Spinal Restoration, Inc. announced that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.
If successful, the Biostat System Phase III study could have an extensive, far-reaching impact on the diagnosis and treatment of discogenic chronic low back pain-a debilitating health condition that affects an estimated four million adults in the U.S. annually.
About the Biostat System
The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.
More detailed information about the Biostat System study is available at http://www.clinicaltrials.gov (Study Identifier: NCT01011816).