Spinal Restoration Reaches Agreement with FDA on the Special Protocol Assessment (SPA) for the Phase 3 Trial of the Biostat® System
December 15, 2009
Phase 3 Study Enrollment to Begin in Early 2010
AUSTIN, Texas – December 15, 2009
Spinal Restoration, Inc. announced today it has received a Special Protocol Assessment concurrence letter from the U.S Food and Drug Administration (FDA) for the design of its Phase 3 study of the Biostat System for the treatment of chronic discogenic low back pain. The SPA is an agreement between Spinal Restoration and the FDA that the Phase 3 study design, endpoints, and planned statistical analysis are adequate to provide necessary data that, depending on outcome, could support a Biologic License Application (BLA). Spinal Restoration anticipates patient enrollment in this Phase 3 study will begin in early 2010.
The Phase 3 trial is a multicenter, randomized, blinded (patient and evaluator), placebo controlled study designed to assess the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic low back pain. Study success will be determined by comparing the success rates between the investigational and control populations at the 6-month primary endpoint.
“SPA concurrence is a momentous achievement in the regulatory pathway for the Biostat System,” said Gary Sabins, President and CEO. “Spinal Restoration is now well positioned to be the first company to initiate a Phase 3 clinical study of a biologic intradiscal therapy for the treatment of chronic low back pain.”
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 disc disruptions, reducing inflammation, and enhancing tissue repair.
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 System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain. Visit www.spinalrestoration.com for more information.
President and CEO
Director of Product Development and Marketing