FDA Grants Breakthrough Device Designation to ORTHOSON's Bio-Structural Gel
ORTHOSON , a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio-Structural Gel product has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
- ORTHOSON , a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio-Structural Gel product has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
- 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.
- “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.
- “We believe the Breakthrough Device Designation for our Bio-Structural Gel is a testament to our team's spirit of innovation and dedication.