Sequencing by Recognition


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Sequencing by Recognition

  1. 1. 1 ASU’s Neuro-Stim Chip: Next Generation Microelectronic Neurostimulation Bruce C. Towe, Ph.D Professor of Bioengineering Harrington Department of Bioengineering
  2. 2. 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
  3. 3. Neuro-Stim Chip Profile Pt electrode Pt electrode PVDF stack (piezoelectric) Diode 13 gauge needle 5 mm
  4. 4. 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)
  5. 5. Neuro-Stim Chips’ Role in the Marketplace
  6. 6. 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
  7. 7. Conventional Medical Therapeutic Technologies • Pacemakers • Brain and nervous system neurostimulators • Bladder sensors/stimulators • Bions/ functional electrical stimulation Towe, B.C.
  8. 8. 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
  9. 9. 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)
  10. 10. 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
  11. 11. 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 Cleared In 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 Stimulation PNS – Peripheral Nerve Stimulation VNS – Vagus Nerve Stimulation DGS – Direct Gastric Simulation
  12. 12. Precedent for Reimbursement Spinal Cord Stimulation for Pain Relief Code 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 tremor 95961 Identify electrode implantation sites $422 61886 Implant generator $1885 61867 Implant one lead $7677 61868 Implant additional leads $2023 Source: Medtech Insight
  13. 13. The Plan Moving Forward
  14. 14. 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