A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

Inclusion Criteria In order to be eligible to participate in this study, subjects must meet all of thefollowing criteria:

1. Male or female; skeletally mature; age 22-69 years, inclusive.
2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain,paresthesia or paralysis in a specific nerve root distribution C3 through C7,including at least one of the following:
3. Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale [VAS]scale).
4. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5scale.
5. Abnormal sensation including hyperesthesia or hypoesthesia; and/or
6. Abnormal reflexes.
7. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
8. Radiographically determined pathology at the level to be treated correlating toprimary symptoms including at least one of the following:
9. Decreased disc height on radiography, computed tomography (CT), or magneticresonance imaging (MRI) in comparison to a normal adjacent disc.
10. Degenerative spondylosis on CT or MRI.
11. Disc herniation on CT or MRI.
12. NDI Score of ≥ 30% (raw score of ≥15/50).
13. Preoperative neck or arm pain ≥ 40 (out of 100) on Preoperative Neck and Arm PainQuestionnaire.
14. Unresponsive to non-operative, conservative treatment (including but not necessarilylimited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/oranalgesics) for:
15. Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset;or
16. Have the presence of progressive symptoms or signs of nerve root/spinal cordcompression despite continued non-operative conservative treatment.
17. Appropriate for treatment using an anterior surgical approach, including having noprior surgery at the operative level and no prior cervical fusion or cervicalartificial disc procedure at any level.
18. Medically cleared for surgery.
19. Physically and mentally able and willing to comply with the Protocol, including theability to read and complete required forms and willing and able to adhere to thescheduled follow-up visits and requirements of the Protocol.
20. Written informed consent provided by Subject Exclusion Criteria Patients are not permitted to enroll in the two-level BAGUERA®C study if they meet any of

the following exclusion criteria:

1. Have an active systemic infection or infection at the operative site.
2. Have a history of or anticipated treatment for active systemic infection, includingHIV or Hepatitis C.
3. More than one immobile vertebral level between C1 to C7 from any cause including butnot limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
4. Previous trauma to the C3 to C7 levels resulting in significant bony ordisco-ligamentous cervical spine injury.
5. Had any prior spine surgery at the operative level(s).
6. Had a prior fusion or artificial disc procedure at any cervical level.
7. Axial neck pain alone in the absence of other symptoms of radiculopathy ormyeloradiculopathy.
8. Disc height less than 3 mm as measured from the center of the disc in a neutrallateral position.
9. Radiographic confirmation of severe facet joint degeneration or confirmed clinicalevidence that facet joint degeneration is a major contributor to the subject's pain.
10. Have osteoporosis or osteopenia, defined as a DEXA bone density measured T-score of ≤ -1.5 (i.e. -1.6, -1.7, etc.). A DEXA performed within 24 months of the surgery datemay be used to determine eligibility. For subjects without a DEXA within 24 months ofthe surgery date a score of ≥ 6 on either the SCORE or MORES requires a DEXA todetermine eligibility. Note: The SCORE (Simple Calculated Osteoporosis RiskEstimation) form should be administered if the subject is female. The MORES (MaleOsteoporosis Risk Estimation Score) form should be administered if the subject ismale.
11. Have Paget's disease, osteomalacia or any other metabolic bone disease other thanosteoporosis, which is addressed above.
12. Severe diabetes mellitus requiring daily insulin management.
13. Have an active malignancy that includes a history of any invasive malignancy (exceptnon-melanoma skin cancer), unless the subject was treated with curative intent andthere had been no clinical signs or symptoms of the malignancy for at least fiveyears.
14. Symptomatic SCDD or significant cervical spondylosis at more than two levels.
15. Spondylolysis.
16. Marked cervical instability on resting lateral or flexion-extension radiographsdemonstrated by:
17. Translation ≥ 3.5 mm, and/or
18. Greater than 11° angular difference to that of either adjacent level.
19. Known allergy to Titanium, Vanadium, Aluminum, Cobalt, Chromium, Molybdenum orPolyethylene.
20. Segmental angulation of greater than 11° at treatment or adjacent levels.
21. Pregnant at time of enrollment, or with plans to become pregnant within the next threeyears.
22. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect themusculoskeletal system.
23. Congenital bony and/or spinal cord abnormalities that affect spinal stability.
24. Have diseases or conditions that would preclude accurate clinical evaluation (e.g.neuromuscular disorders, confirmed fibromyalgia, etc.).
25. Concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. Highdose steroid use is defined as:
26. Daily, chronic use of oral steroids of 5 mg/day or greater.
27. Daily, chronic use of inhaled corticosteroids (at least twice per day).
28. Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg within one month of the study procedure.
29. Have current or recent history of substance abuse (alcoholism and/or narcoticaddiction) requiring intervention.
30. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical GuidelinesBody Mass Index (BMI) > 40).
31. Use of any investigational drug or other investigational medical device within thelast 30 days prior to surgery.
32. Taking medications known to interfere with bone/soft tissue healing (e.g., high-doseoral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).High dose steroid use is defined as part of Exclusion Criterion #23.
33. Currently pursuing litigation (defined as litigation that will likely influence thepatient's ability or willingness to accurately report their treatment outcomes)related to the neck or cervical spine injury.
34. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day).
35. Circumstances that may interfere with completion of follow-up examinations, includinglocation of residence.
36. Belong to a vulnerable population (e.g., prisoner, wards of the court ordevelopmentally disabled).
37. Currently experiencing an acute or chronic episode of confirmed specific mentalillness (psychosis, major affective disorder, or schizophrenia), or manifestingphysical symptoms without a diagnosable medical condition to account for the symptoms,which may indicate symptoms of psychological rather than physical origin.
38. Have an uncontrolled seizure disorder.
39. Received cervical spine epidural steroids within 14 days prior to surgery.