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Theradaptive's OsteoAdapt SP Spinal Fusion Trial Expands to ALIF and LLIF Procedures

• Theradaptive's OsteoAdapt SP clinical trial expands to include anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF) procedures, alongside the existing transforaminal interbody fusion (TLIF) approach. • The FDA approved expansion triples the number of investigational sites in the U.S., facilitating broader patient access to the study of this novel therapy for degenerative disc disease. • OsteoAdapt SP combines a modified bone morphogenetic protein-2 (BMP-2) with a synthetic bone graft, aiming to enhance bone formation while minimizing off-target effects compared to traditional BMP-2. • Enrollment for ALIF and LLIF study participants is expected to commence in early 2025, potentially accelerating the path to market for this investigational biologic.

Theradaptive has received FDA approval to expand its Phase I/II clinical trial for OsteoAdapt SP to include anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF) procedures, in addition to the already approved transforaminal interbody fusion (TLIF) approach. This expansion triples the number of investigational sites across the U.S. and is set to begin enrolling patients in early 2025. The OASIS trial is designed to evaluate the safety and efficacy of OsteoAdapt SP in treating degenerative disc disease.

Addressing a Broad Spectrum of Spinal Fusion Needs

According to Theradaptive, the inclusion of ALIF and LLIF, along with TLIF, allows the company to address the vast majority of degenerative lumbar fusion procedures. Frank Vizesi, Chief Scientific Officer at Theradaptive, noted that ALIF and LLIF are gaining popularity among spine surgeons due to their capacity to accommodate larger interbody cages and a greater volume of graft material to encourage fusion. M. Craig McMains, MD, of OrthoIndy, performed the world's first ALIF with the OsteoAdapt SP implant as part of this clinical trial.

OsteoAdapt SP: A Novel Approach to Bone Regeneration

OsteoAdapt SP is an investigational biologic that combines Theradaptive’s protein AMP, a modified version of bone morphogenetic protein-2 (BMP-2), with a synthetic bone graft. The modification is designed to minimize off-target effects while maintaining the therapeutic benefits of BMP-2. Preclinical studies have indicated that OsteoAdapt SP achieves faster and more robust bone formation compared to traditional autografts.

Clinical and Commercial Implications

Theradaptive's CEO, Luis Alvarez, emphasized that the expansion of the OASIS trial underscores the value of the three breakthrough designations awarded by the FDA. He stated that this expansion enables the company to treat a larger number of patients and strengthens their confidence in the path to commercialization. The ongoing TLIF trial is progressing as planned, with multiple sites already activated and enrolling patients.

About Degenerative Disc Disease

Degenerative disc disease is characterized by the deterioration of spinal joints, leading to pain and dysfunction. OsteoAdapt SP aims to address this condition by promoting bone formation and spinal fusion. The trial is currently enrolling patients to evaluate the safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine.
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Reference News

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OrthoIndy debuts new spine technique in clinical trial
beckersspine.com · Feb 4, 2025
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Theradaptive expands FDA-approved spinal fusion clinical trial - MassDevice
massdevice.com · Dec 11, 2024

Theradaptive received FDA approval to expand its OsteoAdapt SP clinical trial for spinal fusion, adding ALIF and LLIF in...

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Theradaptive Obtains FDA IDE Approval to Study OsteoAdapt™ SP in Additional Spinal ...
prnewswire.com · Dec 10, 2024

Theradaptive's FDA-approved expansion of its Phase I/II clinical program includes three spinal fusion indications (ALIF,...

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