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

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

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

4. Clinical Trial Results

5. Clinical Trial Design Open Surgical Approach
Prospective, randomized controlled design
Investigational Treatment LT-CAGE™ Device / InFUSE™ Bone Graft
Control Treatment LT-CAGE ™ Device / autogenous bone 3

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

7. Study Entrance Criteria
Single level
Symptomatic degenerative disc disease
Inclusion/exclusion criteria 5

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

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

10. Demographic Information18

11. Surgery Data 18

12. Study Results Based on 24-Month Data

13. Overall Success Fusion  15 point improvement in Oswestry score
Neurological maintenance or improvement
No serious adverse event possibly associated to the device
No second surgery failure 41

14. Overall Success Rates

15. Achieved Primary Objective

16. Safety Overview Adverse events Second surgery procedures
Antibody formation

17. Adverse Events

18. Adverse Events

19. Comparison of Adverse Events in Investigational and Control Treatment Groups9

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

21. Adverse Events
Typical for patient population
Not unanticipated

22. Second Surgery Procedures

23. Classifications Revisions Removals Supplemental Fixations Reoperations
Other 10

24. Classifications Revisions - Failure Removals - Failure
Supplemental Fixations - Failure
Reoperations
Other 10

25. Second Surgeries 18

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

27. Comparision of Authentic Positive Responses Similar for both groups
One patient in each group had positive response to rhBMP-2. (<1%)
13% in each group had positive response to bovine 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:
Adverse events and second surgery procedures
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:
High fusion rates
Pain relief
Maintenance or improvement in neurological status

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

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

33. Fusion Success Rates

34. Oswestry Low Back Pain Disability Questionnaire31

35. Mean Oswestry Scores

36. Oswestry Success 15 Point Improvement

37. Neurological Status Measurements
Motor Function
Sensory
Reflexes
Straight Leg Raise 39

38. Neurological Success Rates

39. Secondary Effectiveness Endpoints
Back pain
Leg pain
Disc height maintenance
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
Data augment safety profile
Supports approval of implantation method
Identical protocol to open study
134 Investigational patients
14 Sites

45. Surgery Data - Laparoscopic
2 days shorter hospital stay
45% treated on outpatient basis
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 Months33

49. Fusion Success Rates - Laparoscopic Study

50. Case Histories

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

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

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

57. Open Surgical Approach InFUSE™ Treatment Group
36 year old male
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
Achieved Primary Objective - Overall Success Rate Statistically Equivalent to Control
Benefits - Shorter Operative Times and Less Blood Loss than Control 45

62. Important Benefits of InFUSE™ Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device
Induces bone formation
Eliminates the need to harvest autogenous bone graft in spinal fusion procedures 45

63. Conclusions - Laparoscopic Surgical Approach Clinical Trial
Achieved Primary Objective - Overall Success Rate Statistically Equivalent (and Superior) to Control
Benefits - Shorter Hospital Stays and Faster Return to Work 45

64. InFUSE™ Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device
SAFE AND EFFECTIVE 45