FDAnews
www.fdanews.com/articles/123006-spinal-restoration-reaches-agreement-on-special-protocol-for-phase-iii-trial

Spinal Restoration Reaches Agreement on Special Protocol for Phase III Trial

December 15, 2009
Spinal Restoration, Inc. announced Tuesday 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.
Earth Times