Theradaptive Wins FDA Nod for Pivotal Trial of OsteoAdapt SP

Theradaptive revealed that the U.S. Food and Drug Administration (FDA) approved it to begin the pivotal Phase 3 clinical trial evaluating OsteoAdapt SP, its next-gen regenerative therapeutic for spinal fusion procedures.

The OASIS trial is assessing 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) to treat symptomatic degenerative diseases of the lumbar spine.

Theradaptive claims it’s the only advanced therapeutics company conducting investigational device exemption (IDE) studies with indications across all three of these surgical indications.

The approval builds on successful treatment of about 100 participants in earlier clinical experience and expansion of enrollment at sites in Australia and Israel. The move to pivotal study is a significant step on the path to FDA premarket approval (PMA) and U.S. commercialization of OsteoAdapt SP.

The OASIS trial was developed using technology licensed from the DHA Office of Medical Technology Transfer.

“Receiving authorization to initiate our pivotal Phase 3 trial is a defining milestone for Theradaptive and an important step toward delivering a much-needed solution for patients living with degenerative spinal conditions,” said Dr. Luis Alvarez, founder and CEO of Theradaptive. “Our focus is now on disciplined clinical execution and close collaboration with leading investigators to generate the high-quality data needed to advance this field and improve patient outcomes.”

Earlier this year, the company forged a strategic partnership agreement with Alphatec (ATEC) to widen the scope of osteoconductive bone grafts in spinal fusions.