-exposure system. "X-spine is the ideal partner to bring this technology to the worldwide marketplace; the company has an excellent track record of bringing innovative technology to fruition through its top-down emphasis on engineering, research, and development," stated Dr. Goel. In addition to his duties as principal of Gamma Spine, Dr. Goel is the Endowed Chair & McMaster-Gardner Professor of Orthopaedic Bioengineering at the University of Toledo, Ohio.

By entering into this license agreement, X-spine furthers its strategy to address the continuing market trend towards smaller, cost-effective procedures in spinal surgery. "Surgeons are demanding procedure options which are less invasive for patients, less costly for payers, but maintain the ease, safety and efficacy of traditional full-exposure procedures," states Dr. Kirschman. "We feel that the Gamma technology effectively addresses that demand."

About X-spine Systems, Inc

Based in Ohio, privately-held X-spine (www.x-spine.com) manufactures and markets implants and instrumentation worldwide for the treatment of a wide range of spinal pathologies. X-spine is an emerging leader in the design and development of novel technologies for the benefit of spinal patients and practitioners.

About Gamma Spine

Based in Toledo, Ohio, Gamma Spine, founded by Vijay Goel, Ph.D., is a developer of proprietary technologies based upon the advanced analysis of spinal biomechanics.

Miamisburg, Ohio. — May 4, 2009 —X-spine, an emerging manufacturer of implants and instruments for spinal surgery, announces FDA clearance of its new Calix spinal implant system. The system is designed to function as a cervical intervertebral fixation device as well as a vertebral body replacement device in the thoracic and lumbar spine. The Calix system is manufactured from PEEK-Optima polymer, which enjoys widespread adoption in spinal surgery due to its excellent mechanical and biological properties. The system is X-spine's sixth FDA-cleared spinal product. "We are excited about the Calix because it represents our first product to address cervical interbody fixation," states Dr. David Kirschman, X-spine CEO. "X-spine has earned tremendous growth in the anterior cervical plating market with our Spider Cervical plating system, so the addition of an interbody product to pair with it represents a great opportunity for us." X-spine will introduce the product at the American Association of Neurological Surgeons meeting in San Diego, CA on the 5th of May.

X-spine is an emerging leader in the development and manufacture of novel technologies for the treatment of spinal disease. Based in Ohio, privately-held X-spine markets spinal implants and surgical instruments worldwide for the treatment of spinal degenerative disease, deformity, trauma, and spinal tumors.

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.