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ASU’s Neuro-Stim Chip: Next Generation Microelectronic Neurostimulation

Bruce C. Towe, Ph.D

Professor of Bioengineering Harrington Department of

Bioengineering

400m

- 200m- 150m- 100m

- 50m0

50m100m150m200m250m300m350m

T ime ( s )18 : 34 : 55 . 14418 : 34: 53. 418 18 : 34 : 53 . 600 18: 34: 53 . 800 18 : 34 : 53. 999 18 : 34 : 54 . 200 18: 34: 54 . 400 18: 34: 54 . 600 18: 34: 54. 800

Opportunity Snapshot• Neuro-Stim Chip offers technological breakthrough in electronic circuit

design – Implantable microdevices on the size scale of less than 1 mm diameter by 3-

10 mm length– Two prototypes with difference sources for power generation

• Ultrasonic powered neurostimulator• Radio Frequency (RF) powered neurostimulator

• Abundant applications covering large markets– Pain, Depression, Rehabilitation, Cardiac, etc– Neurostimulator markets in U.S. expected to reach $2 billion by 2010*

• Validated FDA approval pathways for Parkinson’s and Chronic Pain– Established players in space (Medtronic, St. Jude)– Reimbursement precedence

*estimates provided from Windover Information: Medtech insight 2006 November

Neuro-Stim Chip Profile

Pt electrode

Pt electrode

PVDF stack (piezoelectric)

Diode

13 gauge needle

5 mm

Two Product Development Strategies

Ultrasonic Powered Neurostimulator Radiofrequency powered neurostimulator

• Can act both to stimulate tissue function as well as sense bioelectric events and wirelessly transmit the signals that allow monitoring of effectiveness

• It involves a new technological approach that allows for large numbers of addressable channels (64-128)

• Powered externally by a device placed on the skin near or over the implant – lower battery drain than radiofrequency neurostimulator.

• Size: 1mm

• Depends on externally applied radio waves rather than ultrasound for power

• It also involves a new technological approach that allows for extreme miniaturization, but multichannel is in the future

• Size: 500-800 microns Smaller and can be implanted more deeply (6 in vs. 2 in)

Neuro-Stim Chips’ Role in the Marketplace

US Neurostimulator Markets Expanding*

• In 2005 the total US neurostimulation products market, including cochlear implants estimated at roughly $830 M

• Market growth at a compound annual rate of more then 17% and expected to grow to 5 billion in the next decade

*estimates provided from Windover Information: Medtech insight 2006 November

Sample Growth Areas Projected Revenue

Direct spinal cord stimulation for pain

Expected to double from $375M to $675M in the next five years

Neurostimulation for depression

Increase to $230M during the next 5 years

Migraine and urge incontinence treatment

Another $571M in sales by 2012

Vagal nerve stimulation for obesity?

Depends on acceptance, but perhaps very large

Conventional Medical Therapeutic Technologies

• Pacemakers• Brain and nervous system neurostimulators• Bladder sensors/stimulators• Bions/ functional electrical stimulation

Towe, B.C.

http://www.neuromodulation.nl/specialist/Paralysis.html

Some Varieties of Microelectronic Implants

BIONS tm. Boston Scientific Inc.

Bions Neurostimulator Veri-Chip ID tag, medical information storage

Bions 2.0 mm x 16 mm

The Neuro-Chip Vs. Comparable Microstimulators

Our device with 14 Ga needle

Boston Scientific Inc.Implanted with an internal battery

Medtronic Implantables (leads not shown)

Advantages to Smaller, Less Invasive Devices

• Smaller implants = Minimally invasive– the difference between major surgery and outpatient injection– more comfortable for patients and interfere less with normal anatomy

• Passive device– no internal power consumption – no internal battery– most electronic “complexity” resides outside of body - upgradable

• Accuracy of placement– can deploy device next to target of stimulation– can deploy multiple devices over larger area for improved function

Neuro-Stim Chip’s Potential

Condition: Treatment

Prevalence/ Incidence

Companies FDA Regulatory Status

Estimated Implants to Date/Implants per year

Chronic Pain:SCS & PNS

50M/ 5M

Medtronic, St. Jude Medical

Cleared 110,000/16,000

Epilepsy:VNS

2.7M/ 500,000

Cyberonics Cleared 30,000/6,000

Chronic Depression:VNS

15M/4M

Cyberonics Cleared 22,500/1,250

Urge Urinary Incontinence:SNS

12M/150,000

Medtronic, Uroplasty, NDI Medical

ClearedIn trials

25,000/3,000

Obesity:VNS & DGS

5M/250,000

Cyberonics, EnteroMedic, IntraPace, Leptos Biomedical, Medtronic, MetaCure

In development In trials

SCS – Spinal Code Stimulation DBS – Deep Brain Stimulation SNS – Sacral Nerve StimulationPNS – Peripheral Nerve Stimulation VNS – Vagus Nerve Stimulation DGS – Direct Gastric Simulation

Precedent for Reimbursement

Spinal Cord Stimulation for Pain ReliefCode Description Typical reimbursement

(2005 figures)63650 Implant percutaneous lead $3474

63660 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural

$4897

64685 Incision and subcutaneous placement of spinal neurostimulator pulse generator

$2373

Deep Brain Stimulation for Parkinson’s Disease and essential tremor95961 Identify electrode implantation sites $42261886 Implant generator $188561867 Implant one lead $7677

61868 Implant additional leads $2023

Source: Medtech Insight

The Plan Moving Forward

Next Steps

• Raise $4 – 5 million to achieve the following – Chronic animal feasibility testing – in progress– Commercial design – need pre-production prototype/implant packaging– In vivo animal testing– Pre-IDE meeting– cGMP prototype– Investigator IDE – we have the MD’s

• Potential Exit through Acquisition– Advanced Neuromodulation Systems (ANS) acquired by St. Jude in Nov

2005 – Medtronic and Cyberonics continue to allocate resources to neuromodulation