AUSTIN, Texas–(BUSINESS WIRE)–Spinal Restoration, Inc. announced today it has submitted the 6-month primary endpoint results from an ongoing 2-year IDE pilot study of the Biostat® System for treatment of chronic low back pain due to symptomatic internal disc disruptions to the Food and Drug Administration. The results of this three site, 15 patient pilot study are a key component of Spinal Restoration’s petition to initiate a larger pivotal trial.
“Submission of the 6-month outcomes from the pilot study of the Biostat System is another major milestone completed by Spinal Restoration,” said Gary Sabins, President and CEO. “We are very pleased by both the safety and efficacy measures obtained in the pilot study and believe they are supportive of moving into a pivotal study. This submission is a critical step in our efforts to bring this exciting intradiscal therapy to millions of patients who suffer from chronic discogenic low back pain.”
The 6-month results of the pilot study will be presented at the International Spine Intervention Society (ISIS) annual meeting in Toronto this July. In addition, complementary results from an animal model investigation of the Biostat System have been accepted for presentation at the North American Spine Society (NASS) annual meeting in November.
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 disruptions, reducing inflammation, and enhancing tissue repair.
Note: The Biostat System is an investigational device and is limited by federal law to investigational use only.