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Kuros to Begin Fibrin-PTH Clinical Trial in Spinal Fusion -

Kuros Biosciences gained FDA approval for its Investigational New Drug (IND) application to initiate a Phase IIA clinical trial to evaluate Fibrin-PTH orthobiologic material (KUR-113) in single level transforaminal lumbar interbody fusion to treat degenerative disc disease, with autograft as comparator. This IND application is considered to be the first ever approval by FDA to evaluate a drug/biologic combination product candidate for lumbar interbody fusion. The prospective, randomized, controlled, open-label, multi-center parallel group study has a primary endpoint of radiographic interbody fusion, using CT-scans at 12 months. (Kuros Biosciences, 9/3/19)