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SpinalMotion Enrolls 80th Patient in U.S. Cervical and Lumbar Artificial Disc Clinical Studies

Posted on: Tuesday, 27 September 2005, 09:00 CDT

Worldwide Clinical Experience Tops 600 Patients; Company Secures $5 Million Growth Capital Line

SpinalMotion, developer of investigational artificial discs for treating patients with degenerative disc disease, today reported significant progress on two clinical trials aimed at evaluating its Kineflex(TM) lumbar disc and Kineflex/C(TM) cervical disc implants. Earlier this year, the company received Investigational Device Exemption (IDE) approvals from the U.S. Food & Drug Administration (FDA) to commence the studies, which began during the second quarter. As of now, over 80 patients are enrolled in the U.S.-based studies, bringing to over 600 the number of patients worldwide implanted with a Kineflex disc. The company is also expected to close a $5 million growth capital line next month.

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 for accurate placement. Both discs are currently approved for sale in South Africa, where they were developed.

"Our two U.S. clinical trials are progressing well and we are pleased with the early feedback," said David Hovda, President and CEO of SpinalMotion. "With Kineflex discs being implanted internationally for three years now, we are excited to be adding U.S. data to our worldwide clinical experience."

As reported earlier by SpinalMotion, the lumbar trial involves 25 U.S. sites. In this randomized study, the investigational SpinalMotion Kineflex(TM) 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(TM) to fusion. Both trials are designed to demonstrate equivalent 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. 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, building upon a design and clinical work conducted initially by Southern Medical, a spinal implant company in South Africa, and Ulrich Hahnle, M.D., an orthopedic spine surgeon in South Africa. 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: Business Wire

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