Convenient

Report
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.
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