SpinalMotion, Inc. (SpinalMotion) has filled a Pre-Market Approval (PMA) application to US Food & Drug Administration (FDA) for the Kineflex lumbar artificial disc. In addition, the company has secured $27.4 million in Series D funding and enrolled 20% of estimated patients for a laterally placed lumbar artificial disc clinical study.
The lumbar PMA clinical study involved 21 US 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. In total, the company has enrolled and completed two year follow up on over 750 patients in its US 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.”