Microwave Stimulators NANS December 6th, 2012 Laura Tyler Perryman, MS, MBA PhD Candidate, Arizona State University 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 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. 2 Revolutionizing Pain Management 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. 3 Neural Stimulation Electrodes 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. Page 4 FNS Neuroprostheses 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. Page 5 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. Page 6 The Time is Right 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 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. Page 7 Clinician and Patient Needs 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 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. 3/11 Page 8 Old School Product Development 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. 3/11 Page 9 21st Century Product Development 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. Page 10 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 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 *pilot data. Pending additional data and submission 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. 11 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 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. 12 NOT a BION® or Inductive Other wireless products utilizing coils need coils externally Large external is difficult for the patient to wear, limiting compliance 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. 13 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. 14 Same Efficacy, Tried and True Charged Balanced, biphasic pulses Selection of polarity of electrodes Pulse frequencies up to 1200 Hz (future to 5000 Hz) Pulse widths from 50 to 500μs (future to 1ms) Option for placement of dual arrays crossed BUT- Only one lead!! 8 electrode percutaneous version How do you revolutionize an industry with a new technology platform? 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. 15 Any Lead Flexibility No open port EVER 100% percutaneous 14G placement No batteries, No extension tunneling No revisions every 4 to 7 years Use MicroFlexTM with ANY lead or paddle, 8 or 16 contact lead header Passive MicroStimTM forward compatible MRI expanded capabilities Sample commercial paddle leads Sample commercial percutaneous leads 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. 16 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. 17 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. 18 Thank You Go Forward. Revolutionize. 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. 19