Spinal Restoration completes enrollment for pilot study of Biostat system

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.

The pilot study is being conducted at three clinical sites which are led by three clinical researchers of interventional spine therapies, Kevin Pauza (Tyler, Texas), Way Yin (Bellingham, Washington), and Wayne Olan (Bethesda, Maryland).

According to the company, 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. Six month clinical results from this three site, 15 patient study are expected to be available in early 2009.

Gary Sabins, president and CEO of Spinal Restoration, said: “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.”