Confirmatory Clinical Study of Oxiplex

Inclusion Criteria:

1. Be between 22 and 70 years of age;

2. Have symptomatic posterior or posterolateral disc herniation at L4-L5 or L5-S1 with
radiographic confirmation of nerve compression using MRI that requires partial
surgical discectomy with or without laminotomy;

3. Have radiculopathy (e.g., decreased motor strength, sensory deficits, decreased
reflexes) from specific nerve root distribution from L4 to S1 with positive straight
leg raise (0-60 degrees);

4. Have at least one of the following:

1. At least six weeks of prior conservative treatment (e.g., physical therapy and/or
use of anti-inflammatory medications, narcotics, and muscle relaxants at the
manufacturer's recommended therapeutic dose);

2. The patient is experiencing intractable pain; or

3. There is substantial progression of loss of neurological function.

5. Have VAS leg pain score in the ipsilateral leg of at least 60mm on a 100mm scale;

6. Have VAS back pain score of at least 50mm on a 100mm scale;

7. Be appropriate for treatment using a posterior surgical approach;

8. Be likely to return for all follow-up visits; and

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

Exclusion Criteria:

Pre-Operative Exclusion Criteria:

1. Radiographic confirmation (via MRI) of severe facet disease or facet degeneration at
the index lumbar level;

2. Prior spine surgery at any lumbar level;

3. Subject requires spinal surgery other than a partial discectomy (with or without
laminotomy) to treat leg/back pain (osteophyte removal is allowed);

4. Previous trauma to the lumbar spine resulting in fracture or documented ligament
injury;

5. Documented presence of a free nuclear fragment at lumbar levels other than the study
level;

6. Axial back pain only (no radicular symptoms);

7. Recent history (within previous six months) of chemical or alcohol dependence;

8. Active systemic infection;

9. Infection at the site of surgery;

10. Cauda equina syndrome or neurogenic bowel/bladder dysfunction;

11. Any terminal, systemic or autoimmune disease;

12. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's
disease); as defined by use of anti-resorptive medications or a history of fragility
fracture;

13. Any disease, condition or surgery which might impair healing, such as:

- Diabetes mellitus requiring daily insulin management,

- Active malignancy,

- History of metastatic malignancy;

14. Treatment with any epidural steroids within four (4) weeks prior to the surgery;

15. Treatment with any oral steroids within ten (10) days prior to the surgery;

16. Treatment with aspirin or other non-steroidal anti-inflammatory drugs within
seventy-two (72) hours prior to the surgery;

17. Currently experiencing an episode of major mental illness (psychosis, major affective
disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable
medical condition to account for the symptoms, which may indicate symptoms of
psychological rather than physical origin;

18. Pregnancy at time of enrollment, or planning to become pregnant, since this would
contraindicate surgery2;

19. Currently a prisoner;

20. Currently involved in litigation which may influence the subject's reporting of
symptoms including workers comp;

21. Participation in any other investigational drug, biologic or medical device study
within the last six months prior to study surgery;

22. Requires removal of far lateral disc herniations at L4/5 or L5/S1.

Intra-operative Exclusion Criteria:

In case the surgeon identifies during surgery any circumstance that contradicts to the
patient's participation in the trial, the surgeon should exclude the patient from trial
participation. Exclusion reasons are:

1. Severe facet disease or facet degeneration at the index lumbar level;

2. Dural entry during surgery;

3. Discovery of intraspinal tumor during surgery;

4. Requires spinal fusion;

5. Multilevel herniation or the need to involve more than one level;

6. Exploration of contralateral side;

7. Epidural fat placement;

8. Application of products to the exposed neural element, including:

- Amniotic tissue or fluids

- Adhesives

- Steroids

- Platelet rich plasma

- Gelfoam

- Allograft tissue

- Fibrin glue

- Dural patches

9. Surgical determination that a hemostatic agent must remain at the surgery site;

10. Surgical determination of the need for any other device (that would interfere with
interpretation of the study results) to remain at the surgery site (e.g., surgical
drains);

11. Adverse events or complications assessed during surgery that rule out the use of
Oxiplex (e.g., infection, local osteoporosis);

12. Application of a sealant or other attempt to repair annular tear;

13. Implantation of antibiotic powder into the surgical wound. (Antibiotic irrigation may
be used in the treatment group prior to Oxiplex application and the control group
following surgery. No irrigation is allowed after Oxiplex application.);

14. The presence of a dural tear and/or opening found during the surgical procedure.