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THANK YOU SINCERELY Joshua Prager and Ali Rezai Ben Pless and Salim Hayek Tom Tefft, Michael Demane Mona Patel, Brad Maruca

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GOALS and RULES Lets bring industry and stake holders an event to provide a platform to discuss the relevant issues for the INVIGORATION of the field of Neuromodulation. (BE POSITIVE) Each moderators should set the stage for the need, showcase some emerging technologies, and the panel will THOUGHTFULLY discuss opportunities, challenges.

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GOALS Technology Spinal Cord Stimulation Regulatory and Economics Study Designs Peripheral Nerve Stimulation Intrathecal therapy Wrap-up

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TRANSFORMATIVE technology - changes the practice of medicine? NeuroNavigation Endovascular Surgery Minimally invasive Spinal Neurosurgery Bone Morphogenic Protein Endscopic Neursorgery Hemostatic Agents Deep Brain Stimulation/ NEUROMODULATION 20

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NEUROMODULATION Market revenue source: Dodds, Matthew. Citi Research, A Division of Citigroup Global Markets, Inc. Neuromodulation Market Model, September 17, 2012 2011 Market Revenue 2011 Market Units ($ millions)(estimate) Spinal Cord Stimulation (SCS)$1,28660,643 Deep Brain Stimulation (DBS)$39324,104 Sacral Neuromodulation (SNM)$38641,233 Vagal Nerve Stimulation (VNS)$2118,612 Targeted Drug Delivery$34029,565 (Intrathecal Pain & Spasticity) Global Neuromodulation Market$2,616164,158 15 1997

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Approved VNS for Epilepsy, Depression DBS for PD, ET, OCD, Dystonia SCS for limb and body pain IT for pain, spasticity PNS for Urge incontinence 10

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DBS for Depression, Epilepsy SCS for CHF RNS for Epilepsy PNS for Headache, asthma, GI TECHNOLOGY PENETRATION Horizon +5 NEUROMODULATION REMAINS QUITE EXCITING ROBUST

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OP Ed Remember that we are treating patients who have the worst of the worst problem

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The Creative Destruction of Medicine 7 billion people >3 million doctors >10,000 hospitals >6000 prescription drugs >4000 procedures & operations Supplements, herbs, alternative treatments

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? In the Future SPINAL CARE IS FRAGMENTED Motrin/ Medications Physical Therapy Accupuncture Chiropractor Epidural Steroid Injection Spinal Surgeries Neurostimulation Who gets what where when why? Define Patient Needs (DISEASE MANAGEMENT) Practice Guidelines Define Success Define Technology GAPS Advance Understanding of the disease

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? In the Future SPINAL CARE IS FRAGMENTED Motrin/ Medications Physical Therapy Accupuncture Neurostimulation Chiropractor Epidural Steroid Injection Spinal Surgeries Who gets what where when why? Define Patient Needs (DISEASE MANAGEMENT) Practice Guidelines Define Success Define Technology GAPS Advance Understanding of the disease

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Choosing the Right Patient

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In the Future Who gets what where when why? (Practice Guidelines) Define Patient Needs (DISEASE MANAGEMENT) Define Success Define Technology GAPS Advance Understanding of the disease I dont want no WIRE in my back!

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Equipment Familiarity Device Complications Minimal Invasiveness Ease of use - programming How do we make people good and WANT to FEEL BIONIC? Navigation MRI Guidance INTRA OP MER? SPINAL Flouroscopy/ XRT? Wires running around the body Ease of Programming Device Comfort Healing

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In the Future Who gets what where when why? (Practice Guidelines) Define Patient Needs (DISEASE MANAGEMENT) Define Success Define Technology GAPS Advance Understanding of the disease

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Practice of Medicine is Evolving Neurosurgery (General) Vascular Tumor Functional Epilepsy Spine Pediatric Neurology, hematology Medical and Radiation onc Movement Disorder Neurology Epilepsy neurology, Neuropsych Pain, PM&R Pediatrics Maybe an Opportunity in the field of Internventional Headache and Epilepsy Management

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Defining Role of Device Development CONVERGENCE CARDIAC Manufacturing IPG Lead design and material (2-16/20) Sensing (rhythm, closed loop, posture, LFP) Home/ Remote monitoring Diagnostics Health care IT systems Objectification of patient symptoms

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In the Future Who gets what where when why? (Practice Guidelines) Define Patient Needs (DISEASE MANAGEMENT) Define Success Define Technology GAPS Advance Understanding of the disease HEADACHE LIFE TRANSFORMING How do we get the Patients involved to let their voices get heard? Medicine is a science of uncertainty and an art of probability.

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Studies - DESIGN Effectiveness - The extent to which a treatment achieves its intended purpose Efficacy - The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions

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In the Future Who gets what where when why? (Practice Guidelines) Define Patient Needs (DISEASE MANAGEMENT) Define Success Define Technology GAPS Advance Understanding of the disease

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SCS Heart Failure Refractory Angina Peripheral Vascular Disease Peripheral Neuropathy INDICATIONS:

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In the Future Who gets what where when why? (Practice Guidelines) Define Patient Needs (DISEASE MANAGEMENT) Define Success Define Technology GAPS Advance Understanding of the disease

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TRIALS Occipital Stimulation for Headaches Deep Brain Stimulation for Depression Cortical Stimulation for Stroke DBS and RNS for Epilepsy VNS for Obesity What have we learned about the disease and science? - Brian Kopell

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Disruptive Forces EASY TO USE, EASY TO CONSUME

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Pharmaceutical Challenges R&D1995 - $15billion 2010 - $85billion Approved drugs 1996 56 2010 21 100,000 sales reps for 700,000 physicians 250,000 defibrillators implanted on the rise

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Pharmaceutical Challenges Dendreon vaccine for Prostrate revs up immune system, costs $93,000, four month survival advantage Rheumatoid Arthritis - $14 billion, remicade, Enbrel, humira half effective 10% actually active and beneficial How many drugs are wasted?

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Costs of medications Avinza 90mg Qday $338/month ($4056) Percocet 5/325 Qid $465/month ($5580) Oxycontin 40mg Bid $421/month ($5052) Neurontin 600mg Tid $375/month ($4500) A typical regimen for chronic pain might include a sustained release drug, Oxycontin, a breakthrough drug, Percocet and a Neuromodulator, Neurontin which cost over $1000/month Budd K. Spinal Cord Stimulation: Cost- Benefit Study.Neuromodulation 2002;5:75-78 Cost neutrality is reached within 5 years following SCS implant

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OUR ADVANTAGES Compliance Gains in the Costs of unused medications Low risk, low rewards (medications) Higher risk, higher rewards (intervention) Take it for the rest of my life (medicine) When does it work, how well does it work (medicine) Opiod Abuse SCS Study Defining role for intervention for spine surgeries

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OPPORTUNITY NANS Foundation SOCIETY TO TAKE UPON A TRANSFORMATIVE APPROACH REGISTRIES GUIDELINES POSITION STATEMENT DEFINE THE TECHNOLOGICAL GAPS

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OPPORTUNITY Care more particularly for the individual patient than the special features of the disease. - Sir William Osler 1899 COLLABORATION PATIENTS PHYSICIANS SOCIETY INDUSTRY REGULATORY

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Conclusion White Papers & Neuromodoulation Consider a Neuromodulation community forum Survey the membership to define the gaps Email ideas, collaboration, new thoughts Ashwini.sharan@jefferson.edu