www.heliusmedical.com | csnx: hsm | otcqb: hsdt a revolution in mind csnx: hsm otcqb: hsdt june 2015

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.


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


• 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

4

• 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


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


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


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


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


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


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).


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

11

Case Studies – Multiple SclerosisA Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29)


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.


• 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


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


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


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


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


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


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


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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un

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hys

icia

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atis

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tien

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as

suffi

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ntly

re

cove

red


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)


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


Financial Information

• Financings– $1.8M from private placement closed April 30, 2015

23

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: -


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


Helius Medical Technologies, Inc. 41 University Drive, Suite 400Newtown, PA 18940

T: 215 809 2018E: [email protected]: www.heliusmedical.com

US Investor ContactTodd James, Senior Vice President, The Trout Group LLC

646-378-2926

[email protected]

mailto:[email protected]


APPENDIX


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




Total 4,920,000

Warrants

CAD $1.00 Exercise Price 8,430,000


Total 8,882,032


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


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


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


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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