1. InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065 Hallett H. Mathews, M.D. Richmond, Virginia

2. n Primary study objective met n High fusion rates n Shorter operative times and less blood loss n Avoided complications and pain associated with bone graft harvesting Important Findings

3. InFUSE™Bone Graft versus Autograft Harvested from Iliac Crest

4. Clinical Trial Results

5. Clinical Trial Design Open Surgical Approach n Prospective, randomized controlled design n Investigational Treatment - LT-CAGE ™ Device / InFUSE ™ Bone Graft n Control Treatment - LT-CAGE ™ Device / autogenous bone

6. Study Objectives n Primary Objective Equivalence in Overall Success n Secondary Objectives

7. Study Entrance Criteria n Single level n Symptomatic degenerative disc disease n Inclusion/exclusion criteria

8. Patient Evaluation n Preoperatively n Surgery/Discharge n Postoperatively: 6 Weeks, 3 Months, 6 Months 6 Weeks, 3 Months, 6 Months 12 Months, 24 Months 12 Months, 24 Months

9. Patient Population n Patients - 143 received InFUSE™ Bone Graft - 143 received InFUSE™ Bone Graft - 136 received autogenous bone graft - 136 received autogenous bone graft n 16 Investigational Centers

10. Demographic Information

11. Surgery Data

12. Study Results Based on 24-Month Data

13. Overall Success n Fusion n  15 point improvement in Oswestry score n Neurological maintenance or improvement n No serious adverse event possibly associated to the device n No second surgery failure

14. Overall Success Rates

15. Achieved Primary Objective Achieved Primary Objective

16. Safety Overview n Adverse events n Second surgery procedures n Antibody formation

17. Adverse Events

19. Comparison of Adverse Events in Investigational and Control Treatment Groups

20. Differences noted in: n Graft Site Events - Occurred in 6% of control group Occurred in 6% of control group None in investigational group None in investigational group n Urogenital Resolved prior to discharge Resolved prior to discharge

21. Adverse Events n Typical for patient population n Not unanticipated

22. Second Surgery Procedures

23. Classifications n Revisions n Removals n Supplemental Fixations n Reoperations n Other

24. Classifications n Revisions - Failure n Removals - Failure n Supplemental Fixations - Failure n Reoperations n Other

25. Second Surgeries

26. Assessment of Antibody Formation n n rhBMP-2 n n Bovine Type I Collagen n n Human Type I Collagen

27. Comparision of Authentic Positive Responses Similar for both groups n One patient in each group had positive response to rhBMP-2. (<1%) n 13% in each group had positive response to bovine Type I collagen. None of these patients had positive results for human Type I collagen. None of these patients had positive results for human Type I collagen.

28. Safety Summary Investigational and Control group rates are similar for: n Adverse events and second surgery procedures n Antibody responses InFUSE™ Bone Graft eliminates graft harvesting adverse events and pain

29. InFUSE™ Bone Graft / LT-CAGE™ Device Safe for its intended use

30. Effectiveness Overview InFUSE ™ Bone Graft / LT-CAGE ™ Device patients had: n High fusion rates n Pain relief n Maintenance or improvement in neurological status

31. Fusion n Primary endpoint n CT scans and radiographs utilized n Two teams of independent reviewers

32. Fusion Criteria n Radiographic - Bridging trabecular bone - Bridging trabecular bone - Segmental stability - Segmental stability - Lucent line criteria - Lucent line criteria n No “pseudarthrosis” second surgery

33. Fusion Success Rates

34. Oswestry Low Back Pain Disability Questionnaire

35. Mean Oswestry Scores

36. Oswestry Success 15 Point Improvement

37. Neurological Status Measurements n Motor Function n Sensory n Reflexes n Straight Leg Raise

38. Neurological Success Rates

39. Secondary Effectiveness Endpoints n Back pain n Leg pain n Disc height maintenance n SF-36

40. Back Pain Results - 24 Months

41. Graft Site Pain in Control Patients Mean Scores

42. Graft Site Appearance in Control Patients

43. Use of InFUSE™Bone Graft eliminates: Negatives of Graft-site Appearance, Pain and Morbidity

44. Laparoscopic Clinical Trial n Data augment safety profile n Supports approval of implantation method n Identical protocol to open study n 134 Investigational patients n 14 Sites

45. Surgery Data - Laparoscopic n 2 days shorter hospital stay n 45% treated on outpatient basis n Returned to work 20 days sooner

46. Overall Success Rates - Laparoscopic Study

47. Safety Results - Comparable to Open Surgical Treatment Group

48. Laparoscopic Versus Control 24 Months

49. Fusion Success Rates - Laparoscopic Study

50. Case Histories

51. Control Treatment Group n 37 year old female n L5 - S1 Level

53. Control Treatment Group n 38 year old female n L5 - S1 Level

55. Open Surgical Approach InFUSE™ Treatment Group n 42 year old male n L4 - L5 Level

57. Open Surgical Approach InFUSE™ Treatment Group n 36 year old male n L5 - S1 Level

59. As demonstrated in animal and human studies: CT scans most practical and definitive method for detecting bone formation and determining fusion.

60. Patient Satisfaction - 24 Months

61. Conclusions Open Surgical Approach Clinical Trial n Achieved Primary Objective - Overall Success Rate Statistically Equivalent to Control n Benefits - Shorter Operative Times and Less Blood Loss than Control

62. Important Benefits of InFUSE™ Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device n Induces bone formation n Eliminates the need to harvest autogenous bone graft in spinal fusion procedures

63. Conclusions - Laparoscopic Surgical Approach Clinical Trial n Achieved Primary Objective - Overall Success Rate Statistically Equivalent (and Superior) to Control n Benefits - Shorter Hospital Stays and Faster Return to Work

64. InFUSE™ Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device SAFE AND EFFECTIVE