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A Revolution in Mind June 2015 CSNX: HSM OTCQB: HSDT.

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Presentation on theme: "A Revolution in Mind June 2015 CSNX: HSM OTCQB: HSDT."— Presentation transcript:

1 A Revolution in Mind June 2015 CSNX: HSM OTCQB: HSDT

2 Disclaimer This presentation contains certain forward-looking statements that may involve a number of risks and uncertainties. Actual events or results could differ materially from Helius Medical Technologies expectations and projections. The Ontario Securities Commission has neither approved nor disapproved the information contained in this presentation. Except for statements of historical fact relating to the Company, certain information contained herein constitutes "forward-looking statements". Forward-looking statements are frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. These factors include the inherent risks involved in the development of medical devices and FDA or other international regulatory agencies, product obsolescence, the uncertainties involved in patent defense and complexities and timelines associated with medical device product approvals in multiple jurisdictions. The possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. Circumstances or management's estimates or opinions could change. The reader is cautioned not to place undue reliance on forward-looking statements.

3 Overview Helius Medical Technologies
Medical device company focused on neurological wellness and the development of unique, non-invasive, technologies to enable the brain to heal itself Portable Neuromodulation Stimulator or PoNS™ Device Electrode-covered oral device delivering specially-patterned nerve impulses to a patient's brain through appliance placed on the tongue PoNS treats neurological symptoms caused by disease or trauma Clinical experience with over 200 patients U.S. Armed Forces Collaboration Collaborative Research and Development Agreement (CRADA) Army our development partner and first customer Development and Clinical Trials Testing and studies, to date, provide encouraging indications Clearance by FDA expected Q3/Q4 2016

4 Management Team Philippe Deschamps
President, CEO 28 years in the Health Sciences industry MediMedia Health Marketing Services President and CEO - GSW Worldwide operations Director of Neuroscience Marketing at Bristol-Myers Squibb Jonathan Sackier Chief Medical Officer 30 years in the Health Sciences industry An innovator and pioneer of new technologies Has helped build several companies including medical technology, research and product-design and medical contract sales organizations Experienced management team with expertise in healthcare and business development

5 Scientific Team: Inventors of PoNS TM Technology
TACTILE COMMUNICATION AND NEUROREHABILITATION LABORATORY UNIVERSITY OF WISCONSIN–MADISON Department of Biomedical Engineering Founded in 1992 by a pioneer of Neuroplasticity, Dr. Paul Bach-Y-Rita Research center using various areas of science to study the theory and application of applied neuro­plasticity, the brain’s ability to reorganize in response to new information, needs, and pathways Research objective to develop solutions for sensory and motor disorders TCNL Project Directors: Mitchell E. Tyler, Kurt Kaczmarek, Yuri P. Danilov >20 years of individual experience in their respective fields of neuroscience, biomedical science, and engineering. Co-discoverers of the retention effect and neurorehabilitation potential of tongue electrotactile stimulation Recognized experts in electrotactile stimulation Invented core tongue display technology Over 65 years combined experience in neuroscience, biomedical science, and engineering

6 Important Core Concept - Neuroplasticity
The ability of the brain to remain “plastic”, enabling new learning and the capacity to compensate for damage The PoNS Device provides stimulation to the brain-stem and other brain structures via the cranial nerves We believe this stimulation, when combined with a “task” (physical, cognitive or mental exercises) enhances the brain’s self recovery mechanism “re-engage” existing neural networks reinforces new learning PPAE guidance: This is a stacked Column chart showing Army, DHP & Other funding in $M Other: is funds POM’d by others RAD2 Chart version from “RAD2 Program Plan Supporting Spreadsheet_bjw_rwp 25June12”.

7 PoNS TM 4.0 Device & MOA Theory
Targeted Nerves The trigeminal and facial nerves are stimulated by an electro array placed on the tongue Stimulation translates into neural impulses, delivered directly into the brain stem, then dispersed throughout the brain Stimulation seems to affect capacity organization and function of the structures

8 PoNS TM Development and Corporate Timeline
2014 (Q2) Helius acquired NHC and concurrently closed $7.6M Private Placement Initiated PoNS 4.0 Development Process 2013 (Q1) Entered into CRADA with US Army for R&D of PoNS in TBI 2010 PoNS 2.2 Experimental Device Released 2014 (Q4) Established Scientific Advisory Board led by Dr. Jonathan Sackier Issued 2 Patents for NINM for Rehabiliation of Brain Function 1990 Tactile Communications and Neurorehabilitation Laboratory (TCNL) Founded at University of Wisconsin-Madison 2015 (Q2) PoNS 4.0 Released and Manufactured for Registrational Trial Issued 3rd Patent for NINM for Rehabilitation of Brain Function Completed recruitment of MS Pilot ’90’s ’00’s 2010–2012 2013 2014 2015 2014 (Q3) Began TBI Pilot Studies for PoNS at UW-Madison Completed Commercial Design Specification and received prototype of PoNS 4.0 Began Trading on CSE under HSM Symbol 2007 PoNS 1.0 Experimental Device Developed 2013 (Q1) NHC founded as a 50/50 joint venture between ANR (inventors of the PoNS) and MPJ HealthCare (medical device commercialization experts). 2015 (Q1) Modified CRADA to Speed Development of PoNS 4.0 Enrolled first subjects in MS Feasibility Study Listed on OTCQB under HSDT symbol Closed of CAD $2.2M Private Placement

9 PoNS TM retrospective analysis by Optum Health
6/3/ Optum conducted a third-party retrospective analysis to test statistical significance of patient outcomes from the use of PoNSTM device plus physical therapy versus physical therapy alone (standard of care) Compiled data from 4 studies in patients with resistant neurological conditions secondary to disease or trauma In these studies, patient outcomes were evaluated using the following ‘patient outcome tests’: Dynamic Gait Index (DGI), Sensory Organization Test (SOT), Multiple Sclerosis Impact Scale-29 (MSIS-29) and Activities-specific Balance Confidence Scale (ABCScore). Data across studies were aggregated by ‘patient outcome test’ and tested for statistical significance CONCLUSION: The use of the PoNSTM device in conjunction with physical therapy produced a statistically significant better outcome in patients with resistant neurological conditions secondary to disease or trauma

10 Data Analysis - Comprehensive
The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks. It consists of 8 functional walking tests that are performed by the subject and marked out of three, according to the lowest category which applies. 24 is the highest individual score possible and scores of 19 or less have been related to increase incidence of falls. The Multiple Sclerosis Impact Scale (MSIS-29) is a 29-item self-report rating scale for measuring the physical and psychological impact of multiple sclerosis (MS). The sensory organization Test is a composite score is calculated and normalized for age and gender. Changes in Composite score of 5 points or greater are considered clinically significant.

11 A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29)
Case Studies – Multiple Sclerosis A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29) Anxiety Sleep Wellbeing Bladder/Bowel Control Spasms in Limbs Tremors Using Hands Stiffness Clumsiness Balance Concentration Limits on Work Slowness Self Transport Clinically Significant Psycho-Social Physical Physical Tasks Impatience Depending on Others Mental Fatigue Limits on Mobility Heavy Limbs Uncoordinated Confidence Moving Indoors Grip Carry Things Limits on Socializing Spontaneity Worry about MS Severity of Symptoms Not at All Extreme One measure is a standard SELF-survey capturing 20 physical and 9 psychological measures of the impact of MS on daily living. Notice impact on symptoms common in multiple neurological disorders: MS, PD, TBI, Stroke, perhaps even cognitive and psycho-social disorders 11 11

12 Case Studies – Traumatic Brain Injury (TBI)
Pilot Study evaluating Balance using the Sensory Organization Test (SOT) after PoNSTM + Exercise Sensory Organization Test (SOT) is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. There are 6 independent sensory conditions tested, each condition consisting of three twenty second trials. ▲ of 5.0 = Clinically Significant Change SOT Points Four female subjects, mean 48.3 y/o Moderate, close-head non-penetrating, concussive TBI 9-11 Glasgow Coma Scale

13 Traumatic Brain Injury (TBI)
$76.5B Cost to US /$10B+Total Estimated Market Size No SUITABLE ALTERNATIVE FOR TREATMENT AVAILABLE Military Athletic / Civilian Common Types of TBI due to Military Activity Explosive blast injury Overpressure Penetrating injury Diffuse axonal injury Causes of Civilian TBI Blunt trauma Motor Vehicle Accident Sports Related Injury Assaults 100,000+ cases of TBI reported in US 30,000/year Active Duty Soldiers TBI 300,000 Retired Soldiers TBI 28% of patients at Walter-Reed result in treatment >$100,000,000 annually 30% Chronic Disability $5B+ Estimated Market Size (mild to moderate) PPAE guidance: This is a stacked Column chart showing Army, DHP & Other funding in $M Other: is funds POM’d by others RAD2 Chart version from “RAD2 Program Plan Supporting Spreadsheet_bjw_rwp 25June12”. ESTIMATED MARKET SIZE 5.3M living with TBI related disability1 1.75M cases of TBI reported in U.S./year 30% result in chronic symptoms 1) 2010 – 2012, United States Source: _______

14 US Army Medical Research and Material Command
Cooperative Research and Development Agreement (CRADA) with the US Armed Forces signed January 2013 US Army commits non-dilutive funding and resources for PoNS™ research US Army provides regulatory expertise, access to special regulatory relationship with the FDA, facilities and personnel as needed Recent Agreement Modification signed January 2015 Transfers mTBI trial sponsorship to Helius Expedites commencement of mTBI trial, now projected for Q2:15 Expands PoNS™ research into tinnitus, PTSD and sleep disturbances

15 Regulatory Pathway FDA deemed the PoNSTM device a ‘non-significant risk device’ Does not pose a significant risk to human subjects 90-day regulatory review upon submission for de-novo clearance Seeking a de-novo clearance from the FDA in 2 indications Balance disorder related to mild to moderate TBI Reviewed and cleared the registrational trial protocol Primary endpoint is improvement in balance Gait and Balance disorders related to MS Parallel path to EU CE Mark and Health Canada MDL approval

16 PoNS™ Clinical Trials in TBI
Chronic balance deficit due to mild-to-moderate Traumatic Brain Injury (TBI) Feasibility study underway at the TCNL at the University of Wisconsin-Madison with 44 patients Pivotal Phase III trial to commence in Q2:15 at Oregon Health and Science University (Portland, OR) Orlando Regional Medical Center (Orlanda, FL) McGill University’s Montreal Neurological Institute and Hospital (Montreal, QC) 120 patient double-blind, active control study Primary endpoint is improvement in chronic balance deficit at 5-weeks Interim data results at 90 patients

17 Obtain Clearance/ Approval
PoNS ™ Clinical Milestones Pre-clinical Pilot Study Begin FDA Reg. Trial Complete FDA Reg. Trial Submit FDA Filing Obtain Clearance/ Approval PoNS™ 4.0 Device | Cranial Nerve Non-Invasive Neuromodulation + Exercise CLINICAL STAGE PROGRAMS Traumatic Brain Injury Q2:15 Q4:15 Q2:16 Q3:16 Multiple Sclerosis Q2:17 Q3:17 Q4:17 *Results Q4:15 * Interim data from Montreal Neuro pilot 4Q15

18 Quality ManagementSystem
PoNS™ Device Design Milestones Phase 1 Specification Lock Design Lock Mfg. Clinical Supplies Mfg. Production Quality ManagementSystem PoNS™ 4.0 Device | Design and Manufacturing Timeline Timeline Q2:14 Q3:14 Q4:14 Q2:15 Q3:15 Q4:15

19 Intellectual Property
Issued Patents: September 2014 – US Patent No. 8,849,407 Skin Stimulation + physical therapy = Therapeutic outcome December US Patent No. 8,909,345 Oral Cavity Stimulation + Physical exercise = Therapeutic output March 2015 – US Patent No. 9,020,612 Oral Cavity Stimulation + Cognitive exercise = Therapeutic outcome Pending Patent Applications: Skin stimulation + cognitive exercise = Therapeutic output 26 Design and utility pending patent for the PoNS 4.0 commercial device Future Patent Applications: Proskauer Rose LLP aiding in expansion of IP development

20 Healthcare Transaction Model
Patient Self Identified based on DTC Promotion Healthcare Provider Identified Patient purchases PoNS device though cash or private insurance reimbursement from the Accredited Physical therapy center/Therapist Physician Prescribes PoNS device Prescribes Certified Physical Therapy Center/Therapist accredited in PoNS training Prescribes course of 14 weeks of therapy Accredited Physical Therapy Center Orders PoNS device from Helius and direct shipped from OEM to the patient at first visit Performs training for patient based on diagnosis and needs Obtains reimbursement for services from private and public insurance Discharges patient to home therapy Physical Therapy Phone Center Monitors the patient daily for the first two weeks of at home therapy through phone or video interphase Monitors the patient weekly (3-14) basis to ensure compliance and adherence to treatment protocol Directs the patient back to the physician for assessment when 14 weeks of therapy are over Cycle continues until physician is satisfied patient has sufficiently recovered

21 1,750 million, 550,000 with Chronic disability
Market Opportunity # of existing Patients New Patients/ year Multiple Sclerosis 1,000,000 10,000 TBI 5,300,000 1,750 million, 550,000 with Chronic disability Parkinson’s 750,000 60,000 Stroke 7,000,000 795,000 Alzheimer’s Disease 5,400,000 1,200,000 Depression 21,000,000 11,000,000 PTSD 15,400,000 8,225,000 ADHD 5,752,000 2,600,000 Chronic Pain 100,000,000 5,000,000 PoNS device + physical or other therapy potentially treats the symptoms of multiple brain disorders/trauma Each Indication requires clinical trial (16 months and $3M of funding)

22 PoNS™ Initial Therapeutic Focus Areas
Discovery / Preclinical Pilot Study FDA Registration Clinical Trial PoNS™ 4.0 Device | Cranial Nerve Non-Invasive Neuromodulation + Exercise CLINICAL STAGE PROGRAMS Traumatic Brain Injury Q2:15 Multiple Sclerosis Q2:16 Preliminary Data / Direct Evidence PRELIMINARY EVALUATION STAGE PROGRAMS Stroke Tinnitus (Ringing of Ears) Chronic Pain Post-traumatic Stress Disorder (PTSD) Sleep Disorders

23 Financial Information
CSNX: HSM | OTCQB: HSDT Market Cap $138M Current Shares Outstanding: 64M Shares Fully Diluted Shares: 78M Shares (incl. Options and Warrants) Cash: $1.5M Debt: - Financings $1.8M from private placement closed April 30, 2015

24 Summary Proprietary breakthrough non-invasive technology to relieve neurological symptoms through precise neuro-stimulation via the tongue Immediate addressable market of over $5B upon FDA clearance; market penetration potential in additional neurological indications High unmet need, limited existing treatment alternatives DOD partnership helps defray development cost and is our first significant customer Anticipated commercialization roll-out 2H 2016

25 US Investor Contact Todd James, Senior Vice President, The Trout Group LLC Helius Medical Technologies, Inc.  41 University Drive, Suite 400 Newtown, PA 18940 T: E: W:

26 Appendix

27 Capital Structure & Financial Information
Shares Shares outstanding 63,968,461 Stock Options 4,920,000 Warrants from financings 8,882,032 Fully Diluted 77,770,493 Ownership* # Shares Management 33,000,000** * all approximations above Stock Options CAD $0.60 Exercise Price 3,770,000 CAD $2.52 Exercise Price 100,000 CAD $2.92 Exercise Price 550,000 CAD $2.96 Exercise Price 400,000 CAD $3.20 Exercise Price Total 4,920,000 ** Included in Fully Diluted Share Count Financial Overview: $7.2M investment ($3M from NIH, $4.1 private non-dilutive donations) $6.9M from concurrent financing with new listing $1.8M from private placement closed April 30, 2015 $1.5M Total in treasury Non-Dilutive Commitment: US Army $11M est. for development of registration trial and regulatory submission $20.0M est. for development of further indications (Tinnitus, PTSD and Sleep Disturbance) $9.0M non-dilutive investment by US Army to date Warrants CAD $1.00 Exercise Price 8,430,000 CAD $3.00 Exercise Price 452,032 Total 8,882,032

28 Scientific Advisory Board (SAB) Established
Jonathan Sackier, M.D., Chairman Scientific Advisory Board Ron Alterman, M.D., M.B.A. Harvard professor Neurosurgeon at Beth Israel (BIDMC) Expertise in movement rehabilitation D. James Surmeier, M.D. Chair of the Department of Physiology and Director of Parkinson’s Disease Research Center at Northwestern University Carl Hauser, M.D. Director of Trauma at BIDMC visiting professor of Surgery at Harvard Medical School Reggie Edgerton, M.D., Ph.D Professor in the Departments of Neurobiology, Integrative Biology and Physiology and Neurosurgery at UCLA Member of the Brain Research Institute Scott Parazynski, M.D. Former NASA astronaut Inventor/leader in the medical device/research fields Rick Celebrini, Ph.D Physiotherapist, Founder of Fortius Institute, Retired Canadian professional soccer player Canadian Medical team member at 3 Olympic games Head of Sports Medicine and Science for the Vancouver Whitecaps FC Catherine Cho, M.D. MSCR Assistant Professor in the Department of Neurology at The Icahn School of Medicine at Mount Sinai Gale Pollock, R.N., Former Commander of the US Army Medical Command Acting Surgeon General of the Army Fellow at the American College of Healthcare Executives, American Academy of Nursing and National Board of Corporate Directors. Jennifer Sweet,  M.D. Department of Neurological Surgery University Hospitals Case Medical Center

29 Competitive Landscape
Helius NeuroSigma Cyberonics and Others Cefaly Annual Sales None $243M Just approved FDA Type of Device Non Invasive Non Invasive and Minimally Invasive Invasive: Implantable Forehead Cutaneous stim. Approved Indications Drug Resistant Epilepsy Migraine Headache Units Sold 65,000 -- Anticipated Indications TBI, MS, Parkinson and Stroke Drug resistant Epilepsy, Post Traumatic Stress Disorder, Obesity, Cachexia Targeted Nerve Trigeminal and Facial Trigeminal Vagus Product Name PoNS Monarch VNS Product Classification TBD Class III Class II FDA Cleared No Yes

30 Financial Results & Projections
Cyberonics Case Study Focus on neuromodulation: developed and markets VNS Therapy System, a vagus nerve stimulation device implantation for refractory epilepsy and treatment resistant depression Ticker: CYBX Mkt Cap: $1.3bn VNS Device: Vagus Nerve Stimulation MOA: Unknown Indication: Epilepsy, Depression FDA-Approved Marketed WW Unmet medical need for treatment refractory epilepsy patients, estimated 9mm people with epilepsy >400,000 U.S. patients indicated for VNS Therapy Key Indication VNS Therapy System Surgically implanted medical device delivering electrical pulsed signals to vagus nerve MOA not fully understood, but positive clinical results Clear evidence towards seizure reduction in refractory epilepsy Financial Results & Projections Over $250M in annual Revenues Estimated >10% y/y growth Market Conditions Majority of IP expired in 2011, but no new competition entering in VNS epilepsy space Continued demand for patient therapies in neuromodulation >3,000 physicians using VNS Therapy >100,000 implants to date Cyberonics provides important precedent for Helius adoption and success

31 Operational Milestones
PoNSTM (4.0) with OEM contract medical device manufacture and design company Ximedica Design work complete with first clinical scale capacity Q1:15 Generate Army Deployment Plan Q3:16 Ensure VA system PT infrastructure is created for maximum deployment efficiency Create Physical Therapy Support Network Develop partnership with national suppliers by June 2015 Develop certification plan for PTCs by May 2015 Develop home base compliance monitoring structure ready to deploy Q2: 16 Obtain CPT reimbursement code for device reimbursement Q1:17 Develop International Regulatory Submission Package Q1:15 Drive submission to Health Canada on a parallel track to the US submission


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