Clinical Research

The U.S. Food and Drug Administration has approved an Investigational Device Exemption (IDE) pilot study of the Biostat® Disc Augmentation System. Enrollment in the 15 patient pilot study is expected to begin at three clinical sites in July 2008 and initial clinical results from the study are expected to be available in early 2009. The study results will be combined with additional preclinical testing data to support an application to start a larger, pivotal trial of the Biostat Disc Augmentation System.