Microwave Stimulators NANS December 6 th, 2012 Laura Tyler Perryman, MS, MBA PhD Candidate, Arizona State University

2 Disclosures  Laura Tyler Perryman, MS, MBA, CSM, PMP  Founder, Stimwave Technologies, Inc.  Founder, Neural Diabetes Foundation, Inc.  PhD Candidate, Biomedical Engineering, ASU  Discussing NON-APPROVED devices for neuromodulation indications Laura Tyler Perryman. Copyright 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.

3 Revolutionizing Pain Management

Neural Stimulation Electrodes Laura Tyler Perryman. Copyright 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. Page 4

FNS Neuroprostheses Laura Tyler Perryman. Copyright 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. Page 5

Page 6 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 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 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. Page 7

Clinician and Patient Needs 3/11 Page 8 Laura Tyler Perryman. Copyright 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.  Clinician (start with top down rather than bottom up)  Less Procedure Time  Flexibility  Permanent with Minimal Incision  Multiple Leads  Built in Anchoring  Existing Leads  Patient  Convenience  Ease of Use  Stay out of hospital overnights  Easy upgrade pathways for existing patients

Old School Product Development 3/11 Page 9 Laura Tyler Perryman. Copyright 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.

21 st Century Product Development Page 10 Laura Tyler Perryman. Copyright 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.

Disruptive MicroStim TM Solution Passive microsize device platform for pain management  No internal batteries or toxic materials  3T full body MRI conditional goal*  Ga needle insertion widens reach targets  1 cm to 6 cm long leads, 0.5 mm to 1.2 mm diameters  2 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 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. 11 *pilot data. Pending additional data and submission

Laura Tyler Perryman. Copyright 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. 12 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

Laura Tyler Perryman. Copyright 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. 13 NOT a BION® or Inductive  Other wireless products utilizing coils need coils externally  Large external is difficult for the patient to wear, limiting compliance

Microwave SCS Components Laura Tyler Perryman. Copyright 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. 14

Laura Tyler Perryman. Copyright 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. 15 Same Efficacy, Tried and True

 No open port EVER  100% percutaneous 14G placement  No batteries, No extension tunneling  No revisions every 4 to 7 years  Use MicroFlex TM with ANY lead or paddle, 8 or 16 contact lead header  Passive MicroStim TM forward compatible  MRI expanded capabilities Laura Tyler Perryman. Copyright 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. 16 Any Lead Flexibility Sample commercial percutaneous leads Sample commercial paddle leads

17 Convenience Laura Tyler Perryman. Copyright 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.

MicroStim TM 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 MicroStim TM with wide array of options  Compliant- compact discreet external device with Bluetooth utilizes breakthrough engineering for energy and information transmission Laura Tyler Perryman. Copyright 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. 18

19 Thank You Laura Tyler Perryman. Copyright 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.