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A Revolution in Mind CSNX: HSM Corporate Presentation July 2014.

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Presentation on theme: "A Revolution in Mind CSNX: HSM Corporate Presentation July 2014."— Presentation transcript:

1 A Revolution in Mind CSNX: HSM Corporate Presentation July 2014

2 | CSNX: HSM 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. 1

3 2 | 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

4 | 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 outstanding60,540,083 Options- Warrants from financing 7,620,000 Broker Warrants from Financing914,400 Convertible debenture2,564,705 Fully Diluted71,639,188 Ownership*# Shares Management 33,000,000 * all approximations above 3

5 The PoNS ™ Device “Amplifying the body’s ability to heal itself” Next Generation Device (Jun 2014) Cranial Nerve Non-Invasive Neuromodulation 5 | CSNX: HSM

6 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. 6 | CSNX: HSM

7 PoNS 4.0 Device 7 | CSNX: HSM

8 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 MS Example: A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29) 8 | CSNX: HSM

9 Weeks DGI change * p < 0.05 ** p < 0.01 *** p < 0.005 Clinically significant Mean DGI 10 Active 10 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 9 | CSNX: HSM

10 Example Data : TBI – 4 Patient Pilot study Four female subjects, mean 48.3 y/0 Moderate, close-head non-penetrating, concussive TBI 9-11 Glasgow Coma Scale SENSORY ORGANIZATION TEST (SOT) ▲ =5.0 Clinically Significant Change SOT Points 10 | CSNX: HSM

11 5.3M living with TBI related disability 1.750 TBI/ year 30% chronic disability 600,000 Retired Soldiers TBI 60,000 Active Duty Soldiers TBI $76.5B Cost 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) 11 | CSNX: HSM

12 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. 12 | CSNX: HSM

13 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… 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 13 | CSNX: HSM

14 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 14 | CSNX: HSM

15 Milestones and use of Proceeds (cont.) Retained Proskauer IP Firm to expand IP development –The PoNS TM 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 15 | CSNX: HSM

16 Potential Indications for PoNS Therapy Preliminary Data Theoretical basis Direct Evidence 17 | CSNX: HSM

17 Market Opportunity # of existing PatientsNew Patients/ year Multiple Sclerosis1,800,00010,000 TBI (Sports concussive injury) 5,300,000 1,750 million, 550,000 with Chronic disability Parkinson’s750,00060,000 Stroke7,000,000795,000 Alzheimer’s Disease5,400,0001,200,000 Depression21,000,00011,000,000 PTSD15,400,0008,225,000 ADHD5,752,0002,600,000 Chronic Pain100,000,0005,000,000 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) 18 | CSNX: HSM


19 Competitive Landscape NHCNeuroSigma Cyberonics and Others Cefaly Annual SalesNone $243MJust approved FDA Type of DeviceNon Invasive Non Invasive and Minimally Invasive Invasive: Implantable Forehead Cutaneous stim. Approved Indications None Drug Resistant Epilepsy Migraine Headache Units SoldNone 65,000-- Anticipated Indications TBI, MS, Parkinson and Stroke Drug resistant Epilepsy, Post Traumatic Stress Disorder, Obesity, Cachexia Targeted Nerve Trigeminal VagusTrigeminal Product NamePoNSMonarch?Cefaly Product Classification TBD Class IIIClass II FDA ClearedNo Yes Product Classification Class IITBDClass IIIClass II 20 | CSNX: HSM

20 US Medical Technology M&A under $750M 21 | CSNX: HSM

21 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. 22 | CSNX: HSM THE TEAM Philippe Deschamps, President, Chief Executive Officer and Director

22 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. 25 | CSNX: HSM THE TEAM Jonathan Sackier, Chief Medical Officer

23 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. 23 | CSNX: HSM THE TEAM Kurt Kaczmarek, Mitch Tyler, Yuri Danilov Board Directors, Inventors of PoNS Technology

24 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. 24 | CSNX: HSM THE TEAM Montel Williams, Spokesperson, Personal User & Shareholder

25 Helius Medical Technologies, Inc. Suite 1980, 1075 West Georgia Street Vancouver, BC, Canada, V6E 3C9 T: 267-756-7028 E: W:

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