SpinalMotion Submits Lumbar Disc PMA

* Reuters is not responsible for the content in this press release.

Thu Nov 12, 2009 10:00am EST

Completes $27.4M Financing, Enrolls Lateral Lumbar Disc Patients in Clinical
Study
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.

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



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.