A Revolution in Mind
November 2017
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A Revolution in Mind November 2017 1 www.heliusmedical.com | - - PowerPoint PPT Presentation
A Revolution in Mind November 2017 1 www.heliusmedical.com | TSE:HSM |OTCQB:HSDT Legal Disclaimers This presentation includes certain statements that may constitute forward-looking statements within the meaning of the U.S. Private
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This presentation includes certain statements that may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements contained in this presentation, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. These statements are based on management’s expectations at the time the statements are made and are subject to risks, uncertainty, and changes in circumstances, which may cause actual results, performance, financial condition or achievements to differ materially from anticipated results, performance, financial condition
“calls for,” “could” “depends,” “estimate,” “expect,” “extrapolate,” “foresee,” “goal,” “intend,” “likely,” “might,” “plan,” “project,” “propose,” “potential,” “target,” “think,” and similar expressions, or that events or conditions “may,” “should occur” “will,” “would,” or any similar expressions are generally intended to identify forward-looking statements. The forward-looking statements in this presentation include but are not limited to statements relating to: progress, reports and interpretation of results from clinical studies, clinical development plans, product development activities, future product candidate success, plans for U.S. Food and Drug Administration (“FDA”) filings and their subsequent approvals, the safety and effectiveness of the PoNSTM device and the Company’s ability to commercialize the PoNSTM device. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions at the time they were made, they are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could cause the actual results to differ materially from those in the forward-looking statements include: uncertainties regarding the FDA regulatory approval process, including whether the results of our clinical trials will be sufficient to support an FDA approval of the PoNSTM device for marketing or whether the FDA may require that the Company conduct future clinical trials; future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the intellectual property landscape; financial market conditions; continued availability of capital and financing; and future business decisions made by the Company and its competitors. These and additional risks and uncertainties are more fully described in the Company’s Transition Report on Form 10-K/T for the period ended December 31, 2016 filed with the Securities and Exchange Commission (“SEC”) on April 3, 2017 and the Company’s
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by applicable securities laws, the Company undertakes no obligation to update or alter these forward-looking statements (and expressly disclaims any such intention or obligation to do so) in the event that management's beliefs, estimates, opinions, or other factors should change. www.heliusmedical.com | TSE:HSM |OTCQB:HSDT
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(Division of inVentivHealth)
Bristol-MyersSquibb
President and CEO Chairman and Director
Chief Medical Officer
medicaltechnologies
including medical technology, research and product-design and medical contract salesorganizations
CFO and COO
public companyCAO
Aptalis Pharmaceuticals
MM Pharmaceutical Solutions 3
Tickers: HSM:TSX, HSDT:OTCQB Market Cap 10/18/17: US$306.8M Shares Outstanding as of 10/18/17: 95.3M Price: HSM.T - CAD$3.97 | HDST - US$3.20 Shares Incl. Warrants& Options - 10/18/17: 115.4 M 52 Week High: US $4.14 | 52 Week Low: $1.20 CAD $5.09 | 52 Week Low: CAD$1.61 Mgmt Ownership as of 10/18/17: 32.5 M (39.9 M Incl. Options) Average Daily Volume CAD/US: 207K/36K 6/30/17 Cash & Equivalents: US$6.9 M, $0 Debt Gross Proceeds from 6/17 PP: $5.3M
HSDT 4
($3M totalcommitment – final milestone on FDA Clearance)
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research into fully-funded tinnitus, PTSD, sleep disturbances and pain studies if the initial TBI trial results are positive
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TACTILE COMMUNICATION AND NEUROREHABILITATION LABORATORY (“TCNL”)
UNIVERSITY OF WISCONSIN–MADISON
Department of BiomedicalEngineering
Founded in 1992 by a pioneer of neuroplasticity, Dr. Paul Bach-Y-Rita
plasticity, the brain’s ability to reorganize in response to new information, needs, and pathways
TCNL Project Directors: Mitchell E. Tyler, Kurt Kaczmarek, Yuri P .Danilov
biomedical science and engineering
electrotactile stimulation
Key Publications
1. Danilov YP et al. “New Approaches to neurorehabilitation: cranial nerve non-invasive neuromodulation (CN-NINM) technology. SPIE
2. Tyler ME et al. “Non-invasive neuromodulation to improve gait and chronic multiple sclerosis: a randomized double-blind controlled pilot trial. J. NeuroEngineering and Rehabilitation. 2014.
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appliance placed on the tongue
symptoms caused by disease or trauma
pilot studies (MS, TBI and CP) and case series in other neurologic diseases have generated encouraging results.
completed
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Exclusively licensed from inventors (4% royalty):
Skin Stimulation + Physical Therapy = Therapeutic Outcome Skin Stimulation + Cognitive Therapy = Therapeutic Outcome Oral Cavity Stimulation + Physical Therapy = Therapeutic Outcome Oral Cavity Stimulation + Cognitive Therapy = Therapeutic Outcome Oral Cavity Stimulation with Pulse Generator + Exercise = Therapeutic Outcome Oral Cavity Stimulation + Cognitive Therapy = Treatment of Tinnitus and other Neurological Disorders Oral Cavity Stimulation + Exercise = Enhanced Human Performance
Oral or Skin Stimulation + Physical or Cognitive Exercise = Enhanced Human Performance Oral or Skin Stimulation + Exercise = Treatment of Sleep Disorder
Patents owned by Helius (no royalty):
Helius patents transferred to CMS (China Medical System Holdings:
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▪ The Dynamic Gait Index (DGI) is a clinical tool to assess gait. ▪ 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 (SOT) is a composite score calculated and normalized for age and gender. A composite change of 5 points or greater is considered statistically significant. ▪ The anecdotal nature of the Optum analysis would not be suitable for a regulatory submission
Study Test Subjects Statistically Significant (p<0.05)?
MS Pilot Dynamic Gait Index (DGI) 13 Yes MS - RCT 10 Yes NIMN Balance Disorders 23 Yes TOTAL 46 Yes MS Pilot Multiple Sclerosis Impact Scale (MSIS-29) 12 Yes MS - RCT 10 Yes TOTAL 22 Yes NIMN Sensory OrganizationTest (SOT) 10 Yes Stroke 5 Yes TOTAL 15 Yes NIMN Activities-Specific Balance ConfidenceScale 15 Yes TOTAL 15 Yes 12
Multiple Sclerosis Traumatic Brain Injury (TBI) Parkinson’s Disease Stroke Alzheimer's Disease Depression PTSD Cerebral Palsy
✓ Pilot Study Complete
Ongoing Registrational Clinical Trial Potential for Future Development
Brain Processing Speed and Human Performance
* See appendix
Ongoing Pilot Study 13
device from the patient, initializes device for use and schedules therapy sessions with patient
device and 5 Weeks with Certified Physical Therapy Center/Therapist accredited in PoNS™ training
through self-pay
from existing private and public insurance or self-pay
Part 1: In-Clinic Training (2 Weeks) Part 2: In-Home Therapy (3 Weeks) Physical Therapy Effectiveness Assessment
(by Physical Therapist and Prescribing Physician)
Additional In-Home Therapy (5 Week Increments)
Repeated Until Progress Levels Off
basis for 3 weeks to ensure compliance and adherence to treatment protocol and reports results to physician
PT when 5 weeks of therapy are completed and renews Rx as warranted
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symptoms
Common Types of TBI due to Military Activity: Explosive blast injury Penetrating injury Diffuse axonal injury
Causes of Civilian TBI: Blunt trauma Motor vehicle accident Sports related injury Violence/Assaults Falls
year
symptoms
1,2,3,4,5,6 see appendix
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Montreal Neurological Institute Royal Melbourne Hospital
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Active Arm Placebo Arm Active Arm PlaceboArm Active Arm PlaceboArm
**dorsolateral prefrontal cortex (DLPFC) ***rostral anterior cingulate cortex (rACC)
14 subject (7/7) study: All received physiotherapy with Group A receiving HFP PoNS™ stimulation and Group B non-perceivable stimulation PoNS™
Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19
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www.heliusmedical.com | TSE:HSM |OTCQB:HSDT HFP Stim Arm No Perceptible Stim Arm
Group A: Post PoNS™ device training fMRI shows significant increase in BOLD signal inthe left DLPFC** (t=3.55, p=0.01), rACC*** (t=3.057, p=0.02) and a trend for significance in the right DLPFC (t=2.3, p=0.06).
Group B: Baseline as well as post-PoNS™ fMRI shows sub-threshold peaks in bilateral DLPFC and rACC. Paired-t tests comparing pre and post PoNS™ scans did not reveal any significant changes.
P=0.01 P=0.02
**dorsolateral prefrontal cortex (DLPFC) ***rostral anterior cingulate cortex (rACC)
Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19
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Class II
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Clinical Study A double-blind, randomized, controlled* study of the safety and effectiveness of the PoNS™ device for translingual noninvasive neuromodulation stimulation (“TLNS”) training in subjects with a chronic balance deficit due to mTBI. Indication Chronic balance deficit due to non-severeTBI Start Date August 2015 Treatment Completion August 18, 2017 Description Helius as sponsor launched a Pivotal clinical trial in conjunction with US Army Medical Research and Material Command at:
Study population and Endpoints
Responder = increase in SOT ≥ 15
week 5
*- PoNS 4.0 versus same device with low perceivable stimulation intended to be ineffective.
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If responder analysis is statistically significant If responder analysis is not statistically significant Collapse HFP and LFP into a single group Assess secondary endpoints: increase in SOT from pre-training at 2 and 5 weeks Assess secondary endpoints: mean increase in SOT from pre-training at 2 and 5 weeks
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75.4 60.7 10 20 30 40 50 60 70 80 Responders
Responders High Frequency Pulse (HFP) + PT Responders Low Frequency Pulse (LFP) + PT
P<0.081
N=61 N=61
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10 20 30 40 50 60 70 80 SOT Score HFP + PT SOT Score LFP + PT
Baseline Week 2 Week 5 P<0.025** ∆ 21.3 ∆ 27.7 ∆ 17.1 ∆ 23.6 Normal Range SOT Score
N=61 N=61
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*HFP: Mean increase over baseline at end of Week 2 = 20.9 with 95% lower confidence limit of 16.6, p< 0.025 **HFP: Mean Increase over baseline at end of Week 5 = 27.3 with 95% lower confidence limit of 23.1, p<0.025 ***LFP: Mean Increase over baseline at the end of Week2 = 15.7 with 95% lower confidence limit of 11.4, p<0.025 ****LFP: Mean Increase over baseline at the end of Week5 = 21.7 with 95% lower confidence limit of 16.7, p<0.025
P<0.025* P<0.025*** P<0.025****
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Device N Mean SD SE 95% Conf. Interval p-value HFP 61 20.9 16.66 2.13 16.6 25.2 LFP 61 15.7 16.65 2.13 11.4 20.0 Combined* 122
16.79 1.52 15.3 21.3 P<0.0005
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Device N Mean SD SE 95% Conf. Interval p-value HFP 61 27.6 17.42 2.23 23.1 32.1 LFP 61 21.7 19.58 2.51 16.7 26.7 Combined* 122
18.69 1.69 21.3 28.0 P<0.0005
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2 4 6 8 10 12 14 HFP + PT LFP + PT
Baseline Week 2
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5 10 15 20 25 30 35 40 45 50 HFP + PT LFP + PT
Baseline Week 5
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10 20 30 40 50 60 70 80 90 Baseline Week 2 Week 14 Week 26 ∆ 33.8
∆ 20.9 ∆ 29.7 ∆ 33.8 ∆ 25.8 ∆ 33.9 Normal Range SOT Score
N=22 N=21
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5 10 15 20 25 PT+ HFP Stim PT+ LFP Stim Baseline Week 2 Week 14 Week 26
N=22 N=21
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5 10 15 20 25 30 35 40 45 HFP + PT LFP + PT
Baseline Week 2 Week 14 Week 26
N=22 N=21
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complementary services) to drive clinic adoption
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Phil Deschamps pdeschamps@heliusmedical.com Josh Berg josh@bergcapitalmarkets.com Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │Newtown, PA 18940 T: 215 944-6100 │E: info@heliusmedical.com │W: www.heliusmedical.com
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Catherine Cho, M.D. MSCR Assistant Professor in the Department of Neurology at The Icahn School of Medicine at Mount Sinai Ann M. Graybiel Institute Professor at MIT Carl Hauser, M.D. Director of Trauma at BIDMC Visiting professor of Surgery at Harvard Medical School Raj K. Narayan, M.D., FACS, FAANS Professor and Chairman, Department of Neurosurgery and Director, Northwell Neuroscience Institute, Hofstra Northwell School of Medicine Scott Parazynski, M.D. Former NASAastronaut Inventor/leader in the medical device/research fields Ali R. Rezai, M.D. Director, Center for Neuromodulation at the Ohio State University 47 Deborah Backus, PT, PhD, FACRM Director of MS Research at the Shepherd Center President of ACRM
Philippe Deschamps
Vice Admiral Ed Straw (retired)
Blane Walter
Mitch Tyler
Tom Griffin
Dane Andreeff
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Slide 21: Multiple Sclerosis Pilot Study 1. Helius press release November 15, 2015. Slide 22/23: Results from MS Pilot Study 1. American Congress of Rehabilitation Medicine (ACRM) has accepted a submission from Helius for a panel discussion – “PoNS™ Therapy: non-invasive investigational cranial nerve neuromodulation to augment therapeutic interventions” – at ACRM’s 93rd Annual Conference (October 30 to November 4, 2016, in Chicago, IL) 2. In January 2017, we received confirmation that the manuscript “Non-invasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplasticchanges in patients with multiple sclerosis: a multimodal neuroimaging study” was accepted for publication in the Journal: Multiple Sclerosis Journal: Experimental, Translational and Clinical. Publication data not set. Slide 22: Results from MS Pilot Study 1. In January 2017, we received confirmation that the manuscript “Non-invasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplasticchanges in patients with multiple sclerosis: a multimodal neuroimaging study” was accepted for publication in the Journal: Multiple Sclerosis Journal: Experimental, Translational and Clinical. Publication data not set. Slide 21: Cerebral Palsy Study 1. Published (in Russian ) “Journal of Restorative Medicine and Rehabilitation” (http://www.vvmr.ru/). Results of the study were presented in an oral session at the International Conference for Innovation in Angio-Neurology held in Moscow on September 23-24, 2016 (http://www.altaastra.com/2016/07/angioneurology), (certified English translation available) 2. Company Press Release Sept 6, 2016
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Slide 15: Traumatic Brain Injury 1. Addressable market: 5.3 million people with chronic disability multiplied by 40% having a balance disorder tied to TBI. 2. http://dvbic.dcoe.mil/dod-worldwide-numbers-tbi 3. http://www.ncsl.org/documents/statefed/health/TBI_Vets2013.pdf 4. http://www.msktc.org/tbi/factsheets/Balance-Problems-After-Traumatic-Brain-Injury 5. http://www.cdc.gov/traumaticbraininjury/pdf/BlueBook_factsheet-a.pdf 6. http://www.cdc.gov/traumaticbraininjury/pdf/TBI_Report_to_Congress_Epi_and_Rehab-a.pdf
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