Osteo-Adapt SP is developed for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis
Theradaptive has secured FDA breakthrough medical device status for its Osteo-Adapt SP spinal fusion implant. (Credit: kalhh from Pixabay)
Biopharmaceutical firm Theradaptive has secured breakthrough medical device status from the US Food and Drug Administration (FDA) for its Osteo-Adapt SP spinal fusion implant.
Osteo-Adapt SP has been developed for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis.
The company has designed its regenerative implants to facilitate precise tissue regeneration for different tissue types and clinical indications.
The new technology is said help deliver better outcomes and provide enhanced safety, as well as provide improved ease of use.
Theradaptive clinical and regulatory operations senior vice president John Greenbaum said: “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.
“This opens the door to entirely new treatments for conditions that currently have very few options.”
The FDA breakthrough devices programme will allow the company to have priority review and interactive communication with the FDA regarding device development and clinical trial protocols during the premarket review process.
Theradaptive is involved in the development of a therapeutic delivery platform technology for targeted tissue regeneration, which is estimated to have a total addressable market of more than $10bn in various clinical indications.
The company, which was spun out of the Massachusetts Institute of Technology, secured significant research and development support from the US Department of Defense.
Theradaptive carries out operations from Frederick of Maryland and Boston of Massachusetts.