Frederick-based Theradaptive gets FDA approval for spine fusion clinical trials

Theradaptive, the Frederick-based targeted regenerative therapeutics company, Thursday gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.

With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain.

Theradaptive’s spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion (TLIF) procedures, whereby vertebrae in the lower back are fused in a minimally invasive posterior procedure. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis, and spinal stenosis.

The company’s therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically precise and locally sustained therapeutic delivery. IDE approval from the FDA serves as a key milestone for this platform and will generate its first human clinical data, thus opening a new chapter in Theradaptive’s growth into a clinical-stage company.

Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study. The study will produce early interim data to permit interim assessments of safety and efficacy.