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This document provides an overview of focused ultrasound technology. It discusses how focused ultrasound is a non-invasive therapeutic technology that can be used as an alternative or adjunct to surgery, radiation therapy, and drug delivery to treat conditions like tumors, metastatic cancer, Parkinson's disease, and back pain. It explains that focused ultrasound uses intersecting beams of ultrasound focused with precision to target and treat tissue while avoiding damage to surrounding areas. The document outlines the various effects it can have on tissue and discusses its applications and development. It positions focused ultrasound as a technology that could improve quality of life for millions of patients worldwide.

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Focused Ultrasound
“Without health there can be no happiness.”
Two Stories Focused Ultrasound Technology Focused Ultrasound Foundation
Focused Ultrasound Early stage, revolutionary, noninvasive therapeutic technology Alternative or adjunct  Surgery  Radiation therapy  Drug delivery Transform treatment  Benign and malignant tumors  Metastatic cancer  Parkinson‟s disease & epilepsy  Back pain, hypertension
Early Stage MR 30 years ago  Unknown  Revolutionized diagnoses  Affects everyone Focused Ultrasound today  Unknown; “Medicine‟s Best Kept Secret”  As important to therapy as MR is to diagnoses  In 10 years, may affect everyone Infancy  Not science fiction  Real today
Essential Tremor Treatment Awake, no anesthesia No incisions No burr holes No electrodes No infection No blood clots No brain damage
Uterine Fibroid Pre-treatment
Uterine Fibroid Hysterectomy        Major surgery General anesthesia Painful Hospitalization 6 weeks recovery Side effects No more children Focused Ultrasound        Noninvasive, no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility
Uterine Fibroid Pre-treatment 9 months post-treatment
Breast Cancer Pre-treatment Two weeks post treatment
What is Focused Ultrasound? How does it work?
Marriage of Two Innovative Technologies Focused ultrasound  Treat tissue deep in body non-invasively
Marriage of Two Innovative Technologies Magnetic resonance (MR) or ultrasound (US) imaging  Identify and target tissue to be treated  Guide and control treatment in real time  Immediate confirmation of effectiveness
Focused Ultrasound: The Principle Analogous to a magnifying glass focusing rays of the sun…
Focused Ultrasound: The Principle Multiple intersecting beams of ultrasound  Focused with extreme accuracy (1 mm diameter)  Target in body • Individual beams pass harmlessly through adjacent tissue • Profound effect at point of convergence
Effects at Focal Point Thermal ablation Histotripsy Deliver drugs Dissolve clots: sonothrombolysis Radiation sensitization Drug activity enhancement Sonodynamic therapy Coagulate blood vessels Amplification of cancer biomarkers Immunomodulation Neuromodulation Vasodilation Vasoconstriction Variety of effects, variety of disorders Stem cell delivery
Destroy Tissue: Thermal Ablation Heating any tissue to 130 F (56 C) for 1 second  Denatures proteins  100% cell death: normal and abnormal
Focal Drug Delivery Deliver drugs in high concentrations  Precisely where needed, minimizing systemic toxicity
Lipid Microbubbles
Lipid Microbubbles Chemotherapeutic agents; genes; growth factors
Microbubbles Injected
Distribution of Microbubbles
Drugs Released at Focal Point
Focused Ultrasound Procedure Targeting Planning Treating Confirming Uterine Fibroids Essential Tremor Brain Tumors
Focused Ultrasound vs Radiation Single treatment Immediate and verifiable effect Greater precision and accuracy Real time localization No cumulative dose No limitations on lesion size No limitations on number of treatments No secondary malignancies 100% cell death Sharp margins
Sharp Margins Liver Treated 1 mm Brain
Global Development Landscape Conceptual Preclinical Anecdotal Pilot Pivotal Other Approvals FDA Reimbursement Neurological Oncological Musculoskeletal Essential Tremor Parkinson‟s Disease Neuropathic Pain Brain Tumors OCD Epilepsy Stroke Hydrocephalus Trigeminal Neuralgia Alzheimer‟s Disease Cancer Pain Depression Bone Prostate Tumors Thyroid/Parathyroid Breast Cancer Pancreas Soft Tissue Liver Kidney Head, Neck Cancer Lung Bladder Colon Esophagus Back Pain Osteoid Osteoma Osteoarthritis Sacroilitis Women’s Health Cardiovascular Miscellaneous Uterine Fibroids Uterine Adenomyosis Breast Fibroadenomas Hypertension Atherosclerosis Atrial Fibrillation Septal Perforation Acute Tubular Necrosis Obesity Diabetes Glaucoma Benign Prostatic Hypertrophy Ureterocele
Global Development Landscape Reimbursement Sparse Clinical Trials Regulatory: FDA Uterine Fibroids Pain from Bone Metastasis Anecdotal Osteoarthritis Thyroid/Parathyroid Brain Tumors Hypertension Breast Tumors OCD Pancreatic Tumors Kidney Tumors Liver Tumors Neuropathic Pain Parkinson‟s Disease Essential Tremor Soft Tissue Tumors Prostate Cancer Uterine Adenomyosis Breast Fibroadenomas Regulatory: Outside US Essential Tremor Parkinson‟s Disease Neuropathic Pain Uterine Fibroids Uterine Adenomyosis Breast Fibroadenomas Breast Tumors Prostate Cancer Thyroid/Parathyroid Pain from Bone Metastasis Pancreatic Tumors Liver Tumors Soft Tissue Tumors Osteoid Osteoma Back Pain Kidney Tumors Preclinical Hydrocephalus Epilepsy Alzheimer‟s Disease Stroke Atherosclerosis Obesity Atrial Fibrillation Diabetes Septal Perforation Sacroilitis Trigeminal Neuralgia Glaucoma Acute Tubular Necrosis Benign Prostatic Hypertrophy Head & Neck Cancer Lung Cancer Ureterocele Conceptual Cancer Pain Bladder Cancer Colon Cancer Esophageal Cancer Depression
Imagine the Future Advances in technology  Imaging  Focused ultrasound  Focal drug delivery Undreamed-of applications
Snake Oil: Cure-all
Magnetic Resonance Imaging Insert MR videos
Limitations Scoliosis Leukemia Traumatic Injuries
Potential Impact on Millions of People Urgent need: widespread availability of focused ultrasound  Saving time, saving lives Delay results in unnecessary death, disability and suffering  Countless individuals: friends, family, you
The Problem Medical device development and adoption slow Decades: concept to adoption as standard of care
Process, Complicated and Inefficient Patient advocacy Evidence, safety, efficacy, cost Technology R&D IP generation and protection Design, engineering, manufacturing Pre-clinical proof of concept Regulatory approval Marketing, sales, support Training and credentialing Insurance reimbursement Physician and Scientist education Physician advocacy
Organizations with Different Agendas Patients Academic research sites Private philanthropy Disease specific foundations NIH Venture capital, private equity Industry FDA Insurers Patient advocacy organizations Medical societies Treatment facilities Physicians, numerous specialties
Obstacles Technical and engineering Awareness and acceptance, patients and physicians Cultural and turf issues Financial Regulatory Reimbursement
The Solution Obscure No roadmap, examples or formulas Obligated to invent
The Challenge "There is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success, than to take the lead in the introduction of a new order of things."
It‟s all about the patients saving time, saving lives
Purpose of the Foundation Development Adoption Millions of Lives Improved
Overview Founded 2006  Catalyst to accelerate the development and adoption of FUS Charlottesville based, global impact Tax exempt, high performance, entrepreneurial  Market driven, action and results oriented Essence of activities  Foster collaboration  Knowledge: create, aggregate, share Model  Venture philanthropy, social entrepreneurship  Private funding bridges gap between research & treatment
Unique, Hybrid Organization Device: platform technology Variety of clinical indicators Fulfill multiple roles Focused Ultrasound Foundation Medical & Scientific Society Manufacturers Trade Association Patient Advocacy Organization Patient Support Organization Research & Education Foundation
Vision Focused Ultrasound     Improve quality of life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible
Mission Accelerate development of new applications     Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care Accelerate adoption as standard of care
Culture Patient centric  Uncompromisingly, passionately, obsessively committed to rapidly improving quality of life Catalytic, small, nimble, potent  Reputation, contagious enthusiasm and energy  Instill in others enthusiasm and energy to precipitate change Entrepreneurial  Create reality from imagined future through human action  Accomplishments exceed assets available Pioneering  Pursuit of excellence  Hard work, risk taking, innovation
Strategic Focus It's all about the patients: saving time, saving lives  Litmus test of actions and expenditures
Positioning, Nexus of Organizations Academic research sites Venture capital, Patients Academic private equity Treatment facilities research sites Private philanthropy Disease specific foundations Industry Insurers NIH Private Disease specific Venture capital, private equity philanthropy foundations Industry Insurers FDA Patients Patient advocacy organizations Patient advocacy Medical societies organizations Treatment facilities Medical societies FDA NIH Physicians, Physicians, numerous specialties numerous specialties
Currency and Incentives Reputation: trusted, independent, unbiased, 3rd party Contagious passion and enthusiasm Information Funding
Activities Influence direction Foster collaboration Change behavior and policy Create knowledge: clinical evidence, best practices & standards Cultivate the next generation Convene the community Collect and disseminate information Increase awareness: communications Overcome barriers
Influence Direction Define areas of clinical benefit Prioritize indications Market oriented approach  Segment to achieve natural advantage  Pick battles  Rapid success
Foster Collaboration Rapidly achieve a critical mass of effort and knowledge Approach  Stimulate innovation  Leverage intellectual capital  Coordinate activities, avoid duplication
Change Behavior & Policy Amalgamate stakeholders into a cohesive ecosystem  Patient centric  Sense of urgency
Develop Evidence of Safety, Efficacy Organize, conduct and fund research Niche: translational, application > discovery  Preclinical, clinical, technical  High risk, early stage, broad impact Iconoclastic model  Collaboration vs. individual glory  Patient centric vs. investigator centric  Commercially successful products vs. publications, grants, promotion Programs, tightly managed, milestone driven  External award: investigator initiated • Competitive, peer reviewed  Internal, Foundation initiated • Brain, liver • Contracts with academia, industry
Establish Best Practices, Set Standards Research, training, patient care Centers of Excellence: multidisciplinary luminary sites  Showcase for technology  Venue for collaboration Partnership of academia, industry and the Foundation
Centers of Excellence UVA Focused Ultrasound Center  Partnership     University of Virginia Commonwealth of VA FUS Foundation InSightec and GE Institute for Cancer Research, London  Partnership  Royal Marsden Hospital  FUS Foundation  Philips Medical
Cultivate the Next Generation Educate clinicians and scientists Fund fellowships and internships
Convene the Community Organize and fund meetings, symposia, workshops  Exchange knowledge and ideas  Foster collaborations and partnerships Foundation Organized Foundation Supported
Collect and Disseminate Knowledge Website Newsletter Journal Collaborative Network Social Media
Website – fusfoundation.org Encyclopedia of Focused Ultrasound Source of information  Comprehensive  Trusted  Up to date
Newsletter Published monthly
Journal Online, open access, peer reviewed Partnership with International Society for Therapeutic Ultrasound
Collaborative Network Inventory, updated quarterly on website     Laboratory research sites, investigators and projects Clinical research sites Commercial treatment sites Manufacturers
Social Media facebook.com/focusedultrasound @FUSFoundation
Increase Awareness: Communications Inform stakeholders, heat up environment, advance field Awareness events Media relations
Media Relations
Media Relations (cont.)
Media Relations (cont.)
Overcome Barriers Regulatory: partner with FDA, bridge not a barrier  Pathway for new indications: preclinical & clinical studies Reimbursement: obtain coverage & payment  Evidence of safety, efficacy, cost  Patient advocacy  Physician advocacy
Strategy Leverage capital: Cofunding and funding, indirect costs, royalties Best in class management practices  Transparency, accountability  Continuous quality improvement, policies, procedures, systems Align vision, mission, strategy, organization, culture, resources Prime the pump  Engage Foundations, Government, Industry, VC's  Assume functions of Foundation
Organization Flat: flexible, responsive to market and technology shifts 17 Athletes, A-players     Unbounded, highly intelligent, highly educated Healthcare professionals with over 140 years of experience 3 Ph.D.'s, 3 M.B.A.'s, 2 M.D.'s Interns Organized in teams
Portfolio of Programs Research Collaborative network Educational fellowships Meetings, symposia, workshops Centers of Excellence Regulatory Reimbursement Communications Website Newsletter Online, open-source journal Accelerate development and adoption
Board of Directors…active, engaged, passionate Neal F. Kassell, M.D. Edward D. Miller, M.D. Chairman, Focused Ultrasound Foundation Professor, Department of Neurosurgery, University of Virginia Former CEO, Johns Hopkins Medicine Dorothy N. Batten Frederic H. Moll, M.D. Former Director, Landmark Communications Co-founder, Intuitive Surgical Co-founder and Executive Chairman, Hansen Medical S. Morry Blumenfeld, Ph.D. Steve H. Rusckowski Founding Partner, Meditech Advisors Management CEO, Quest Diagnostics Former CEO, Philips Healthcare Eugene V. Fife Lodewijk J.R. de Vink Founding Principal, Vawter Capital Founding Partner, Blackstone Health Care Partners John R. Grisham Andrew C. von Eschenbach, M.D. Author Daniel P. Jordan, Ph.D. President Emeritus, Thomas Jefferson Foundation, Inc. President, Samaritan Health Initiatives
Academic and Corporate Relationships S. Morry Blumenfeld, Ph.D.  InSightec, Shareholder Neal F. Kassell, M.D.  InSightec, Shareholder  UVA, Faculty Member Andrew C. von Eschenbach, M.D.  Histosonics, Director and Shareholder
Council Purpose  Harness goodwill, increase awareness Members  Passionate, enthusiastic advocates • • • • • • • • • • • • Jane P. Batten (Co-chair) Charles H. Seilheimer, Jr. (Co-chair) John B. Adams, Jr. Ellen Block Edgar M. Bronfman, Sr. Thomas N. & Nancy J. Chewning Norwood & Marguerite Davis Diane Heller Cecelia S. Howell Dean L. Kamen Robert Khayat, Ph.D. Shirley Lin, Ph.D. • • • • • • • • • • • • Amanda Megargel Michael Milken Paula Newcomb Wyndham G. Robertson Mary Lou Seilheimer Alice H. Siegel Aaron Stern, M.D., Ph.D. Howard & Fredi Stevenson Jack Syer The Honorable Nicholas F. Taubman Kitchie Tolleson Linda K. Zecher
Resources – Financial Capital Committed to date $54 million     62% from Individuals 24% from Corporations/Organizations 10% from Government 3% from Foundations Next 3 years: invest additional $25 million      Research Fellowships Centers of Excellence Regulatory & Reimbursement Symposium, Website, Newsletter, Journal
Fund Raising Model Patients are impatient Target venture philanthropists     Rapid decisions Results oriented Staying power Substantial capacity (value every dollar, every donor)
Value Proposition Once in a lifetime opportunity  Investment with extraordinary return  Social not economic Big idea, compelling story, noble cause Perfect timing Best in class management practices
Results – Accelerating Adoption Magic moment in evolution  Opportunity to make a difference Early stage  Small investment = large impact No major theoretical or technical barriers  Development > Discovery Brute force application of $ enormous progress
Accelerating Development and Adoption 2026 +$20 2024 +$35 2022 +$50 million 2020 +$65million 2028 2030 +$5 2013 Development Adoption Millions of Lives Improved
It’s all about the patients It‟s all about the patients: Saving time, Saving lives Saving time, Saving lives
Focused Ultrasound Manufacturers Acublate SJTU SUNTEC
Research and Commercial Treatment Sites 140+ Research sites 380+ Commercial treatment sites
87
88
89
90
91
92
93
94
Global Development Landscape 2 Reimbursement FDA 14 2 2 Other Approvals Pivotal Pilot Anecdotal Preclinical 14 4 Q3 2013 Conceptual
Dissolve Bloodclots: Sonothrombolysis 1/4
Dissolve Bloodclots: Sonothrombolysis 2/4
Dissolve Bloodclots: Sonothrombolysis 3/4
Dissolve Bloodclots: Sonothrombolysis 4/4
Procedure: Targeting Structures to be avoided Region to be treated
Procedure: Planning Automatic planning
Procedure: Treatment Temperature measurement
Procedure: Guidance Move to next target
Procedure: Confirmation Pre treatment Treatment plan Post treatment
Internship Program Back to Activities Slide Back to Organization Slide
Procedure: Targeting Structures to be avoided Region to be treated 1/4
Procedure: Planning Automatic planning Manual adjustment 2/4
Procedure: Treatment Real time guidance Temperature measurement Adjust treatment parameters 3/4
Procedure: Confirmation Confirmation of effectiveness Retreat if necessary 4/4
Pre-treatment 1/5
Targeting 2/5
Planning 3/5
Post-treatment Confirmation 5/5
Sonication size
Unique Accelerate development of device Platform technology  Multiple mechanisms of action  Variety of medical disorders 116
Patient Support Organization Advocacy Group: Grass Roots  Increase Awareness • Patients • Physicians • Insurers Facilitate Reimbursement Fibroid Relief: Prototype FR Website – 71,000 visitors since January 2009 117
Team Mark Adcock Rachel Browning Matt Eames, Ph.D. Jessica Foley, Ph.D. Arik Hananel, M.D., M.B.A, BsCs Melissa Healy Sara Horton Heather Huff-Simonin, M.B.A. Robin Jones Neal Kassell, M.D. Susan Klees Pamela Minetti, M.B.A. Dave Moore, M.Sc. Jill Roberts Whitney Robertson Mary Rose Serafini John Snell, Ph.D. Interns 118
Potential Impact, Urgent Need Cumulative adoption Without the Foundation With the Foundation 2000 2010 2020 Millions of People 2030
Use of Funds       Research Meetings, Symposia, Workshops Fellowships Centers of Excellence Reimbursement Initiative Core Programs $9 million $1 million $1 million $1 million $1 million $7 million 120
Research  External Awards $2 million  Parkinson‟s Disease $2.4 million  Brain Tumors $850,000  Pancreatic Cancer $250,000  Liver Cancer $250,000  Breast Cancer $600,000  Stroke $600,000  Epilepsy $500,000  Brain Technology $800,000  Back Pain $500,000 $9 million 121
Management Practices Highest standards, not-for-profit, for profit  Best practices: policies, processes, systems  Continuous Quality Improvement  People Strategic Plan  Reviewed and updated frequently  Acting > studying and planning Culture  Entrepreneurial, market driven, results oriented  Patient centric: It‟s all about the patients Operating plan and program management  Updated annually, quarterly, weekly 1/3 122
Management Practices Governance     Articles of incorporation, bylaws Board of Directors; represent all stakeholders Audit & compensation committees Legal review Finance      Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage 2/3 123
Management Practices People      Philosophy: „A‟ players, athletes Quarterly performance review against objectives Biannual external compensation review Structured hiring/termination process Employee handbook Research awards and contracts     Contracting: legal and sponsored program expertise Peer reviewed: research advisory committee Competitive: program funding committee Monitoring: milestones, progress reports, payments IT Infrastructure  Backups, security, redundancy 3/3 124
Use of Funds        Research Fellowships Centers of Excellence Communications Reimbursement Miscellaneous Development $9.6 million $1.4 million $4.1 million $3.6 million $1.8 million $400,000 $2.2 million $23 million 125
Individual Donors (updated 9/19/12) Anonymous Bob and Glorie Bailie Baker Construction Group Aimee and Frank Batten, Jr. Foundation D.N. Batten Foundation Frank* and Jane Batten Mr. and Mrs. David A. Beach Anson and Debra Beard The Bernstein Law Firm, LLC Ms. Lois Berry Birdsall Family Fund Ellen and Ronald Block Family Foundation Dr. and Mrs. S. Morry Blumenfeld Rich and Roxanne Booth Charles R. Bronfman Edgar M. Bronfman and Jan Aronson Peter and Nancy Brooks Scott Byron and Company, Inc. Phebe Cambata The Caruthers Foundation Mr. and Mrs. Norton E. Cater Mr. and Mrs. John Chamales Roy R. Charles Charitable Trust Derwood and Johanna Chase Tom and Nancy Chewning Christian Broadcasting Network, Inc. Moffett and Dupre Cochran Mr. and Mrs. Victor M. Dandridge, Jr. Mr. and Mrs. Terrence D. Daniels Mr. and Mrs. John Stewart Darrell Mrs. Margareta C.H. Douglas* Mrs. Francis Dulaney Joan and Barry Elman Mr. and Mrs. Albert D. Ernest Fibroid Foundation Eugene V. Fife Family Foundation Bruce D. Fisher Margaret and Thomas Flynn Penny and John Freund Mr. and Mrs. Donald Geller Struthers and Frederick Gignoux Mark and Judy Giles Leslie and Richard Gilliam Mr. and Mrs. Donald Goldsmith Ms. Audrey Gould Julann Griffin Marge and Joe Grills Mr. and Mrs. Eugene R. Hack, Jr. 1/3 126
Individual Donors (updated 9/19/12) Jim and Sue Haden Carolyn Hadesman and Family John A. Hartford Foundation, Inc. Matching Gift Program The Hassenfeld Foundation Diane and David* Heller Herndon Foundation Mary Buford and Frederick P. Hitz The Joseph M. and Lisa B. Hogan Charitable Fund Ulrike Hoffmann-Burchardi and Dirk Willes Horton Foundation Fund in CACF The Horwich Family Foundation Mr. and Mrs. Robert M. Huff Chad D. Inman Dean Johnson Mr. Thomas N.P. Johnson, III Lou and Dan Jordan Drs. Neal and Lee Kassell Marcia and Jonathan Kean The Keeley Family Foundation The Kellogg Organization, Inc. Mr. and Mrs. Donald A. King, Jr. Mr. and Mrs. Douglas M. Kinney Mr. James B. Klutznick Mrs. Delores J. Kuberka Mr. and Mrs. Fritz R. Kundrun Diana Levin Lawrence and Carol Levy Dr. Stanley H. Levy John L. Lewis, IV Mr. and Mrs. Harvey L. Lindsay, Jr. Terry J. Lockhart Mr. and Mrs. John Lucey St. Luke‟s Hospital John and Dudley MacFarlane Chrisanne Mannion Paul and Diane Manning Jill Kiersky and Andrew Marcus Mr. and Mrs. Donald Mazzoni Janice McArdle Cancer Research Foundation Patrick McCarthy Melville Foundation Methodist Hospital Milken Family Fund Mitford Children‟s Foundation Frederic Moll Mr. and Mrs. Victor A. Morgenstern Thos. Nelson Jr. Initiative of the Community Foundation Serving Richmond and Central Virginia Paula and Rob Newcomb Dick and Judy Nunley 2/3 127
Individual Donors (updated 9/19/12) Joy Marie Polefrone Prince Charitable Trusts Dr. M.G. Pat Robertson The Robertson Foundation Wyndam Robertson Mr. and Mrs. Thomas C. Rodeno Felicia W. Rogan Madison Rogers Harry and Ady Rosenberg Mr. and Mrs. Charles M. Rotgin Steve and Deborah Rusckowski Mr. Raymond L. Rusnak Cari and Michael Sacks The Adler Schermer Foundation Valerie Beth Schwartz Foundation Mr. and Mrs. Charles H. Seilheimer, Jr. Linda Rae Sher Rick and Sherry Sharp, The Community Foundation Serving Richmond and Central Virginia Dr. James A. Shield, Jr. Alice H. Siegel Mr. and Mrs. Thomas A. Silberman Jane-Ashley and Peter Skinner Albert H. Small The Eddie and Jo Allison Smith Family Foundation, Inc. Oscar F. Smith/Marjorie Smith Charles Charitable Fund of the Community Serving Richmond and Central Virginia Robert H. Smith Family Foundation Mr. and Mrs. Francis M. Stanis Barbara and Cyrus Sweet III Virginia and John Syer Fay Davis Taylor In Memory of Bertrand L. Taylor III Sandra Thomas Jane Tolleson Ms. Cecile Trop Sarah Beck and Wojtek Uzdelewicz Eleanor Cameron Van Clief Foundation Mrs. Faith Van Clief Sheri Waddell Mr. and Mrs. Herbert S. Wander Mark Warner and Lisa Collis The Watterson Foundation R. Ted and Sheila Weschler Custis Westham Fund of the Community Foundation Serving Richmond and Central Virginia Jane Woldenberg Family Foundation Laurie and Bruce Zessar Michael Zoller Family Philanthropic Fund 3/3 128
Corporate Donors and Sponsors Abbott Laboratories Cooley Godward Kronish Crutchfield Corporation EDAP Elbit Elekta GE Healthcare IGT Imasonic InSightec International Society for Therapeutic Ultrasound (ISTU) JJA Instruments JP Morgan The Kellogg Organization, Inc. Meditech Advisors Methodist Hospital Microsoft Ogilvy Public Relations Philips Healthcare Siemens St. Luke‟s Hospital Supersonic Imagine Theraclion University of Virginia Varian Medical Systems Foundation 129
Process, complicated and inefficient Patient advocacy Evidence, safety, efficacy, cost Technology R&D IP generation and protection Design, engine ering, manufacturing Pre-clinical proof of concept Regulatory approval Marketing, sales, support Training and credentialing Insurance reimbursement Physician and Scientist education Physician advocacy
Uterine Fibroids before treatment planning post-treatment Approved: FDA 2004, CE: 2003
Pain Palliation of Bone Metastases Patient with osteolytic breast cancer metastasis at right iliac bone Pain score of 5.5 before treatment reduced to 0 at 3M follow up CT Before Treatment Note: At 3M new bone formation and thickening of cortical layer in treatment area
Prostate Cancer - Transrectal
Prostate Cancer - Transurethral
Breast Cancer Pre-treatment Two weeks post treatment
Liver Tumors post treatment dose maps (in blue) and post treatment T1W C
Facet Rhizotomy Focused ultrasound energy treats in the same locations as RF ablation
Neuropathic Pain – Zurich Research
Brain Tumors Accumulated thermal dose at end of treatment Diffusion weighted image immediately after treatment T1w contrast enhanced image immediately after treatment
Capsulotomy for OCD 140
Focused Ultrasound Foundation FUSF

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Fusf presentation to share 11.20

  • 1.
  • 2.
    “Without health therecan be no happiness.”
  • 3.
  • 4.
    Focused Ultrasound Early stage,revolutionary, noninvasive therapeutic technology Alternative or adjunct  Surgery  Radiation therapy  Drug delivery Transform treatment  Benign and malignant tumors  Metastatic cancer  Parkinson‟s disease & epilepsy  Back pain, hypertension
  • 5.
    Early Stage MR 30years ago  Unknown  Revolutionized diagnoses  Affects everyone Focused Ultrasound today  Unknown; “Medicine‟s Best Kept Secret”  As important to therapy as MR is to diagnoses  In 10 years, may affect everyone Infancy  Not science fiction  Real today
  • 6.
    Essential Tremor Treatment Awake,no anesthesia No incisions No burr holes No electrodes No infection No blood clots No brain damage
  • 7.
  • 8.
    Uterine Fibroid Hysterectomy        Major surgery Generalanesthesia Painful Hospitalization 6 weeks recovery Side effects No more children Focused Ultrasound        Noninvasive, no incision Conscious sedation Minimal discomfort Outpatient 1 day recovery No side effects Preserved fertility
  • 9.
  • 10.
  • 11.
    What is FocusedUltrasound? How does it work?
  • 12.
    Marriage of TwoInnovative Technologies Focused ultrasound  Treat tissue deep in body non-invasively
  • 13.
    Marriage of TwoInnovative Technologies Magnetic resonance (MR) or ultrasound (US) imaging  Identify and target tissue to be treated  Guide and control treatment in real time  Immediate confirmation of effectiveness
  • 14.
    Focused Ultrasound: ThePrinciple Analogous to a magnifying glass focusing rays of the sun…
  • 15.
    Focused Ultrasound: ThePrinciple Multiple intersecting beams of ultrasound  Focused with extreme accuracy (1 mm diameter)  Target in body • Individual beams pass harmlessly through adjacent tissue • Profound effect at point of convergence
  • 16.
    Effects at FocalPoint Thermal ablation Histotripsy Deliver drugs Dissolve clots: sonothrombolysis Radiation sensitization Drug activity enhancement Sonodynamic therapy Coagulate blood vessels Amplification of cancer biomarkers Immunomodulation Neuromodulation Vasodilation Vasoconstriction Variety of effects, variety of disorders Stem cell delivery
  • 17.
    Destroy Tissue: ThermalAblation Heating any tissue to 130 F (56 C) for 1 second  Denatures proteins  100% cell death: normal and abnormal
  • 18.
    Focal Drug Delivery Deliverdrugs in high concentrations  Precisely where needed, minimizing systemic toxicity
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
    Drugs Released atFocal Point
  • 24.
  • 25.
    Focused Ultrasound vsRadiation Single treatment Immediate and verifiable effect Greater precision and accuracy Real time localization No cumulative dose No limitations on lesion size No limitations on number of treatments No secondary malignancies 100% cell death Sharp margins
  • 26.
  • 27.
    Global Development Landscape Conceptual Preclinical Anecdotal Pilot Pivotal OtherApprovals FDA Reimbursement Neurological Oncological Musculoskeletal Essential Tremor Parkinson‟s Disease Neuropathic Pain Brain Tumors OCD Epilepsy Stroke Hydrocephalus Trigeminal Neuralgia Alzheimer‟s Disease Cancer Pain Depression Bone Prostate Tumors Thyroid/Parathyroid Breast Cancer Pancreas Soft Tissue Liver Kidney Head, Neck Cancer Lung Bladder Colon Esophagus Back Pain Osteoid Osteoma Osteoarthritis Sacroilitis Women’s Health Cardiovascular Miscellaneous Uterine Fibroids Uterine Adenomyosis Breast Fibroadenomas Hypertension Atherosclerosis Atrial Fibrillation Septal Perforation Acute Tubular Necrosis Obesity Diabetes Glaucoma Benign Prostatic Hypertrophy Ureterocele
  • 28.
    Global Development Landscape Reimbursement Sparse ClinicalTrials Regulatory: FDA Uterine Fibroids Pain from Bone Metastasis Anecdotal Osteoarthritis Thyroid/Parathyroid Brain Tumors Hypertension Breast Tumors OCD Pancreatic Tumors Kidney Tumors Liver Tumors Neuropathic Pain Parkinson‟s Disease Essential Tremor Soft Tissue Tumors Prostate Cancer Uterine Adenomyosis Breast Fibroadenomas Regulatory: Outside US Essential Tremor Parkinson‟s Disease Neuropathic Pain Uterine Fibroids Uterine Adenomyosis Breast Fibroadenomas Breast Tumors Prostate Cancer Thyroid/Parathyroid Pain from Bone Metastasis Pancreatic Tumors Liver Tumors Soft Tissue Tumors Osteoid Osteoma Back Pain Kidney Tumors Preclinical Hydrocephalus Epilepsy Alzheimer‟s Disease Stroke Atherosclerosis Obesity Atrial Fibrillation Diabetes Septal Perforation Sacroilitis Trigeminal Neuralgia Glaucoma Acute Tubular Necrosis Benign Prostatic Hypertrophy Head & Neck Cancer Lung Cancer Ureterocele Conceptual Cancer Pain Bladder Cancer Colon Cancer Esophageal Cancer Depression
  • 29.
    Imagine the Future Advancesin technology  Imaging  Focused ultrasound  Focal drug delivery Undreamed-of applications
  • 31.
  • 32.
  • 33.
  • 34.
    Potential Impact onMillions of People Urgent need: widespread availability of focused ultrasound  Saving time, saving lives Delay results in unnecessary death, disability and suffering  Countless individuals: friends, family, you
  • 35.
    The Problem Medical devicedevelopment and adoption slow Decades: concept to adoption as standard of care
  • 36.
    Process, Complicated andInefficient Patient advocacy Evidence, safety, efficacy, cost Technology R&D IP generation and protection Design, engineering, manufacturing Pre-clinical proof of concept Regulatory approval Marketing, sales, support Training and credentialing Insurance reimbursement Physician and Scientist education Physician advocacy
  • 37.
    Organizations with DifferentAgendas Patients Academic research sites Private philanthropy Disease specific foundations NIH Venture capital, private equity Industry FDA Insurers Patient advocacy organizations Medical societies Treatment facilities Physicians, numerous specialties
  • 38.
    Obstacles Technical and engineering Awarenessand acceptance, patients and physicians Cultural and turf issues Financial Regulatory Reimbursement
  • 39.
    The Solution Obscure No roadmap,examples or formulas Obligated to invent
  • 40.
    The Challenge "There isnothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success, than to take the lead in the introduction of a new order of things."
  • 41.
    It‟s all aboutthe patients saving time, saving lives
  • 42.
    Purpose of theFoundation Development Adoption Millions of Lives Improved
  • 43.
    Overview Founded 2006  Catalystto accelerate the development and adoption of FUS Charlottesville based, global impact Tax exempt, high performance, entrepreneurial  Market driven, action and results oriented Essence of activities  Foster collaboration  Knowledge: create, aggregate, share Model  Venture philanthropy, social entrepreneurship  Private funding bridges gap between research & treatment
  • 44.
    Unique, Hybrid Organization Device:platform technology Variety of clinical indicators Fulfill multiple roles Focused Ultrasound Foundation Medical & Scientific Society Manufacturers Trade Association Patient Advocacy Organization Patient Support Organization Research & Education Foundation
  • 45.
    Vision Focused Ultrasound     Improve qualityof life and longevity Millions of patients worldwide Serious medical disorders Shortest time possible
  • 46.
    Mission Accelerate development ofnew applications     Fulfill unmet critical medical need Superior to best current therapies Reimbursable Widely available as standard of care Accelerate adoption as standard of care
  • 47.
    Culture Patient centric  Uncompromisingly,passionately, obsessively committed to rapidly improving quality of life Catalytic, small, nimble, potent  Reputation, contagious enthusiasm and energy  Instill in others enthusiasm and energy to precipitate change Entrepreneurial  Create reality from imagined future through human action  Accomplishments exceed assets available Pioneering  Pursuit of excellence  Hard work, risk taking, innovation
  • 48.
    Strategic Focus It's allabout the patients: saving time, saving lives  Litmus test of actions and expenditures
  • 49.
    Positioning, Nexus ofOrganizations Academic research sites Venture capital, Patients Academic private equity Treatment facilities research sites Private philanthropy Disease specific foundations Industry Insurers NIH Private Disease specific Venture capital, private equity philanthropy foundations Industry Insurers FDA Patients Patient advocacy organizations Patient advocacy Medical societies organizations Treatment facilities Medical societies FDA NIH Physicians, Physicians, numerous specialties numerous specialties
  • 50.
    Currency and Incentives Reputation:trusted, independent, unbiased, 3rd party Contagious passion and enthusiasm Information Funding
  • 51.
    Activities Influence direction Foster collaboration Changebehavior and policy Create knowledge: clinical evidence, best practices & standards Cultivate the next generation Convene the community Collect and disseminate information Increase awareness: communications Overcome barriers
  • 52.
    Influence Direction Define areasof clinical benefit Prioritize indications Market oriented approach  Segment to achieve natural advantage  Pick battles  Rapid success
  • 53.
    Foster Collaboration Rapidly achievea critical mass of effort and knowledge Approach  Stimulate innovation  Leverage intellectual capital  Coordinate activities, avoid duplication
  • 54.
    Change Behavior &Policy Amalgamate stakeholders into a cohesive ecosystem  Patient centric  Sense of urgency
  • 55.
    Develop Evidence ofSafety, Efficacy Organize, conduct and fund research Niche: translational, application > discovery  Preclinical, clinical, technical  High risk, early stage, broad impact Iconoclastic model  Collaboration vs. individual glory  Patient centric vs. investigator centric  Commercially successful products vs. publications, grants, promotion Programs, tightly managed, milestone driven  External award: investigator initiated • Competitive, peer reviewed  Internal, Foundation initiated • Brain, liver • Contracts with academia, industry
  • 56.
    Establish Best Practices,Set Standards Research, training, patient care Centers of Excellence: multidisciplinary luminary sites  Showcase for technology  Venue for collaboration Partnership of academia, industry and the Foundation
  • 57.
    Centers of Excellence UVAFocused Ultrasound Center  Partnership     University of Virginia Commonwealth of VA FUS Foundation InSightec and GE Institute for Cancer Research, London  Partnership  Royal Marsden Hospital  FUS Foundation  Philips Medical
  • 58.
    Cultivate the NextGeneration Educate clinicians and scientists Fund fellowships and internships
  • 59.
    Convene the Community Organizeand fund meetings, symposia, workshops  Exchange knowledge and ideas  Foster collaborations and partnerships Foundation Organized Foundation Supported
  • 60.
    Collect and DisseminateKnowledge Website Newsletter Journal Collaborative Network Social Media
  • 61.
    Website – fusfoundation.org Encyclopediaof Focused Ultrasound Source of information  Comprehensive  Trusted  Up to date
  • 62.
  • 63.
    Journal Online, open access,peer reviewed Partnership with International Society for Therapeutic Ultrasound
  • 64.
    Collaborative Network Inventory, updatedquarterly on website     Laboratory research sites, investigators and projects Clinical research sites Commercial treatment sites Manufacturers
  • 65.
  • 66.
    Increase Awareness: Communications Informstakeholders, heat up environment, advance field Awareness events Media relations
  • 67.
  • 68.
  • 69.
  • 70.
    Overcome Barriers Regulatory: partnerwith FDA, bridge not a barrier  Pathway for new indications: preclinical & clinical studies Reimbursement: obtain coverage & payment  Evidence of safety, efficacy, cost  Patient advocacy  Physician advocacy
  • 71.
    Strategy Leverage capital: Cofundingand funding, indirect costs, royalties Best in class management practices  Transparency, accountability  Continuous quality improvement, policies, procedures, systems Align vision, mission, strategy, organization, culture, resources Prime the pump  Engage Foundations, Government, Industry, VC's  Assume functions of Foundation
  • 72.
    Organization Flat: flexible, responsiveto market and technology shifts 17 Athletes, A-players     Unbounded, highly intelligent, highly educated Healthcare professionals with over 140 years of experience 3 Ph.D.'s, 3 M.B.A.'s, 2 M.D.'s Interns Organized in teams
  • 73.
    Portfolio of Programs Research Collaborativenetwork Educational fellowships Meetings, symposia, workshops Centers of Excellence Regulatory Reimbursement Communications Website Newsletter Online, open-source journal Accelerate development and adoption
  • 74.
    Board of Directors…active,engaged, passionate Neal F. Kassell, M.D. Edward D. Miller, M.D. Chairman, Focused Ultrasound Foundation Professor, Department of Neurosurgery, University of Virginia Former CEO, Johns Hopkins Medicine Dorothy N. Batten Frederic H. Moll, M.D. Former Director, Landmark Communications Co-founder, Intuitive Surgical Co-founder and Executive Chairman, Hansen Medical S. Morry Blumenfeld, Ph.D. Steve H. Rusckowski Founding Partner, Meditech Advisors Management CEO, Quest Diagnostics Former CEO, Philips Healthcare Eugene V. Fife Lodewijk J.R. de Vink Founding Principal, Vawter Capital Founding Partner, Blackstone Health Care Partners John R. Grisham Andrew C. von Eschenbach, M.D. Author Daniel P. Jordan, Ph.D. President Emeritus, Thomas Jefferson Foundation, Inc. President, Samaritan Health Initiatives
  • 75.
    Academic and CorporateRelationships S. Morry Blumenfeld, Ph.D.  InSightec, Shareholder Neal F. Kassell, M.D.  InSightec, Shareholder  UVA, Faculty Member Andrew C. von Eschenbach, M.D.  Histosonics, Director and Shareholder
  • 76.
    Council Purpose  Harness goodwill,increase awareness Members  Passionate, enthusiastic advocates • • • • • • • • • • • • Jane P. Batten (Co-chair) Charles H. Seilheimer, Jr. (Co-chair) John B. Adams, Jr. Ellen Block Edgar M. Bronfman, Sr. Thomas N. & Nancy J. Chewning Norwood & Marguerite Davis Diane Heller Cecelia S. Howell Dean L. Kamen Robert Khayat, Ph.D. Shirley Lin, Ph.D. • • • • • • • • • • • • Amanda Megargel Michael Milken Paula Newcomb Wyndham G. Robertson Mary Lou Seilheimer Alice H. Siegel Aaron Stern, M.D., Ph.D. Howard & Fredi Stevenson Jack Syer The Honorable Nicholas F. Taubman Kitchie Tolleson Linda K. Zecher
  • 77.
    Resources – FinancialCapital Committed to date $54 million     62% from Individuals 24% from Corporations/Organizations 10% from Government 3% from Foundations Next 3 years: invest additional $25 million      Research Fellowships Centers of Excellence Regulatory & Reimbursement Symposium, Website, Newsletter, Journal
  • 78.
    Fund Raising Model Patientsare impatient Target venture philanthropists     Rapid decisions Results oriented Staying power Substantial capacity (value every dollar, every donor)
  • 79.
    Value Proposition Once ina lifetime opportunity  Investment with extraordinary return  Social not economic Big idea, compelling story, noble cause Perfect timing Best in class management practices
  • 80.
    Results – AcceleratingAdoption Magic moment in evolution  Opportunity to make a difference Early stage  Small investment = large impact No major theoretical or technical barriers  Development > Discovery Brute force application of $ enormous progress
  • 81.
    Accelerating Development andAdoption 2026 +$20 2024 +$35 2022 +$50 million 2020 +$65million 2028 2030 +$5 2013 Development Adoption Millions of Lives Improved
  • 82.
    It’s all aboutthe patients It‟s all about the patients: Saving time, Saving lives Saving time, Saving lives
  • 83.
  • 84.
    Research and CommercialTreatment Sites 140+ Research sites 380+ Commercial treatment sites
  • 86.
  • 87.
  • 88.
  • 89.
  • 90.
  • 91.
  • 92.
  • 93.
  • 94.
    Global Development Landscape 2 Reimbursement FDA 14 2 2 OtherApprovals Pivotal Pilot Anecdotal Preclinical 14 4 Q3 2013 Conceptual
  • 95.
  • 96.
  • 97.
  • 98.
  • 99.
    Procedure: Targeting Structures to beavoided Region to be treated
  • 100.
  • 101.
  • 102.
  • 103.
  • 104.
    Internship Program Back toActivities Slide Back to Organization Slide
  • 105.
    Procedure: Targeting Structures tobe avoided Region to be treated 1/4
  • 106.
  • 107.
    Procedure: Treatment Real timeguidance Temperature measurement Adjust treatment parameters 3/4
  • 108.
    Procedure: Confirmation Confirmation ofeffectiveness Retreat if necessary 4/4
  • 109.
  • 110.
  • 111.
  • 113.
  • 114.
  • 115.
    Unique Accelerate development ofdevice Platform technology  Multiple mechanisms of action  Variety of medical disorders 116
  • 116.
    Patient Support Organization AdvocacyGroup: Grass Roots  Increase Awareness • Patients • Physicians • Insurers Facilitate Reimbursement Fibroid Relief: Prototype FR Website – 71,000 visitors since January 2009 117
  • 117.
    Team Mark Adcock Rachel Browning MattEames, Ph.D. Jessica Foley, Ph.D. Arik Hananel, M.D., M.B.A, BsCs Melissa Healy Sara Horton Heather Huff-Simonin, M.B.A. Robin Jones Neal Kassell, M.D. Susan Klees Pamela Minetti, M.B.A. Dave Moore, M.Sc. Jill Roberts Whitney Robertson Mary Rose Serafini John Snell, Ph.D. Interns 118
  • 118.
    Potential Impact, UrgentNeed Cumulative adoption Without the Foundation With the Foundation 2000 2010 2020 Millions of People 2030
  • 119.
    Use of Funds       Research Meetings,Symposia, Workshops Fellowships Centers of Excellence Reimbursement Initiative Core Programs $9 million $1 million $1 million $1 million $1 million $7 million 120
  • 120.
    Research  External Awards $2million  Parkinson‟s Disease $2.4 million  Brain Tumors $850,000  Pancreatic Cancer $250,000  Liver Cancer $250,000  Breast Cancer $600,000  Stroke $600,000  Epilepsy $500,000  Brain Technology $800,000  Back Pain $500,000 $9 million 121
  • 121.
    Management Practices Highest standards,not-for-profit, for profit  Best practices: policies, processes, systems  Continuous Quality Improvement  People Strategic Plan  Reviewed and updated frequently  Acting > studying and planning Culture  Entrepreneurial, market driven, results oriented  Patient centric: It‟s all about the patients Operating plan and program management  Updated annually, quarterly, weekly 1/3 122
  • 122.
    Management Practices Governance     Articles ofincorporation, bylaws Board of Directors; represent all stakeholders Audit & compensation committees Legal review Finance      Monthly reporting with audit committee review External audit of annual financials and 990 Annual 501(c)(3) tax status review Prudent investment policy Comprehensive insurance coverage 2/3 123
  • 123.
    Management Practices People      Philosophy: „A‟players, athletes Quarterly performance review against objectives Biannual external compensation review Structured hiring/termination process Employee handbook Research awards and contracts     Contracting: legal and sponsored program expertise Peer reviewed: research advisory committee Competitive: program funding committee Monitoring: milestones, progress reports, payments IT Infrastructure  Backups, security, redundancy 3/3 124
  • 124.
    Use of Funds        Research Fellowships Centersof Excellence Communications Reimbursement Miscellaneous Development $9.6 million $1.4 million $4.1 million $3.6 million $1.8 million $400,000 $2.2 million $23 million 125
  • 125.
    Individual Donors (updated9/19/12) Anonymous Bob and Glorie Bailie Baker Construction Group Aimee and Frank Batten, Jr. Foundation D.N. Batten Foundation Frank* and Jane Batten Mr. and Mrs. David A. Beach Anson and Debra Beard The Bernstein Law Firm, LLC Ms. Lois Berry Birdsall Family Fund Ellen and Ronald Block Family Foundation Dr. and Mrs. S. Morry Blumenfeld Rich and Roxanne Booth Charles R. Bronfman Edgar M. Bronfman and Jan Aronson Peter and Nancy Brooks Scott Byron and Company, Inc. Phebe Cambata The Caruthers Foundation Mr. and Mrs. Norton E. Cater Mr. and Mrs. John Chamales Roy R. Charles Charitable Trust Derwood and Johanna Chase Tom and Nancy Chewning Christian Broadcasting Network, Inc. Moffett and Dupre Cochran Mr. and Mrs. Victor M. Dandridge, Jr. Mr. and Mrs. Terrence D. Daniels Mr. and Mrs. John Stewart Darrell Mrs. Margareta C.H. Douglas* Mrs. Francis Dulaney Joan and Barry Elman Mr. and Mrs. Albert D. Ernest Fibroid Foundation Eugene V. Fife Family Foundation Bruce D. Fisher Margaret and Thomas Flynn Penny and John Freund Mr. and Mrs. Donald Geller Struthers and Frederick Gignoux Mark and Judy Giles Leslie and Richard Gilliam Mr. and Mrs. Donald Goldsmith Ms. Audrey Gould Julann Griffin Marge and Joe Grills Mr. and Mrs. Eugene R. Hack, Jr. 1/3 126
  • 126.
    Individual Donors (updated9/19/12) Jim and Sue Haden Carolyn Hadesman and Family John A. Hartford Foundation, Inc. Matching Gift Program The Hassenfeld Foundation Diane and David* Heller Herndon Foundation Mary Buford and Frederick P. Hitz The Joseph M. and Lisa B. Hogan Charitable Fund Ulrike Hoffmann-Burchardi and Dirk Willes Horton Foundation Fund in CACF The Horwich Family Foundation Mr. and Mrs. Robert M. Huff Chad D. Inman Dean Johnson Mr. Thomas N.P. Johnson, III Lou and Dan Jordan Drs. Neal and Lee Kassell Marcia and Jonathan Kean The Keeley Family Foundation The Kellogg Organization, Inc. Mr. and Mrs. Donald A. King, Jr. Mr. and Mrs. Douglas M. Kinney Mr. James B. Klutznick Mrs. Delores J. Kuberka Mr. and Mrs. Fritz R. Kundrun Diana Levin Lawrence and Carol Levy Dr. Stanley H. Levy John L. Lewis, IV Mr. and Mrs. Harvey L. Lindsay, Jr. Terry J. Lockhart Mr. and Mrs. John Lucey St. Luke‟s Hospital John and Dudley MacFarlane Chrisanne Mannion Paul and Diane Manning Jill Kiersky and Andrew Marcus Mr. and Mrs. Donald Mazzoni Janice McArdle Cancer Research Foundation Patrick McCarthy Melville Foundation Methodist Hospital Milken Family Fund Mitford Children‟s Foundation Frederic Moll Mr. and Mrs. Victor A. Morgenstern Thos. Nelson Jr. Initiative of the Community Foundation Serving Richmond and Central Virginia Paula and Rob Newcomb Dick and Judy Nunley 2/3 127
  • 127.
    Individual Donors (updated9/19/12) Joy Marie Polefrone Prince Charitable Trusts Dr. M.G. Pat Robertson The Robertson Foundation Wyndam Robertson Mr. and Mrs. Thomas C. Rodeno Felicia W. Rogan Madison Rogers Harry and Ady Rosenberg Mr. and Mrs. Charles M. Rotgin Steve and Deborah Rusckowski Mr. Raymond L. Rusnak Cari and Michael Sacks The Adler Schermer Foundation Valerie Beth Schwartz Foundation Mr. and Mrs. Charles H. Seilheimer, Jr. Linda Rae Sher Rick and Sherry Sharp, The Community Foundation Serving Richmond and Central Virginia Dr. James A. Shield, Jr. Alice H. Siegel Mr. and Mrs. Thomas A. Silberman Jane-Ashley and Peter Skinner Albert H. Small The Eddie and Jo Allison Smith Family Foundation, Inc. Oscar F. Smith/Marjorie Smith Charles Charitable Fund of the Community Serving Richmond and Central Virginia Robert H. Smith Family Foundation Mr. and Mrs. Francis M. Stanis Barbara and Cyrus Sweet III Virginia and John Syer Fay Davis Taylor In Memory of Bertrand L. Taylor III Sandra Thomas Jane Tolleson Ms. Cecile Trop Sarah Beck and Wojtek Uzdelewicz Eleanor Cameron Van Clief Foundation Mrs. Faith Van Clief Sheri Waddell Mr. and Mrs. Herbert S. Wander Mark Warner and Lisa Collis The Watterson Foundation R. Ted and Sheila Weschler Custis Westham Fund of the Community Foundation Serving Richmond and Central Virginia Jane Woldenberg Family Foundation Laurie and Bruce Zessar Michael Zoller Family Philanthropic Fund 3/3 128
  • 128.
    Corporate Donors andSponsors Abbott Laboratories Cooley Godward Kronish Crutchfield Corporation EDAP Elbit Elekta GE Healthcare IGT Imasonic InSightec International Society for Therapeutic Ultrasound (ISTU) JJA Instruments JP Morgan The Kellogg Organization, Inc. Meditech Advisors Methodist Hospital Microsoft Ogilvy Public Relations Philips Healthcare Siemens St. Luke‟s Hospital Supersonic Imagine Theraclion University of Virginia Varian Medical Systems Foundation 129
  • 129.
    Process, complicated andinefficient Patient advocacy Evidence, safety, efficacy, cost Technology R&D IP generation and protection Design, engine ering, manufacturing Pre-clinical proof of concept Regulatory approval Marketing, sales, support Training and credentialing Insurance reimbursement Physician and Scientist education Physician advocacy
  • 130.
  • 131.
    Pain Palliation ofBone Metastases Patient with osteolytic breast cancer metastasis at right iliac bone Pain score of 5.5 before treatment reduced to 0 at 3M follow up CT Before Treatment Note: At 3M new bone formation and thickening of cortical layer in treatment area
  • 132.
    Prostate Cancer -Transrectal
  • 133.
    Prostate Cancer -Transurethral
  • 134.
  • 135.
    Liver Tumors post treatmentdose maps (in blue) and post treatment T1W C
  • 136.
    Facet Rhizotomy Focused ultrasoundenergy treats in the same locations as RF ablation
  • 137.
    Neuropathic Pain –Zurich Research
  • 138.
    Brain Tumors Accumulated thermaldose at end of treatment Diffusion weighted image immediately after treatment T1w contrast enhanced image immediately after treatment
  • 139.
  • 140.

Editor's Notes

  • #2 Thank you for your interest in the Focused Ultrasound Foundation. Please note that directions to various slide functions can be found in the Notes section throughout the presentation. Prior to starting the presentation, please ensure the sound on your computer has been silenced.
  • #7 This slide contains a series of videos and images. Please click the page to advance the slide.
  • #17 Because of its variety of effects or biomechanisms, this technology is applicable to a variety of diseases, and the research opportunities are abundant. The three primary mechanisms of focused ultrasound are destroying tissue, delivering drugs, and dissolving blood clots. Other mechanisms are also being investigated.
  • #25 Each of the images to the right act as a link to slides depicting the treatment of that specific indication.
  • #28 This global landscape slide shows milestones reached by each of the different diseases that are currently being treated or have been proposed for treatment using focused ultrasound technology. Uterine Fibroid treatment has benefitted 8,000 patients worldwide while earning the CE Mark and FDA approval. Treatment for Bone Metastases has provided pain relief to several hundred patients, and this CE Mark therapy achieved FDA approval in 2012. Researchers performed a pilot study at the University of Virginia in 2011 on 15 patients with Essential Tremor, and the initial results have initiated a continued study. Researchers at the University of Zurich have treated 30 patients with intractable Neuropathic Pain from conditions like shingles, amputations, or nerve with injuries. Data from studies conducted on several hundred patients with Breast Tumors in Japan, Germany, and Italy has been stuck at the FDA for 4 years; hopefully this log jam will soon be broken. Two patients with Parkinson’s Disease were treated in Zurich, and we began a pilot study at the University of Virginia in October 2012. Other cancer studies include Prostate Cancer (30 patients in Russia, Italy, Canada, Singapore, and India); Pancreatic Tumors (5 patients in London and Rome); Liver Tumors (a handful in London); and Brain Tumors (new studies enrolling in Toronto, Zurich, and Charlottesville). Ongoing experiments that will lead to clinical trials are currently being conducted on Stroke, Diabetes, Benign Prostatic Hypertrophy, Alzheimer’s Disease, Osteoarthritis, and Osteoid Osteoma. Preclinical studies are underway for Epilepsy. Experiments for Hypertension, Kidney Tumors, Thyroid Tumors, Esophageal Tumors, Colon Tumors, Bladder Tumors, and other Soft Tissue Tumors are on the drawing board. Finally, Korean researchers are organizing a trial for Obsessive-Compulsive Disorder.
  • #31 Imagine treating a brain tumor without surgery, radiation therapy and/or the harmful effects of chemotherapy.
  • #34 Focused ultrasound technology is not applicable to all conditions. It will not work to treat aneurysms (in the head or abdomen), multiple sclerosis (better treatments are on the horizon), leukemia (there is nothing to target), lung tumors (ultrasound does not go through air), or traumatic brain injuries.
  • #44 The Focused Ultrasound Foundation is a unique, innovative medical technology research, education and advocacy organization that serves as the catalyst for the development and adoption of focused ultrasound.The Foundation was founded in 2006 as an entrepreneurial, tax-exempt organization that is market driven, high performance, and action and results oriented.  It is located in Charlottesville, Virginia but exerts a global impact.The Foundation's uniqueness derives from the fact that it is addressing a technology rather than a pharmaceutical. Furthermore, it is a platform technology that exerts a wide range of biological effects ̶ or mechanisms of action ̶ on a wide variety of medical disorders.The Foundation is on the leading edge of both the venture philanthropy and social entrepreneurship movements and has become a prime example of how private philanthropy can work in conjunction with academia, government and industry to bridge the gap between laboratory research and widespread patient treatment.
  • #72 Click the first blue arrow to read more about the Foundation’s management practices. Click the second blue arrow to learn how the Foundation ‘primes the pump.’
  • #73 To execute this strategy, the foundation has created an organization which is very flat and flexible and responsive to rapid shifts in the market and technology.  The organization was built with the philosophy that ‘A's attract A's and B's attract C’s’ and is populated by individuals who are athletes – who can perform multiple functions. 
  • #78 Select the blue arrows to view further details, including a donor list and appropriation of funds.
  • #83 This slide marks the end of the presentation. The slides that follow are linked to various places within the previous slides.
  • #84 Seven years ago, one small, pioneering Israeli company (InSightec) began commercializing focused ultrasound technology. Today, the industry has grown to nine companies worldwide. Philips Electronics, a large, conservative Dutch company that has a reputation for creating very high quality medical devices, jumped in with both feet and embraced this technology a few years ago, and this fact is a true validation of the field.
  • #85 At this early stage of innovation (infancy, as previously noted), approximately 100 commercial treatment sites are located around the world. This number represents only 2% of the estimated 5,000 sites needed when focused ultrasound is in widespread use. Another 150 research sites are conducting scientific studies, and about half of these are in the United States.
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  • #106 To execute this strategy, the foundation has created an organization which is very flat and flexible and responsive to rapid shifts in the market and technology.  The organization was built with the philosophy that ‘A's attract A's and B's attract C’s’ and is populated by individuals who are athletes – who can perform multiple functions. 
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