Paradigm Spine to Fund Trailblazing Genetic Research to Introduce the First Diagnostic Test Able to Predict Idiopathic Scoliosis

Test Could Benefit Millions of Children Globally

Jun 05, 2006, 01:00 ET from Paradigm Spine, LLC

    NEW YORK, June 5 /PRNewswire/ -- A newly developed diagnostic test that
 promises to radically change the treatment of adolescent idiopathic
 scoliosis is to be evaluated in trials funded by Paradigm Spine, LLC.
 ('Paradigm'). The trials will be conducted at Montreal's renowned
 Sainte-Justine University Hospital Center ('Ste.-Justine'), known globally
 for its research into scoliosis and other neuro-musculoskeletal diseases.
 Paradigm focuses on development of less invasive and tissue-sparing
 treatments for spinal diseases.
     Marc R. Viscogliosi, Paradigm's Chief Executive, told an audience at
 Ste.- Justine: "I believe we may be on the brink of discovering the secret
 to the causes of scoliosis that until now were so complex that children
 were diagnosed purely on visual examination -- long after the disease had
 taken hold."
     Paradigm signed an agreement with Ste.-Justine to provide cash and
 various other resources through 2008 to complete trials of a blood test
 devised by Dr. Alain Moreau, director of Ste. Justine's Bone Molecular
 Genetics and Skeletal Malformations Laboratories.
     For Dr. Moreau, successful trials will validate work begun in 2001
 under the auspices of the Yves Cotrel Foundation, in France, and continued
 at Ste.- Justine. Idiopathic scoliosis afflicts more than one million
 adolescents (10- 16 years old), in North America of which 13% may undergo
 therapeutic bracing treatment or some form of surgical correction.
     To date the test has proven effective in identifying the presence of a
 genetic marker in animals and post-scoliotic patients. The proposed
 clinical trials are intended to demonstrate the effectiveness of the test
 using blood samples from early-stage scoliosis patients and an unaffected
 control group.
     "Dr. Moreau's trailblazing work suggests a major scientific
 breakthrough that would change the way adolescent scoliosis is diagnosed
 and treated. We have followed his work for some time and are delighted to
 provide support for this critical trial," Mr. Viscogliosi said.
     In its agreement with Ste.-Justine, Paradigm will receive the exclusive
 worldwide license to commercialize, manufacture, distribute, or sub-license
 any device, genetic tests, therapeutic agents, or any future technology
 derived from Dr. Moreau's scoliosis research.
     Dr. Moreau said: "Scoliosis is a gradual, debilitating condition, both
 physically and psychologically. Treatment is difficult because, until the
 curvature of the spine exceeds a 'normal' angle, indicating scoliotic
 progression, very little can be done to correct it. We hope that this new
 test will provide the answer so that timely and less invasive measures can
 be adopted to effectively treat the disease."
     According to Dr. Moreau, the results of his research, that began in
 2001, made him optimistic that the progression of scoliosis would be
 predictable in infants using well understood genetic markers.
     "The possibility of applying the results to future genetically based
 therapies is also very real and obviously quite exciting," Dr. Moreau
     Paradigm has followed closely Dr. Moreau's research and that of his
 colleagues for more than five years through its relationship with his
 colleague at Ste.-Justine, Dr. Charles Rivard. Dr. Rivard is the inventor
 of Orthobiom, an experimental non-fusion treatment for late stage
 scoliosis, also being developed by Paradigm.
     Mr. Viscogliosi added: "Underwriting Dr. Moreau's research will, we
 hope, be life changing not only for affected children, but also for my
 family. Having spent most of our working lives in the field of
 musculoskeletal research and development, my brothers and I are now
 fortunate to be able to provide significant funds for advancing
 life-changing treatments and technologies.
     During the past decade the Viscogliosi brothers have supported
 orthopedic and musculoskeletal development work at three university
 hospital spine units in France and at the New York Hospital for Special
 Surgery, the NYU Hospital for Joint Diseases, and the American Spinal
 Injury Association. The Viscogliosi brothers also founded the Spine
 Arthroplasty Society and several other spine-related organizations.
     The clinical trials for Dr. Moreau's new diagnostic test will include
 panels of children attending the three Ste.-Justine scoliosis clinics, as
 well as a control group of children with no symptoms of the disease. The
 results of the trials are expected to be available in early 2008.
     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 is concentrating on building a multi-product non-fusion
 portfolio. One product is the coflex(TM) device, a posterior non-fusion
 interspinous dynamically-functional implant, which has a long clinical
 history of over a decade of use and has been implanted in more than 10,000
 patients suffering from low back pain and lumbar spinal stenosis.
     Paradigm Spine's second core platform is the Orthobiom(TM) technology,
 also in development for over a decade. The Orthobiom(TM) technology treats
 adolescent idiopathic scoliosis, a condition in children which causes
 severe curvature of the spine and which is usually surgically treated with
 a spinal fusion procedure. The Orthobiom(TM) system is a non-fusion
 alternative designed to preserve the motion and growth of the child's
 spine. It is a revolutionary product that could potentially help the lives
 of tens of thousands of children each year.
     Paradigm Spine, LLC was founded in 2004 by Viscogliosi Brothers, LLC
 ('VB') and, in May 2006, completed a Series C private funding of $14
 million. 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
     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
     For more, visit:
     About CHU Sainte-Justine and its Research Centre
     The Sainte-Justine University Hospital Centre is the largest
 mother-child centre in Canada. It encompasses 450 beds, admits 19,000
 people annually and welcomes 260,000 patients at its Outpatients Clinic.
 With over 4,000 employees, it is one of the four largest pediatric centres
 on the American continent. Its research centre employs 163 researchers and
 320 postdoctoral graduates and training students. Important clinical and
 fundamental research activities are conducted there to better understand
 health problems of the mother, the foetus, the child and teenager, to
 optimize diagnostics and therapeutic solutions and offer genuine prevention
 programs. Affiliated with the Universite de Montreal, the Sainte-Justine
 UHC is by far Quebec's largest pediatric training centre, and a leader in
 Canada. Each year, it welcomes about 4,000 students. The global reach of
 the Sainte-Justine UHC and its research centre is considerable. The
 Sainte-Justine UHC will be celebrating its 100th anniversary in 2007.
     For more, visit:

SOURCE Paradigm Spine, LLC