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ORTHOSON’s Bio-Structural Gel was granted Breakthrough Device Designation by FDA. This micro-invasive treatment is designed to alleviate back pain due to degenerative disc disease.
ORTHOSON’s Bio-Structural Gel follows the natural fissures of degeneration in the nucleus pulposus of the intervertebral disc, before gelling in situ to form a highly-hydrated biology-supporting structure. The patented pNIPAM-DMAc co-polymer is designed to mimic the body’s own natural tissue in the nucleus pulposus, while restoring mechanical function of the intervertebral disc.
Bio-Structural Gel is scheduled to be clinically available next year.
“Gaining Breakthrough Device Designation is a significant achievement that will prioritize our work with the FDA as we go through the regulatory process,” said Ken Reali, chair of ORTHOSON. “ORTHOSON’s innovative Bio-Structural Gel is a significant innovation essential to changing the course of degenerative disc disease and positively impacting the multitudes of patients who have lower back pain.”
Source: ORTHOSON Limited
