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SpinalMotion Submits Lumbar Disc PMA


11/12/2009 8:38:30 AM

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MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SpinalMotion, developer of the investigational Kineflex® lumbar and Kineflex/C® cervical disc implants for treating patients with degenerative disc disease (DDD), today reported that it has submitted the Pre-Market Approval (PMA) to FDA for the Kineflex lumbar artificial disc. The company also announced that it has secured $27.4 million in Series D funding and reached 20% enrollment for a laterally placed lumbar artificial disc clinical study.

The lumbar PMA clinical study involved 21 U.S. sites and a two-year patient follow-up period. During the study, the SpinalMotion Kineflex lumbar disc was compared to another FDA-approved lumbar artificial disc.

“Submitting our lumbar PMA caps more than six years of work in product development, clinical studies, and patient follow up,” explains David Hovda, SpinalMotion president and CEO. “We are very pleased with this milestone and the support of our clinical centers, and we look forward to working with FDA in the coming months.”

Securing Series D funding is another significant milestone for the company. SpinalMotion plans to use the additional funds for completing its Kineflex/C cervical disc PMA application and developing its next-generation artificial discs. It total, the company has enrolled and completed two year follow up on over 750 patients in its U.S. clinical trials. SpinalMotion continues to make progress on its lateral lumbar disc study, with approximately 20% enrollment completed.

“Our success in raising money indicates strong support from the investors who know us best,” said David Hovda. “We welcome our new investor, DAFNA Capital Management, and look forward to continuing our progress in developing motion preserving technologies for spinal patients.”

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 lower-back pain. In fact, an estimated 18% of the population has debilitating back pain at any given time. These demographics, along with the tremendous cost 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. The company was founded in June 2003 and is located in Mountain View, California. To learn more, visit 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.

Contact:

SpinalMotion David Hovda, 650-947-3472 ext. 210

Read at BioSpace.com

   

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