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Corporate Presentation

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Presentation on theme: "Corporate Presentation"— Presentation transcript:

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

Overview 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 | CSNX: HSM 2

4 Capital Structure & Financial Information
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 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) | CSNX: HSM 3

5 Cranial Nerve Non-Invasive Neuromodulation
The PoNS™ Device Next Generation Device (Jun 2014) PPAE guidance: This is a stacked Column chart showing Army, DHP & Other funding in $M Other: is funds POM’d by others RAD2 Chart version from “RAD2 Program Plan Supporting Spreadsheet_bjw_rwp 25June12”. “Amplifying the body’s ability to heal itself” | CSNX: HSM 5

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. PPAE guidance: This is a stacked Column chart showing Army, DHP & Other funding in $M Other: is funds POM’d by others RAD2 Chart version from “RAD2 Program Plan Supporting Spreadsheet_bjw_rwp 25June12”. | CSNX: HSM 6

PoNS 4.0 Device | CSNX: HSM 7

MS Example: A Spectrum of Symptoms Multiple Sclerosis Impact Scale (MSIS-29) 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 One measure is a standard SELF-survey capturing 20 physical and 9 psychological measures of the impact of MS on daily living. Notice impact on symptoms common in multiple neurological disorders: MS, PD, TBI, Stroke, perhaps even cognitive and psycho-social disorders | CSNX: HSM 8 8 8

9 Example Data: 20 Patient Multiple Sclerosis Pilot Study
Weeks DGI change * p < 0.05 ** p < 0.01 *** p < 0.005 Study entry 2 wks lab 4 wks home 8 wks home 12 wks home Two groups (10 each): “Active” PoNS + exercises “Control” PoNS + exercises “Control” PoNS = no electrical stimulus So I won’t bore you with too many details, so I’ll just show the gait results, which is more than enough. Highlight: DGI vs study entry Mean results +/- 1 SE Both groups improve  exercises effective Active group improves more  tongue stimulation helps Statistical significance * Clinical significance Clinically significant Mean DGI 10 Active 10 Control | CSNX: HSM 9

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

11 First Indication: Concussive Traumatic Brain Injury (TBI)
Military US: – 100,000+ cases 28% of patients at Walter-Reed >$100,000,000/year Explosive blast injury, Overpressure, Penetrating injury, Diffuse axonal injury 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 PPAE guidance: This is a stacked Column chart showing Army, DHP & Other funding in $M Other: is funds POM’d by others RAD2 Chart version from “RAD2 Program Plan Supporting Spreadsheet_bjw_rwp 25June12”. Blunt trauma MVAs Sports Assaults | CSNX: HSM 11

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. | CSNX: HSM 12

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 | CSNX: HSM 13

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 | CSNX: HSM 14

15 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 | CSNX: HSM 15

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

17 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) | CSNX: HSM 18

18 Appendix

19 Competitive Landscape
NHC NeuroSigma Cyberonics and Others Cefaly Annual Sales None $243M Just approved FDA Type of Device Non Invasive Non Invasive and Minimally Invasive Invasive: Implantable Forehead Cutaneous stim. Approved Indications Drug Resistant Epilepsy Migraine Headache Units Sold 65,000 -- Anticipated Indications TBI, MS, Parkinson and Stroke Drug resistant Epilepsy, Post Traumatic Stress Disorder, Obesity, Cachexia Targeted Nerve Trigeminal Vagus Product Name PoNS Monarch ? Product Classification TBD Class III Class II FDA Cleared No Yes | CSNX: HSM 20

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

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

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

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

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

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

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