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Spinal Kinetics Completes First Patient Implant
in Initial U.S.
Clinical Trial
M6(TM)-C Artificial Cervical Disc Design
is First to Replicate Natural Disc with Artificial Nucleus and
Annulus
March 4, 2008
SUNNYVALE, Calif.--(BUSINESS WIRE)--Spinal Kinetics, a leader
and innovator in advanced generation artificial disc technology,
today announced that it has enrolled the first U.S. Feasibility
Study patient and successfully implanted the company's M6-C artificial
cervical disc. This first procedure was completed at Olympia Medical
Center in Beverly Hills, California by leading spine surgeon Carl
Lauryssen, M.D., from the Institute for Advanced Spinal Research.
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.
The M6 artificial disc represents the company's first non-fusion,
motion preservation products to treat degenerative diseases of
the spine. The M6 is an advanced generation artificial disc developed
to replace an intervertebral disc damaged by cervical disc degeneration.
It is the only artificial disc that replicates the anatomic structure
of a natural disc by incorporating an artificial nucleus and annulus.
Together, the artificial nucleus and annulus are designed to provide
the same motion 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 proprietary surgical instrumentation. This
specialized system was designed with surgeon feedback and is intended
for simple, safe, and reproducible M6 implantation.
"We are extremely pleased with our recent FDA approval to move
forward with the M6 feasibility trial, as well as completion of
our first U.S. implantation by Dr. Lauryssen and his team at Olympia," says
Tom Afzal, Spinal Kinetics President and CEO. "The M6 artificial
cervical disc represents our initial commitment as an organization
to provide both physicians and patients alike the most innovative
motion preservation technologies for treating degenerative diseases
of the spine."
Artificial disc technology provides an alternative to spinal fusion
in the treatment of degenerative disc disease. Preserving motion
with an artificial disc provides an opportunity to restore biomechanical
function at the treated level after disc removal, as well as the
possibility to reduce subsequent degeneration of adjacent segments.
"The M6 artificial disc represents the latest advancement in artificial
disc technology with its unique structural and performance characteristics
and its ease of use," states Carl Lauryssen, M.D., Chief of Spine
Surgery at Olympia Medical Center in Beverly Hills, California. "As
a physician, I am excited that this technology is now clinically
available to patients, allowing us to conduct a strict and regimented
study to prove the M6's clinical benefits."
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.

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