AUSTIN, Texas, September 9, 2008 — Spinal Restoration, Inc. announced today it has completed enrollment in the Investigational Device Exemption (IDE) pilot study of the Biostat 00AE,(R) Disc Augmentation System. Six month clinical results from this three site, 15 patient study are expected to be available in early 2009.
The goal of the study is to examine the safety and efficacy of the Biostat Disc Augmentation System in the treatment of chronic discogenic low back pain resulting from Internal Disc Disruptions (IDD). The pilot study is being conducted at three clinical sites which are led by three of the world’s leading clinical researchers of interventional spine therapies, Dr. Kevin Pauza (Tyler, TX), Dr. Way Yin (Bellingham, WA), and Dr. Wayne Olan (Bethesda, MD).
“Spinal Restoration would like to thank our three clinical investigators and their staffs for their efforts in enrolling this pilot study in such a short period,” said Gary Sabins, President and CEO of Spinal Restoration, Inc. “This pilot study is a critical step in our combined efforts to bring this exciting intradiscal therapy to millions of patients who suffer from chronic discogenic low back pain.”
The Biostat Disc Augmentation System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, 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 pain by sealing the painful disruptions, reducing inflammation, and enhancing tissue repair.
Results from the pilot study will be combined with results from ongoing laboratory and animal research to support an application for a pivotal trial of the Biostat Disc Augmentation System in 2009.
About Spinal Restoration
Spinal Restoration restores patients’ lives by delivering new therapies that address unmet needs in spine health management. These therapies are minimally invasive, early interventions with clinically proven results. The company is working with a diverse, highly regarded group of clinical and scientific advisors to develop the Biostat Disc Augmentation System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain. Visit www.spinalrestoration.com for more information.