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PRESS RELEASES
Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103
PARADIGM
SPINE RECEIVES CE MARK FOR DYNAMIC CERVICAL IMPLANT.
NEW YORK NY, December 7, 2006 - Paradigm Spine, LLC, a developer
of innovative posterior non-fusion spinal implant solutions, announced
that it has received a European Union CE Mark for its Dynamic Cervical
Implant (DCI™)
The CE Mark will allow Paradigm Spine to begin marketing the DCI™
in Europe and many countries around the world that recognize the certification.
The DCI™ is a titanium implant that is designed for patients suffering
from early stage degenerative disc disease (DDD) in the cervical spine.
Paradigm's DCI™ implant was developed originally through collaboration
between Guy Matge, MD and Fixano, SAS , both of France, in 2001. Fixano
was acquired by Viscogliosi Bros., LLC, the founder of Paradigm Spine,
in 2005.
The DCI™ is a dynamic cervical nucleus-like replacement device
designed to maintain flexion and extension as well as compression. It
has a long-term clinical experience of up to four years in a multi-patient
trial that has yielded positive results to date.
Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said,
"With the benefit of the CE mark, we are planning to expand our
marketing of the DCI™ implant to surgeons treating patients with
early stage DDD. It is simple to implant through a minimally invasive
procedure and promises to be a viable motion-preserving alternative
to total disc replacement or fusion," he added.
Dr. Matge, inventor of the device, said, "the DCI™ implant
is designed with axial compliance properties that closely mimic those
of the intact segment of the cervical spine."
About Paradigm Spine, LLC
Paradigm
Spine is a company focused on providing indication specific posterior
non-fusion solutions for orthopedic spine surgeons and neurosurgeons
focused on treating spinal conditions and diseases.
The company's founding philosophy is "Surgeon Centric, Indication
Specific, Data Driven," and focuses on providing the best clinical
outcomes for patients suffering from chronic back pain. The Company
has 38 employees at its New York headquarters and an office in Wurmlingen,
Germany, including a 7-member direct sales force in Germany.
The company is concentrating on building a multi-product non-fusion
portfolio. The company's signature product is the coflex™ posterior,
non-fusion interspinous dynamically-functional implant. The company
has commenced a multi-center IDE clinical trial of the coflex™
implant in the United States.
Paradigm Spine's other core platform is the Orthobiom™ technology,
which has been in development for over a decade. The Orthobiom™
technology treats adolescent idiopathic scoliosis, a condition that
causes severe curvature of the spine that can be corrected surgically
through a spinal fusion procedure. The Orthobiom™ system is a
non-fusion alternative designed to preserve the motion and growth of
the child's spine. It is regarded as a revolutionary product with the
potential to help the tens of thousands of children diagnosed annually
with scoliosis.
Paradigm Spine, LLC was founded in 2004 by Viscogliosi Brothers, LLC.
(VB). Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony
G. Viscogliosi in New York City, in 1999, VB is the first venture capital/private
equity and merchant banking firm dedicated to the $26.4 billion musculoskeletal/orthopedics
device sector of the health care industry.
Today, VB is a leading independent firm, with a mission to create, build
and finance companies founded on innovations developed by surgeons and
uniquely focused on "life-changing" musculoskeletal/orthopedic
technologies. VB has worldwide surgeon, industry and trade relationships
and significant financial expertise in the musculoskeletal/orthopedic
sector.
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