Healthcare Industry News:  degenerative disc disease 

Devices Orthopaedic Neurosurgery

 News Release - May 2, 2007

SpinalMotion's Kineflex(R) Artificial Lumbar Disc Long-Term Data Presented at International Spine Meeting

MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--SpinalMotion, developer of the investigational Kineflex® lumbar and Kineflex/C® cervical disc implants for treating patients with degenerative disc disease (DDD), today reported long-term data from outside the United States for the first 100 lumbar disc patients, and near completion of enrollment in the U.S. cervical trial.


Dr. Ulrich R. Hahnle, the first investigator to treat a series of patients with the Kineflex lumbar disc, published a paper in the Winter 2007 SAS Journal reporting two-year results of the first 100 patients in a single-center, prospective, longitudinal study. With an objective to evaluate insertion technique, clinical outcomes, and patient satisfaction at two-years post-implantation, the study showed good clinical results.

According to the published paper, 95% of disc implants were radiologically in the ideal position; post-operative hospitalization averaged 2.8 days; and all patients who were employed before surgery returned to work an average of 31 days after surgery. The clinical outcomes showed that 88 of the patients had good or excellent results after two years.

In addition to announcing the first long-term data, the company reported that enrollment in its IDE clinical trail evaluating the Kineflex/C disc is near completion, with over 95% of patients currently enrolled. Enrollment in the IDE clinical trial evaluating the Kineflex lumbar disc was completed in the fourth quarter of 2006. With the two U.S. clinical studies and extensive South African experience, over 2,000 Kineflex and Kineflex/C discs are now implanted in patients worldwide.

"This continues to be an exciting time at SpinalMotion," commented David Hovda, President and CEO. "We are obviously pleased with our first long-term lumbar results, the completion of enrollment in our lumbar study, and the imminent completion of enrollment in our cervical trial.

David Hovda is presenting on the company at the Spine Technology Summit in Berlin, prior to the May 1-4 SAS meeting. Both Kineflex discs will also be featured during an SAS industry workshop and in poster presentations at the meeting.

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.

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 25 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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