Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (March 2020)
24 slides from Solana's investor presentation, Mar 24, 2020
Slide 1: A Revolution in Mind
A Revolution in Mind March 2020 Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, including whether the results of our clinical trials will be sufficient to support an FDA, C
Slide 3: Helius Leadership Team: Experienced Leadership With Healthcare and Commercialization Expertise
30+ years in the health sciences industry Former CEO at MediMedia Health Former President and CEO at GSW Worldwide (Division of inVentiv Health) Former Director of Neuroscience Marketing at Bristol-Myers Squibb Philippe Deschamps President, Chief Executive Officer & Chairman Dr. Jonathan Sackier Chi
Slide 4: Strategic Vision: PoNS Lifecycle Management
Strategic Vision PoNS Lifecycle Management +$10bn potential global market $10-15bn potential global market $1.5tn potential global market 2020 - 2023 +$10bn 2021 - 2027 2025 - 2030 $1.5tn(2) Wellness / Betterment Preventative and Personalized Medicine Human Performance Improvement Cognitive Maintena
Slide 5: Tongue Based Neuromodulation
The PoNS™ investigational medical device gently stimulates the surface of the tongue which excites the neural network flowing to the brain. This neural activity is believed to enable neuroplasticity which may restore lost function. Tongue Based Neuromodulation The neural network originating in the t
Slide 6: Smart Device
Smart Device The PoNS™ is a smart device that tracks frequency, duration and intensity of use PoNS - One Smart Device Data Intelligence Capabilities Data captured is uploaded to the cloud for analysis, the results of which support treatment decisions and also provide compliance profiles for payer re
Slide 7: Regulatory Status
Canada PoNS is an authorized class II medical device. The device is intended for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is intended for use as a short term t
Slide 8: Multiple Sclerosis Study – Mild and Moderate MS
Study entry 2 wks lab 4 wks home 8 wks home 12 wks home Weeks DGI* Change *p < 0.05 **p < 0.01 *** p < 0.005 Clinically significant Two groups (10 each): “Active” PoNS + exercises Placebo PoNS + exercises Multiple Sclerosis Study – Mild and Moderate MS (EDSS score 3.5-6) Tyler et al. Journal of Neur
Slide 9: Summary of Real-World Evidence in MS Patients Treated with PoNS in Canada
14 Data on file. Helius Medical Technologies Treatment outcomes for patients treated in Canada are captured in the company developed validated data capture system. 39 patients with MS were treated with PoNS in Canada between March 2019 and September 2019. Using all available data from the treated MS
Slide 10: Regulatory Status – US (continued)
Pursuit of clearance for mmTBI indication: Our U.S. regulatory strategy initially focused on pursuing de novo classification and clearance of the PoNS device from the FDA for the treatment of chronic balance deficit due to mmTBI. FDA declined request for de novo classification in April 2019 In reach
Slide 11: US Regulatory Strategy: mmTBI Indication
Designed new clinical protocol (“TBI-002”) intended to support a request for de novo classification of the PoNS device Based on the receipt of FDA’s final minutes from the pre-sub meeting Finalized our clinical protocol for a new trial, TBI-002 Multi-center, randomized trial in the U.S. and Canada c
Slide 12: Real-World Canadian Clinical Experience
Real-world results of initial TBI patients consistent with Helius’ two RCTs in mmTBI: Patients demonstrated the same pattern of positive change over their course of treatment Majority of patients showed improvement in comfortable gait speed, a measure of their ability to walk, with meaningful clinic
Slide 13: Helius – Canadian Market Opportunity
Helius – Canadian Market Opportunity www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Multiple Sclerosis (“MS”) Helius’ target markets in Canada are expected to provide meaningful real world clinical experience in preparation for US launch Multiple Sclerosis (“MS”) Mild-to-Moderate Traumatic Brain Inju
Slide 14: Commercializing PoNS Treatment in Canada: Canadian Strategic Focus
Establish robust network of authorized Clinic locations to deploy PoNS 7 authorized Clinic locations established in 2019 7 additional locations in the first two months of 2020 It takes approximately 6 weeks for the first patients to be treated in a newly authorized clinic Submitted label expansion i
Slide 15: Clinical Support for PoNS Treatment: RCT Enrollment Criteria
Clinical Support for PoNS Treatment™: RCT Enrollment Criteria for Mild-to-Moderate TBI with Chronic Balance Deficit(1),(2) Safety and efficacy of PoNS Treatment™ demonstrated in two double-blind randomized controlled trials (RCTs): PoNS™ Registrational Trial in TBI (“TBI-001”) Long-Term Treatment St
Slide 16: Long-term Treatment Study in mmTBI Demonstrates Significant, Sustained Improvement
In patients with mmTBI, balance was significantly better at 2 Weeks, 14 Weeks and 26 Weeks 0 10 20 30 40 50 60 70 80 90 SOT Baseline Week 26 ∆ 29.8 ∆ 21.0 ∆ 33.8 Normal Range SOT Score Week 14 N=221 12-week washout period – no stimulation On average, patients with mmTBI improved from an impaired SOT
Slide 17: Additional Clinical Progress and Potential Opportunities
Balance Maintenance in Baby Boomers (78M people) Neurological Wellness (1 billion people) Human Performance Stroke (7M People; 795K new each year) Cerebral Palsy (764K People) Indication and Target Population - US* Potential for Future Development PoNS Treatment™ Additional Clinical Progress and Pot
Slide 18: Extensive IP Portfolio: A Significant Barrier to Competitor Entry
Extensive IP Portfolio A Significant Barrier to Competitor Entry Exclusively licensed from inventors (4% royalty): 9 US Medical Method Patents Issued Patents expire between 2029 and 2031 Patents owned by Helius (no royalty): 29 US Patents Issued 41 Foreign Patents Issued Patents expire between 2026
Slide 19: Investor Contact
Investor Contact: Mike Piccinino, CFA 443-213-0500 investorrelations@heliusmedical.com Helius Medical Technologies, Inc. │642 Newtown Yardley Road, Suite 100 │Newtown, PA 18940 T: 215 944-6100 │E: investorrelations@heliusmedical.com │W: www.heliusmedical.com www.heliusmedical.com | Nasdaq:HSDT | TSX
Slide 20: References
References Slide 15-16: Clinical Support for PoNS Treatment™ Archives of Rehabilitation Research and Clinical Translation (2019), doi: https://doi.org/10.1016/j.arrct.2019.100026 Slide 19: Disease State Prevalence Multiple Sclerosis - http://www.nationalmssociety.org/About-the-Society/MS-Prevalence
Slide 21: Appendix
Appendix www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM
Slide 22: Multiple Sclerosis Study Evaluating PoNS on Balance Deficit
9 14 40 30 50 60 90 80 70 BASELINE 2 4 6 8 10 12 14 Weeks ACTIVE SHAM ROLLOVER SOT Composite Scores www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 P=.015 Relative to Baseline P=
Slide 23: fMRI Changes vs. Healthy Controls
fMRI Changes vs. Healthy Controls 26 Group A Active Arm Group B Placebo Arm Active ArmPlacebo ArmActive Arm Active ArmPlacebo Arm www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 P
Slide 24: Working Memory fMRI
27 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). Group B: Baseline as well as post- PoNS™ fMR
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