Theradaptive earned the FDA's investigational device exemption approval to broaden its clinical research for the OsteoAdapt SP implant, the company said Dec. 10.
The new approval allows the company to expand its clinical program to include two more spinal fusion indications and triple the number of investigational sites in the U.S., according to a news release.
All indications approved are anterior lumbar interbody fusion, transforaminal lumbar interbody fusion and lateral lumbar interbody fusion.
OsteoAdapt SP is a biologic designed for patients with degenerative disc disease. The company is studying it in a Phase I/II clinical trial for patients with degenerative diseases of the lumbosacral spine.