Theradaptive Secures FDA Approval to Advance OASIS Trial to Pivotal Study Evaluating OsteoAdapt® SP in Spinal Fusion

FDA authorization marks critical milestone enabling advancement of next-generation bone regeneration therapy for patients with degenerative spinal diseases

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.

This approval builds on a robust clinical foundation, including the successful treatment of approximately 100 participants in earlier clinical experience, and the expansion of enrollment across sites in Australia and Israel. The advancement to pivotal study marks a significant step on the path to FDA premarket approval (PMA) approval 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."

About Degenerative Spinal Conditions

80% of American adults will experience low back pain in their lifetime, and nearly one in three live with a diagnosed degenerative spinal condition. As the population ages, prevalence will continue to rise — driving demand for safer, more effective, and more innovative treatments, and underscoring the importance of advancing therapies like those in Theradaptive's clinical programs.

About the Orthobiologics Market

The global bone graft substitute segment is a significant and expanding market, currently valued at over $3 billion and projected to exceed $5 billion by the early 2030s. For nearly 25 years, the recombinant protein segment has been led by a single commercialized legacy product, which achieved peak annual revenues nearing $900 million. The anticipated commercialization of OsteoAdapt represents a pivotal opportunity to disrupt this long-standing market concentration, capture meaningful share, and deliver substantial value to Theradaptive's stakeholders.

OsteoAdapt® SP and AMP2™ Technology

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.

Note: OsteoAdapt® SP is an investigational device and is not approved for commercial sale. Limited by U.S. Federal law to investigational use only.

About Theradaptive

Theradaptive  is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, dental, and soft tissue repair and targeted therapeutics in diverse areas such as immuno-oncology. The company leverages its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. For more information about Theradaptive and its clinical development program, visit www.theradaptive.com and follow the company on LinkedIn.

The work was supported by the Assistant Secretary of Defense for Health Affairs in the Department of Defense, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.

Media & Investor Contact:
Serena Santiago - [email protected]

SOURCE Theradaptive