Expanding Orthopedics Launches a Multi-Center Clinical Study in Europe Using the XPED Pedicle Screw System[TM]

Expanding Orthopedics Inc., a medical device company developing innovative solutions for spinal care, announced today the initiation of a multi-center post-market study in Europe of its novel expanding XPED Pedicle Screw for spinal fusion

Oct 03, 2011, 14:53 ET from Expanding Orthopedics Inc.

OR AKIVA, Israel, October 3, 2011 /PRNewswire/ --

Expanding Orthopedics Inc. (EOI) launched a post-market, prospective study in Europe, assessing the performance and usability of the Company's XPED Expanding Pedicle Screw System[TM] for spinal fusion. Up to 50 patients will be enrolled in this multi-center study and will be followed for up to 24 months post implantation using quality-of-life questionnaires and radiographic assessments. The renowned spine team of the Stauferklinikum in Germany is leading the study, with other centers due to join in the coming months.

     (Photo: http://www.newscom.com/cgi-bin/prnh/20111003/484783 )

The XPED Pedicle Screw System is a complete spinal implant system including both standard and expandable pedicle screws as well as all necessary instrumentation.  The XPED system is designed to provide greater fixation in various bone conditions as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine.  The XPED expandable screw's 4-wing design increases the contact area with the bone, thus facilitating improved bone anchoring. This unique design allows for natural bone in-growth process which provides secondary natural fixation. The XPED Pedicle Screw System is CE marked and commercially available across Europe.

"Initial anchoring and long-term fixation of the pedicle screw within the vertebral body are crucial for successful spinal fusion", said Ronald Rissel, MD, Head of Spine Center, Stauferklinikum, Mutlangen, Germany. "A growing number of our patients undergoing spine fusion surgery suffer from an impaired bone condition as a result of chronic diseases, an unhealthy lifestyle and aging spine. In these patients, standard pedicle screws are sub-optimal, leading to a higher risk of screw loosening and resulting in a high re-operation rate. I expect the XPED expandable screw's innovative design to provide enhanced anchoring and potentially improve patient outcome."

"We are very honored to have one of the leading European centers in the field of orthopedics take part in this study" said Mr. Ofer Bokobza, CEO of Expanding Orthopedics Inc. "The XPED Pedicle Screw System and its unique design are based on the Company's proprietary expanding platform technology. Up to 20% of patients undergoing spinal fusion with pedicle screws can benefit from the XPED Pedicle Screw System, which represents a worldwide market potential of about $1B. We expect the XPED Pedicle Screw System to improve surgery outcome and significantly increase quality-of-life of treated patients".

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is a privately owned company whose mission is to develop innovative orthopedic products that augment the natural healing process of the body, preserve healthy bone and improve long-term patient outcome. The Company is spearheaded by seasoned management team with proven industry experience, and is backed by prominent spine surgeons from the US and Europe. EOI owns a broad patent portfolio covering the XPED and additional spine and orthopedic applications.

David Elkaim, VP Marketing and Sales
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SOURCE Expanding Orthopedics Inc.