ORTHOSON Earns Breakthrough Status for Bio-Structural Gel for Degenerative Disc Disease

ORTHOSON, a company developing novel treatments for back pain, has received breakthrough status from the U.S. Food and Drug Administration for its Bio-Structural Gel. The micro-invasive treatment aims to alleviate back pain due to degenerative disc disease (DDD).
 
The Bio-Structural Gel follows the natural fissures of degeneration in the intervertebral disc’s nucleus pulposus, before gelling in-situ to create a highly hydrated, biology-supporting structure. Its patented pNIPAM-DMAc co-polymer mimics the body’s natural tissue in the nucleus pulpous and restores the disc’s natural function, according to the company.
 
The gel is being developed in partnership with the University of Oxford’s Institute of Biomedical Engineering, the University of Sheffield, and Sheffield Hallam University and is expected to be in the clinic 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. Helping to guide the development and marketability of this product is the reason I joined the ORTHOSON Board at this exciting stage in the company evolution. Congratulations to the ORTHOSON team!”
 
“This recognition by the FDA is a result of the great work of ORTHOSON’s technical team of engineers, working closely with our academic collaborators and external advisors,” added ORTHOSON’s head of regulatory and quality Mey Saied, Ph.D., RAC. “It shows we have the capability, vision, and plan to meet the challenge of developing a new class of treatment for back pain head-on.”