FREDERICK, Md., April 30, 2026 /PRNewswire/ — Theradaptive, Inc., a clinical-stage biotechnology company pioneering targeted protein therapeutics for tissue regeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company to initiate the 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 (TLIF), Anterior Lumbar Interbody Fusion (ALIF), and Lateral Lumbar Interbody Fusion (LLIF) procedures for the treatment of symptomatic degenerative diseases of the lumbosacral spine. Theradaptive is the only advanced therapeutics company conducting investigational device exemption (IDE) studies with indications across all three of these surgical indications, positioning it to address the majority of spinal fusion needs.