Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

This is a prospective, open-label, single-arm, single-center study. There is no randomization
or blinding. Subjects will receive the Intercept System procedure to treat one or two motion
segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Inclusion Criteria:

- Skeletally mature subjects age 25-70 years, inclusive

- Chronic lower back pain for at least six months

- Failure to respond to at least six months of non-operative conservative management

- Oswestry Disability Index (ODI) at time of evaluation of at least 30 points

- Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels
from L3 to S1

Exclusion Criteria:

- Radicular pain by history or evidence of pain neurological deficit within the past one
year.

- Previous surgery performed on the lumbar spine

- Current or history of symptomatic spinal stenosis

- Current or history of osteoporotic or tumor-related vertebral body compression
fracture

- Current or history of vertebral cancer or spinal metastasis

- Current or history of spinal infection

- Metabolic bone disease

- BMI greater or equal to 40

- Any radiographic evidence of other important back pathology

- MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at
non-consecutive levels, or at vertebral bodies other than L3 to S1

- Any back pathology related to trauma, evidence of vertebral compression fracture or
other spinal pathology that could affect assessment of response to back pain

- Subjects who are bed bound

- Demonstrates 3 or more Waddell's signs of Inorganic Behavior

- Any evidence of current systemic infection