STIMULAIS · A novel muscular micro-electro-stimulation device for the enhanced treatment of adolescent idiopathic scoliosis avoiding bracing and invasive open surgery

Adolescent idiopathic scoliosis (AIS) is a progressive structural spinal deformity that affects around 2-3% of children aged between 10 and 16 in the world. Current conservative treatments (bracing and physiotherapy) are not sufficiently effective in stopping curve progression, so that more than 40.000 patients per year need an invasive fusion surgery that eliminates spine mobility. Recent studies evidenced that the spine deformity is a musculoskeletal expression of a central nervous system disorder that affects the paraspinal muscles inducing an imbalance of forces acting over the vertebral segments. The results of these studies and the work of a renowned clinical research group participating in the project (UCV) constitute the basis for the StimulAIS project, whose main objective is the development of a novel device for the treatment of AIS by muscular electro-stimulation of the deep paraspinal rotator muscles. The novel system will provide a customized treatment protocol to each patient, with targeted stimulation and real time control to maintain stimulation effectiveness and maximize treatment outcome. This device will be capable of stopping progression of the curvature and of correcting it, avoiding the side effects of current solutions, reducing the rate of surgery, and being cost effective compared to the abovementioned methods. The consortium integrates three SMEs along the product value chain, experienced in manufacturing and distribution of medical devices, surgical instruments and electrotherapy systems. The core R&D activities will be carried out by UCV, and two more RTD centers, namely IBV and FRAUNHOFER-IPMS, who have the necessary capabilities to achieve the objectives through development, integration and validation stages. The expected potential market for the StimulAIS device is about 400M€ in Europe and total Consortium’s turnover expected within four years after implementation will reach over 45M€, being around 9M€ the consortium benefits.