THANK YOUSINCERELYJoshua Prager and Ali Rezai Ben Pless and Salim HayekTom Tefft, Michael DemaneMona Patel, Brad Maruca

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.

GOALS

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

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

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) $1,286 60,643

Deep Brain Stimulation (DBS) $393 24,104

Sacral Neuromodulation (SNM) $386 41,233

Vagal Nerve Stimulation (VNS) $211 8,612

Targeted Drug Delivery $340 29,565

(Intrathecal Pain & Spasticity)

Global Neuromodulation Market $2,616 164,158

151997

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

5

• DBS for Depression, Epilepsy

• SCS for CHF• RNS for Epilepsy• PNS for Headache, asthma,

GI

TECHNOLOGYPENETRATION

Horizon+5

NEUROMODULATIONREMAINS

QUITE EXCITINGROBUST

OP EdRemember – that we are treating patients who have the worst of the worst problem…

The Creative Destruction of Medicine

7 billion people>3 million doctors>10,000 hospitals>6000 prescription drugs>4000 procedures & operationsSupplements, herbs, alternative

treatments

?In the Future …

SPINAL CARE IS FRAGMENTED

Motrin/ MedicationsPhysical Therapy

AccupunctureChiropractor

Epidural Steroid InjectionSpinal 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

?In the Future …

SPINAL CARE IS FRAGMENTED

Motrin/ MedicationsPhysical Therapy

AccupunctureNeurostimulation

ChiropractorEpidural 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

Choosing the Right Patient

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!

Equipment• Familiarity• Device Complications• Minimal Invasiveness• Ease of use

- programming

How do we make people good and

WANT to FEEL BIONIC?

NavigationMRI GuidanceINTRA OP MER?SPINAL Flouroscopy/ XRT?Wires running around the bodyEase of ProgrammingDevice ComfortHealing

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

Practice of Medicine is EvolvingNeurosurgery (General)

VascularTumorFunctionalEpilepsySpinePediatric

Neurology, hematologyMedical and Radiation oncMovement Disorder NeurologyEpilepsy neurology, NeuropsychPain, PM&RPediatrics

Maybe an Opportunity in the field of Internventional Headache and Epilepsy Management

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

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

HEADACHELIFE

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.”

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

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

SCSHeart FailureRefractory AnginaPeripheral Vascular DiseasePeripheral Neuropathy

INDICATIONS:

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

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

Disruptive Forces

EASY TO USE, EASY TO CONSUME

Pharmaceutical Challenges

• R&D 1995 - $15billion2010 - $85billion

• Approved drugs 1996 – 562010 – 21

• 100,000 sales reps for 700,000 physicians

• 250,000 defibrillators implanted on the rise

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?

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

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

OPPORTUNITY

NANS FoundationSOCIETY TO TAKE UPON A

TRANSFORMATIVE APPROACHREGISTRIESGUIDELINES

POSITION STATEMENTDEFINE THE TECHNOLOGICAL GAPS

OPPORTUNITY

Care more particularly for the individual patient than the special features of the disease.

- Sir William Osler 1899 COLLABORATION

PATIENTSPHYSICIANS

SOCIETYINDUSTRY

REGULATORY

Conclusion

• White Papers & Neuromodoulation

• Consider a Neuromodulation community forum

• Survey the membership to define the gaps

Email – ideas, collaboration, new thoughtsAshwini.sharan@jefferson.edu