Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (February 2017)
29 slides from Solana's investor presentation, Feb 8, 2017
Slide 1: A Revolution in Mind
A Revolution in Mind February 8, 2017 Exhibit 99.2 A final base shelf prospectus containing important information relating to the securities described in this document has been filed with the securities regulatory authorities in each of the provinces of Canada. A copy of the final base shelf prospec
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements and forward-looking information as such terms are defined under applicable U.S. federal securities and Canadian securities legislation. All statements other than statements of historical fact contained in this presentation const
Slide 3: Meet the Helius Management Team
Over 30 years in the health sciences industry Former CEO at MediMedia Health Marketing Services Former President and CEO at GSW Worldwide Former Director of Neuroscience Marketing at Bristol-Myers Squibb Meet the Helius Management Team Philippe Deschamps President and CEO Chairman and Director 31 ye
Slide 4: Equity Overview
Equity Overview: *as of 02/01/17 Helius Medical Technologies: HSM and HSM.WT (TSX), HSDT (OTCQB) Average daily volume ~80k Capital Structure * Market Cap US$148.0M (HSM:TSX, HSDT:OTCQB ) ($1CAD=$0.7523USD) Current Outstanding: 84.53 M Shares Fully Diluted: 104.8 M Shares (incl. outstanding options a
Slide 5: Funding to Date
Funding to Date TCNL Lab funding: $7.1M ($3.0M NIH grants, $4.1M in cash donations from treated subjects) – 2008-2013 Cash from Private Placement/Prospectus Offerings/Warrants: $7.0M initial investment reverse merger – Q2 2014 $1.0M convertible debenture – Q2 2014 $2.8M non-brokered private placemen
Slide 6: The Inventors of PoNS Technology
The Inventors of PoNS™ Technology 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
Slide 7: Portable Neuromodulation Stimulator (PoNS)
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 chronic neurological symptoms caused by disease or trauma. Used inv
Slide 8: Patent portfolio and licensing
Exclusively licensed from inventors (4% royalty): 3 US Medical Method Patents Issued Skin Stimulation + physical therapy = Therapeutic outcome Oral Cavity Stimulation + physical therapy = Therapeutic outcome Oral Cavity Stimulation + cognitive therapy = Therapeutic outcome 5 US Patent Applications A
Slide 9: Third-Party Review of Early Stage Data
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
Slide 10: Results from MS Pilot Study
Results from MS Pilot Study Multiple Sclerosis (MS) pilot study evaluating the putative additive beneficial effects of PoNS™ device stimulation when combined with physiotherapy* - Trial performed at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center 14 subject
Slide 11: fMRI Changes Vs Healthy Controls
fMRI Changes Vs Healthy Controls Active Arm Active Arm Active Arm Placebo Arm Placebo Arm Placebo Arm Voxels of Interest ( ) **dorsolateral prefrontal cortex (DLPFC) ***rostral anterior cingulate cortex (rACC) * * * * * * * See appendix
Slide 12: Working Memory fMRI
Active Arm Placebo Arm 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). Working Memory fMRI* **dorsolateral prefrontal cortex (DLPFC) ***
Slide 13: MS Study: Balance (Sensory Organization Test) Results
Analysis of the total composite score: Both groups show a trend for improvement, which was more consistent in the Active Group. T-tests comparing the week 14 SOT score to the pre-score reveals that the improvement from baseline for the Active Group is significant (p<0.001) while the Sham group diffe
Slide 14: Cerebral palsy study results
65 subject (45 active, 20 control) study included children (ages 3-13) with Gross Motor Function Classification Scores (GMFCS) ranging from II-IV All subjects received 10 days of standard physiotherapy and movement control therapy with the active group receiving 20-25 minutes of concomitant electro-
Slide 15: Key Therapeutic Areas for PoNS Utility
Key Therapeutic Area Where Neurostimulation Plays a Treatment Role Have Potential for PoNSTM Utility* Multiple Sclerosis Traumatic Brain Injury (TBI) Parkinson’s Disease Stroke Alzheimer's Disease Depression PTSD Cerebral Palsy Helius Involvement Indication Pilot Study Complete Ongoing Registrationa
Slide 16: The Neurostimulation Device Market is Rapidly Growing
The Neurostimulation Device Market is Rapidly Growing Market drivers encourage medical innovation when surgical and pharmaceutical treatment fail to solve patient symptoms. Aging population leading to increased incidence rates of target diseases Growing demand for minimally invasive medical procedur
Slide 17: Traumatic Brain Injury (TBI)
30,000/year active duty soldiers withTBI³ 200,000 retired soldiers diagnosed with TBI4 20-30% of new cases result in chronic symptoms5 Traumatic Brain Injury (TBI) Military Athletic / Civilian Common Types of TBI due to Military Activity: Explosive blast injury Overpressure Penetrating injury Diffus
Slide 18: Funding From U.S. Army Medical Research and Material Command
Funding From U.S. Army Medical Research and Material 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 $1.8M+ in expense reimbursement contributed to the project to date U.S. Army pro
Slide 19: Regulatory Pathway
Regulatory Pathway 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 clearan
Slide 20: Clinical Study Title
Clinical Study Title A double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS™ device for cranial nerve noninvasive neuromodulation (“CN-NINM”) training in subjects with a chronic balance deficit due to mTBI. Indication Chronic balance deficit due to non-severe T
Slide 21: Manufacturing Progress
Manufacturing Progress Class II, 510k FDA submissions largely focus on quality systems and design and manufacturing history files Current expected FDA submission: Q3/Q4 2017 We expanded our development and manufacturing capabilities by contracting with Cambridge Consulting to: assume responsibility
Slide 22: Anticipated PoNS Clinical Milestones
(1) Current plan based on availability of funding, among other factors Anticipated PoNS™ Clinical Milestones Pre-clinical Pilot Study Begin FDA Reg. Trial Complete FDA Reg. Trial Submit FDA Filing Obtain Clearance/ Approval PoNS™ 4.0 Device | Cranial Nerve Non-Invasive Neuromodulation + Physical The
Slide 23: Helius Corporate Activity Estimated Timeline
Aug 2017 Complete distribution infrastructure Initiate physiotherapy and rehabilitation center partnerships Helius Corporate Activity Estimated Timeline Q1 2017 Jan 2017 S-3, $100M U.S. Shelf Complete MJDS Base Prospectus in Canada Mar 2017 Complete TBI Sham V Active Study Apr 2017 Complete cognitio
Slide 24: Helius Medical Technologies, Inc. contact details
Helius Medical Technologies, Inc. │41 University Drive, Suite 400 │Newtown, PA 18940 T: 215 809-2018 │E: [email protected] │W: www.heliusmedical.com Investor Contact: Brian Bapty T: 604 652-3950 [email protected]
Slide 25: Appendix and References
APPENDIX AND REFERENCES Helius | TSX: HSM |
Slide 26: Scientific Advisory Board
Scientific Advisory Board Jonathan Sackier, M.D., Chairman Scientific Advisory Board Ron Alterman, M.D., M.B.A. Harvard professor Neurosurgeon at Beth Israel (BIDMC) Expertise in movement rehabilitation Carl Hauser, M.D. Director of Trauma at BIDMC Visiting professor of Surgery at Harvard Medical Sc
Slide 27: Governance – Board of Directors
Governance – Board of Directors Philippe Deschamps Chairman of the Board, Company CEO Vice 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 G
Slide 28: References
References Slide 10: Results from MS Pilot Study Helius press release November 15, 2015. Slide 11/12: Results from MS Pilot Study American Congress of Rehabilitation Medicine (ACRM) has accepted a submission from Helius for a panel discussion – “PoNS™ Therapy: non-invasive investigational cranial ne
Slide 29: References
References Slide 18: Traumatic Brain Injury (“TBI”) Finkelstein E, Corso P, Miller T and Associates. The Incidence and Economic Burden of Injuries in the United States. New York (NY): Oxford University Press; 2006. Addressable market: 5.3 million people with chronic disability multiplied by 40% havi
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