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Biostat Disc Augmentation System
- Development stage
- Discontinued
- Lead developer
- Spinal Restoration
- Modality
- Recombinant Proteins and Enzymes
- Administration
- Percutaneous
01
Overview
The Biostat Disc Augmentation System is a biologic-device combination product developed by Spinal Restoration, Inc. for the treatment of chronic low-back pain associated with symptomatic internal disc disruption (IDD). The system consists of Biostat Biologx Fibrin Sealant, a human-derived fibrin sealant composed of fibrinogen and thrombin, and a proprietary pressure-controlled delivery device. When injected into the lumbar intervertebral disc, the fibrinogen and thrombin react to form a fibrin clot. This mechanism is intended to seal annular fissures, prevent the leakage of inflammatory mediators from the nucleus pulposus, and provide a structural scaffold that may support tissue repair. Development of the system was terminated following a Phase III clinical trial (BIOSTAT-III) that failed to meet its primary efficacy endpoints.
- Brand names
- BiostatBiostat Biologx
- Other names
- Biostat Biologx Fibrin SealantBiostat System
02
Targets
F2 (Thrombin)
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