Study of Nucel for One and Two Level Lumbar Interbody Fusion

Two hundred non-randomized subjects will participate in the study at up to ten clinical sites
in the United States. Participants will be between 18 and 75 years of age. All subjects will
have been established with lumbar spine disease at one or two levels of the lumbar spine that
requires lumbar interbody fusion procedure as per the opinion of the treating surgeon. The
diseases included in the study are spondylosis, degenerative disc disease and
spondylolisthesis. All subjects who meet the inclusion criteria and do not meet the exclusion
criteria and who elect to participate and sign the informed consent will be included in the
study.

Inclusion Criteria:

1. Be between 18 and 75 years of age

2. Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis
or degenerative disc disease, or at either one or two levels of lumbar spine.

3. In the opinion of the treating surgeon, must already be a qualified candidate for
interbody lumbar fusion surgery with supplemental fixation.

4. Be likely to return for regular follow-ups until the end of the study period.

5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

1. Previous lumbar spine fusion surgery at operative level.

2. Back pain due to acute trauma.

3. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or
chronic infection, malignancy, other space occupying lesions and metabolic bone
demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)

4. No chronic steroid or chronic prescription NSAID use within three (3) months prior to
surgery.

5. Any active malignancy, infectious process, or documented chronic autoimmune disease.

6. Any other concurrent medical disease or treatment that might impair normal healing
process.

7. Recent history (within past 6 months) of any chemical or alcohol dependence.

8. Morbid obesity (BMI > 40).

9. Currently a prisoner.

10. Currently experiencing a major mental illness (psychosis, schizophrenia, major
affective disorder) which may indicate that the symptoms are psychological rather than
of physical origin.

11. Pregnancy at the time of enrollment or planned pregnancy, which would interfere with
follow-up imaging.