CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Effects of Spinal Cord Stimulation of the Dorsal Root Ganglion (DRG) in the Treatment of Chronic, Intractable Pain: Long-Term Results from Two Prospective Clinical Trials L Liem, M.D. F Huygen, M.D., Ph.D Marc Russo, M.D. JP Van Buyten, M.D. I Smet, M.D. Paul Verrills, M.D. Professor Michael Cousins, M.D. Raj Sundaraj, M.D. Charles Brooker, M.D. NANS 2012

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Disclosures Philips Boston Scientific Spinal Modulation Caution: The Spinal Modulation Axium™ Spinal Cord Stimulator System is currently an investigational device in the United States and is not approved for use in the United States.

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Specialized delivery system for efficient access to the foramen Small, flexible leads have been designed specifically for stimulation of the DRG Small, non- rechargeable neurostimulator designed to complement the lead and system Conventional Lead DRG Lead Spinal Cord Stimulation Targeting the Dorsal Root Ganglion

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Clinical Study Design 2 prospective clinical trials Sites in Europe and Australia enrolled subjects N=32 subjects implanted with Spinal Modulation Axium™ Spinal Cord Stimulator System Primary and secondary outcome measures captured Two (2) on-off periods to demonstrate “rebound” pain 3-30 days Stimulation turned off Trial 1 week Screen Fail Baseline 4 weeks 1 year Baseline Implant Trial Exit 1 week off 1 week off yes no 6 months 3 months 8 weeks* Stimulation turned off Success?

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Study Outcomes Primary Efficacy was determined by Visual Analog Scale (VAS)  Both overall pain and regional (“segmented”) VAS scores were collected over time based upon primary, secondary and/or tertiary areas of pain Safety was evaluated by collecting adverse events during the course of the trial Secondary Health Related Quality of Life (HR-QoL) – EQ-5D Profile of Mood States (POMS) Brief Pain Inventory (BPI) Subject Satisfaction Paresthesia Intensity with Changes in Bodily Position

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Subject Diagnoses Diagnosis#INS FBSS9 CRPS8 Post-surgical neuropathic pain conditions7 Radicular pain8 Total Implants32

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. PRIMARY OUTCOMES Visual Analog Scores (VAS)

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Primary Outcomes – Overall Pain Relief 60% reduction at 12 months VAS (mm) n=32 n=30n=24 n=17

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. 66% reduction at 12 months * Diagnoses include CRPS, Post-Surgical Pain, FBSS, Radicular Pain Primary Outcomes – Leg Pain* VAS (mm) n=25 n=24n=19n=22n=19n=13

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. 82% reduction at 12 months * Diagnoses include CRPS, Post-Surgical Pain, FBSS Primary Outcomes – Foot Pain* VAS (mm) n=13 n=9n=12n=10n=6

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. 1 week No Stim 1 week No Stim Assessing Rebound Pain after Stimulation is Turned Off

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Less Lead Migration than traditional SCS Stimulation leads for SCS of the DRG reported <3% migration rates. Traditional SCS (PROCESS trial) reports migration rate of 10%. 1 1 Kumar, et al, Pain, 2007

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. SECONDARY OUTCOMES

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Limited Changes in Paresthesia Intensity N=22

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Painful Regions Paresthesia Therapeutic targeting: Specific & Painful Regions Example representations of painful regions and areas of therapeutic coverage. Paresthesias could be generated in both discrete and broad coverage zones. Most paresthesias were generated over the painful regions with little extraneous paresthesias in non-painful regions.

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. EQ-5D: Independent Outcomes Baseline6 months

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Brief Pain Inventory- Overall Outcomes Significant improvements in both Pain Interference and Pain Severity measures (*p<0.05)

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Profile of Mood States: POMS Outcomes

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. Conclusions Clinical data from European and Australia clinical trials show that the Axium™ SCS System can provide significant long-term pain relief in CRPS, Post-Surgical Neuropathies, and FBSS Body positions (standing versus supine) did not affect the intensity of paresthesia and is stable over 12 months Stimulation can be isolated to specific anatomical regions such as the foot and leg Therapy is stable long term with less than 3% lead migration Secondary measures of quality of life, mood and activity are all improved complimenting the reductions in pain.

CAUTION: The Spinal Modulation Axium™ Spinal Cord Stimulator System is an investigational device and is limited by United States law to investigational use only. THANK YOU