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www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
A Revolution in Mind
CSNX: HSM
OTCQB: HSDT
June 2015
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 2
DisclaimerThis 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.
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 3
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
Overview
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
• 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
Management Team
Philippe DeschampsPresident, CEO
Experienced management team with expertise in healthcare and business development
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• 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
Jonathan SackierChief Medical Officer
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 5
Scientific Team: Inventors of PoNS TM Technology
Over 65 years combined experience in neuroscience, biomedical science, and engineering
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
TACTILE COMMUNICATION AND NEUROREHABILITATION LABORATORYUNIVERSITY OF WISCONSIN–MADISONDepartment 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 neuro plasticity, the brain’s ability to reorganize in response to new information, needs, and pathways
• Research objective to develop solutions for sensory and motor disorders
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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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 7
PoNS TM 4.0 Device & MOA Theory
• 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
Targeted Nerves
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 8
2014 (Q4)• Established Scientific
Advisory Board led by Dr. Jonathan Sackier
• Issued 2 Patents for NINM for Rehabiliation of Brain Function
’00’s
PoNS TM Development and Corporate Timeline
1990Tactile Communications and Neurorehabilitation Laboratory (TCNL) Founded at University of Wisconsin-Madison
2007PoNS 1.0 Experimental Device Developed
2010PoNS 2.2 Experimental Device Released
2013 (Q1)Entered into CRADA with US Army for R&D of PoNS in TBI
2014 (Q2)• Helius acquired NHC and
concurrently closed $7.6M Private Placement
• Initiated PoNS 4.0 Development Process
2013 (Q1)NHC founded as a 50/50 joint venture between ANR (inventors of the PoNS) and MPJ HealthCare (medical device commercialization experts).
’90’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
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
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
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PoNS TM retrospective analysis by Optum Health
• 6/3/2015 - 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
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 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.
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).
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
Anxiety
SleepWellbeing
Bladder/Bowel Control
Spasms in LimbsTremors
Using Hands
Stiffness
Clumsiness
Balance
Concentration
Limits on Work
SlownessSelf Transport
Clinically Significant
Psy
cho
-So
cia
lP
hysi
cal
Physical Tasks
Impatience
Depending on Others
Mental Fatigue
Limits on Mobility
Heavy Limbs
Uncoordinated
Confidence
Moving Indoors
GripCarry Things
Limits on Socializing
Spontaneity
Worry about MS
Severity of SymptomsNot at All Extreme
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Case Studies – Multiple SclerosisA Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29)
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 12
Subject A Subject B Subject C Subject D0
10
20
30
40
50
60
70
80
90
100
Before and After 5 days of CN-NINM Training
Before After
62
10
22
47
Four female subjects, mean 48.3 y/o
Moderate, close-head non-penetrating, concussive TBI
9-11 Glasgow Coma Scale
▲ of 5.0 = Clinically Significant Change
SO
T P
oin
ts
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.
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 13
• 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)
Traumatic Brain Injury (TBI)
Military Athletic / Civilian
1) 2010 – 2012, United States Source: _______
Common Types of TBI due to Military Activity
• Explosive blast injury
• Overpressure
• Penetrating injury
• Diffuse axonal injury
• $76.5B Cost to US /$10B+Total Estimated Market Size • No SUITABLE ALTERNATIVE FOR TREATMENT AVAILABLE
Causes of Civilian TBI
• Blunt trauma
• Motor Vehicle Accident
• Sports Related Injury
• Assaults
• 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 17
Pre-clinicalPilot
StudyBegin 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 Q2:16 Q2:17 Q3:17 Q4:17*Results Q4:15
PoNS ™ Clinical Milestones
* Interim data from Montreal Neuro pilot 4Q15
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 18
Phase 1Specification
LockDesign Lock
Mfg. Clinical Supplies
Mfg.Production
Quality Management
System
PoNS™ 4.0 Device | Design and Manufacturing Timeline
Timeline
Q2:14
Q3:14
Q4:14
Q2:15 Q3:15 Q4:15
PoNS™ Device Design Milestones
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 19
Intellectual Property
Issued Patents:• September 2014 – US Patent No. 8,849,407
• Skin Stimulation + physical therapy = Therapeutic outcome
• December 2014 - 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
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
Accredite
d Physical Therapy Cent
er
•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
Cyc
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on
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es
un
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hys
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is s
atis
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pa
tien
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as
suffi
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ntly
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cove
red
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 21
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)
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 22
Discovery / Preclinical
Pilot StudyFDA 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
PoNS™ Initial Therapeutic Focus Areas
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
Financial Information
• Financings– $1.8M from private placement closed April 30, 2015
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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: -
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 25
Helius Medical Technologies, Inc. 41 University Drive, Suite 400Newtown, PA 18940
T: 215 809 2018E: info@heliusmedical.comW: www.heliusmedical.com
US Investor ContactTodd James, Senior Vice President, The Trout Group LLC
646-378-2926
tjames@troutgroup.com
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APPENDIX
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
Capital Structure & Financial Information
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
Ownership* # Shares
Management 33,000,000**
* all approximations above
** Included in Fully Diluted Share Count
27
Shares
Shares outstanding 63,968,461
Stock Options 4,920,000
Warrants from financings 8,882,032
Fully Diluted 77,770,493
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 100,000
Total 4,920,000
Warrants
CAD $1.00 Exercise Price 8,430,000
CAD $3.00 Exercise Price 452,032
Total 8,882,032
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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
Carl Hauser, M.D. Director of Trauma at BIDMCvisiting professor of Surgery at Harvard Medical School
Scott Parazynski, M.D. Former NASA astronautInventor/leader in the medical device/research fields
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.
D. James Surmeier, M.D.Chair of the Department of Physiology and Director of Parkinson’s Disease Research Center at Northwestern University
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
Rick Celebrini, Ph.D Physiotherapist, Founder of Fortius Institute, Retired Canadian professional soccer playerCanadian Medical team member at 3 Olympic gamesHead of Sports Medicine and Science for the Vancouver Whitecaps FCCatherine Cho, M.D. MSCR
Assistant Professor in the Department of Neurology at The Icahn School of Medicine at Mount Sinai
Jennifer Sweet, M.D.Department of Neurological Surgery University Hospitals Case Medical Center
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 29
Competitive Landscape Helius NeuroSigma
Cyberonics and Others
Cefaly
Annual Sales None None $243M Just approved FDA
Type of Device
Non InvasiveNon Invasive and Minimally Invasive
Invasive: ImplantableForehead Cutaneous
stim.
Approved Indications
None NoneDrug Resistant
EpilepsyMigraine Headache
Units Sold None None 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 Trigeminal
Product Name PoNS Monarch VNS Cefaly
Product Classification
TBD TBD Class III Class II
FDA Cleared No No Yes Yes
Product Classification
Class II TBD Class III Class II
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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
• Unmet medical need for treatment refractory epilepsy patients, estimated 9mm people with epilepsy
• >400,000 U.S. patients indicated for VNS Therapy
• 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
• 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
• Over $250M in annual Revenues • Estimated >10% y/y growth
Cyberonics provides important precedent for Helius adoption and success
Ticker: CYBX
Mkt Cap: $1.3bn
VNS Device: Vagus Nerve Stimulation
MOA: Unknown
Indication: Epilepsy, Depression
FDA-Approved
Marketed WW
Key Indication VNS Therapy System
Financial Results & Projections Market Conditions
30
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT 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