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 added.
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 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.
For more, visit: http://www.paradigmspine.com
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: http://www.chu-sainte-justine.org/
Paradigm Spine, LLC
CONTACT: Marc R. Viscogliosi of Paradigm Spine, LLC, +1-212-583-9700 ext.103; or Chris Storer of Creative Partners PR, Cell: +1-203-952-6403,cstorer@creativepartners.com
