A Revolution in Mind
June 2015
CSNX: HSM
OTCQB: HSDT
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
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.
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2
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
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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
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Scientific Team: Inventors of PoNS Technology
TM
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
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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
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PoNS 4.0 Device & MOA Theory
TM
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
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PoNS Development and Corporate Timeline
TM
2014 (Q2)
•
2013 (Q1)
2010
Entered into CRADA
with US Army for R&D
of PoNS in TBI
•
Helius acquired NHC and
concurrently closed $7.6M Private
Placement
Initiated PoNS 4.0 Development
Process
PoNS 2.2
Experimental
Device Released
1990
2014 (Q4)
•
Tactile Communications
and Neurorehabilitation
Laboratory (TCNL)
Founded at University of
Wisconsin-Madison
’90’s
’00’s
•
2015 (Q2)
Established Scientific
Advisory Board led by
Dr. Jonathan Sackier
Issued 2 Patents for
NINM for Rehabiliation
of Brain Function
•
•
•
2010–2012
2014
2013
PoNS 4.0 Released and
Manufactured for Registrational
Trial
Issued 3rd Patent for NINM for
Rehabilitation of Brain Function
Completed recruitment of MS
Pilot
2015
2014 (Q3)
•
•
2007
2013 (Q1)
PoNS 1.0
Experimental Device
Developed
NHC founded as a 50/50 joint
venture between ANR
(inventors of the PoNS) and
MPJ HealthCare (medical
device commercialization
experts).
•
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)
•
•
•
•
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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
8
PoNS retrospective analysis by Optum Health
TM
• 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
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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. www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
Case Studies – Multiple Sclerosis
Psycho-Social
A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29)
Confidence
Concentration
Impatience
Anxiety
Worry about MS
Mental Fatigue
Sleep
Wellbeing
Physical
Bladder/Bowel Control
Spontaneity
Slowness
Self Transport
Limits on Work
Using Hands
Limits on Mobility
Limits on
Depending on Others
Socializing
Uncoordinated
Spasms in Limbs
Tremors
Heavy Limbs
Stiffness
Clumsiness
Moving
Indoors
Clinically Significant
Not at All
Balance
Carry
Things
Grip
Physical Tasks
Severity of Symptoms
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Extreme
11
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.
Before and After 5 days of CN-NINM Training
100
90
47
10
SOT Points
80
70
22
62
▲ of 5.0 = Clinically
Significant Change
60
50
40
30
Four female subjects, mean 48.3 y/o
20
Moderate, close-head nonpenetrating, concussive TBI
10
9-11 Glasgow Coma Scale
0
Subject A
Subject B
Before
Subject C
Subject D
After
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Traumatic Brain Injury (TBI)
•
•
$76.5B Cost to US /$10B+Total Estimated Market Size
No SUITABLE ALTERNATIVE FOR TREATMENT AVAILABLE
Athletic / Civilian
Military
Common Types of TBI
due to Military Activity
Causes of Civilian TBI
• Explosive blast injury
• Motor Vehicle Accident
• Overpressure
• Sports Related Injury
• Penetrating injury
• Assaults
• Blunt trauma
• Diffuse axonal injury
• 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
• 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
• 30% Chronic Disability
• $5B+ Estimated Market Size (mild to
moderate)
1) 2010 – 2012, United States Source: _______
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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
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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
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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
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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
Multiple Sclerosis
*
*Results Q4:15
Q2:15
Q4:15
Q2:16
Q3:16
Q2:16
Q2:17
Q3:17
Q4:17
Interim data from Montreal Neuro pilot 4Q15
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PoNS™ Device Design Milestones
Phase 1
Specification
Lock
Design Lock
Mfg. Clinical
Supplies
Mfg.
Production
Quality
Management
System
Q3:15
Q4:15
PoNS™ 4.0 Device | Design and Manufacturing Timeline
Timeline




Q2:14
Q3:14
Q4:14
Q2:15
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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
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19
Healthcare Transaction Model
Cycle continues until physician
is satisfied patient has
sufficiently recovered
Patient
Physician
Accredited
Physical
Therapy
Center
Physical
Therapy Phone
Center
• 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
• Prescribes PoNS device
• Prescribes Certified Physical Therapy Center/Therapist accredited in PoNS training
• Prescribes course of 14 weeks of therapy
• 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
• 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
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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
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
100,000,000
5,000,000
Parkinson’s
Chronic Pain
• 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)
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21
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
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22
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
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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
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24
US Investor Contact
Todd James, Senior Vice President, The Trout Group LLC
646-378-2926
tjames@troutgroup.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
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25
APPENDIX
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26
Capital Structure & Financial Information
Ownership*
Shares
Shares outstanding
63,968,461
# Shares
Management
33,000,000**
* all approximations above
Stock Options
Stock Options
4,920,000
Warrants from financings
8,882,032
CAD $0.60 Exercise Price
3,770,000
77,770,493
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
Fully Diluted
** 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
Total
4,920,000
Warrants
• 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
CAD $1.00 Exercise Price
8,430,000
CAD $3.00 Exercise Price
452,032
Total
www.heliusmedical.com | CSNX: HSM | OTCQB: HSDT
8,882,032
27
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
Jennifer Sweet, M.D.
Department of Neurological Surgery University Hospitals
Case Medical Center
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.
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28
Competitive Landscape
Helius
NeuroSigma
Cyberonics and
Others
Cefaly
None
None
$243M
Just approved FDA
Non Invasive
Non Invasive and
Minimally Invasive
Invasive: Implantable
Forehead Cutaneous
stim.
Approved
Indications
None
None
Drug Resistant
Epilepsy
Migraine Headache
Units Sold
None
None
65,000
--
TBI, MS, Parkinson
and Stroke
Drug resistant
Epilepsy, Post
Traumatic Stress
Disorder, Obesity,
Cachexia
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
Annual Sales
Type of Device
Anticipated
Indications
Targeted
Nerve
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29
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
Key Indication
•
Mkt Cap:
$1.3bn
VNS Device:
Vagus Nerve
Stimulation
MOA:
Unknown
•
Unmet medical need for treatment
refractory epilepsy patients, estimated
9mm people with epilepsy
>400,000 U.S. patients indicated for
VNS Therapy
VNS Therapy System
•
•
•
Financial Results & Projections
Indication:
Epilepsy,
Depression
Market Conditions
•
FDA-Approved
Marketed WW
•
•
Over $250M in annual Revenues
Estimated >10% y/y growth
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
Cyberonics provides important precedent for Helius adoption and success
30
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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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31