Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion implant.
Frederick, Maryland-based Theradaptive designed the Osteo Adapt SP implant for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis.
According to a news release, the company touts its regenerative implants as best-in-class with designs to permit precise tissue regeneration for a variety of tissue types and clinical indications.
Cleveland Clinic’s Dr. George Muschler said in the release that the technology may provide “several significant advantages” over current state-of-the-art offerings in spinal fusion and musculoskeletal repair, including improved safety and more consistent outcomes.
“This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible,” Theradaptive SVP of Clinical & Regulatory Operations John Greenbaum said. “This opens the door to entirely new treatments for conditions that currently have very few options.”