Remotely Controlled Spinal Stimulation Devices

Transcription

1 Remotely Controlled Spinal Stimulation Devices Concept Origins Spinal cord stimulation background Limitations of current devices Design criteria for new devices Device concept Market considerations Development objectives

2 University of Iowa Neurosurgery Research Training Program Select highly intelligent, intensely motivated residents Systematically guide each trainee through their individualized research and discovery process Recruit world-renowned research mentors

3 Original Concept Group Iowa Brian Dalm MD: Neurosurgery Resident Timothy Brennan MD PhD: Vice-Chair for Research - Pain Research and Clinical Pain Management Matthew Howard MD: Professor and Dept. Head - Human Neurophysiology Research UVA George Gillies PhD: UVA Research Professor - Medical Device Inventor and Medical Physics Marcel Utz PhD: UVA Associate Professor - Microelectronics and Micro-fabrication

4 Spinal Cord Stimulation (SCS) History 1960 s - advent of human SCS treatment

5 Spinal Cord Stimulation (SCS) History Initially intra-dural and extra-dural device placement Intra-dural device concept abandoned Tethering between the spinal cord and dura Increased risk of cerebrospinal fluid (CSF) leak Poor control of electrode location relative to targeted sub-region of the spinal cord

6 Extra-Dural Spinal Cord Stimulators (all current devices)

7 Key Anatomical Considerations

8 University of Iowa Human Neurophysiology Research

9 Brugge JF, Howard MA: Encyclopedia of the Brain, Elsevier Science, 2002 Brugge JF, Howard MA: Encyclopedia of the Brain, Elsevier Science, Vol 2, pp , 2002

10 General Clinical Research Center (GCRC)

11 University of Iowa Human Brain Research Laboratory Speech and Hearing Research Faculty: Funding Support: NIH (NIDCD/NINDS), Welcome Trust, Dana Foundation, U.S. Dept State (Fullbright), Hoover Foundation

12 Extra-Dural Stimulation Patterns Derived from: Holsheimer J. Spinal Cord 36: , Holsheimer J. Neuromodulation 5:25-31, 2002 Holsheimer J, et al. Neuromodulation 10: 34-41, 2007

13 Functional Access to Spinal Cord Pathways

14 Functional Access to Spinal Cord Pathways Using Current SCS Devices < 1 %

15 Poor Activation Pattern = Suboptimal Results Percentage of patients reporting > 50% pain relief - 38 % (Taylor RS et al. Spine 30: , 2004) - 53 % (North RB et al. Spine 30: , 2005) - 48 % (Kumar KA et al. Pain 132: , 2007)

16 Design Specifications Optimal SCS Device Direct contact with the spinal cord Dense coverage with electrode array Ultra-thin implant profile No mechanical connection between spinal cord and dura

17 The Iowa-Patch (I-Patch) Concept

18 The I-Patch System (flexible micro-electronics)

19 The I-Patch System

20 The I-Patch System

21 Spinal Cord Pathway Access Current SCS vs. I-Patch* (* including penetrating electrode variants)

22 Market Considerations Size (source: GlobalData) - currently $1 billion estimate: $ 2.6 billion Market Leaders - Medtronic - St. Jude - Boston Scientific

23 Market Considerations Size (source: GlobalData) - currently $1 billion estimate: $ 2.6 billion Market Leaders - Medtronic - St. Jude - Boston Scientific Competing Concepts - none identified in medical literature search - none identified in patent search - U.S. Patent Application (U.Iowa-UVA, 10/28/10)

24 Development Objectives

25 Development Objectives Develop a device that is more effective than current spinal cord stimulators in treating patients with chronic pain

26 Development Objectives Develop a device that is more effective than current spinal cord stimulators in treating patients with chronic pain Develop new SCS clinical applications (e.g. movement disorders)

27 Development Objectives Develop a device that is more effective than current spinal cord stimulators in treating patients with chronic pain Develop new SCS clinical applications (e.g. movement disorders) Make discovers about the functional organization of the human spinal cord

28 Development Plan

29 Development Plan Build an outstanding R&D team Carryout pre-clinical studies Develop device prototypes and perform invitro testing Acute intra-operative experiments (human and experimental animal) Chronic implant experiments (sheep) Launch pilot human clinical trials

30 University of Iowa Neurosurgery/Human Experimental Neurophysiology Chandan Reddy MD, Saul Wilson MD, Hiroyuki Oya MD PhD, Hiroto Kawasaki MD PhD, Matthew Howard MD, Haiming Chen Anesthesiology/Pain Research Timothy Brennan MD PhD Pathology/Spinal Cord Histology Katherine Gibson-Corley DVM PhD Experimental Animal Spinal Surgery Tony Smith, Doug Fredericks

31 University of Virginia Medical Physics George Gillies PhD Microelectronics Marcel Utz PhD, Suk-Hyeung Song PhD, Qiujun Huang Neurological Devices Med-Tech Expertise Daniel O Connell MBA (Neuroventures LLC)

32 Iowa State College of Veterinary Medicine Experimental Animal Spinal Cord Physiology Nick Jeffery DVM PhD University of Twente Spinal cord electrical stimulation modeling Jan Buetenweg PhD

33 Medical Device Technology Partner Evergreen Medical Inc. - Randy Nelson, CEO - Steve Scott, Material Sciences - Rob Shurig, Material Sciences - Brian Kunley, Microelectronics

34 Funding Strategy Grants (philanthropic, NIH, DARPA etc.) AND Commercial (start-up vs. licensing R&D)

35 Stereotaxis Inc. (St. Louis, Missouri) UVA/U. Washington (Seattle) /Washington U. (St. Louis) tech transfer program IPO (Goldman Sachs) 2004 Number of cardiac patients treated to date > 50,000 Market Capitalization range approx. $200 - $600 million Potential Cardiac Market Size - > $1 Billion Med-Tech catalyst for St. Louis - State of Missouri

36 Intellectual Property UIRF Case: Title: Remotely controlled devices for direct spinal cord stimulation Type: Provisional application Filed: November 11th 2010 Claims: 3 independent claims, 32 total. Attorney: Jim Heslin, Wilson Sonsini (+20 yrs devices)

37 I-Patch Development Plan Phase Product stage/ Status Milestone(s) Timline Funding Research Concept and Prototypes In vivo proof of principle Core patent filed 12 mos. <$1 M Start-up Acute human device(s) Chronic animal testing Human intraoperative data Animal Proof of Concept 12 mos. $1 2 M Seed Pre-clinical Pre-clinical development of ipatch system File IDE Indication Selection 18 mos. $3 5 M Series A Feasibility 0-25 patients study Clinical POC Indication 24 mos. $5 10 M Series A/B Pivotal patient study Approval 36 mos. $30 50 M Series C

38 Neuromodulation Transactions Year Company Market Activity Price Revenue/ Stage 2004 Advanced Bionics Pain/ Hearing Loss 2005 Advanced Neuromodulation Systems Pain Acquired by BostonScientific Acquired by St. Jude Medical $1.15b $82m Market $1.3b $145m Market 2005 Transneuronix Obesity Acquired by Medtronic $250m up front $0 Phase II 2006 Northstar Neuroscience Stroke IPO $110m raised $0 Phase II 2007 Cyberonics Obesity License to J&J $9.5M up front $0 Pilot 2007 Enteromedics Obesity IPO $40m raised $0 Phase II 2008 NDI Medical Urology Product line acquired by Medtronic 2011 IntElect Medical DBS Acquired by Boston Scientific $42m $0 Phase II ~$80m $0 Phase II