Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (May 2017)
26 slides from Solana's investor presentation, May 23, 2017
Slide 1: A Revolution in Mind
Helius Medical Technologies A Revolution in Mind May 2017 Helius MEDICAL TECHNOLOGIES www.heliusmedical.com | TSX: HSM | OTCQB: HSDT
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements and forward-looking information as such terms are defined under applicable U.S. federal securities and Canadian securities legislation. All statements other than statements of historical fact contained in this presentation const
Slide 3: Management
Helius Medical Technologies Management Philippe Deschamps President and CEO Chairman and Director • Over 30 years in the health sciences industry • Former CEO at MediMedia Health Marketing Services (Division of inVentiv Health) • Former President and CEO at GSW Worldwide • Former Director of Neurosc
Slide 4: Equity Overview: Helius Medical Technologies
Equity Overview: Helius Medical Technologies Tickers: HSM:TSX, HSDT:OTCQB Market Cap 5/17/17: US$129.0 M Shares Outstanding as of 5/17/17: 91.25 M Price: HSM.T - CAD$2.06 | HDST - US$1.56 Shares Incl. Warrants & Options as of 5/17/17: 111.4 M 52 Week High: CAD$2.59 | 52 Week Low: CAD$1.01 Mgmt Owner
Slide 5: Developing a platform technology for neurologic disease or trauma
Helius Medical Technologies Developing a platform technology for the treatment of symptoms of neurologic disease or trauma Portable Neuromodulation Stimulator (“PoNS™”) • Delivers specially-patterned nerve impulses to the lower brainstem through disposable appliance placed on the tongue • Combined w
Slide 6: The Inventors of PoNS Technology
The Inventors of PoNS™ Technology TACTILE COMMUNICATION AND NEUROREHABILITATION LABORATORY (“TCNL”) UNIVERSITY OF WISCONSIN–MADISON Department of Biomedical Engineering THE UNIVERSITY WISCONCIN MADISON Founded in 1992 by a pioneer of neuroplasticity, Dr. Paul Bach-Y-Rita • Research center using vari
Slide 7: Third-Party Review of Early Stage Data
Third-Party Review of Early Stage Data Optum Retrospective Analysis: The Use of PoNSTM Therapy Led to Better Outcomes in Patients With Resistant Neurological Conditions OPTUMTM Study Test Subjects Statistically Significant (p<0.05)? MS Pilot MS - RCT NIMN Balance Disorders TOTAL Dynamic Gait Index (
Slide 8: Results from Multiple Sclerosis Pilot Study: fMRI Changes Vs Healthy Controls
Results from Multiple Sclerosis Pilot*Study fMRI Changes Vs Healthy Controls 14 subject study: All received physiotherapy with 7 receiving PoNS™ device stimulation and 7 in the sham group. **VOIs BOLD signal vs. Healthy Controls Left DLPFC % BOLD Change * 1 0.8 0.6 0.4 0.2 0 *** Group A Group B Pre
Slide 9: Results from Multiple Sclerosis Pilot Study: Working Memory fMRI
Results from Multiple Sclerosis Pilot Study Working Memory fMRI* Group A: Post PoNS™ device training fMRI shows significant increase in BOLD signal in the left DLPFC** (t=3.55, p=0.01), rACC*** (t=3.057, p=0.02) and a trend for significance in the right DLPFC (t=2.3, p=0.06). Group A Pre-PoNS Active
Slide 10: Cerebral Palsy (CP) Pilot Study
Cerebral Palsy (CP) Pilot Study* 65 subject (45 active/20 control) study included children (ages 3-13) with Gross Motor Function Classification Scores (GMFCS) ranging from II-IV All subjects received 10 days of standard physiotherapy and movement control therapy with the active group receiving 20-25
Slide 11: Therapeutic Areas With Potential PoNS Utility
Therapeutic Areas With Potential PoNSTM Utility* Indication Traumatic Brain Injury (TBI) Multiple Sclerosis Cerebral Palsy Cognition and Human Performance Stroke Parkinson’s Disease Alzheimer’s Disease Depression PTSD Helius Involvement Ongoing Registrational Clinical Trial Pilot Study Complete Pote
Slide 12: PoNS Ongoing Pivotal Trial in TBI
PoNS™ Ongoing Pivotal Trial in TBI Clinical Study Title A double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS™ device for cranial nerve noninvasive neuromodulation (“CN-NINM”) training in subjects with a chronic balance deficit due to mTBI. Indication Chronic
Slide 13: Clearly Defined Regulatory Pathway
Clearly Defined Regulatory Pathway FDA deemed the study of the PoNSTM for mild-moderate TBI a ‘non-significant risk (NSR) device study’ under the IDE regulations Assessed the study as not posing a significant risk to human subjects FDA guidance points to 120-day regulatory review upon submission for
Slide 14: Anticipated PoNS Clinical Milestones
Anticipated PoNS™ Clinical Milestones HELIUS MEDICAL TECHNOLOGIES Pre-clinical Pilot Study Begin FDA Reg. Trial Complete FDAReg. Trial Submit FDA Filing Obtain Clearance/ Approval PoNS™ 4.0 Device | Cranial Nerve Non-Invasive Neuromodulation + Physical Therapy CLINICAL STAGE PROGRAMS Traumatic Brain
Slide 15: Funding From U.S. Army Medical Research and Material Command
Funding From U.S. Army Medical Research and Material Command CRADA with the U.S. Army Medical Research and Material Command effective February 2013 U.S. Army commits non-dilutive funding and resources for PoNS™ research $1.8M+ in expense reimbursement received on the project to date; additional $0.5
Slide 16: Traumatic Brain Injury Market
Traumatic Brain Injury Market Large Population: 2.1 million people with balance disorder related to non severe TBI1 Unmet Need: Current treatment paradigm offers few viable therapeutic options Military Athletic / Civilian Common Types of TBI due to Military Activity: Explosive blast injury Overpress
Slide 17: Building a Moat: Extensive IP Portfolio
Building a Moat: Extensive IP Portfolio Exclusively licensed from inventors (4% royalty): 7 US Medical Method Patents Issued Skin Stimulation + Physical Therapy = Therapeutic Outcome Skin Stimulation + Cognitive Therapy = Therapeutic Outcome Oral Cavity Stimulation + Physical Therapy = Therapeutic O
Slide 18: PoNS Therapy Healthcare Transaction Model
PoNS™ Therapy Healthcare Transaction Model 1 • Patient agrees to PoNS™ Therapy - purchases a device and 5 Weeks with Certified Physical Therapy Center/Therapist accredited in PoNS™ training • Patient pays for to PoNS™ Therapy Device (only) through self-pay 2 • PoNS™ Accredited Physical Therapist rec
Slide 19: Helius Corporate Activity Estimated Timeline
Helius Corporate Activity Estimated Timeline Q1 2017 • S-3, $100M U.S. Shelf Effective • Complete MJDS Base Prospectus in Canada • Completed $9.5M Registered Offering February 2017 • Begin work on MS registrational trial • Launch 3 new sites for TBI registrational trial and increase enrollment rate
Slide 20: Investor Contact
Helius MEDICAL TECHNOLOGIES Investor Contact: Phil Deschamps pdeschamps@heliusmedical.com Josh Berg josh@bergcapitalmarkets.com Helius Medical Technologies, Inc. | 41 University Drive, Suite 400 | Newtown, PA 18940 T: 215 809-2018 | E: info@heliusmedical.com | W: www.heliusmedical.com Helius MEDICAL
Slide 21: Appendix and References
APPENDIX AND REFERENCES Helius MEDICAL TECHNOLOGIES www.heliusmedical.com | TSX: HSM | OTCQB: HSDT
Slide 22: Funding to Date
Funding to Date TCNL Lab funding: • $7.1M ($3.0M NIH grants, $4.1M in cash donations from treated subjects) – 2008-2013 Cash from Securities Offerings: • $7.0M initial investment in connection with reverse merger – Q2 2014 • $1.0M convertible debenture – Q2 2014 • $2.8M non-brokered private placemen
Slide 23: Scientific Advisory Board
Scientific Advisory Board Jonathan Sackier, M.D., Chairman Scientific Advisory Board Ron Alterman, M.D., M.B.A. D. James Surmeier, M.D. Harvard professor Chair of the Department of Physiology and Director of Neurosurgeon at Beth Israel (BIDMC) Parkinson’s Disease Research Center at Northwestern Expe
Slide 24: Governance – Board of Directors
Governance – Board of Directors Philippe Deschamps • Chairman of the Board, Company CEO Vice Admiral Ed Straw (retired) • Director • Former head of the Defense Logistics Agency at DOD Blane Walter • Director • Partner at Talisman Capital; Former Chairman CEO, InVentiv Health Inc. Dr. Huaizheng Peng
Slide 25: References
References Slide 8: Multiple Sclerosis Pilot Study 1. Helius press release November 15, 2015. Slide 8/9: Results from MS Pilot Study 1. American Congress of Rehabilitation Medicine (ACRM) has accepted a submission from Helius for a panel discussion – “PoNS™ Therapy: non-invasive investigational cran
Slide 26: References
References Slide 11: Therapeutic Area With Potential for PoNSTM Utility • Multiple Sclerosis - http://www.nationalmssociety.org/About-the-Society/MS-Prevalence • TBI - http://www.cdc.gov/traumaticbraininjury/pdf/TBI_Report_to_Congress_Epi_and_Rehab-a.pdf • Parkinson’s - http://www.pdf.org/en/parkins
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