SUNNYVALE, CA–(Marketwire – May 15, 2012) – Spinal Kinetics, Inc., the designer and manufacturer of the innovative M6® Artificial Disc, today announced that the German District Court in Mannheim has dismissed Synthes’ patent infringement claim involving German utility model No. DE 20321645U1 against Spinal Kinetics. The court also ordered that certain litigation costs are to be paid by Synthes.
The M6-C cervical and M6-L lumbar artificial discs help patients suffering from degenerative disc disease of the spine; a common cause of chronic and severe back and neck pain. The M6 technology provides an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of adjacent discs. Introduced internationally in 2006, M6 has quickly become one of the market leaders in Europe and is available in over 17 countries worldwide. With over 16,000 implants to date, the M6 continues to generate enthusiasm among both patients and surgeons desiring motion preservation.
“We are very pleased with the German District Court’s decision in this case,” said Tom Afzal, Spinal Kinetics’ President and CEO. “The German District Court’s decision, along with the earlier U.S. Federal District Court’s finding in December 2011, further validates our global intellectual property position.” In the U.S. case a jury found that Spinal Kinetics did not infringe on the Synthes patent in question (U.S. Patent No. 7,429,270), and, in addition, the jury also found the Synthes patent to be invalid.
The M6 is the only artificial disc that replicates the biomechanics of a natural disc by incorporating both an artificial nucleus and annulus. In the U.S., Spinal Kinetics has successfully completed an FDA IDE Pilot Study of the M6-C in patients with both single and two level cervical disc disease and has received approval from the FDA to initiate a large, multi-center Pivotal Study of the M6-C cervical disc.
About Degenerative Disc Disease
Between each vertebra throughout the spine is an intervertebral disc; a shock-absorbing pillow that helps maintain proper spacing, stability, and motion within the spine. Each disc has a fibrous outer band called the annulus fibrosus that encases a central, gel-like substance called the nucleus pulposus. The nucleus and annulus work together to absorb shock, help stabilize the spine, and provide a controlled range of motion between each vertebra. Degenerative disc disease is a condition caused by the breakdown of the intervertebral discs. Often brought on by age, the spine begins to show signs of wear and tear as the discs dry out and shrink. These age-related changes can put pressure on the spinal cord and nerves and may cause back pain and other spinal conditions such as spinal stenosis or a herniated disc.
About Spinal Kinetics
Founded in 2003, Spinal Kinetics is a privately held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to their unique biomechanical properties that mimic natural discs. The company is located in Sunnyvale, California.