Positive 2-year outcomes were reported from the Biostat System pilot study for the treatment of discogenic low back pain. The results were presented by Way Yin at the Annual Meeting of the International Spine Intervention Society (ISIS).
The study demonstrated that the encouraging outcomes reported at the 6-month primary endpoint were well maintained through the final 2-year evaluation. No new safety events were reported during the extended follow-up period. Patients reported a mean 56% reduction in pain at the 6-month primary endpoint and the average reduction remained at 50% for both the 1-year and 2-year evaluations. Measures of patient function demonstrated similar positive trends.
The Biostat System (Spinal Restoration) 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.
“We are very pleased with the durability of the safety measures and pain and function improvements observed in the pilot study of the Biostat System,” commented Gary Sabins, president and CEO of Spinal Restoration. “These data provide further evidence of the potential of this exciting new technology and increase our anticipation for the results of the ongoing FDA regulated phase III study of the Biostat System.”
Spinal Restoration initiated a phase III IND study of the Biostat System in March 2010. Twenty US clinical sites are participating in the study and more than half of the 260 patients allowed by the protocol have been enrolled to date.
If successful, the Biostat System phase III study could have an extensive, far-reaching impact on the diagnosis and treatment of discogenic chronic low back pain. The Biostat System is the first intradiscal biologic therapy for discogenic pain to enter into a phase III clinical trial.