Spinal Kinetics Completes Patient Enrollment of Initial U.S. Clinical Trial

[Harrison]

Tuesday, Jun. 24, 2008
Spinal Kinetics Completes Patient Enrollment of Initial U.S. Clinical Trial

M6(TM)-C Artificial Cervical Disc Successfully Implanted in Patients with Single and Two Level Degenerative Disc Disease

SUNNYVALE, Calif. — Spinal Kinetics, a leader and innovator in advanced generation artificial disc technology, today announced that it has successfully completed patient enrollment in it's M6-C artificial cervical disc U.S. Feasibility Study. A total of thirty patients, with either single or two level degenerative disc disease, were implanted with the M6-C cervical disc. The study was completed at three participating study centers located in North Carolina and California. Last December the company received approval from the U.S. Food and Drug Administration (FDA) to initiate a study evaluating the M6-C artificial cervical disc with patients suffering from degenerative disc disease of the cervical spine; a common cause of neck and arm pain. These thirty patients will continue to be followed to assess the preliminary safety and effectiveness of the M6-C cervical disc.

The M6 artificial disc represents the company's first motion preservation product to treat degenerative diseases of the spine. The M6-C is an advanced generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. It is the only artificial disc designed to replicate the anatomic structure of a natural disc by incorporating an artificial nucleus and annulus. Together, the artificial nucleus and annulus are designed to provide similar motion and performance characteristics of a natural disc.

The M6's compressible polymer nucleus is designed to simulate the function of the native nucleus, while the surrounding multi-layer high tensile strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions. The M6 artificial disc is implanted with surgical instrumentation that was designed with surgeon feedback and is intended for simple, safe and reproducible M6 implantation.

"The completion of patient enrollment for our M6-C U.S. Feasibility Trial is a major milestone for our organization and we look forward to the follow up results of these thirty patients," says Tom Afzal, Spinal Kinetics President and CEO. "We are extremely grateful to our investigators and their research organizations in helping us complete enrollment in such a rapid manner. We now look forward to our continued partnership with them as we move into the follow up phase of the trial."

The Feasibility Trial results will be used to gain FDA clearance to initiate a broader U.S. pivotal trial to study the safety and efficacy of the M6-C artificial cervical disc in a larger population of patients with degenerative disc disease of the cervical spine.

"Overall we were extremely pleased with the intra-operative performance of the M6 cervical disc, as well as the simplicity and ease of implanting the device during the study," states Thomas Dimmig, MD, Principal Study Investigator from Triangle Orthopedic Associates in Durham, NC. "The natural design characteristics of this artificial disc may provide added clinical benefit for our disc replacement patients by more accurately replicating the biomechanical motion of the natural disc we remove. We will be closely assessing our patient outcomes to gain further insight to the benefits of this unique design."

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 company is located in Sunnyvale, California. For more information on the company and the M6 artificial disc visit www.spinalkinetics.com.

Spinal Kinetics, Inc Tom Afzal, President/CEO, 408-636-2500