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PRESS RELEASES
Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103
PARADIGM
SPINE RECEIVES CE
MARK FOR COFLEX-F INTERSPINOUS FUSION DEVICE.
NEW YORK NY, December 15, 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 coflex-F!".
The CE Mark will allow Paradigm Spine to begin marketing the coflex-F!"
in Europe and many countries around the world that recognize the certification.
Coflex-F™ is an interspinous fusion device intended for use as
an adjunct to lumbar fusion in skeletally mature patients with clinically
symptomatic one- or two-level degenerative disc disease (DDD) from L1-L5.
Coflex-F™ is an indication-specific evolution of Paradigm's coflex!",
a dynamically functional non-fusion interspinous implant used in the
treatment of moderate to severe spinal stenosis, and currently undergoing
an FDA-approved clinical trial in the United States.
The coflex-F™ system, including implants and instruments, was
developed with a surgeon team to specifically address the needs of patients
suffering from DDD. Coflex-F™ is intended to provide a level of
segmental spinal stabilization similar to that of pedicle screws, but
less invasive, tissue sparing and preserving pedicle anatomy.
Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said,
"This milestone demonstrates our commitment to developing a comprehensive
portfolio of spine non-fusion products.
"Although coflex-F™ is a fusion product, the intended application,
with its unique features and benefits, may assist in reducing the long-term
incidence of adjacent segment degeneration in DDD patients," he
added.
Coflex-F™ becomes Paradigm's third product to receive a CE Mark,
including coflex!" and the Dynamic Cervical Implant (DCI!"),
which received CE Mark on December 5, 2006.
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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