Preclinical Research
The Biostat® System has been specifically design
to safely deliver BIOSTAT BIOLOGX® Fibrin Sealant into intervertebral
discs with painful internal disc disruptions. Preclinical studies have
demonstrated that the Biostat® Delivery Device allows for unhurried,
controlled application of BIOSTAT BIOLOGX while improving the setting
kinetics and flow characteristic of the material within the disc.1
CT image of an
intervertebral disc after injection of radiopaque contrast solution
(left) compared to a physical section of the same disc after treatment
with the Biostat System (right) shows similar flow patterns of BIOSTAT
BIOLOGX (labeled with methylene blue) and contrast within the disc.
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Preclinical studies of the Biostat System also provide strong evidence
for the potential benefits of intradiscal application of BIOSTAT BIOLOGX.
Researchers at the University of California San Francisco demonstrated
that injured discs which where supplemented with BIOSTAT BIOLOGX had
significantly improved disc health after 12 weeks compared to injured
discs which were left untreated. In addition, supplementation of injured
discs with BIOSTAT BIOLOGX reduced the production of inflammatory
factors associated with pain and increased the production of the growth
factor TGF-β, an important protein involved in soft tissue healing.2
Additional preclinical studies demonstrated that disc cells exposed to BIOSTAT BIOLOGX produced lower levels of enzymes responsible for the
degradation of disc tissues.3 These preclinical studies suggest that intradiscal application of BIOSTAT BIOLOGX with the Biostat System may
enhance the repair of painful internal disc disruptions.
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12-week postprocedure histological sections |
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| Normal Disc | ||
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| Injured and untreated disc | ||
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| Injured disc treated with the Biostat System |