Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

The Biostat System is a combination product combining a resorbable biologic product with a
delivery device system used to prepare and insert the biologic material into a lumbar
intervertebral disc.

Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar
intervertebral disc, which appears as fissures, cracks or tears within the internal
structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain
located in the low back (axial pain) but also as somatic referred pain involving the
posterior hips, buttocks, lateral hips, groin, or posterior thighs.

The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies,
physical examination, or symptoms alone, and is best established with meticulously conducted
disc provocation studies (provocation discography) that include pressure manometry and
identification of an adjacent normal disc.

This treatment and study are not designed for patients exhibiting other potential sources of
chronic low back pain such as more advanced degenerative disc disease with significant loss
of disc height (>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).