Spinal Restoration, Inc. announced today the completion of enrollment in the Phase III Investigational New Drug (IND) study of the Biostat System. The Phase III clinical trial is a 260-subject, randomized, blinded, placebo controlled study designed to assess the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic low back pain. The study is being conducted at 20 centers across the U.S.
“If successful, the Phase III study of the Biostat System could have an extensive, far-reaching impact on the diagnosis and treatment of millions of patients who suffer from the debilitating effects of chronic discogenic low back pain.”
Gary Sabins, President and CEO of Spinal Restoration, expressed high praise for the commitment and tireless efforts of the clinical investigator teams that are participating in the study. "The Phase III study of the Biostat System is one of the most ambitious clinical studies ever attempted by interventional spine physicians. Spinal Restoration is extremely honored to be working with this team of investigators who are dedicated to developing the rigorous scientific evidence necessary to clearly demonstrate the safety and efficacy of the Biostat System." Mr. Sabins concluded by saying, "If successful, the Phase III study of the Biostat System could have an extensive, far-reaching impact on the diagnosis and treatment of millions of patients who suffer from the debilitating effects of chronic discogenic low back pain."
The Biostat System is the first intradiscal biologic therapy for discogenic pain to complete enrollment of a Phase III IND study. Enrollment of the study was initiated in 2010 after Spinal Restoration reached Special Protocol Assessment concurrence with the U.S. Food and Drug Administration for the study design, endpoints, and planned statistical analysis. Study success will be determined by comparing the success rates of the investigational and control groups at the 6-month primary endpoint. Additional information about the Biostat System study is available at www.clinicaltrials.gov (Study identifier: NCT01011816). Spinal Restoration expects the outcomes from this study, along with data from its previous preclinical and pilot clinical studies, to provide the basis for a Biologic License Application to the FDA in 2013.
COVID-19 increases chronic fatigue risk