a revolution in mind csnx: hsm corporate presentation july 2014

A Revolution in Mind

CSNX: HSM

Corporate Presentation

July 2014

www.heliusmedical.com | CSNX: HSM

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.

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2www.heliusmedical.com | CSNX: HSM

Helius Medical Technologies Inc. is a medical device holding company, enabling technologies with the potential to heal us. The company is targeting vastly underserved markets with a ground breaking device to significantly enhance the body’s ability to heal itself.

The company’s initial asset is The PoNS™ Device PoNS treats Neurological Symptoms caused by disease or trauma The PoNS™ Device has numerous potential medical indications; tested for MS,

Stroke, Tinnitus... Existing TBI treatments largely ineffective: > 35 years since new treatments Sizeable scope for treatment; ~660k US military TBI sufferers, 5.3M living with TBI

related disability. US armed forces committed ~$30+M (non-dilutive) to advance to FDA approval Testing and studies, to date, provide encouraging indications Potential FDA approval anticipated by Q3, 2016

Overview

www.heliusmedical.com | CSNX: HSM

Capital Structure & Financial Information

Financial Overview:• $7.2 million investment ($3M from NIH, $4.1 private non dilutive donations)• $6.9 million from concurrent financing with new listing• $7.0 million Total in treasury post listing on CSE

• Non Dilutive Commitment: US Army– $18.5M est. for development of registration trial and regulatory submission. – $20.0M est. for development of further indications

(Tinnitus, PTSD, Sleep Improvement, Pain Management)

Shares

Shares outstanding 60,540,083

Options -

Warrants from financing 7,620,000

Broker Warrants from Financing 914,400

Convertible debenture 2,564,705

Fully Diluted 71,639,188

Ownership* # Shares

Management 33,000,000

* all approximations above

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The PoNS™ Device

“Amplifying the body’s ability to heal itself”

Next Generation Device (Jun 2014)

Cranial Nerve Non-Invasive Neuromodulation


Important Core Concept - Neuroplasticity• Neuroplasticity describes the ability of the brain to remain “plastic”

• The PoNS Device provides stimulation to the brain-stem and other

brain structures via the cranial nerves• This stimulation when combined with a “task” (physical, cognitive or

mental exercises) – seems to amplifies the brains self recovery

mechanism– reinforces new learning – “re-engage” existing neural networks.

• Multiple disease symptoms appear to be improved.


PoNS 4.0 Device


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

MS Example: A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29)


Weeks

DG

I ch

ang

e

* p < 0.05** p < 0.01*** p < 0.005

Stu

dy e

ntry

2 w

ks la

b

4 w

ks h

ome

8 w

ks h

ome

12 w

ks h

ome

Clinically significant

Mean DGI10 Active10 Control

Example Data: 20 Patient Multiple Sclerosis Pilot Study

Two groups (10 each):

1. “Active” PoNS + exercises

2. “Control” PoNS + exercises

“Control” PoNS = no electrical stimulus


Example Data : TBI – 4 Patient Pilot study

Subject A Subject B Subject C Subject D0

10

20

30

40

50

60

70

80

90

100

Balance Sensory Organization Test (SOT),

Before and After 5 days of CN-NINM Training

Before After

62

10

22

47

Four female subjects, mean 48.3 y/0Moderate, close-head non-penetrating, concussive TBI9-11 Glasgow Coma ScaleSENSORY ORGANIZATION TEST (SOT)

▲=5.0 Clinically Significant Change

SO

T P

oin

ts


5.3M living with TBI related disability1.750 TBI/ year 30% chronic disability

600,000Retired Soldiers TBI

60,000Active Duty Soldiers TBI

$76.5BCost to US

30%Chronic Disability

Civilian• Blunt trauma

• MVAs

• Sports

• Assaults

Military• US: 2010-2012 – 100,000+ cases

• 28% of patients at Walter-Reed >$100,000,000/year

• Explosive blast injury, Overpressure, Penetrating injury, Diffuse axonal injury

First Indication: Concussive Traumatic Brain Injury (TBI)


Existing TBI Treatment Largely Ineffective

• “Treatment plan” involves rehabilitation efforts to teach patients how to cope with their specific injury-related symptoms.

• Non-responsive TBI patients have no treatment protocol

• All single therapy development has failed in multicenter clinical trials

• In last 35 years no new treatment for TBI have been suggested or brought forward.

• This is an underserved market with high morbidity associated cost burden….a fact well appreciated by the US Army.


US Army Sponsored Registration Plan

• Seeking a de-novo clearance from the FDA for the treatment of Balance disorder related to mild to moderate TBI…..study primary endpoint is improvement in balance.

• Confirmed as Class II, non-significant risk, device.• Collaborative Research and Development Agreement (CRADA) with

the US Armed Forces– Armed forces will be providing the facilities and personnel to

perform the registrational clinical trials in Balance Disorder – Providing regulatory expertise and access to special regulatory

relationship with the FDA– Committed to funding additional clinical trials estimated

commitment in money and services $30M+– Research collaboration agreement signed 1/22/2013


Milestones and use of Proceeds

• First commercial PoNS (4.0) device design and manufacturing with Ximedica– Complete Phase 1B by Q2 calendar 2014– Complete Phase 2 by Q3, calendar 2014– Complete Phase 3-5 by December 31, 2014

• Clinical Trial for FDA approval in TBI– Interim data from UW pilot November 2014 will instruct

registration trial design– Registration clinical trial by January 30, 2015– Complete trial Q1, 2016– Submit FDA filing Q2, 2016 – Obtain approval Q3, 2016


Milestones and use of Proceeds (cont.)• Retained Proskauer IP Firm to expand IP development

– The PoNSTM device intellectual property is the subject of U.S. Patent Application 12/348,301 and Provisional Patent Application 61/019,061; 61/020,265

– Maximize claims in US though collaborative relationship with USPTO – Use combination of medical method and PoNS to generate new IP

• Generate Army Deployment Plan– 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, 2016

• Obtain CPT reimbursement code for device reimbursement Q1, 2017• Develop International Regulatory Submission Package (Q1, 2015)

– Drive submission to Health Canada on a parallel track to the US submission


Potential Indications for PoNS Therapy

Multiple Sclerosis

Spinal Cord Injury

Parkinson's Disease

Epilepsy

Anxiety

TBI

Hearing Loss

Stroke

Sleep Disorders

Attention Disorders

Depressive Disorders

Chronic Pain

Alzheimer's disease

$0 $50 $100 $150 $200 $250 $300 $350 $400

$9

$10

$10

$16

$47

$48

$56

$57

$75

$77

$83

$95

$366

140 Million Individuals in North America Alone

Cost to US

$Billions

Dis

ea

se

or

Tra

um

a

Preliminary Data

Theoretical basis

Direct Evidence


Market Opportunity # of existing Patients New Patients/ year

Multiple Sclerosis 1,800,000 10,000

TBI (Sports concussive injury) 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 $2M of funding)


APPENDIX

Competitive Landscape NHC 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 Trigeminal Vagus Trigeminal

Product Name PoNS Monarch ? Cefaly

Product Classification

TBD TBD Class III Class II

FDA Cleared No No Yes Yes

Product Classification

Class II TBD Class III Class II


US Medical Technology M&A under $750M


Phil Deschamps offers extensive experience in pharmaceutical and Healthcare commercialization. The depth of his expertise stems from his 28 years in the Health Sciences industry half of which was spent at Bristol Myers Squibb and half on the service side as CEO GSW Worldwide, a leading healthcare commercialization company. In February 2012 he joined MediMedia Health, a marketing services company as CEO. In October 2013 became CEO of Helius Medical Technologies.

Deschamps oversaw MediMedia Health Marketing Services business. He was responsible for the strategic development of the organization, nurturing their clients and developing new non personal Communication products and services for the Healthcare industry

At GSW, Deschamps was President and CEO and was responsible for the GSW Worldwide operations which includes offices in the 15 major markets around the world with a turnover of $160M. He primarily consulted on global marketing and commercialization, new business model development for pharmaceutical, device and diagnostics companies.

Before joining GSW Worldwide Deschamps served as director of neuroscience marketing at Bristol- Myers Squibb (BMS) in Princeton, N.J., where he participated on several pre-launch Global Marketing teams in the neuroscience and pain therapeutic areas. He also held several marketing positions in the neuroscience, pain and metabolic therapeutic areas throughout his career.

Deschamps has a BSc. From the University of Ottawa in Canada.


THE TEAM

Philippe Deschamps, President, Chief Executive Officer and Director

Jonathan Sackier has over 30 years of healthcare experience. Trained in Britain as a surgeon & recruited to the USA in 1989 he helped lead the laparoscopic surgery revolution. As a Professor at George Washington University in Washington, DC, he founded, and funded the Washington Institute of Surgical Endoscopy, a center for education, research, innovation and technology transfer.

He is Visiting Professor of Surgery and Medicine at the University of Virginia where he teaches pro bono and his activities in basic and clinical research funded by multiple grants have led to many publications, chapters and books. He has served multiple journals in editorial or reviewer functions, been involved in medical societies at the highest level and been honored for his work in many countries.


THE TEAM

Jonathan Sackier, Chief Medical Officer

Drs Kaczmarek, Tyler and Danilov founded in 1992, the Tactile Communication & Neurorehabilitation Laboratory (TCNL). It is located at the University of Wisconsin-Madison. TCNL is a research center that uses the experience of many different 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. Their research is aimed at developing solutions for sensory and motor disorders. The center has three core areas that form the backbone of their research: neuromodulation, sensory substitution, and electrotactile stimulation.

They are committed to enhancing the rehabilitation process. They envision a future with a faster and more complete rehabilitation from sensory and motor disorders. They strive to improve existing therapies and develop new ones for conditions, which, in the past, had few or no options. Based on the work of our founder Paul Bach-y-Rita, M.D., the originator of the line of our current research, we believe that neuroplasticity is at the heart of all successful neurorehabilitation.

The PoNS device is a result of their efforts at discovering a means to induce the brains neuroplasiticy to enhance rehabilitative care.


THE TEAM

Kurt Kaczmarek, Mitch Tyler, Yuri DanilovBoard Directors, Inventors of PoNS Technology

Montel Williams earned his media celebrity status as an inspirational Emmy Award winning television personality whom Americans invited into their homes for more than 17 years. He is a decorated former naval officer, inspirational speaker, author, entrepreneur and advocate for patients worldwide.

Mr Williams is a personal user of the PoNS technology and is passionate about bringing this technology to market for the benefits of patients suffering from neurological symptoms

In addition to Helius Medical Technologies, Mr. Williams has several business interest in HealthCare, Renewable Energy and Consumer Products.


THE TEAM

Montel Williams, Spokesperson, Personal User & Shareholder

Helius Medical Technologies, Inc. Suite 1980, 1075 West Georgia StreetVancouver, BC, Canada, V6E 3C9

T: 267-756-7028E: [email protected]: www.heliusmedical.com

a revolution in mind csnx: hsm corporate presentation july 2014

Documents

hsm slide

pons device pons

overview slide

active pons

exercises control pons

hsm disclaimer

generation device

mind csnx