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London Bridge Hospital Orientation

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Presentation on theme: "London Bridge Hospital Orientation"— Presentation transcript:

1 London Bridge Hospital Orientation

2 What Is SCS? Spinal cord stimulation (SCS) is a reversible and minimally invasive therapy for reducing chronic leg pain Typical indications include patients with : Failed Back Surgery Syndrome (FBSS) Intractable neuropathic leg pain Complex Regional Pain Syndrome (CRPS) SCS has been in use for more than 40 years to treat patients with chronic, neuropathic pain Current players: Medtronic, St Jude Medical and Boston Scientific Nevro Confidential

3 What Is SCS? SCS procedure involves:
percutaneous or surgical implantation of leads into the epidural space leads are connected to an implantable pulse generator (IPG) Electrical pulses delivered to the spinal cord alleviate pain SCS trial to permanent implant process: “Temporary trial” Percutaneous lead insertion Intra-operative testing & programming Therapy at home for several days/weeks “Permanent implant” IPG implanted & connected to lead If >50% pain relief Nevro Confidential

4 Conventional SCS’s Unmet Needs
Paresthesia-dependent masking of pain Paresthesia (an altered sensation) is felt as an electrical “buzzing” or tingling sensation in the extremities The position of the leads and the electrical parameters programmed determine the location and intensity of the paresthesia Paresthesia commonly induces a shocking sensation as body position changes 71% of SCS patients surveyed found paresthesia uncomfortable, sometimes worse than the pain itself Nevro Confidential

5 Conventional SCS’s Unmet Needs
Failure to adequately treat low back pain Attempted and failed to achieve consistent and durable back pain relief: Medtronic St. Jude Boston Scientific Leg pain relief commonly unmasks underlying back pain post-SCS Attempts to relieve back pain commonly over-stimulate the legs Unresolved back is a major opportunity—NANS 2010 survey respondents indicated that: 43% of their current SCS patients complained of unresolved back pain SCS procedure volume would grow 110% if they had access to a device that allowed them to effectively treat low back pain Nevro Confidential

6 Conventional SCS’s Unmet Needs
Inefficient use of theatre and physician time Intra-operative testing involves an iterative approach with poor guidelines for lead placement and optimal parameter selection Patient must be awakened in the operating room to provide feedback to the physician regarding coverage of painful regions with paresthesia Nevro Confidential

7 Conventional SCS’s Unmet Needs
Continued need for opiates to provide relief for unaddressed (back) pain 65% of SCS study candidates were on opiates at baseline Continued management of narcotic analgesics is an additional burden for physician and patient with significant concerns regarding addiction Nevro Confidential

8 Nevro System Benefits Relief of leg and back pain
Intra-operative procedure simplicity Anatomic versus physiologic lead placement Reduced physician management burden No paresthesia or shocking Limited return office visits required Reduced device complexity for patients Reduced need for opiates and opiate management Nevro Confidential

9 Nevro Clinical Trials US Feasibility Study
Evaluation during temporary trial considering: Patient preference for Nevro versus Conventional SCS Presence of paresthesia, jolting and shocking Short-term pain relief International Multi-center Trial Evaluation of Nevro’s permanently implantable SCS system considering: The long-term, sustainable relief of leg and back pain Functional improvements reported by patients Opiate use post-implant Nevro Confidential

10 Nevro provides better pain relief (77% vs 56%)
US Feasibility Trial Results Pain Relief (10 point Visual Analog Score) 10 Nevro provides better pain relief (77% vs 56%) Show only CRF data. Use Bar graph Baseline, commercial, Day 4 P < 0.001 P < 0.001 Nevro Confidential

11 US Feasibility Trial Results Pain Relief
More positive screenings result in more implants In terms of pain relief with Nevro, on average had 76% pain relief, and Commercial had on average 56% pain relief. But this data needs to be explained too much. So using patient with > 50% pain reduction is more clear cut and implies trial to perm ratio. 14 out of 24 20 out of 24 Nevro Confidential

12 US Feasibility Trial Results Patient Preference
12 88% of Patients Prefer Nevro Therapy (N=24) Prefer Nevro 21 out of 24 patients chose Nevro therapy over Conventional SCS Nevro patients: do not experience paresthesia do not need to adjust therapy with changes in body position are not shocked during body position changes Nevro Confidential

13 International Multi-center Trial Results Long-term Data Comparison
Nevro versus PROCESS* Trial Results 3x better relief of back pain Nearly 2x better leg pain relief 50% improvement in function 3x less opiate use *most credible Conventional SCS study to date (1)Pain relief is measured by difference in VAS. (2)Functional Improvement is measured by reduction in Oswestry Disability Index score. 0 = no disability, 100= extreme disability. Higher reduction in score represents better functional improvement. (3)Kumar, 2007, PAIN. Pain relief data are extrapolated from graphs in the article. Nevro Confidential

14 International Multi-center Trial Results Nevro: Succeeding Where Conventional SCS Has Failed
87% Success Rate in SCS Failures! Nevro Confidential

15 Other Results and Benefits
No reported paresthesia Less programming for doctor and patient No movement-dependent jolting/shocking Fewer patient complaints and office visits Improved sleep At 6 months, sleep disturbance reduced by 82% Eliminated (83%) or reduced opiate use at 6 months Less narcotic management and concern over addiction Shorter procedure time More time to enjoy life or perform more procedures! Nevro Confidential

16 Nevro Corp Profile Co-Founded by Mayo Clinic CE Mark received May 2010
Licensed technology and know how $50M invested to date by leading healthcare investors CE Mark received May 2010 International thought leader support Jean-Pierre VanBuyten, MD-Belgium Adnan Al-Kaisy, MD-UK Jaimie Henderson, MD-Stanford University Others Plenary session presentations approved or planned at: North American Neuromodulation Society Annual Meeting Dec 2010 American Academy of Pain Management Meeting March 2011 International Neuromodulation Society Meeting May 2011 Nevro Confidential

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