Healthcare Industry News:  degenerative disc disease 

Devices Neurosurgery Orthopaedic

 News Release - May 9, 2006

SpinalMotion Reports Significant Progress on Artificial Disc Clinical Trials

Nears 1,400 Artificial Disc Implants Worldwide

MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--May 9, 2006--SpinalMotion, developer of investigational artificial discs for treating patients with degenerative disc disease (DDD), today reported that it continues to make significant progress on two United States (U.S.)-based Investigational Device Exemption (IDE) clinical trials for the Kineflex(TM) lumbar disc and Kineflex/C(TM) cervical disc implants. Nearly 400 patients are enrolled in the studies; more than half the required number of patients. Since October 2002, approximately 1,400 Kineflex lumbar and cervical discs have been implanted worldwide.

The SpinalMotion Kineflex lumbar disc and the Kineflex/C cervical disc are second-generation, metal on metal designs intended to preserve motion with low wear. They feature a proprietary, straight-forward implant technique that includes specialized instruments designed to facilitate accurate placement. Both discs have CE Mark and are currently approved for sale in South Africa, where they were developed.

"We are pleased with our clinical trial progress and the feedback we are receiving from our investigators," states David Hovda, President and CEO of SpinalMotion. "We are also excited by progress that has been made in the South African market, where the discs are commercialized."

Investigators involved in SpinalMotion's clinical trials will make oral and poster presentations during the Spine Arthroplasty Society (SAS6) meeting this week in Montreal, Canada. Presentations will relate both clinical experience as well as biomechanical outcomes from a study comparing motion enabled by Kineflex to that of the intact human spine. In addition, the Company will host break-out sessions featuring information on the IDE trial progress and international clinical experience.

SpinalMotion also announced that it is developing a posteriorly-placed lumbar artificial disc and expects to conduct a feasibility clinical study in South Africa later this year. The Company believes it will be one of the first to implant a posterior lumbar disc, and will discuss plans for developing and evaluating the disc at the SAS6 meeting.

About SpinalMotion's U.S. IDE Clinical Trials

SpinalMotion received approvals from the U.S. Food & Drug Administration (FDA) in 2005 to commence both IDE studies, which began during the third quarter. The lumbar trial involves 25 U.S. sites. In this randomized study, the investigational SpinalMotion Kineflex lumbar disc is being compared to another FDA-approved lumbar artificial disc. The cervical trial involves 20 U.S. sites and features a randomized study comparing the investigational SpinalMotion Kineflex/C to fusion. Both trials are designed to compare clinical success rates to their respective controls. A two-year follow-up period is planned for both trials.

About the Artificial Disc Market

The National Center for Health Statistics reports that 14% of new patient visits to physician offices (approximately 13 million annually) are for complaints of low back pain. In fact, an estimated 18% of the population has debilitating back pain at any given time. Merrill Lynch estimates that more than 230,000 cervical fusions and over 200,000 lumbar fusions will be performed in the U.S. in 2006. They also forecast that up to 70% of cervical fusion patients will be candidates for disc replacement. These demographics, along with the tremendous costs to society and the focus on new treatments, have made spinal implants the fastest growing segment of the orthopedic market.

About SpinalMotion

SpinalMotion is focused exclusively on spinal disc arthroplasty, developing innovative technology designed to further enhance options for patients suffering from degenerative disc disease. SpinalMotion was founded in June 2003. The company is located in Mountain View, California. To learn more, visit our website at www.spinalmotion.com.

Caution: Kineflex and Kineflex/C Spinal Systems are Investigational devices in the United States and are limited by United States law to investigational use.

Any forward-looking statements are subject to risks and uncertainties. Actual results may differ substantially from anticipated results.


Source: SpinalMotion

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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