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THANK YOU SINCERELY

THANK YOU SINCERELY. Joshua Prager and Ali Rezai Ben Pless and Salim Hayek Tom Tefft , Michael De ma ne Mona Patel, Brad Maruca. GOALS and RULES.

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THANK YOU SINCERELY

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  1. THANK YOUSINCERELY Joshua Prager and Ali Rezai Ben Pless and Salim Hayek Tom Tefft, Michael Demane Mona Patel, Brad Maruca

  2. GOALS and RULES • Let’s 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.

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

  4. 20 TRANSFORMATIVE technology - changes the practice of medicine? • NeuroNavigation • Endovascular Surgery • Minimally invasive Spinal Neurosurgery • Bone Morphogenic Protein • EndscopicNeursorgery • Hemostatic Agents • Deep Brain Stimulation/ NEUROMODULATION

  5. 15 NEUROMODULATION 1997 Market revenue source:  Dodds, Matthew.  Citi Research, A Division of Citigroup Global Markets, Inc. Neuromodulation Market Model, September 17, 2012

  6. 10 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

  7. 5

  8. +5 Horizon NEUROMODULATION REMAINS QUITE EXCITING ROBUST • DBS for Depression, Epilepsy • SCS for CHF • RNS for Epilepsy • PNS for Headache, asthma, GI TECHNOLOGY PENETRATION

  9. OP Ed Remember – that we are treating patients who have the worst of the worst problem…

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

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

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

  13. Choosing the Right Patient

  14. 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 don’t want no WIRE in my back!

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

  16. 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

  17. 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

  18. 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

  19. 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.”

  20. 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

  21. 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

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

  23. 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

  24. 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

  25. Disruptive Forces EASY TO USE, EASY TO CONSUME

  26. Pharmaceutical Challenges • R&D 1995 - $15billion 2010 - $85billion • Approved drugs 1996 – 56 2010 – 21 • 100,000 sales reps for 700,000 physicians • 250,000 defibrillators implanted on the rise

  27. 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?

  28. 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 Cost neutrality is reached within 5 years following SCS implant Budd K. Spinal Cord Stimulation: Cost-Benefit Study.Neuromodulation 2002;5:75-78

  29. 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) • OpiodAbuse – SCS Study • Defining role for intervention for spine surgeries

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

  31. OPPORTUNITY Care more particularly for the individual patient than the special features of the disease. - Sir William Osler 1899 COLLABORATION PATIENTS PHYSICIANSSOCIETYINDUSTRYREGULATORY

  32. 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

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