November 2017 - Helius Medical€¦ · intellectual property landscape; financial market conditions; continued availability of capital and financing; and future bus iness decisions

A Revolution in Mind

November 2017

www.heliusmedical.com | TSE:HSM | OTCQB:HSDT1

Legal DisclaimersThis 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 or achievements. All statements contained herein that are not clearly historical in nature are forward-looking and the words “anticipate,” “believe,” “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 other public filings with the SEC and the Canadian securities regulators, which can be obtained from either www.sec.gov or www.sedar.com.

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.


• Over 30 years in the health sciences industry• Former CEO at MediMedia Health Marketing• Former President and CEO at GSW Worldwide

(Division of inVentiv Health)• Former Director of Neuroscience Marketing at

Bristol-Myers Squibb

Helius Medical TechnologiesManagement

Philippe DeschampsPresident and CEO Chairman and Director

Jonathan SackierChief Medical Officer• 31 years in the health sciences industry• Trained surgeon and pioneer of new

medical technologies• Has helped build several companies

including medical technology, research and product-design and medical contract sales organizations

Experienced management team with expertise in health sciences and commercialization

Joyce LaViscountCFO and COO• 29 years in the health sciences industry• Accomplished pharmaceutical/healthcare

public companyCAO• Former Executive Director/group controller at

Aptalis Pharmaceuticals• Former Chief Operating Officer and CFO

MM Pharmaceutical Solutions

3

Equity Overview: Helius MedicalTechnologiesTickers: 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

Funding toDateTCNL Lab Funding:• $7.1M ($3.0M NIH grants, $4.1M in cash donations from treated subjects) – 2008-2013

Cash from Securities Offerings:• $7.0M initial investment in connection with reverse merger – Q2 2014• $1.0M convertible debenture – Q2 2014• $2.8M non-brokered private placement – Q2 & Q3 2015• $7.0M A&B Company (China) strategic investment – Q4 2015• $8.0M US private placement/prospectus offering in Canada – Q2 2016• $1.4M from exercise of warrants – Q2 2016• $9.5M from underwritten registered public offering – Q12017• $5.3M non-brokered private placement – Q2 2017• $42M total funding through September 30, 2017

• Additional Non-Dilutive Funding: US Army• $2.6M expense reimbursement received through September 8, 2017, from sole source contract;

($3M totalcommitment – final milestone on FDA Clearance)

5

Funding From U.S.Army Medical Research andMaterial Command

CRADA with the U.S. Army Medical Research and Material Command effective February 2013

• U.S. Army commits non-dilutive funding and resources for PoNS™ research

• U.S. Army provides regulatory support, facilities and personnel asneeded

• December 2015 modification extends CRADA through December 2017 and expands PoNS™research into fully-funded tinnitus, PTSD, sleep disturbances and pain studies if the initial TBItrial results are positive

• Army extended development CRADA to12/31/18 and commercialization through 12/31/2021

• Sole Source Cost-Share Contract executed July 2015 for TBI Trial

• $2.6M in expense reimbursement received on the project to date

• Significant financial support for TBI clinical and registrational trial

• Helius sponsor of regulatory and clinical development

• Army has agreed to extend contract to 12/31/18

6

The Inventors of PoNS™TechnologyTACTILE COMMUNICATION AND

NEUROREHABILITATION LABORATORY (“TCNL”) 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 neuro-

plasticity, 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• Over 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

Key Publications1. Danilov YP et al. “New Approaches to neurorehabilitation: cranial nerve non-invasive neuromodulation (CN-NINM) technology. SPIE

Proceedings. 2014.2. 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.

7

PoNSTM Designed to Stimulate the Trigeminal and Facial Nerves Through the Tongue


Portable Neuromodulation Stimulator (“PoNS™”)• Delivers specially-patterned nerve impulses to the lower brainstem through disposable

appliance placed on the tongue• Combined with specialized physiotherapy may help treat patients with chronicneurological

symptoms caused by disease or trauma• Used investigationally with over 250 patients at the University of Wisconsin-Madison. Testsin

pilot studies (MS, TBI and CP) and case series in other neurologic diseases have generated encouraging results.

• Pivotal study for the treatment of symptoms of TBI (120 subjects, multiple sites)completed

Developing a platform technology for the treatmentof symptoms of neurologic disease or trauma

9

PoNS™, Neuroplasticity and Traffic Jams• Neurological disease or trauma impedes

conduction of nerve signals from periphery to brain or brain to periphery, whether to loss of tissue from TBI or stroke, impaired “insulation” in MS or other issues.

• Driving has become easier with GPS enabled devices.

• If one sees a traffic jam ahead, a sane driver plots an alternative course and does not just drive up to the jam andstop.........

• ....but in neurological disease or trauma that is exactly what happens, the signal just stops

• Neuroplasticity implies that another route can be found• PoNS™ acts, like an angry driver leaning on their car horn,

notifying the CNS that it needs to move and then, the therapy acts as a guide to help signals navigate from brain toperiphery

10

Exclusively licensed from inventors (4% royalty):•7 US Medical Method Patents Issued

Skin Stimulation + Physical Therapy = Therapeutic OutcomeSkin Stimulation + Cognitive Therapy = Therapeutic OutcomeOral Cavity Stimulation + Physical Therapy = Therapeutic OutcomeOral Cavity Stimulation + Cognitive Therapy = Therapeutic OutcomeOral Cavity Stimulation with Pulse Generator + Exercise = Therapeutic OutcomeOral Cavity Stimulation + Cognitive Therapy = Treatment of Tinnitus and other Neurological DisordersOral Cavity Stimulation + Exercise = Enhanced Human Performance

•2 US Patent Applications PendingOral or Skin Stimulation + Physical or Cognitive Exercise = Enhanced Human PerformanceOral or Skin Stimulation + Exercise = Treatment of Sleep Disorder

•1 US Patent Application Forthcoming – to be filed Q4 2017: Treatment of AddictionPatents owned by Helius (no royalty):

•25 US Patents Issued•4 US Patent Applications Pending•1 US Patent Application Forthcoming – to be filed Q4 2017: Mouth-Breathing and Retainer Features•1 Eurasian Patent Issued•2 Australian Patent Applications Allowed•10 Non-US Patent Applications Pending: Europe (2); Canada (2); Russia (2); Australia (2); Israel (2)•11 Non-US Design Patents Issued: Europe (1); Canada (7); Russia (3)

Helius patents transferred to CMS (China Medical System Holdings:•3 Chinese Design Patents

Building a Moat: Extensive IP Portfolio

11

▪ 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

Third-PartyReview of Early Stage DataOptum RetrospectiveAnalysis: TheUseofPoNSTMTherapyLedtoBetterOutcomesin

PatientsWithResistantNeurologicalConditions

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 PilotMultiple Sclerosis Impact

Scale (MSIS-29)

12 Yes

MS - RCT 10 Yes

TOTAL 22 YesNIMN

Sensory Organization Test (SOT)

10 Yes

Stroke 5 Yes

TOTAL 15 Yes

NIMN Activities-Specific Balance Confidence Scale

15 Yes

TOTAL 15 Yes

12

Therapeutic Areas With PotentialPoNSTM Utility*

Multiple Sclerosis

Traumatic Brain Injury (TBI)

Parkinson’s Disease

Stroke

Alzheimer's Disease

Depression

PTSD

Cerebral Palsy

Indication

✓Pilot Study Complete

Helius Involvement

Ongoing Registrational Clinical Trial

Potential for Future Development

Brain Processing Speed and Human Performance

* See appendix

Ongoing Pilot Study

13

PoNS™ Therapy Healthcare Transaction Model

2 • PoNS™ Accredited Physical Therapist receives device from the patient, initializes device for use and schedules therapy sessions with patient

1• Patient agrees to PoNS™ Therapy - purchases a

device and 5 Weeks with Certified Physical Therapy Center/Therapist accredited in PoNS™ training

• Patient pays for to PoNS™ Therapy Device (only) through self-pay

3 • Physical Therapist performs training for patient based on diagnosis and needs

• Physical Therapist obtains reimbursement for services from existing private and public insurance or self-pay

• Physical Therapist discharges patient to home therapy

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

4• Physical Therapist monitors the patient on a weekly

basis for 3 weeks to ensure compliance and adherence to treatment protocol and reports results to physician

• Physician evaluates patient progress provided by the PT when 5 weeks of therapy are completed and renews Rx as warranted

14

• 30,000/year active duty soldiers with TBI

• 200,000 retired soldiers diagnosed with TBI

• 20-30% of new cases result in chronic symptoms

Traumatic Brain Injury

Military Athletic / Civilian

Common Types of TBI due to Military Activity: Explosive blast injury

Penetrating injury

Diffuse axonal injury

• Large Population: 2.1 million people with balance disorder related to non severe TBI

• Unmet Need: Current treatment paradigm offers few viable therapeutic options

Causes of Civilian TBI: Blunt trauma

Motor vehicle accident

Sports related injury

Violence/Assaults

Falls

• 1.7M new cases of TBI reported in U.S. each year

• 20-30% of new cases result in chronic symptoms

• 3.2 - 5.3M living with TBI related disability1,2,3,4,5,6 see appendix


Neuroprotective Effects of Trigeminal Nerve Stimulation in Severe Traumatic Brain Injury

Nature Scientific Reports, Chiluwal A, Narayan R, Chung W et al. July 28, 2017

“These data provide strong early evidence that activation of the trigeminal nerve system affords neuroprotection following brain damage.”“If the benefits of TMS in TBI can be replicated in ... humans, it could have tremendous impact in trauma resuscitation and TBI management.”Professor Raj Narayan, Chairman of Neurosurgery and TBI expert, chose to join our SAB in the wake of this publication

• Rat model of TBI• Standardized injury• With or without trigeminal nerve stimulation• Improved blood flow• Smaller lesion• Better blood brain barrier • Less edema• Lower pro-inflammatory markers


What is the Sensory Organization Test (SOT)The Sensory Organization Test (SOT):• Uses computerized posturography to quantify a patient’s

use of sensory input: vision, vestibular and somatosensory cues to maintain postural stability

• The SOT utilizes six “conditions” to interpret a patient’s degree of sway, with a score of 100 implying excellent balance and 0 demonstrating none

• A change in score of 8 points is deemed clinically significant (Wrisley, D. et al. 2007)

• SOT is referenced, reliable, reproducible and accepted as a metric for measurement tool for TBI it is the primary effectiveness endpoint for our trial

• In our studies, patients with TBI-induced balance issues scored approximately 40, at which point they may require walking aids and are at increased risk of further falls.


Effect of Physical Therapy Alone in Treatment of Balance Disorder in TBI

Dr. Deborah Backus, PhD

Director of MS Research at the Shepherd Center and President of the American Congress of Rehabilitation Medicine has more than 30 years of experience in neurological rehabilitation and research says:

“Most clinicians recognize that functional gains are significantly limited with physical therapy alone in treating balance deficits in TBI”

• Pattern of vestibular recovery for PT alone in TBI subjects:• In the literature, we observe a typical change of 8-13 points on the SOT

Composite Score following vestibular rehabilitation therapy, and is usually progressively accomplished over a period of 6 to 9 months (Brown et al., 2001 and Badke et al., 2004)


Neuromodulation, Neuroplasticity and Trigeminal Nerve Stimulation

• Neuromodulation is the application of external stimuli to provoke changes in brain activity• It occurs through two mechanisms: acute changes to how existing synapses work, and

chronically by the creation of new synapses• The trigeminal and facial nerve innervate the tongue, and stimulating these nerves sends

impulses into the brain. • PoNS™, the portable neuromodulation stimulator is a wearable investigational medical

device that noninvasively stimulates the trigeminal and facial nerve (cranial nerve V, VII) though stimulation of the tongue

• Two iterations of the PoNS™ device were developed (through adjusting software), one delivering 25,740,000 pulses (High Frequency Pulse (HFP)) during a 20 minute treatment and the other, 13,728 (Low Frequency Pulse (LFP)). Despite these varying “pulse frequencies,” a user can detect pulses from both devices.

• Study conducted in Surrey BC, Canada in ten healthy volunteers who were examined with 64 lead electroencephalography (EEG)

• Results demonstrated that in both groups the brain activity at baseline was comparable, but both LFP and HFP stimulation showed increased activity above baseline during stimulation. This led to the hypothesis that both pulse frequencies may have the potential to produce a therapeutic effect.


Regulatory Science vs Clinical Science• Regulatory science is done to satisfy the need for regulatory authorities to

determine the safety and efficacy of an intervention (Drug or medical device)• Regulatory submissions require reliable data from randomized, controlled

multicenter studies as standard for safety and efficacy i.e., study needs to have placebo or sham device

• In the medical device industry the “placebo” is very difficult to establish since medical devices are by definition a noticeable intervention

• In our case, we developed a Low Frequency Pulse (LFP) PoNSTM intended to be a non-therapeutic control

• Since we did not know whether it would be non-therapeutic or not we:• Ensured that patients participating in the trial would have done vestibular

rehabilitation and plateaued in their recovery prior to inclusion• Would allow us to determine if LFP PoNS is clinically active

• Prospectively decide in our statistical analysis plan how to evaluate the data if LFP PoNS showed clinical effect.


Independent Controlled Clinical Trials to Date Demonstrate

• 3 independent randomized controlled clinical trials demonstrate statistically significant improvements in SOT scores when PT + High Frequency Pulse PoNS is compared to PT + no stimulation in multiple disease states

Montreal Neurological Institute

Royal Melbourne Hospital

St. Petersburg State Health Institution «City Hospital №40»


Active Arm Placebo Arm Active Arm PlaceboArm

Active Arm PlaceboArm

**

Results from Multiple SclerosisStudyfMRI Changes in Group A, B vs HealthyControls

**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 ClinicalJanuary-March 2017: 19


www.heliusmedical.com | TSE:HSM | OTCQB:HSDT

HFP Stim Arm No Perceptible StimArm

Group A: Post PoNS™ device training fMRI shows significant increase in BOLD signal in the 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).

Results from Multiple Sclerosis StudyWorking MemoryfMRI

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 ClinicalJanuary-March 2017: 19


http://www.heliusmedical.com/

Clearly Defined RegulatoryPathway

FDA deemed the study of the PoNSTM for mild-moderate TBI a ‘non-significant risk(NSR) device study’ under the IDE regulations

• Assessed the study as not posing a significant risk to human subjects

• FDA guidance points to 120-day regulatory review upon submission for de novo clearance for Class II

FDA indicated that a request for de novo classification into Class II for the mild-moderate TBI indication would be an appropriate path to seek marketing authorization

• Balance disorder related to non-severeTBI

• FDA reviewed and provided feedback on the registrational trial protocol

Concurrent with FDA filing, seeking EU CE Mark, Health Canada MDL and TGA approval

ISO 13485 received in December 2016 from LRQA an independent organization to review companies quality systems; Passed Surveillance Audit 1 – 9/7/17


Th

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-severe TBI

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:• Montreal NeuroFeedback Centre (Montreal, QB)• Oregon Health and Science University (Portland,OR)• Orlando Regional Medical Center (Orlando, FL)• HealthTech Connex (Surrey, BC)• VCU (Richmond, VA)• MedStar National Rehabilitation Center (Washington, DC)• University of Wisconsin (Madison, WI)

Study population and Endpoints

• 120 patient double-blind, controlled study (HFP vs LFP)• Primary endpoint is improvement comparison HFP Vs LFP of responders at 5 weeks.

Responder = increase in SOT ≥ 15• Secondary Endpoints are improvement in SOT scores from baseline at week 2 and

week 5

PoNS™ Registrational Trial in TBI

*- PoNS 4.0 versus same device with low perceivable stimulation intended to be ineffective.


Important Inclusion Criteria For the Study• All subjects were at least one year post injury • Further spontaneous recovery unlikely• All subjects had to:

• have participated in a focused physical rehabilitation program for their TBI related balance disorder and have been deemed by the treating clinician to have reached a plateau

• still have significant balance issues as they entered the study


Statistical Analysis Plan for TBI Study


Assess Primary Endpoint: responder analysis of HFP vs LFP

at 5 weeks

If responder analysis is statistically significant

If responder analysis is not statistically significant

Collapse HFP and LFP into a single groupAssess 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

Statistical Analysis Safety Endpoints• Primary: Frequency of falls, as determined by daily event recording on

the subject data case report form during the in clinic phase. Fall is defined as an episode where a subject lost his or her balance and fell or would have fallen, were it not for another intervention, such as stabilization on the back of a chair or the wall. Stabilization to restore balance during therapy will not be considered a fall.

• Secondary: Frequency of headache, as measured by the Headache Disability Index (HDI) at baseline and at the end-of-treatment (5 weeks).


PoNS Responder Analysis – Primary Endpoint

75.4

60.7

0

10

20

30

40

50

60

70

80

Responders

Percent Responders High Frequency Pulse vs Low Frequency Pulse Stimulation

Responders High Frequency Pulse (HFP) + PT Responders Low Frequency Pulse (LFP) + PT

P<0.081

HFP PoNS group response showed a trend to significant change vs response of LFP PoNS Group

N=61 N=61

Responders = 15 point improvement in SOT above baseline


PoNS Study Data Efficacy

0

10

20

30

40

50

60

70

80

SOT Score HFP + PT SOT Score LFP + PT

HFP Vs LFP Neuro-Stimulation + 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


SOT

Scor

e

*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****

Is the LFP Device Demonstrating Therapeutic Activity?

• It was prospectively contemplated that LFP device might potentially have a therapeutic effect.

• Thus, in the statistical analysis plan it was proposed that if secondary effectiveness endpoints did not generate p-value of less than 0.05, (data showed p<0.087, p<0.081 respectively for both secondary endpoints), subjects in the HFP and LFP groups would be analyzed vs the baseline to determine if the LFP had therapeutic activity.

• The results showed that the HFP PoNS had Mean Increase at the end of Week 2 = 20.9 with 95% lower confidence limit of 20.9. Increase in SOT score from baseline at the end week 2 is significantly greater than zero with p-value < 0.025.

• Control: Mean Increase at the end of Week 2 = 15.7 with 95% lower confidence limit of 11.4. Increase in SOT score from baseline at the end week2 is significantly greater than zero with p-value < 0.025.

• This indicates that the LFP PoNS is not a pure placebo, but has statistically significant activity, which may be not as strong as in HFP.

• The analysis was also performed for the data at the end of week 5 with very similar results.


Secondary Effectiveness Endpoint Combined Data Analysis at Week 2

• When mean of the combined data set is significantly greater than zero, it indicates that results for both devices combined demonstrate statistically significant improvement in SOT scores.

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 18.3 16.79 1.52 15.3 21.3 P<0.0005


Secondary Effectiveness Endpoint Combined Data Analysis at Week 5

• When mean of the combined data set is significantly greater than zero, it indicates that results for both devices combined demonstrate statistically significant improvement in SOT scores.

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 24.6 18.69 1.69 21.3 28.0 P<0.0005


Primary Safety Endpoint Met – Decrease in Number of Falls

0

2

4

6

8

10

12

14

HFP + PT LFP + PT

Falls

Comparison of Falls at Baseline and End of Week 2

Baseline Week 2


Secondary Safety Endpoint Met - Headache Disability Index Showed a General Lowering in Both Groups

0

5

10

15

20

25

30

35

40

45

50

HFP + PT LFP + PT

Headache Disability Index

Baseline Week 5


Long Term Treatment Study

• Study completed May 28th, 2017• Tactile Communication Neurorehabilitation Laboratory at University of Wisconsin-

Madison• Sponsored by US Army • Double blind randomized controlled trial in patients with mild to moderate TBI• 22/21 patients High Frequency Pulse stimulation Vs Low Frequency Pulse stimulation• 14-weeks active treatment, 12-week washout• Study designed to determine what happens after chronic treatment (14 weeks) if

subjects discontinue therapy• Study included a 12 week washout period following 14 weeks of active treatment


Patients in both Groups were Significantly Clinically Better at 2 weeks, 14 weeks and 26 weeks

0

10

20

30

40

50

60

70

80

90

Baseline Week 2 Week 14 Week 26

∆ 33.8

12 weeks washout – no stimulation

• On Average Patients improved from an impaired SOT score to normal SOT Score in 14 weeks of treatment with HFP

• Normal Score was maintained throughout 12 week washout period for HFP

∆ 20.9

∆ 29.7∆ 33.8

∆ 25.8

∆ 33.9Normal Range SOT Score

N=22 N=21

SOT


Dynamic Gait Index

0

5

10

15

20

25

PT+ HFP Stim PT+ LFP Stim

Baseline Week 2 Week 14 Week 26

• Both treatment groups had baseline scores in the 'elevated risk of fall category' (≤ 19; normal=24)• By the end of participation, the scores for both groups approached normal levels (Active: 22.82; Control: 22.65)

N=22 N=21


DGI

Patients in both Groups Demonstrated an overall Reduction in Headaches

0

5

10

15

20

25

30

35

40

45

HFP + PT LFP + PT

Headache Disability Index

Baseline Week 2 Week 14 Week 26N=22 N=21


HDI

Overall ConclusionIn three previously published independent controlled clinical trials:

• PT + HFP PoNS therapy has been observed to be statistically significantly superior to PT with no stimulation in SOT scores

• HFP PoNS therapy produced FMRI confirmed statistically significant neuro plastic change to the brain, while PT alone + non stimulating PoNS did not produce any changes to the brain.

In registrational trial:• Response Rate of High Frequency PoNS (75.4%) showed a trend to be superior to Low Frequency

PoNS (p<0.081)• We did not reach our primary endpoint because the LFP treatment had a significant therapeutic

effect • Achieved secondary efficacy endpoint: HFP and LFP PoNS therapy resulted in a highly statistically

significant improvement vs baseline measurement at all measurement timepoints (p<0.0005)• PoNS therapy achieved the primary safety endpoint, reduction in falls at week 2• There were no device-related serious adverse events

In long term treatment trial: • HFP PoNS therapy subjects achieved normal SOT scores at the end of 14 weeks of treatment

which was sustained over 12 weeks of washout• These results provide encouraging evidence of PoNS Therapy in the treatment of balance disorder in

patients with mild to moderate TBI and we look forward to discussing the data with FDA to secure marketing clearance for the device. We now anticipate that our 510(K) application to the US FDA will be submitted in the first half of 2018, with clearance expected in the second half of 2018.


Situation Analysis5M US patients suffering from chronic symptoms due to TBI, 40% will have balance and gait disorder as their primary complaint - 2 Million potential subjects (PoNS first indication)

All TBIs are accidents… workers compensation is responsible for medical and income replacement costs (avg. cost/claim $315K in medical and income replacement)In chronic phase all severity of patients can be targeted if they are ambulatory and can follow instructionsNo approved therapeutic approach – high need confirmed by all stakeholders (MDs, PTs, payers and patients)No coordination of care – patients not active in the healthcare system in chronic phase - buy services ad hocAlways be more patients needing treatment than we will have the capacity to treat

Constant positive pressure to increase clinic capacity


TBI Market Dynamics

41

Leverage Workers Compensation (WC) payers to drive early reimbursement and entice commercial payers

Perform pre-launch clinical experience programs with target payers to demonstrate efficacy in “real life”Target high visibility Balance and Gait treatment centers for pre-launch clinical experienceLeverage initial clinic brand equity to drive clinic recruitmentLeverage new patients in system to build clinic revenues (MRIs, Sleep Therapy, other

complementary services) to drive clinic adoptionLeverage high demand and system savings to drive premium pricing for Therapy Units (TU) (combination of PT and PoNS stimulation)Target marketing activity at PT clinic systems to drive demand into system

Negotiate exclusivity for given territory and time period to drive co-operative DTC advertising to drive patients into systemLeverage clinic system equity to target PT clinic referral base for efficient deployment of rep.


Strategy

42

Over 200,000 TBI patients in the VA system.DVBIC supports a network of 18 centers, operating out of 13 military treatment facilities and five Department of Veterans Affairs medical centers.

Located in the 12 states that represent 80% of TBI casesSet up pre-launch clinical experience program in high visibility and motivated centers

43www.heliusmedical.com | TSE:HSM | OTCQB:HSDT

Defense and Veteran’s Brain Injury Centers (DVBIC)

Investment Summary

44

• Over $5B initial market opportunity– 100% unmet medical need– No competition

• Platform technology– Over 41 US and international patents that protect method, utility

and design• Well characterized regulatory pathway

– Non significant risk device– Multiple indications

• Strong clinical evidence that it impacts patients lives meaningfully• Large benefits for commercial payers, workers comp and disability

insurance• Clinic benefit – 2M new patients to drive clinic revenue growth



Investor Contact:Phil Deschamps

[email protected] Berg

[email protected]

Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │Newtown, PA 18940

T: 215 944-6100 │E: [email protected] │W: www.heliusmedical.com

Appendix and References

46

Scientific Advisory Board (SAB)Jonathan Sackier, M.D., Chairman Scientific Advisory Board

Catherine Cho, M.D. MSCRAssistant Professor in the Department of Neurology at The Icahn School of Medicine at Mount Sinai

Ann M. GraybielInstitute Professor at MIT

Carl Hauser, M.D.Director of Trauma at BIDMCVisiting professor of Surgery at Harvard Medical School

Raj K. Narayan, M.D., FACS, FAANSProfessor and Chairman, Department of Neurosurgery and Director, Northwell Neuroscience Institute, Hofstra Northwell School of Medicine

Scott Parazynski, M.D. Former NASAastronautInventor/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 CenterPresident of ACRM

Governance – Board of DirectorsPhilippe Deschamps

•Chairman of the Board, Company CEOVice Admiral Ed Straw (retired)

•Director•Former head of the Defense Logistics Agency at DOD

Blane Walter•Director•Partner at Talisman Capital; Former Chairman CEO, InVentiv Health Inc.

Dr. Huaizheng Peng •Director•General Manager, International Operations for China Medical Systems

Mitch Tyler•Director•Co-inventor of the PoNSTM device

Tom Griffin •Director, Chair of the Audit Committee•CFO, Avedro, Inc.

Dane Andreeff •Director•General Partner and Portfolio Manager Maple Leaf Partners, President Andreeff Equity Partners, LLC

48

References

Slide 21: Multiple Sclerosis Pilot Study1. Helius press release November 15, 2015.

Slide 22/23: Results from MS Pilot Study1. 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 neuroplastic changes 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 Study1. In January 2017, we received confirmation that the manuscript “Non-invasive tongue stimulation combined with intensive cognitive and physical

rehabilitation induces neuroplastic changes 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 Study1. 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

49

http://www.vvmr.ru/

http://www.altaastra.com/2016/07/angioneurology

References

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

50

Documents

November 2017 - Helius Medical€¦ · intellectual property landscape; financial market conditions; continued availability of capital and financing; and future bus iness decisions