Spinal Restoration: FDA IDE Biostat® Disc Augmentation System 5/13/08

[Slackwater]

Spinal Restoration, Inc. Receives FDA IDE Approval

Austin, TX - May 13, 2008

Spinal Restoration, Inc. announced today that the U.S. Food and Drug Administration has approved an Investigational Device Exemption (IDE) pilot study of the Biostat® Disc Augmentation System. Enrollment in the 15 patient pilot study is expected to begin at three clinical sites in July.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Spinal Restoration, Inc. is developing a proprietary technology, the Biostat™ Disc Augmentation System, for treating discogenic chronic low back pain. This biologic treatment will offer patients an opportunity for pain relief and disc healing. The procedure, which is called resorbable biologic disc augmentation, involves application of Biostat BIOLOGX™ Fibrin Sealant, a human derived biologic compound, into an internally disrupted disc to occlude the annular fissures and restore a level of mechanical integrity to the annulus fibrosus. Occluding the fissures addresses the chemical pain by preventing leakage of the nucleus pulposus into the outer one-third of the annulus fibrosus or onto the spinal nerve root. With the fissures in the annulus occluded, further degradation of the disc may be avoided, stability within the disc is restored, and healing of the disc may be facilitated.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Biostat BIOLOGX Fibrin Sealant is a biologic sealant and adhesive comprised of highly purified human fibrinogen and thrombin, the two essential blood proteins involved in the formation of a fibrin clot. The Biostat Delivery Device has been specifically designed to mix and deliver these components to painful internal disruptions within the disc where they react to form a dense fibrin matrix. The resulting fibrin sealant is essentially identical to the naturally occurring fibrin matrix which the body forms during the earliest stages of wound healing.

Application of Biostat BIOLOGX Fibrin Sealant may provide pain relief by sealing off annular fissures from inflammatory substances contained in the disc nucleus.

Application of Biostat BILOGX Fibrin Sealant will also lay down a dense fibrin matrix which could support the natural soft tissue healing process in the disc.


Slackwater

[ans]

Thanks Slack.

[Harrison]

It will be interesting to see if this "patch the flat tire" approach provides a long term solution. It seems like a neat idea, but the number of variables to consider for patient qualification...mon Dieu!

It is interesting to see fibrin being used as the "patch kit." I am curious to learn more about how the manufacturer it safely.

Interesting side note: some people with chronic inflammatory diseases (Lyme, sarc, MS, some arthritic conditions) produce too much fibrin in their bodies. Some alternative care docs specifically test fibrin levels as a biomarker of disease states. Also, excess fibrin contributes to "thick" blood, which can also be measured by INR.