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

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

InFUSE™Bone Graft versus Autograft Harvested from Iliac Crest

Clinical Trial Results

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

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

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

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

Patient Population n Patients received InFUSE™ Bone Graft received InFUSE™ Bone Graft received autogenous bone graft received autogenous bone graft n 16 Investigational Centers

Demographic Information

Surgery Data

Study Results Based on 24-Month Data

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

Overall Success Rates

Achieved Primary Objective Achieved Primary Objective

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

Adverse Events

Comparison of Adverse Events in Investigational and Control Treatment Groups

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

Adverse Events n Typical for patient population n Not unanticipated

Second Surgery Procedures

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

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

Second Surgeries

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

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.

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

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

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

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

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

Fusion Success Rates

Oswestry Low Back Pain Disability Questionnaire

Mean Oswestry Scores

Oswestry Success 15 Point Improvement

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

Neurological Success Rates

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

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

Overall Success Rates - Laparoscopic Study

Safety Results - Comparable to Open Surgical Treatment Group

Laparoscopic Versus Control 24 Months

Fusion Success Rates - Laparoscopic Study

Case Histories

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

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

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

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

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

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

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