Microwave Stimulators

NANS December 6th, 2012

Laura Tyler Perryman, MS, MBAPhD Candidate, Arizona State University

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Disclosures

Laura Tyler Perryman, MS, MBA, CSM, PMPFounder, Stimwave Technologies, Inc.Founder, Neural Diabetes Foundation, Inc.PhD Candidate, Biomedical Engineering, ASU

Discussing NON-APPROVED devices for neuromodulation indications

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

3Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

Revolutionizing Pain Management

Neural Stimulation Electrodes

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FNS Neuroprostheses

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Neuromodulation Effectiveness

Size- Is the lead small enough to go anywhere? Convenience- Is it possible to tunnel to the target? Complexity- Is a custom pulse generator required? Acuity- can effects be long term? Contact Positioning- can electrodes be positioned to

activate nerve bundles? Contact Geometry- can electrodes be designed to

optimize the field with safe charge density? Correlation- electrode location correct to provide

therapeutic relief? Pulse parameters- Pulse width, frequency, waveform,

bursts? Pulse Sequences- multichannel, variability, cross talk?

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

The Time is Right

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

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Neuromodulation market expected to more than double in size by 2018-Neurovascular Guidewire Market, 2012

Market size $1.8B in 2011, projected to grow to $4.7B by 20171

-Global Data Report, 2011

Clinician and Patient Needs

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Clinician (start with top down rather than bottom up)Less Procedure TimeFlexibilityPermanent with Minimal IncisionMultiple LeadsBuilt in AnchoringExisting Leads

Patient ConvenienceEase of UseStay out of hospital overnightsEasy upgrade pathways for existing patients

Old School Product Development

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Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

Waterfall

21st Century Product Development

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Agile

Disruptive MicroStimTM Solution

Passive microsize device platform for pain management No internal batteries or toxic materials 3T full body MRI conditional goal* 14-22 Ga needle insertion widens reach targets

1 cm to 6 cm long leads, 0.5 mm to 1.2 mm diameters2 to 8 electrodes per lead depending on placement

Convenient external ergonomic stimulator wearable unit 915 MHz ISM band (868 Mhz for EU) Penetration depths to 12 cm (SCS is ~4 cm to 6 cm) Currents up to 25.5 mA per MicroFlex device

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

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*pilot data. Pending additional data and submission

12Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

No Battery, No Sticky Skin Charger

Patient MUST carry programmer to change amplitude and settings

Rechargeable IPGs also require the external coil system

IPG primary cells replaced ~ every 3 years

13Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

NOT a BION® or Inductive

Other wireless products utilizing coils need coils externally

Large external is difficult for the patient to wear, limiting compliance

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Microwave SCS Components

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

15Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

Same Efficacy, Tried and True

Charged Balanced, biphasic pulsesSelection of polarity of electrodesPulse frequencies up to 1200 Hz (future to 5000 Hz)Pulse widths from 50 to 500μs (future to 1ms)Option for placement of dual arrays crossedBUT- Only one lead!! 8 electrode percutaneous version

How do you revolutionize an industry with a new technology platform?

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No open port EVER100% percutaneous 14G placement No batteries, No extension tunnelingNo revisions every 4 to 7 yearsUse MicroFlexTM with ANY lead or paddle, 8

or 16 contact lead headerPassive MicroStimTM forward compatibleMRI expanded capabilities

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

Any Lead Flexibility

Sample commercial percutaneous leadsSample commercial

paddle leads

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Convenience

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

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MicroStimTM Advantages

Size- 95% smaller than next smallest available generator, fits within anchor or lead (250 mg)

Passive device with simple architecture No internal battery, -easily upgradeable Electronic “complexity” outside of body

Convenience- Elegant, percutaneous procedure,  takes 75% less time

Safe- limits infection sources Flexible- turn key or easily adaptable header

to convert any lead or paddle to use MicroStimTM with wide array of options

Compliant- compact discreet external device with Bluetooth utilizes breakthrough engineering for energy and information transmission

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

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Thank You

Laura Tyler Perryman. Copyright 2012. All rights reserved. This document has been disclosed on a confidential basis and is not for use by any persons but the named recipient, nor may it be reproduced, stored, or copied in any form.

Go Forward. Revolutionize.