Theradaptive Receives US FDA Approval to Initiate P-III Trial of OsteoAdapt SP for Spinal Fusion Procedures
Shots:
- The US FDA has approved initiation of the P-III (OASIS) trial evaluating OsteoAdapt SP as an alternative to autologous & allograft bone graft in TLIF, ALIF, and LLIF procedures for symptomatic degenerative lumbosacral spine disease
- This approval builds on prior clinical experience in ~100 participants & expanded enrollment in Australia & Israel, while the OASIS trial was developed using technology licensed from the DHA Office of Medical Technology Transfer
- OsteoAdapt SP uses its AMP2 rhBMP-2 variant to drive targeted, sustained bone regeneration while reducing off-target effects and improving spinal fusion safety & efficacy
Ref: PRnewswire | Image: Theradaptive |Press Release
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