Spinal Restoration has completed enrolling patients in its Phase III Investigational new drug (IND) study of the Biostat System.
The Biostat System, which comprises a human derived, resorbable Biostat Biologx Fibrin Sealant, features the Biostat delivery device which is a proprietary application system designed to safely and effectively deliver the biologic to the intervertebral disc.
The blinded, randomized and placebo controlled study has enrolled 260-subject to demonstrate the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic low back pain.
The company said the study success will be assessed by comparing the success rates of the investigational and control groups at the 6-month primary endpoint.
Spinal Restoration president and CEO Gary Sabins said, "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 company said the outcomes from the Phase III study, along with data from its previous preclinical and pilot clinical studies will be useful to provide the basis for a biologic license application to the FDA in 2013.