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London Bridge Hospital Orientation. January 2011. COMPANY CONFIDENTIAL NOT FOR DISTRIBUTION. What Is SCS?. Spinal cord stimulation (SCS) is a reversible and minimally invasive therapy for reducing chronic leg pain Typical indications include patients with :
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London Bridge Hospital Orientation January 2011 COMPANY CONFIDENTIALNOT FOR DISTRIBUTION
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
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: • Percutaneous lead insertion • Intra-operative testing & programming • Therapy at home for several days/weeks “Temporary trial” If >50% pain relief • IPG implanted & connected to lead “Permanent implant” Nevro Confidential
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
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
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
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
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
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
US Feasibility Trial ResultsPain Relief (10 point Visual Analog Score) 10 Nevro provides better pain relief (77% vs 56%) P < 0.001 P < 0.001 Nevro Confidential
US Feasibility Trial ResultsPain Relief More positive screenings result in more implants 20 out of 24 14 out of 24 Nevro Confidential
US Feasibility Trial ResultsPatient Preference 12 • 21 out of 24 patients chose Nevro therapy over Conventional SCS 88% of Patients Prefer Nevro Therapy (N=24) Prefer Nevro • 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
International Multi-center Trial ResultsLong-term Data Comparison • Nevro versus PROCESS* Trial Results Nearly 2x better leg pain relief 3x better relief of back pain 3x less opiate use 50% improvement in function • *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
International Multi-center Trial ResultsNevro: Succeeding Where Conventional SCS Has Failed 87% Success Rate in SCS Failures! Nevro Confidential
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
Nevro Corp Profile • Co-Founded by Mayo Clinic • 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