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Top Brainnovations to monitor and improve Brain Health

Given the success of the first Brainnovations Pitch Contest, the 2019 Summit hosted a second Brainnovations edition for selected startups to pitch their innovative solutions to Summit participants and to our distinguished Judges — our very own “Sharp Tank.”

1–2.30pm. Top Brainnovations to monitor and improve Brain Health

Finalist: Kate Sharadin, Founder & CEO of eQuility
Finalist: Nickolai Vysokov, Co-Founder & CEO of BrainPatch
WINNER: Richard Hanbury, Founder & CEO of Sana Health

Judged by: Alexandra Morehouse, Chief Marketing Officer at Banner Health; Dr. Robert Bilder, Chief of Medical Psychology-Neuropsychology at UCLA; Elan Tye, Investor at JAZZ Venture Partners; Dr. Evian Gordon, Founder, Chairman and CMO of Total Brain; Dr. Hagit Alon, VP Scientific Affairs at Joy Ventures; John Cammack, Angel Investor; Kathleen Herath, Vice President Health & Productivity at Nationwide Insurance

Slidedeck supporting presentation and discussion during the 2019 SharpBrains Virtual Summit: The Future of Brain Health (March 7-9th). Learn more at:

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Top Brainnovations to monitor and improve Brain Health

  1. 1. 1. Novelty 2. Scalability 3. Research and IP approach 4. Impact 5. Financial sustainability
  2. 2. Top Brainnovations to monitor and improve Brain Health Finalist: Kate Sharadin, Founder & CEO of eQuility Finalist: Richard Hanbury, Founder & CEO of Sana Health Finalist: Nickolai Vysokov, Co-Founder & CEO of BrainPatch Judged by: Alexandra Morehouse, Chief Marketing Officer at Banner Health; Dr. Evian Gordon, Executive Chairman of Brain Resource; Dr. Hagit Alon, VP Scientific Affairs at Joy Ventures; John Cammack, Angel Investor; Kathleen Herath, Associate Vice President Health & Productivity at Nationwide Insurance; Elan Tye, Investor at JAZZ Venture Partners
  3. 3. 5 | eQuility | March 2019 non-drug • mobile • consumer facing Rx Digital Mobile Apps + Bioelectronic Medicine
  4. 4. 6 | eQuility | March 2019 Overview Exceptional Team The most advanced, non-invasive way to treat CNS & Inflammatory Disorders Combining Consumer Technologies Delivering Rx Medical Solutions Software/Device/Mobile Phone Digital Therapy has Strong Data Early POC Device Data Promising HUGE $100B+ Addressable Markets Depression Anxiety Inflammation IN THE US ALONE Very Strong IP Portfolio Raising $6 Million Series A 45% Clinical 30% Product Dev 25%Admin
  5. 5. 7 | eQuility | March 2019 Founding Team Kate Sharadin Founder & CEO Eric Leuthardt, M.D. Co-Founder & Chief Medical Officer Roy Levien Co-Founder & Chief Digital Officer 22 years in biomedical devices capital markets, business development, incubation – Co- founder MEDX Isreali device/digital health incubator/BOD, 3 incubated projects/companies with Invention Science Fund. Inventor of Pear Therapeutics pivotal combination treatment patents, Professor, neurosurgeon, biomedical engineer, inventor with over 1,100 patents issued/pending Inventor of Pear Therapeutics pivotal combination treatment patents. One of the top 40 most prolific inventors in the world, with over 380 issued patents and 1,260 patent applications.
  6. 6. 8 | eQuility | March 2019 OUR Dror Ben Zeev VP Digital Interventions Marc Stein Device Development Tom Packert VP Information Management Ken Nielsen VP Finance Walter Greenleaf, Ph.D. Stanford Virtual Human Interaction Lab Jim Karkanias, Ph.D. Machine Learning/AI, Chan Zuckerberg Initiative Bashar Badran, Ph.D. Medical University of South Carolina Eric Lenze, M.D. Professor of Psychiatry, Washington University OUR TEAM ADVISORY BOARD
  7. 7. 9 | eQuility | March 2019 digital therapeutcs bluetooth bioelectronic device A Complementary Solution Delivering Healthcare Using Bioelectronic Devices + Digital Therapy Digital Therapy
  8. 8. 10 | eQuility | March 2019 Depression is the leading cause of disability in the U.S. World Health Organization Anxiety affects 18% of American adults National Institute of Mental Health Rheumatoid Arthritis & IBD RA inflammation has been implicated in pathogenesis of depression Arthritis Foundation Other Inflammatory Disorders lays the groundwork for coronary artery disease, diabetes, Alzheimer’s, and cancer Harvard Health eQuility; at the center of the connection Huge Opportunity to Treat Mood & Inflammatory Disorders
  9. 9. 11 | eQuility | March 2019 Rx: $99/Month DEPRESSION MDD Rx Device: $199 U.S. Market: 17M $20B per year Rx: $299/Month INFLAMMATION (RA/IBD) Rx Device: $199 U.S. Market: 5M $20B per year POTENTIAL INDICATIONS Migraines & Cluster Headaches Cognition/Memory/Learning Chronic Inflammation Consumer Wellness Chronic Stress Neuro-rehab Chronic Pain Addiction PTSD Rx: $99/Month ANXIETY Rx Device: $199 U.S. Market: 55M $77B per year $100B+ Addressable U.S. Market
  10. 10. 12 | eQuility | March 2019 A Leading Cause of Disability Major Depressive Disorder (MDD) eQuility’s First Indication 17m1 Americans that suffer from MDD in a given year. $85b2 Economic burden of MDD in the U.S. $200 Billion Worldwide 20303 The year MDD is predicted to become the leading cause of disability worldwide. 50%4 Percent of suicides where depression is present. >350m5 People living with MDD worldwide. $16.8b6 Dollars that will be spent on drugs to treat depression in 2020. 1.CDC – Centers for Disease Control 2. Greenberg, Fournier, Sisitsky, Kessler - ICD-9 claims and DSM-IV criteria 3. Murray and Lobez, 1996; Ustun et al., 2004; WHO, 2012 4. W. Breitbart, “Cancer Pain and Suicide,” in Advances in Pain Research and Therapy, ed. K. M. Foley et al., vol (New York: Raven Press, 1990), 399-412. 5. World Health Organization. 6. Global Industry Perspective, Comprehensive Analysis and Forecast, 2014–2020.
  11. 11. 13 | eQuility | March 2019 Efficacy is Limited, Expensive and/or Invasive MDD Treatments ● Inconvenient ● ⅓ fail remission ● Shortage of therapists ● Side effects ● Limited efficacy ● Multiple prescriptions often needed ● $$$$ ($45k+) ● Invasive surgery ● Limited efficacy ● Implants have a ● 5-year battery life ● $$$ ● Transcranial Magnetic Stimulation ● 30+ in-office procedures required ● Capital equipment purchase MEDICATION TMS IMPLANT PSYCHOTHERAPY Safe Effective Affordable Non-invasive Drug-free
  12. 12. 14 | eQuility | March 2019 What We sell – Product / Service List How Stimulating the Vagus Nerve Affects Organ Systems Heart Decreases heart rate and vascular tone Liver Regulates insulin secretion Gut Stimulates digestion Inflammation Suppresses inflammation via the cholinergic anti-inflammatory pathway Brain/CNS Helps reduce anxiety and depression; opposes stress responses; increases neural plasticity Synergistic with digital software therapy Blood Vessels Reduces blood pressure by decreasing vascular tone Immune System Improves immune activity by suppressing inflammation “Vagus nerve stimulation paired with exposure therapy drives brain plasticity to treat key symptoms of PTSD.” —Texas Biomedical Device Center
  13. 13. 15 | eQuility | March 2019 How Digital Therapeutics Work Structured Software Content Evidenced-based therapy delivered through software Access to New Treatments Clinically-proven, high-quality software Compliment or replace drugs Stronger Engagment Engagment is more critical than the technology Better Compliance Patients engage faster and remain engaged Accessable Anywhere Delivered on a mobile platform allows access all the time, anywhere Population Feedback Enables tracking of multiple users to develop optimum regimens Data Driven Intervention Collect, analyze and apply real world evidence for better treatments Cost Effective Effective and scalable at lower units of cost
  14. 14. 16 | eQuility | March 2019 A Patented Treatment Process Complementary & Synergistic Modalities on One Platform Bioelectronic Stimulation eQuility’s proprietary wearable Bluetooth device electrically stimulates the vagus nerve. Its programmable, low-power design delivers a wide variety of therapy options. It is safe, non-invasive, and proven effective. Mobile Health eQuility’s proprietary digital platform provides personalized, smartphone-based digital solutions for behavior therapy and mindfulness, delivered through an app. clinically proven to be an effective treatment for MDD and other mood disorders. DIGITAL THERAPEUTICS While each treatment can stand alone, when Mobile Therapeutics are paired with Bioelectronic Stimulation, the potency of treatment will be dramatically increased Non-invasive Bioelectronics DIGITAL THERAPEUTCS Mobile Health
  15. 15. 17 | eQuility | March 2019 Literature Supports taVNS and Digital Therapeutics A snapshot of academic papers
  16. 16. 18 | eQuility | March 2019 Modified from Kong et al, 2018 Autonomic Effects Aim 2: Test whether in-ear stimulation alters cytokines in the blood which controls systemic inflammation Reduction of inflammatory reflex signaling significantly reduces cytokine production and attenuates disease severity in models of inflammatory syndromes Aim 1: Test whether in-ear stimulation alters vagal- mediated heart rate variability (HRV) HRV measures are a strong measure of sympathetic and parasympathetic tone in the body and are a clinically meaningful biomarker for depression Anti-Inflammatory Effects eQuility-Sponsored Proof of Concept Study In-Ear Vagal Nerve Stimulation Can Selectively Modulate Physiologic and Metabolic Effect
  17. 17. 19 | eQuility | March 2019 Favorable Regulatory Pathway 2 expert regulatory opinions obtained taVNS Device • 510(k) with predicate options under product code JNX Digital Therapeutic Mobile App • 510(k) Direct De Novo for new product code 1. FDA pre-submission meeting 2. Submit Digital Therapeutic for MDD as stand-alone for clearance 3. Submit tVNS Device for FDA 510K clearance leveraging existing predicates for Anxiety and Major Depressive Disorder (MDD) indications
  18. 18. 20 | eQuility | March 2019 Timeline 2018 Device & Digital Software Plan Developmen t Q3 2019 Device Dev Device optimization Q3 2019 Digital Therapy Licensed Digital Therapeutics licensed to treat MDD. *Exploring bi-polar disorder & sleep Q3 2019 Pilot Study pilot study for stimulation device in MDD. Q3 2019 DT Clinical Study Additional 10 patient study for DT in MDD *Add Sleep Q1 2020 RCT Randomized Controlled Trial for stimulation device Q1 2022 FDA Clearance Of device Q4 2020 FDA Clearance of Digital Therapeutic for MDD
  19. 19. 21 | eQuility | March 2019 Rx Device + Monthly Mobile Therapy Rx Distribution Channels Doctors Clinical Sites Specialty Pharma Device Distributors Originate Rx Distribution
  20. 20. 22 | eQuility | March 2019 Next generation enables data-driven intervention Leveraging eQuility Platform VR/AR Next Digital TherapeuticPhysiological Monitoring Voice & Phenotyping Analysis Machine Learning/AI Compliance Tracking Remote Clinician Support
  21. 21. 23 | eQuility | March 2019 Device and DT Competitive Landscape Criteria Category Product Disorders Treated Regulatory Status Capital Raised Closed Loop eQuility Digital Therapeutics + Bioelectronics Rx Device & Rx Software MDD and other CNS Inflammatory Conducting Clinical Validation $3 million Yes Setpoint Medical Bioelectronics Rx Device/Implant Inflammation FDA Class III $90M No Neuronetics In-office Stimulation Capital Equipment In-office Depression FDA 510(k) Cleared IPO No Fisher Wallace Bioelectronics Non Rx Device Mood Disorders, Chronic Pain FDA 510(k) Cleared N/A No Pear Therapeutics Digital Therapeutics Rx Software Substance Abuse, Schizophrenia FDA De Novo (Cleared) $134M No Electrocore Bioelectronics Rx Device Headaches, Pain, Depression FDA De Novo & CE Mark (Cleared) IPO No Akili Interactive Digital Therapeutics Rx Software ADD, Depression FDA 510(k) $65M No Click Therapeutics Digital Therapeutics Rx Software/ Consumer Smoking Cessation Depression, CHF, Other FDA 510(k) $25 No
  22. 22. 24 | eQuility | March 2019 Forward Looking Statements Disclaimer The information presented is being provided to you by eQuility (the ”Company”) on a confidential basis. Nothing contained herein constitutes investment, legal, tax or other advice nor is it to be relied upon in making an investment or other decision. Certain information contained herein has been obtained from sources prepared by third parties. While such information is believed to be reliable for the purpose used herein, Company does not assume any responsibility for the accuracy or completeness of such information and has not independently verified such information. All modeled performance and amounts included herein are hypothetical, intended for illustrative purposes only and such modeled performance and amounts may not be indicative of past or future results. As such, there can be no assurance that the Company will achieve comparable results or that modeled results will be achieved at all. Nothing in this presentation represents an offer, or a solicitation of an offer, by any party to make an investment.
  23. 23. Neuromodulation technology to end chronic pain. Richard Hanbury CEO richard@sana.io +1 415 630 0467
  24. 24. 100 millionAMERICANS CURRENTLY SUFFER FROM SEVERE PAIN 72,000 deaths last year - 558 in Colorado Today, opioids are still standard of care.
  25. 25. Opioids just mask pain Rest & Recovery Fight or Flight Rest & Recovery Fight or Flight Severe Pain After Opioids
  26. 26. In 1992, the jeep I was driving rolled off a bridge and I was pronounced dead. The nerve damage was so bad I was given 5 years to live.
  27. 27. In my search for pain relief I tried everything first opioids, then devices. 45
  28. 28. Magnetic Electronic Audio-Visual Nothing worked until I discovered the research on brainwave entrainment (BWE).
  29. 29. Magnetic In 1993, I started experimenting with thousands of audio-visual stimulation patterns. I wiped out my pain and saved my life. Since then I have been pain-free.
  30. 30. Sana Pain Relief uses pulsed light and sound to guide users into a deep state of relaxation. increases relaxation Induces Sleep in 10-min Reduces pain
  31. 31. EEG of traumatic brain patient with severe pain EEG after using Sana Relief for 4 hours The Sana device restores hemispheric balance in the brain. 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Back to homeostasis
  32. 32. We’ve piloted studies with collaborators to validate efficacy. Completed Studies
  33. 33. Hattie, age 13 Severe Regional Pain Syndrome "I cut my opioids in half, and could touch my arm without pain for the first time in 3 years. And in one week went back to school." 50% opioid reduction* We’ve achieved success in the most severe cases.
  34. 34. We completed two key clinical milestone studies with leading independent investigators. in recovery and sleep levels 2x improvement 16-person OUD study 2018 2019 in anxiety levels 36% reduction in pain and desire to use 39% reduction 75-person pain study 10- person Fibromyalgia Study80% subjects improved 2019 quality of life More data to follow
  35. 35. Our clinical roadmap is clear. Condition Trial Site Funded Opioid Use Disorder (Trial Complete) ✓ Fibromyalgia ✓ Severe Pain ✗ Neuropathic Pain ✓ Oncology Pain CU Denver Anschutz (TBC) ✗ FDA - deNovo FDA* FDA** FDA** Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 FDA** * breakthrough designation being sought - 2 month process ** self predicated 510k
  36. 36. Patients are already paying out-of-pocket for medical devices. Sana Relief Mask Quell TENS Wearable Non-invasive short term pain relief via grandfathered FDA approved TENS technology. Instant pain relief with long term reduction of the underlying symptoms of chronic pain. $250 + $360 one time per year $250 + $360 one time per year We’re targeting reasonable pricing and broad reimbursement.
  37. 37. CEO & Founder Chief Operating Officer Chief Commercial Officer Chief Financial Officer Richard Hanbury Tasha Bond Steve SandersGeoff Birkett Team Leadership Inventor and developer 25 years with this technology 20 years in med-tech 4 successful exits Launched Nicorette Led merger of Zeneca/Astra 10 years in med-tech $2.5B in M&A experience
  38. 38. Patent 1 Filed 2015 Patent 2 Filed 2016 Patent 3,4 &5 Filed 2018/19 56 We’ve secured strong and broad IP
  39. 39. We’re internationally recognized. Collaborations General Pain Sleep & Anxiety Sleep & Performance Sleep & fatigue mitigation Sleep, Performance, Pain, TBI, & PTSD 57
  40. 40. Neuromodulation technology to end chronic pain. Richard Hanbury CEO richard@sana.io +1 415 630 0467
  41. 41. 1. Novelty 2. Scalability 3. Research and IP approach 4. Impact 5. Financial sustainability
  42. 42. Access recorded talks, Q&A, and more at: SharpBrains.com