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

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

InFUSE™Bone Graft versus Autograft Harvested from Iliac Crest

Clinical Trial Results

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

Study Objectives Primary Objective Equivalence in Overall Success Secondary Objectives

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

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

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

Demographic Information 18

Surgery Data 18

Study Results Based on 24-Month Data

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

Overall Success Rates

Achieved Primary Objective

Safety Overview Adverse events Second surgery procedures Antibody formation

Adverse Events

Adverse Events

Comparison of Adverse Events in Investigational and Control Treatment Groups 9

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

Adverse Events Typical for patient population Not unanticipated

Second Surgery Procedures

Classifications Revisions Removals Supplemental Fixations Reoperations Other 10

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

Second Surgeries 18

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

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.

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

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

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

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

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

Fusion Success Rates

Oswestry Low Back Pain Disability Questionnaire 31

Mean Oswestry Scores

Oswestry Success 15 Point Improvement

Neurological Status Measurements Motor Function Sensory Reflexes Straight Leg Raise 39

Neurological Success Rates

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

Back Pain Results - 24 Months

Graft Site Pain in Control Patients Mean Scores

Graft Site Appearance in Control Patients

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

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

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

Overall Success Rates - Laparoscopic Study

Safety Results - Comparable to Open Surgical Treatment Group

Laparoscopic Versus Control 24 Months 33

Fusion Success Rates - Laparoscopic Study

Case Histories

Control Treatment Group 37 year old female L5 - S1 Level

Control Treatment Group 38 year old female L5 - S1 Level

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

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

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

Patient Satisfaction - 24 Months

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

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

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

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