Drug intelligence / Profile preview

Biostat BIOLOGX Fibrin Sealant

Development stage
Unknown
Lead developer
Spinal Restoration
Modality
Blood Coagulation Factors → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Intralesional
01

Overview

**Biostat BIOLOGX Fibrin Sealant** was an investigational, human-derived resorbable fibrin sealant developed for direct injection into symptomatic lumbar intervertebral discs in patients with chronic discogenic low back pain caused by internal disc disruption. The product contained concentrated human fibrinogen, thrombin, calcium chloride, and synthetic aprotinin acetate. On co-delivery, thrombin converts fibrinogen into a fibrin matrix intended to seal annular fissures and provide a temporary tissue-repair scaffold; aprotinin was included to limit premature fibrin degradation. It was administered using the separate Biostat Delivery Device and should not be conflated with the full Biostat System, which combined the drug product with that delivery device. A pilot study suggested potential benefit, but the randomized Phase 3 study did not meet its primary efficacy criterion versus saline and was terminated. ([forums.studentdoctor.net](https://forums.studentdoctor.net/attachments/pauza-fibringen-pdf.186290/))

Brand names
BIOSTAT BIOLOGX
Other names
BIOSTAT BIOLOGX Fibrin SealantBiostat Fibrin Sealant
02

Targets

F2 (Thrombin)

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