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 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...
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.
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