VB Spine LLC (“VB Spine”), the largest privately-held spine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ScolimiR-3D, an in vitro diagnostic blood test designed to assess the risk of disease progression in patients diagnosed with adolescent idiopathic scoliosis (AIS). The designation is the first granted to a predictive diagnostic scoliosis risk assessment test.
ScolimiR-3D uses a standard blood draw to measure six circulating microRNAs associated with AIS progression and classify a patient’s risk of developing a severe spinal curve. Dr. Alain Moreau and colleagues at the Viscogliosi Laboratory in Molecular Genetics of Musculoskeletal Diseases, part of the Centre de recherche Azrieli du CHU Sainte-Justine and Université de Montréal, developed the underlying science, which was published in Scientific Reports.¹ In that study of 116 AIS patients, the six-microRNA panel that forms the basis of ScolimiR-3D predicted the risk of developing severe scoliosis with 100% sensitivity and 100% specificity in the study’s validation testing.
“For decades, physicians have had limited tools to determine which patients with adolescent idiopathic scoliosis are most likely to experience disease progression,” said Dr. Moreau. “The challenge in scoliosis is not simply detecting the curve—it is knowing where that curve is going. ScolimiR-3D was developed to bring that predictive dimension into clinical care: using a simple blood test to identify progression risk earlier, when there is still an opportunity to personalize treatment and potentially change a patient’s trajectory.”
The Role of VB Spine in Advancing Scoliosis Treatments
Scoliosis management today is largely reactive, with treatment decisions typically made only after curvature has progressed. ScolimiR-3D gives physicians the opportunity to structure conservative treatments, such as bracing, to align with the patient’s risk assessment. It also serves as an additional resource for counseling families across the continuum of care, from diagnosis through treatment planning, by providing a predictive risk assessment that goes beyond the traditional “wait and see” approach.
“Receiving FDA Breakthrough Device Designation is a significant milestone for this technology and for the future of scoliosis care,” said Marc Viscogliosi, co-CEO of VB Spine, speaking on behalf of his brothers and fellow co-CEOs Anthony and John Viscogliosi. “ScolimiR-3D will provide physicians with insights that support earlier, more informed decision-making. We’re proud to work alongside Dr. Moreau and his team to advance this work.”
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. VB Spine’s collaboration with Dr. Moreau has also been recognized through a nomination for the Scoliosis Research Society’s Hibbs Award. Additional research supporting the technology is expected to be presented at the Scoliosis Research Society (SRS) 2026 Annual Meeting, October 6–10 in Sydney, Australia.
Dr. Moreau is a paid consultant of VB Spine. The opinions expressed by Dr. Moreau are his own and not necessarily those of VB Spine. Individual experiences may vary.