The HemiBridgeTM System has passed a Phase I clinical safety trial, with the device showing immediate post-operative decreases in curvature. Of the six individuals enrolled in the study, four patients have completed one-year follow-up visits, with early indications of positive performance results. In all six patients, spine deformities are either stable or improved. In one case, a curve correction of 70 percent occurred in one year, with indications of vertebral growth modification and disc height maintenance.
In the US, the FDA has approved a Humanitarian Use Device (HUD) designation for the HemiBridge System. The protocol for a Phase II trial also has been approved. In Europe, the device already has a CE Mark, giving it regulatory clearance to market. Four additional clinical trial sites, two each in England and Germany, have been prepared for a limited and strategic market release. Korean patents were approved.
Results of device effects on spine biomechanics in an in vitro model have been accepted for publication in the journal Spine. A second set of biomechanical tests is in analysis. Computational model growth modification results were presented at the Orthopaedic Research Society. Clinical safety trial results were presented at meetings of the Pediatric Orthopaedic Society of North America and the International Congress on Early Onset Scoliosis. An Instructional Course was presented at the American Academy of Orthopaedic Surgeons.