Medical Device Daily

A diagnostic test for adolescent idiopathic scoliosis has been developed in trials with funding to be continued by Paradigm Spine (New York) for a test which could be commercialized in 2008, following the results of the clinical trials also expected that year.

The trials will be conducted at Sainte-Justine University Hospital Center (Montreal), which Paradigm said is “known globally for its research into scoliosis and other neuro-musculoskeletal diseases.”

“The diagnostic has already been validated in animals and in scoliotic children, so what we're doing at this point is doing a second level of validation – really the final level of validation comparing scoliotic children with non-scoliotic children,” Marc Viscogliosi, CEO of Paradigm, told Medical Device Daily.

Paradigm entered an agreement with Sainte-Justine to provide cash and “various other resources” through 2008 to complete trials of a blood test developed by Dr. Alain Moreau, director of Sainte-Justine's Bone Molecular Genetics and Skeletal Malformations Laboratory.

“I really think this research is the dawn of a new era for scoliosis,” Viscogliosi said. “And where we are now, in very short order, we're going to be able to identify what kind of children are at risk for curvature progression. And what that will do is allow the children to be treated earlier and to correct the disease and prevent the progression of the disease much sooner in the process.”

Paradigm will receive the exclusive worldwide license to commercialize, make, distribute or sub-license any device, genetic tests, therapeutic agents or “any future technology” developed based on Moreau's research.

“We are very excited about the potential for pharmacological solutions that will result from this,” Viscogliosi said.

He said that the blood test is “for determining melatonin-signaling dysfunction in children. And the level of that dysfunction you can correlate with the scoliotic curve and the evolution of that dysfunction,” he added, noting that the diagnostic is akin to a “biochemical marker.” The current thinking is that the diagnostic test could be conducted on a child “at any age.”

“Scoliosis is a gradual, debilitation condition, both physically and psychologically,” Moreau said in a statement.

Idiopathic scoliosis affects more than 1 million adolescents ages 10-16 in North America, of which 13% may undergo therapeutic bracing or some form of surgical correction, the company said.

“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,” Moreau said. “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.”

Moreau began his work in 2001 funded by the Yves Cotrel Foundation (Paris), work that he has continued at Sainte-Justine. Together with the investment by Paradigm, an amount Viscogliosi said has not been publicly disclosed, the total investment will have totaled in the “millions of dollars,” he said.

Paradigm, which is focused on providing “indication-specific posterior non-fusion solutions for orthopedic spine surgeons and neurosurgeons,” said that it has followed Moreau's research and that of his colleagues for more than five years through its relationship with his colleague at Sainte-Justine, Dr. Charles Rivard. Rivard is the inventor of Orthobiom, which Paradigm describes as an “experimental non-fusion treatment for late-stage scoliosis,” also being developed by Paradigm.

“Dr. Moreau's trailblazing work suggests a major scientific breakthrough that would change the way adolescent scoliosis is diagnosed and treated,” Viscogliosi said. “We have followed his work for some time and are delighted to provide support for this critical trial.”

He said he believes that because of the way scoliosis is managed today, by the time it can be diagnosed, “the disease has already taken hold and has had a huge impact on the child. But if we can catch that disease earlier and say the progression of it is going to be stopped much earlier in the cycle, [then] we can treat that earlier in the cycle.”

Paradigm Spine was founded in 2004 by Viscogliosi Brothers (VB), and in May completed a Series C private funding of $14 million. VB was established by Marc, John and Anthony Viscogliosi in New York in 1999. Paradigm said VB is the first VC/private equity and merchant banking firm devoted to the musculoskeletal-orthopedics device sector of the healthcare industry.

Viscogliosi and his brothers have supported through funding 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 (Atlanta).