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news.Spinal Restoration has announced that the FDA has approved an investigational device exemption 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.
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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. The Biostat Disc Augmentation System has been specifically developed to address chronic low back pain resulting from degenerative cracks and fissures which form within the intervertebral disc.
Initial clinical results from the investigational device exemption (IDE) pilot study are expected to be available in early 2009. These results will be combined with additional preclinical testing data to support an application to start a pivotal trial of the Biostat Disc Augmentation System late 2009.
Gary Sabins, president and CEO of Spinal Restoration, said: “Based upon available data and results from our preclinical testing, we are confident that this clinical study will support the safety and efficacy of this new therapy and help us to advance into a larger pivotal trial of the Biostat Disc Augmentation System.”