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:
https://sharpbrains.com/summit-2019/
4. 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
5. 5 | eQuility | March 2019
non-drug • mobile • consumer facing
Rx Digital Mobile Apps + Bioelectronic Medicine
6. 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
7. 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.
8. 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
9. 9 | eQuility | March 2019
digital
therapeutcs
bluetooth
bioelectronic
device
A Complementary Solution
Delivering Healthcare Using Bioelectronic Devices + Digital
Therapy
Digital Therapy
10. 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
11. 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
12. 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.
13. 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
14. 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
15. 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
16. 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
17. 17 | eQuility | March 2019
Literature Supports taVNS and Digital Therapeutics
A snapshot of academic papers
18. 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
19. 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
20. 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
21. 21 | eQuility | March 2019
Rx Device + Monthly Mobile Therapy Rx
Distribution Channels
Doctors Clinical Sites Specialty Pharma
Device
Distributors
Originate Rx Distribution
22. 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
23. 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
24. 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.
47. 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.
48. 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
49. 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.
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Back to homeostasis
51. 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.
52. 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
53. 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
54. 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.
55. 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