Theradaptive recently disclosed that it has obtained FDA authorization to expand its study on OsteoAdapt SP. This enlarged trial incorporates three types of spinal fusion indications and will increase the number of investigational locations in the U.S. threefold.
Earlier this year, Theradaptive’s OASIS trial was initiated to assess the safety and effectiveness of OsteoAdapt SP in treating degenerative disc disease via the transforaminal interbody fusion (TLIF) method. The new FDA approval now expands to include anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). Recruitment for the added indications is slated to commence in early 2025.
Luis Alvarez, Theradaptive’s CEO, stated in a press announcement: “Theradaptive stands alone as an advanced therapeutics company engaging in IDE studies across ALIF, TLIF, and LLIF indications. This is indicative of the significance of the three breakthrough designations awarded by the FDA, empowering us to reach out to a wider patient population in need of this technology. Our TLIF trial is progressing according to plan, with multiple locations already operational and enrolling participants. This recent ALIF and LLIF approval hastens our market approach and fortifies our confidence in achieving commercialization.”
Designed for patients suffering from degenerative disc disease, OsteoAdapt SP is an experimental biologic leveraging Theradaptive’s AMP protein, a modified form of bone morphogenetic protein-2 (BMP-2), paired with a synthetic bone graft. The adjustments reduce off-target impact while maintaining BMP-2’s therapeutic qualities.
“ALIF and LLIF are gaining traction among spine specialists due to their capacity for larger interbody cages, facilitating a greater volume of graft material to promote fusion,” remarked Frank Vizesi, Theradaptive’s chief scientific officer. “When combined with TLIF, they constitute the majority of degenerative lumbar fusion procedures both presently and in the foreseeable future. Having FDA’s endorsement to investigate OsteoAdapt within these contexts offers Theradaptive the chance to mitigate our regulatory risks and ultimately aid more patients requiring spinal fusion.”
According to the company, preclinical studies have indicated that OsteoAdapt SP leads to quicker and more substantial bone formation compared to traditional autografts. The device is currently under assessment in Theradaptive’s OASIS Phase I/II clinical study.