Spinal Restoration Inc. will begin the third testing phase for its chronic lower back pain treatment, the Biostat System.
The Austin-based biotech company garnered necessary U.S. Food and Drug Administration approvals today that will allow researchers to commence the new study. The FDA’s “special protocol assessment” letter means the project’s design, analysis and possible results could support a biologic license application depending on the outcome.
Spinal Restoration officials said they expect to begin enrolling patients early next year. The trial will use a random, blind placebo process to test the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic back pain.
“SPA concurrence is a momentous achievement in the regulatory pathway for the Biostat System,” said Spinal President and CEO Gary Sabins. “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.”