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Top Brainnovation to improve Brain Health & Performance

  1. 2017 SHARPBRAINS VIRTUAL SUMMIT
  2. 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
  3. 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
  4. 2017 SHARPBRAINS VIRTUAL SUMMIT
  5. 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
  6. 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
  7. 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
  8. 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.
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. accelerates neurological recovery with AR
  16. 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
  17. 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 * * *
  18. Y2Start Clinical Trial FDA 510(k) Pilot Clinical Programs 2018 Y1Preclinical Product Development & Plan Clinical Trials 2017 Y3Focus on Sales & Marketing 2019
  19. 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
  20. @augmentx_rehab @augmentx@augmentxrehab Albert Kwon, M.D. albert.kwon@augmentx.rehab
  21. CO-FOUNDER CEO Ignacio de Ramón
  22. 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
  23. 1909 1949 1990 2015 If the concept of the brain has changed, shouldn’t the cognitive stimulation concept ? 2010 26
  24. Functional connectivity Dual taskSmall-world 27
  25. 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
  26. 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
  27. 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
  28. 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
  29. 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
  30. join us! www.sincrolab.es Nacho De Ramón nacho@sincrolab.es M: +34 630 36 44 25 10
  31. Thank you, Speakers & Participants!
  32. Thank you, Summit Sponsors!
  33. Thank you, Summit Partners!
  34. To learn more, visit sharpbrains.com
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