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.
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