FDA approved an expansion to Theradaptive’s Phase I/II clinical program for OsteoAdapt SP, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the U.S.
OsteoAdapt SP is an investigational biologic designed for patients with degenerative disc disease. It combines AMP2 engineered protein, a modified, adhesive variant of the powerful bone-forming growth factor bone morphogenetic protein-2 (BMP-2) with a synthetic bone graft. This modification allows OsteoAdapt SP to retain BMP-2’s therapeutic benefits while minimizing off-target effects often associated with BMP-2.
In multiple large animal studies, OsteoAdapt has demonstrated more robust and faster bone-formation than the gold standard autograft. OsteoAdapt is limited by Federal (or United States) law to investigational use. Theradaptive is currently enrolling patients in OASIS, its Phase I/II clinical trial evaluating safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine.
The OASIS trial was approved by FDA earlier this year to assess the safety and efficacy of OsteoAdapt SP, Theradaptive’s implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.
FDA approved an expansion to Theradaptive's Phase I/II clinical program for OsteoAdapt SP, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the U.S.
OsteoAdapt SP is an investigational biologic designed for patients with degenerative disc disease. It combines AMP2 engineered protein,...
FDA approved an expansion to Theradaptive’s Phase I/II clinical program for OsteoAdapt SP, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the U.S.
OsteoAdapt SP is an investigational biologic designed for patients with degenerative disc disease. It combines AMP2 engineered protein, a modified, adhesive variant of the powerful bone-forming growth factor bone morphogenetic protein-2 (BMP-2) with a synthetic bone graft. This modification allows OsteoAdapt SP to retain BMP-2’s therapeutic benefits while minimizing off-target effects often associated with BMP-2.
In multiple large animal studies, OsteoAdapt has demonstrated more robust and faster bone-formation than the gold standard autograft. OsteoAdapt is limited by Federal (or United States) law to investigational use. Theradaptive is currently enrolling patients in OASIS, its Phase I/II clinical trial evaluating safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine.
The OASIS trial was approved by FDA earlier this year to assess the safety and efficacy of OsteoAdapt SP, Theradaptive’s implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.
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