Theradaptive Advances Pivotal Phase 3 Trial of OsteoAdapt SP

Theradaptive received FDA approval to initiate a pivotal Phase 3 clinical trial evaluating OsteoAdapt SP, its next-generation regenerative therapeutic for spinal fusion procedures.

The OASIS trial is evaluating OsteoAdapt SP as an alternative to autologous and allograft bone graft in single-level Transforaminal Lumbar Interbody Fusion, Anterior Lumbar Interbody Fusion, and Lateral Lumbar Interbody Fusion procedures for the treatment of symptomatic degenerative diseases of the lumbosacral spine.

In 2024, FDA approved an expansion to Theradaptive’s Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the U.S.

OsteoAdapt SP is Theradaptive’s lead investigational therapeutic, powered by AMP2, a proprietary rhBMP-2 variant engineered to promote targeted, sustained bone regeneration. By minimizing off-target effects and addressing key limitations of current graft materials, OsteoAdapt SP aims to meaningfully improve both the safety and efficacy of spinal fusion.

Source: Theradaptive