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fibrin sealant
- Development stage
- Discontinued
- Lead developer
- Spinal Restoration
- Modality
- Tissue Cells → Other Cell Types → Cell Therapies, Recombinant Proteins and Enzymes
- Administration
- Intradiscal
01
Overview
BIOSTAT BIOLOGX is a human-derived, resorbable biologic tissue sealant (fibrin sealant) developed as part of the Biostat System for the treatment of chronic discogenic low back pain. The product is designed to be delivered intradiscally using a proprietary application system, with the aim of sealing painful disruptions in intervertebral discs, reducing inflammation, and enhancing tissue repair. Its mechanism involves modulation of fibrin within the disc space to promote healing. Developed by Spinal Restoration, Inc., it was evaluated in Phase III clinical trials for patients with single-level discogenic low back pain but did not meet primary efficacy endpoints compared to saline control. The therapy represents a minimally invasive alternative to surgery for patients with internal disc disruption.
- Other names
- BIOSTAT BIOLOGX
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