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2017 SHARPBRAINS VIRTUAL SUMMIT
Top Brainnovations to Improve Brain Health & Performance
Click Therapeutics — pitch
by David Klein, Co-Founder &
CEO
AUGMENTx — pitch
by Dr. Albert Kwon, Co-Founder
& CEO
Sincrolab — pitch by Ignacio
de Ramon, Co-Founder &
CEO
Judges
Alexandra Morehouse, Chief
Marketing Officer at Banner
Health
Colin Milner, Founder and
CEO of the International
Council on Active Aging
(ICAA)
Danny Dankner, CEO and
Co-founder of Applied
Cognitive Engineering
Zack Lynch, General Partner
at JAZZ Venture Partners
2017 SHARPBRAINS VIRTUAL SUMMIT
MISSION: TO BECOME
THE LEADING DIGITAL THERAPEUTICS PROVIDER AND PLATFORM
• We create, validate and commercialize software as treatments
• These Digital Therapeutics™ are based on our clinically validated platform
• They work independently or in conjunction with pharmacotherapies
• Data collected are used to continuously improve & personalize interventions
• Unique and robust intellectual property strategy and portfolio
• Better outcomes through user engagement and neurobehavioral change
2
2017 SHARPBRAINS VIRTUAL SUMMIT
PIPELINE
CT-100: CLICK Neurobehavioral Intervention (CNI) Platform
Chronic Pain
CT-130
Insomnia
CT-141
Clickadian™
PRODUCT INDICATION RESEARCH DEVELOPMENT PILOT STUDY EFFICACY TRIAL
Myocardial Infarction
CT-111
Clickheart™
CT-152
Major Depressive DisorderClickEFMT™
Depressed Mood
CT-151
Clickarise™
Smoking Cessation
CT-101
Clickotine©
2017 SHARPBRAINS VIRTUAL SUMMIT
NOVELTY
ClickEFMT™: A DIGITAL TREATMENT FOR DEPRESSION
4
EFMT targets the imbalance between hyperactive (RED) emotion processing regions and hypoactive
(BLUE) prefrontal regions underlying the cognitive control impairments observed in MDD patients
Emotion Recognition
and Processing
Working
Memory
Emotional Faces Memory Task (EFMT) helps patients with Major Depressive
Disorder (MDD) enhance cognitive control over emotion by practicing
emotion recognition and working memory together
2017 SHARPBRAINS VIRTUAL SUMMIT
RESEARCH
COMPLETED 2 RCTS, AND 1 fMRI STUDY
5
Intervention
Effective and functional connectivity
between key neural nodes investigated
pre-post EFMT training
c) Expectation of benefit and ability to blind: participants in
TAU and no contact controls would know immediately which
trial arm they were in. With SMT, patients were made aware
they were participating in a “study of 2 cognitive training
exercises, and will be assigned to one or the other to
complete over 6 weeks.” Thus, both conditions could
plausibly deliver benefit, clinical equipoise would apply, and
patients and investigators could remain blinded to
hypothesis.
Considered three control conditions for the studies: no-contact, treatment as usual (TAU), and Shapes Memory Task
(SMT), an interactive task matched to EFMT with non-emotional stimuli, and concluded that SMT is the best control for
EFMT for the following reasons:
a) Time and effort: participants
completed the same number of
sessions in both conditions at the
time selected by the participant. In
TAU, time spent in therapy or using
medication would be too variable to
offer an accurate control.
b) Clinician/staff attention:
participants in both trial arms will
received the same engagement with
a clinician or staff member whereas
patients in a no-contact or TAU
control would receive variable
attention from clinician and staff
members.
Sham Control
2017 SHARPBRAINS VIRTUAL SUMMIT
fMRI Study
vs.
Preparing a multi-center, randomized, controlled,
parallel group, FDA phase III registration study
RESEARCH CONTINUED
POSITIVE RESULTS FROM THESE TRIALS AND NEXT STEPS
6
Pilot study Completed Clinical Trial Completed fMRI study
11 EFMT vs. 10 Control
1
28 EFMT vs. 23 Control
2 3
NEXT RESEARCH STEP:
EFMT demonstrated a significant reduction of HAM-D
scores from baseline to outcome (from 21.55 to
10.91) that was greater than CT (from 19.80 to
14.10); F(1,19)= 5.605, p= .029. Error bars indicate ±
1 standard error. * p < .05 between groups.
Published: Iacoviello et al. (2014),
Depression & Anxiety
Data replicated EFMT efficacy
observed in pilot study.
Objective fMRI data support
our hypothesis that EFMT has
a neuroplastic effect.
Publication: Under review Publication: In preparation
*Discuss more in presentation
*Discuss more in presentation *Discuss more in presentation
2017 SHARPBRAINS VIRTUAL SUMMIT
Effective and functional connectivity between
key neural nodes investigated
pre-post EFMT training
SCALABILITY
LAYING GROUNDWORK FOR WIDESPREAD COVERAGE AND SCALE
Electronic Medical Records
Digital nature allows for direct
integration with
Upon FDA clearance, ClickEFMT will
be prescribed by physicians
Commercial
Behavioral
Commercial
Specialty
Government
Pharmacy
Management
25.7 25.2
5.1 15
Our largest
investor Magellan
Health helping to
garner
widespread
reimbursement
and to lay the
groundwork to
scale ClickEFMT
Performance and
efficacy can
improve as
more patients are
treated with
ClickEFMT and
data are used to
optimize treatment
EFFICACY
2017 SHARPBRAINS VIRTUAL SUMMIT
COVERED LIVES (Millions)
7
SCALABILITY CONTINUED
ORGANIZING FOR IMMEDIATELY ENABLED PATIENT ACCESS
Physician prescribes
exactly the same as they
would a drug
Physician sees specific
therapeutic choices and
coverage for each patient
Click + Magellan
structuring system
integrations across the
nation
2017 SHARPBRAINS VIRTUAL SUMMIT
8
PATENT FILINGS INCLUDE:
• Systems and Methods for Treating a Psychiatric Disorder. U.S. Patent Application No. 15/513490
• Claims directed to:
Systems and computer products for conducting a therapy session by sequentially displaying subsets of images
capable of inducing human amygdala activation and modifying a number of images between two images
showing the same emotion based on responses to queries
• Pending applications in AU, CA, EP and JP
• Systems and Methods for Improving Efficiency of a Remote Computing Device. U.S. Patent Application
No. 15/348777
• Claims directed to:
Systems and methods for determining a time at which to send a subsequent message (just in time intervention)
to a patient’s monitoring device based on a patient’s response to a previous message
• Therapeutic System and Remote Patient Monitoring Device. U.S. Patent Application No. 15/563477
• Claims directed to:
A medical treatment system and method configured to i) generate a treatment plan corresponding to the patient,
the treatment plan including a plurality of events (missions/notifications) generated based on the patient profile
and ii) modify the treatment plan in response to previous feedback to the events received from the patient,
INTELLECTUAL PROPERTY
UNIQUE & ROBUST IP STRATEGY & PORTFOLIO
9
*Discuss more in presentation
2017 SHARPBRAINS VIRTUAL SUMMIT
IMPACT
SO WHAT?
10
16.5M adults
with MDD1
Major Depression in the U.S.
75%
would prefer non-
pharmacologic
treatment2
2. McHugh et al., Journal of Clinical Psychiatry
~50% of those
diagnosed with MDD
receive treatment1
Non-pharmacologic
treatment options are
limited
Cognitive behavioral
therapy is not widely
available
~60% of those
diagnosed with MDD
also experience
significant anxiety
symptoms3
1. NIMH 3. Coplan et al., World Journal of Psychiatry
2017 SHARPBRAINS VIRTUAL SUMMIT
Current U.S. healthcare spending on chronic
care is unsustainable.
Launch of ClickEFMT
FDA registration study
2018
Magellan makes
substantial financial
investment into Click
2017
Addressable
market
>$9
billion
Potential peak sales
for ClickEFMT alone
>$1
billion
United States
Economic
burden of
depression3
$210
billion
% of total
spending towards
chronic care2
86%
Total U.S.
healthcare
spending1
$3.2
trillion
FINANCIAL SUSTAINABILITY
THE NUMBERS
Click completes
landmark digital
therapeutic clinical trial
Magellan completes
successful Clickotine
commercial pilot
2016
2016
2. CDC1. CMS 3. APA
2017 SHARPBRAINS VIRTUAL SUMMIT
11
accelerates neurological recovery with AR
Need access to trained therapist at first
Poor compliance
No performance metrics nor reporting
Bulky
On-demand & digital assisted therapy
Better compliance through engagement
Automated progress reports
Small form factor
Mirror Box Therapy
Inpatient Hospitals
~1 year
B2B
Outpatient Clinics
~1 year
B2B
Home Therapy
~2-3 years
B2C
Cloud Data
Analytics
B2B
Public Health
& Interventions
B2G
Go-to-Market and Reimbursement Strategies
Each therapy session can be reimbursed through current billing codes
*
* *
Y2Start
Clinical Trial
FDA 510(k)
Pilot Clinical
Programs
2018
Y1Preclinical
Product
Development
&
Plan Clinical
Trials
2017
Y3Focus on
Sales &
Marketing
2019
ALBERT KWON
MIT, Harvard MD
Pediatrician, Anesthesiologist
Bioengineer, Biologist
JULIEN BOUVIER
ENSIMAG
IT Engineer, AR Expert
Amadeus
SERGIO NAVARRO
MIT, Baylor MD
Future Surgeon
VP of Finance at Goldman Sachs
Mechanical Engineer
MEHDI LEFOUILI
U.T. de Compiegne
IT Engineer, R&D
Amadeus
JINGRU GUO
Parsons, RISD
UI/UX Expert
Amazon Alexa
@augmentx_rehab @augmentx@augmentxrehab
Albert Kwon, M.D.
albert.kwon@augmentx.rehab
CO-FOUNDER CEO
Ignacio de Ramón
Neuropsychologists offers:
personalized treatments, but little
recurrence and high price.
The drugs offer: recurrence and cost
reduction but it is not very specific
yet (general mechanisms of action
that do not take into account the
variability of the subject).
Gamification Apps
Laboratory
Paradigms
Sincrolab uses AI and dual tasks (which allow cognitive stimulation according to the new
paradigm of cognitive stimulation). In addition, it allows to make measurements of the training
with the precision of clinical trials.
25
1909 1949 1990 2015
If the concept of the brain has changed,
shouldn’t the cognitive stimulation concept ?
2010
26
Functional
connectivity
Dual taskSmall-world
27
Same game
but different
characteristics
Receive data from previous
training and analyze them.
Cognitive Profile 1
Cognitive Profile 2
Generate a
new training
Generate a
new training
28
Cognitive Profile
Create personalized
trainings automatically
based on your patients’
cognitive profile
Dashboard for Patients
With Sincrolab you will
have constant and detailed
information on the
performance and each and
every one of your patients.
Dashboard for Therapist
With Sincrolab you have
everything you need to
organize your patients
data, whether you work on
your own or you have a
center with several
employees.
Tasks for children
We help health professionals
manage and generate
personalized cognitive
training plans for children
with neurodevelopmental
disorders.
Tasks for adults
Focused on stimulate
impaired cognitive processes
in neurodegenerative
disorders.
29
75% of the cognition tests
have a tendency in favor
of the SINCROLAB group
42% of the behavioral
tests have a tendency in
favor of the SINCROLAB
group
SIGNIFICANT INCREASE OF FUNCTIONAL CONNECTIVITY
BETWEEN PRE AND POST TRAINING PHASE IN THE
EXPERIMENTAL GROUP
Neuropsychological and Behavioral Assessment
Our Researches
30
Adhd
788
0
200
400
600
800
1000
1Q 2Q 3Q
Active Patients
13346
0
5000
10000
15000
1Q 2Q 3Q
Games Played
31
5
LICENSES
10
LICENSES
50
LICENSES
BASIC PRO ENTERPRISE
49€ 89€ 99€
20%
18%
26%
30%
84%
0% 20% 40% 60% 80% 100%
6 mths
5 mths
4 mths
3 mths
2 mths
% Engagement
2014 / 2016
4 partnerships
1 clinical trial
3 Apps
1 Ai
1 App/Web
R&D 45 Customers
1000 patients
80% engage > 3 months
35.000$ Rev
2 countries
Seed Round 100.000$
200 Customers
5000 patients
80% engage >6 months
>500.000$ Rev
5 countries
Series A 1.000.000$
Customers
Trialing
México
Colombia
Paraguay
Chile
Spain
2017e 2018e
1 clinical trial 1 clinical trial
32
join us!
www.sincrolab.es
Nacho De Ramón
nacho@sincrolab.es
M: +34 630 36 44 25
10
Thank you, Speakers & Participants!
Thank you, Summit Sponsors!
Thank you, Summit Partners!
To learn more, visit sharpbrains.com

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Top Brainnovation to improve Brain Health & Performance

  • 2.
  • 3. Top Brainnovations to Improve Brain Health & Performance Click Therapeutics — pitch by David Klein, Co-Founder & CEO AUGMENTx — pitch by Dr. Albert Kwon, Co-Founder & CEO Sincrolab — pitch by Ignacio de Ramon, Co-Founder & CEO
  • 4. Judges Alexandra Morehouse, Chief Marketing Officer at Banner Health Colin Milner, Founder and CEO of the International Council on Active Aging (ICAA) Danny Dankner, CEO and Co-founder of Applied Cognitive Engineering Zack Lynch, General Partner at JAZZ Venture Partners
  • 6. MISSION: TO BECOME THE LEADING DIGITAL THERAPEUTICS PROVIDER AND PLATFORM • We create, validate and commercialize software as treatments • These Digital Therapeutics™ are based on our clinically validated platform • They work independently or in conjunction with pharmacotherapies • Data collected are used to continuously improve & personalize interventions • Unique and robust intellectual property strategy and portfolio • Better outcomes through user engagement and neurobehavioral change 2 2017 SHARPBRAINS VIRTUAL SUMMIT
  • 7. PIPELINE CT-100: CLICK Neurobehavioral Intervention (CNI) Platform Chronic Pain CT-130 Insomnia CT-141 Clickadian™ PRODUCT INDICATION RESEARCH DEVELOPMENT PILOT STUDY EFFICACY TRIAL Myocardial Infarction CT-111 Clickheart™ CT-152 Major Depressive DisorderClickEFMT™ Depressed Mood CT-151 Clickarise™ Smoking Cessation CT-101 Clickotine© 2017 SHARPBRAINS VIRTUAL SUMMIT
  • 8. NOVELTY ClickEFMT™: A DIGITAL TREATMENT FOR DEPRESSION 4 EFMT targets the imbalance between hyperactive (RED) emotion processing regions and hypoactive (BLUE) prefrontal regions underlying the cognitive control impairments observed in MDD patients Emotion Recognition and Processing Working Memory Emotional Faces Memory Task (EFMT) helps patients with Major Depressive Disorder (MDD) enhance cognitive control over emotion by practicing emotion recognition and working memory together 2017 SHARPBRAINS VIRTUAL SUMMIT
  • 9. RESEARCH COMPLETED 2 RCTS, AND 1 fMRI STUDY 5 Intervention Effective and functional connectivity between key neural nodes investigated pre-post EFMT training c) Expectation of benefit and ability to blind: participants in TAU and no contact controls would know immediately which trial arm they were in. With SMT, patients were made aware they were participating in a “study of 2 cognitive training exercises, and will be assigned to one or the other to complete over 6 weeks.” Thus, both conditions could plausibly deliver benefit, clinical equipoise would apply, and patients and investigators could remain blinded to hypothesis. Considered three control conditions for the studies: no-contact, treatment as usual (TAU), and Shapes Memory Task (SMT), an interactive task matched to EFMT with non-emotional stimuli, and concluded that SMT is the best control for EFMT for the following reasons: a) Time and effort: participants completed the same number of sessions in both conditions at the time selected by the participant. In TAU, time spent in therapy or using medication would be too variable to offer an accurate control. b) Clinician/staff attention: participants in both trial arms will received the same engagement with a clinician or staff member whereas patients in a no-contact or TAU control would receive variable attention from clinician and staff members. Sham Control 2017 SHARPBRAINS VIRTUAL SUMMIT fMRI Study vs.
  • 10. Preparing a multi-center, randomized, controlled, parallel group, FDA phase III registration study RESEARCH CONTINUED POSITIVE RESULTS FROM THESE TRIALS AND NEXT STEPS 6 Pilot study Completed Clinical Trial Completed fMRI study 11 EFMT vs. 10 Control 1 28 EFMT vs. 23 Control 2 3 NEXT RESEARCH STEP: EFMT demonstrated a significant reduction of HAM-D scores from baseline to outcome (from 21.55 to 10.91) that was greater than CT (from 19.80 to 14.10); F(1,19)= 5.605, p= .029. Error bars indicate ± 1 standard error. * p < .05 between groups. Published: Iacoviello et al. (2014), Depression & Anxiety Data replicated EFMT efficacy observed in pilot study. Objective fMRI data support our hypothesis that EFMT has a neuroplastic effect. Publication: Under review Publication: In preparation *Discuss more in presentation *Discuss more in presentation *Discuss more in presentation 2017 SHARPBRAINS VIRTUAL SUMMIT Effective and functional connectivity between key neural nodes investigated pre-post EFMT training
  • 11. SCALABILITY LAYING GROUNDWORK FOR WIDESPREAD COVERAGE AND SCALE Electronic Medical Records Digital nature allows for direct integration with Upon FDA clearance, ClickEFMT will be prescribed by physicians Commercial Behavioral Commercial Specialty Government Pharmacy Management 25.7 25.2 5.1 15 Our largest investor Magellan Health helping to garner widespread reimbursement and to lay the groundwork to scale ClickEFMT Performance and efficacy can improve as more patients are treated with ClickEFMT and data are used to optimize treatment EFFICACY 2017 SHARPBRAINS VIRTUAL SUMMIT COVERED LIVES (Millions) 7
  • 12. SCALABILITY CONTINUED ORGANIZING FOR IMMEDIATELY ENABLED PATIENT ACCESS Physician prescribes exactly the same as they would a drug Physician sees specific therapeutic choices and coverage for each patient Click + Magellan structuring system integrations across the nation 2017 SHARPBRAINS VIRTUAL SUMMIT 8
  • 13. PATENT FILINGS INCLUDE: • Systems and Methods for Treating a Psychiatric Disorder. U.S. Patent Application No. 15/513490 • Claims directed to: Systems and computer products for conducting a therapy session by sequentially displaying subsets of images capable of inducing human amygdala activation and modifying a number of images between two images showing the same emotion based on responses to queries • Pending applications in AU, CA, EP and JP • Systems and Methods for Improving Efficiency of a Remote Computing Device. U.S. Patent Application No. 15/348777 • Claims directed to: Systems and methods for determining a time at which to send a subsequent message (just in time intervention) to a patient’s monitoring device based on a patient’s response to a previous message • Therapeutic System and Remote Patient Monitoring Device. U.S. Patent Application No. 15/563477 • Claims directed to: A medical treatment system and method configured to i) generate a treatment plan corresponding to the patient, the treatment plan including a plurality of events (missions/notifications) generated based on the patient profile and ii) modify the treatment plan in response to previous feedback to the events received from the patient, INTELLECTUAL PROPERTY UNIQUE & ROBUST IP STRATEGY & PORTFOLIO 9 *Discuss more in presentation 2017 SHARPBRAINS VIRTUAL SUMMIT
  • 14. IMPACT SO WHAT? 10 16.5M adults with MDD1 Major Depression in the U.S. 75% would prefer non- pharmacologic treatment2 2. McHugh et al., Journal of Clinical Psychiatry ~50% of those diagnosed with MDD receive treatment1 Non-pharmacologic treatment options are limited Cognitive behavioral therapy is not widely available ~60% of those diagnosed with MDD also experience significant anxiety symptoms3 1. NIMH 3. Coplan et al., World Journal of Psychiatry 2017 SHARPBRAINS VIRTUAL SUMMIT
  • 15. Current U.S. healthcare spending on chronic care is unsustainable. Launch of ClickEFMT FDA registration study 2018 Magellan makes substantial financial investment into Click 2017 Addressable market >$9 billion Potential peak sales for ClickEFMT alone >$1 billion United States Economic burden of depression3 $210 billion % of total spending towards chronic care2 86% Total U.S. healthcare spending1 $3.2 trillion FINANCIAL SUSTAINABILITY THE NUMBERS Click completes landmark digital therapeutic clinical trial Magellan completes successful Clickotine commercial pilot 2016 2016 2. CDC1. CMS 3. APA 2017 SHARPBRAINS VIRTUAL SUMMIT 11
  • 17.
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  • 19. Need access to trained therapist at first Poor compliance No performance metrics nor reporting Bulky On-demand & digital assisted therapy Better compliance through engagement Automated progress reports Small form factor Mirror Box Therapy
  • 20. Inpatient Hospitals ~1 year B2B Outpatient Clinics ~1 year B2B Home Therapy ~2-3 years B2C Cloud Data Analytics B2B Public Health & Interventions B2G Go-to-Market and Reimbursement Strategies Each therapy session can be reimbursed through current billing codes * * *
  • 21. Y2Start Clinical Trial FDA 510(k) Pilot Clinical Programs 2018 Y1Preclinical Product Development & Plan Clinical Trials 2017 Y3Focus on Sales & Marketing 2019
  • 22. ALBERT KWON MIT, Harvard MD Pediatrician, Anesthesiologist Bioengineer, Biologist JULIEN BOUVIER ENSIMAG IT Engineer, AR Expert Amadeus SERGIO NAVARRO MIT, Baylor MD Future Surgeon VP of Finance at Goldman Sachs Mechanical Engineer MEHDI LEFOUILI U.T. de Compiegne IT Engineer, R&D Amadeus JINGRU GUO Parsons, RISD UI/UX Expert Amazon Alexa
  • 23. @augmentx_rehab @augmentx@augmentxrehab Albert Kwon, M.D. albert.kwon@augmentx.rehab
  • 25. Neuropsychologists offers: personalized treatments, but little recurrence and high price. The drugs offer: recurrence and cost reduction but it is not very specific yet (general mechanisms of action that do not take into account the variability of the subject). Gamification Apps Laboratory Paradigms Sincrolab uses AI and dual tasks (which allow cognitive stimulation according to the new paradigm of cognitive stimulation). In addition, it allows to make measurements of the training with the precision of clinical trials. 25
  • 26. 1909 1949 1990 2015 If the concept of the brain has changed, shouldn’t the cognitive stimulation concept ? 2010 26
  • 28. Same game but different characteristics Receive data from previous training and analyze them. Cognitive Profile 1 Cognitive Profile 2 Generate a new training Generate a new training 28
  • 29. Cognitive Profile Create personalized trainings automatically based on your patients’ cognitive profile Dashboard for Patients With Sincrolab you will have constant and detailed information on the performance and each and every one of your patients. Dashboard for Therapist With Sincrolab you have everything you need to organize your patients data, whether you work on your own or you have a center with several employees. Tasks for children We help health professionals manage and generate personalized cognitive training plans for children with neurodevelopmental disorders. Tasks for adults Focused on stimulate impaired cognitive processes in neurodegenerative disorders. 29
  • 30. 75% of the cognition tests have a tendency in favor of the SINCROLAB group 42% of the behavioral tests have a tendency in favor of the SINCROLAB group SIGNIFICANT INCREASE OF FUNCTIONAL CONNECTIVITY BETWEEN PRE AND POST TRAINING PHASE IN THE EXPERIMENTAL GROUP Neuropsychological and Behavioral Assessment Our Researches 30 Adhd
  • 31. 788 0 200 400 600 800 1000 1Q 2Q 3Q Active Patients 13346 0 5000 10000 15000 1Q 2Q 3Q Games Played 31 5 LICENSES 10 LICENSES 50 LICENSES BASIC PRO ENTERPRISE 49€ 89€ 99€ 20% 18% 26% 30% 84% 0% 20% 40% 60% 80% 100% 6 mths 5 mths 4 mths 3 mths 2 mths % Engagement
  • 32. 2014 / 2016 4 partnerships 1 clinical trial 3 Apps 1 Ai 1 App/Web R&D 45 Customers 1000 patients 80% engage > 3 months 35.000$ Rev 2 countries Seed Round 100.000$ 200 Customers 5000 patients 80% engage >6 months >500.000$ Rev 5 countries Series A 1.000.000$ Customers Trialing México Colombia Paraguay Chile Spain 2017e 2018e 1 clinical trial 1 clinical trial 32
  • 33. join us! www.sincrolab.es Nacho De Ramón nacho@sincrolab.es M: +34 630 36 44 25 10
  • 34.
  • 35. Thank you, Speakers & Participants!
  • 36. Thank you, Summit Sponsors!
  • 37. Thank you, Summit Partners!
  • 38. To learn more, visit sharpbrains.com