Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (January 2023)
44 slides from Solana's investor presentation, Jan 23, 2023
Slide 1: Empowering Neuroplasticity: PoNS Therapy for Balance and Gait Deficits
Empowering Neuroplasticity PoNS Therapy ™ for Balance and Gait Deficits in Patients with Neurological Disorders January 2023 NASDAQ:HSDT
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward - looking statements, including statements regarding the Company’s future strategic and operati onal execution, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS ® device, the pur
Slide 3: First and only patented therapy combining trigeminal nerve neurostimulation with physical therapy
The first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to improve functional outcomes in balance and gait The Portable Neuromodulation Stimulator “PoNS” Device Authorized for the treatment of gait deficit due to MS and chronic balance def
Slide 4: A Path to Commercialization: FDA Breakthrough Designation
4 A Path to Commercialization: FDA Breakthrough Designation ▪ Breakthrough Designation granted for the treatment of gait deficit due to symptoms of MS May 2020 ▪ Breakthrough Designation granted for the treatment of dynamic gait and balance deficits following a stroke March 2021 ▪ Received FDA marke
Slide 5: Ongoing Evaluation and Indications
Ongoing Evaluation • Balance Maintenance in Baby Boomers (78M) • Neurological Wellness (1B) • Human Performance ✔ Studies Completed; Additional Study Planned ✔ FDA Breakthrough Designation Gait and balance deficits are commonly experienced by individuals with a variety of neurologic disorders. These
Slide 6: The Long-Lasting Impact of Balance Deficit
The Long - Lasting Impact of Balance Deficit Balance and gait deficit have a significant negative impact on functional status, capacity to return to work, and quality of life 1,2 1. Peterson M, Greenwald BD. Balance problems after traumatic brain injury. Available at http://uwmsktc.washington.edu/si
Slide 7: Recent Milestones and Anticipated Value Creation Events
Recent Milestones and Anticipated Value Creation Events 7 • Initiate pivotal trial in stroke • Renew TBI authorization efforts in US Y 22 Y 24 • Authorized in the US for MS • Launch clinical adoption studies • FDA Breakthrough Designation granted for stroke • Authorized in Australia to improve balan
Slide 8: PoNS Therapy
PoNS Therapy ™
Slide 9: PoNS Device
PoNS Device Empowering the brain and improvement during PoNS Therapy ™ • Mouthpiece electrodes stimulate the tongue surface, sending signals to the brain • The stimulation produced by PoNS is believed to help strengthen the neural connections associated with balance and walking when combined with ph
Slide 10: Tongue Stimulator and Neuromodulation
Tongue Stimulator Facial Nerve (CN - VII) Trigeminal Nerve (CN - V) • When the PoNS device is on, translingual neurostimulation (TLNS) is initiated. • TLNS delivers electrical impulses that stimulate the lingual branch of the trigeminal nerve and the chorda tympani branch of the facial nerve. • This
Slide 11: PoNS Stimulation
• Stimulation intensity of the electrode array on the mouthpiece matches the sensitivity map of the tongue • Electrode array designed to make the sensation felt uniformly in the front and the back, with less input at the front, increasing toward the back • PoNS: Adjustable pulse width = 0 - 60 µs •
Slide 12: 14 Weeks of PoNS Therapy
Phase 2: The patient sees the PoNS Trainer once per week and performs their PoNS Therapy training sessions at home. Phase 1: The patient works with a PoNS Trainer 1 to 2 times per day for 5 days for 2 weeks and completes 1 session per day at home independently. One day per week is a rest day. 14 Wee
Slide 13: Current Strategies for Managing Neurological Disorders
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 13
Slide 14: Commercialization and Reimbursement
Commercialization and Reimbursement
Slide 15: Potential Addressable U.S. Opportunity in Multiple Sclerosis
1 million 70% Americans estimated to be affected by MS 1 Report having difficulties walking 2 Potential Addressable U.S. Opportunity in Multiple Sclerosis 15 1. Wallin, Mitchell T et al. “The prevalence of MS in the United States: A population - based estimate using health claims data.” Neurology vo
Slide 16: Understanding the MS Market Opportunity in US
Understanding the “MS” Market Opportunity in US MS is a well - characterized chronic disease with a fast - growing diagnosed population 1 MS patients are vocal and connected on social media MS patients are cared for by neurologists, a relatively discrete group (approx. 16,000 in USA) Gait dysfunctio
Slide 17: US Commercialization Launch Initiatives
US Commercialization Launch Initiatives • Patient Therapy Access Program (PTAP) • Provides MS patients with gait deficit access to PoNS at a significantly reduced price • Therapeutic Experience Program (TEP) • Helius sponsored open - label, interventional, observational, outcome study • Evaluating P
Slide 18: U.S. Commercial Strategy
• Actively identifying and onboarding neuro rehab clinics currently treating MS patients to provide therapy • Training evolved to online platform to facilitate ease and convenience • PoNS provides a significant value add for PT clinics giving them an impactful tool for treating gait deficit in MS pa
Slide 19: Online Training for PoNS
Online Training for PoNS • Standardized training with reduced training time • Online platform allows for more efficient and broader training to expand commercial access to PoNS Therapy in all 50 states and Canada • Online modules allow training to be completed in 3 hrs or less, at Physical Therapist
Slide 20: Tele-health / E-commerce / Online Pharmacy Initiative
Tele - health / E - commerce / Online Pharmacy Initiative • Partnered with UpScript Health • Streamline access to PoNS Therapy to align with current trends of self - care, home health care, get - it - now • Immediate distribution across all 50 states • Direct to consumer e - commerce platform • Netw
Slide 21: PoNS Established US List Pricing
PoNS Established US List Pricing • Cash pay option available • Discounted modestly below anticipated reimbursement rate • Direct to consumer financing option through a 3rd party • National MS Society - potential financial assistance Established US List Price Controller $17,800 Mouthpiece $7,900 Comp
Slide 22: Reimbursement
Reimbursement 22 • Pursuing commercial and government reimbursement programs with initial cash pay option • Proposed Transitional Coverage of Emerging Technologies (TCET) for Medicare coverage • Registry program to generate evidence for coverage • Designed to gather important health economic informa
Slide 23: Potential Addressable Canadian Opportunity
Canadians Living with Chronic Balance Disorder after mmTBI 2 - 5 350K Potential Addressable Canadian Opportunity 1. Amankwah, Nana et al. “Multiple sclerosis in Canada 2011 to 2031: results of a microsimulation modelling study of epidemiolog ica l and economic impacts.” “La sclérose en plaques au Ca
Slide 24: Canada Commercialization
Canada Commercialization • Engaging with Neuro Rehab clinics across the country • 45 clinics across 8 provinces • Expanding clinics for provincial and national insurance coverage • Public and private insurance pilots for Long term - disability - cases (Across Canada) • Awareness in the medical field
Slide 25: Clinical Evidence: Multiple Sclerosis
Clinical Evidence: Multiple Sclerosis
Slide 26: Multiple Sclerosis Study: Gait Deficit in Mild and Moderate MS
Two groups (10 each): 1. Active Group: PoNS + PT 2. Control Group: Placebo PoNS + PT DGI = Dynamic Gait Index, a measure of the ability to walk Change In DGI Score Versus Time Within The Study Period 0 4.4 6.15 7.7 7.95 3 3.68 4.8 3.45 0 2 4 6 8 10 0 2 6 10 14 DGI Mean Improvement Relative to Week 0
Slide 27: PoNS Therapy for Symptoms Due to Stroke
PoNS Therapy ™ for Symptoms Due to Stroke
Slide 28: FDA Breakthrough Designation for Treatment of Symptoms Due to Stroke
FDA Breakthrough Designation for Treatment of Symptoms Due to Stroke • Announced receipt of FDA Breakthrough Designation on August 17, 2021 • Indication of use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke • PoNS Therapy to be used as an adjunct to a super
Slide 29: Potential Addressable U.S. Opportunity in Stroke
Potential Addressable U.S. Opportunity in Stroke 29 7 million 80% 1. Dobkin BH, Dorsch A. New evidence for therapies in stroke rehabilitation. Curr Atheroscler Rep. 2013;15(6):331.doi:10.1007/s1 188 3 - 013 - 0331 - y. 2. Carmen M. Cirstea. Gait Rehabilitation After Stroke, Should we re - evaluate o
Slide 30: Clinical Evidence Stroke: Pilot Randomized Controlled Trial
Clinical Evidence 1 Stroke – Results from a Pilot Randomized Controlled Trial *Mini - BEST is a 14 - item test that assesses measures dynamic balance, functional mobility, and gait on a 3 - level ordinal scale (0 – 2). IQR, interquartile range. 1. Galea MP et al. Brain Stimul. 2017;10(6):1133 - 35.
Slide 31: Capitalization & Ownership
Capitalization & Ownership
Slide 32: Capitalization, Ownership & Cash Position
Capitalization, Ownership & Cash Position Ownership at September 30, 2022 As Reported # Common Shares (in thousands) % of Common Outstanding Intracoastal Capital LLC 1,000 3.5% Executive Officers and Directors** 980 3.5% Maple Leaf Funds 715 2.5% Columbus Capital Management L.L.C. 278 1.0% ** Comput
Slide 33: Extensive IP Portfolio
Extensive IP Portfolio Exclusively licensed from inventors (4% royalty): • 11 US Medical Method Patents Issued • Patents expire between 2029 and 2041 Patents owned by Helius (no royalty): • 36 US Patents Issued • 53 Foreign Patents Issued • Patents expire between 2026 and 2041 Helius Patents Transfe
Slide 34: First-in-Class Neurotech
First - in - Class Neurotech • Unique and innovative therapy authorized to improve impaired function by stimulating cranial nerves via the tongue, supported by an extensive IP portfolio • Authorized and commercially available in the US for gait deficit due to MS with initial sales in Q2 • Authorized
Slide 35: Thank you
)) Helius MEDICAL TECHNOLOGIES Thank you NASDAQ:HSDT
Slide 36: Appendix
Appendix
Slide 37: Management Team
Dane Andreeff President & CEO Antonella Favit - Van Pelt, MD, PhD Chief Medical Officer ● 20+ years at Maple Leaf Partners as the General Partner and Portfolio manager, a value - based hedge fund which grew to over $2b in assets ● Board member and advisor to Helius for over 3 years, Myocardial Solut
Slide 38: Board of Directors
Sherrie Perkins Director ● 20 years neuromodulation medical device experience in neurology, psychiatry, and sleep medicine ● Former Marketing and Business Development Executive, Cyberonics, Inc. (Nasdaq: CYBX) and LivaNova PLC (Nasdaq: LIVN) ● Former member Board of Directors, eNeura, Inc. ● Former
Slide 39: MS Scientific Advisory Board
MS Scientific Advisory Board 39 • Dr. Deborah Backus, PT, PhD, FACRM, Director, MS Research, Shepherd Center, immediate past president and current Board Member, ACRM • Dr. Francois Bethoux , MD, Director of Rehabilitation Services at the Cleveland Clinic Mellen Center • Dr. Michelle Cameron , MD, PT
Slide 40: Stroke Scientific Advisory Board
Stroke Scientific Advisory Board 40 • Carl J. Hauser , MD, Beth Israel Deaconess Medical Center, Acute Care, Trauma & Critical Care, Lecturer, Surgery, Harvard Medical School • Steven C. Cramer , MD, MMSc, FAAN, FAHA, Susan and David Wilstein Endowed Chair in Rehabilitation Medicine Professor, Depar
Slide 41: PoNS Therapy Mechanism of Action
Neuromodulation: modification of the nervous system by targeted stimuli PoNS Therapy ™ Mechanism of Action 41 Blood oxygen level - dependent (BOLD) signal PoNS device designed to induce Translingual Neurostimulation : trigeminal and facial nerve - mediated neuromodulation via the tongue induces incr
Slide 42: Sensory Organization Test Composite Scores
Change over time for Sensory Organization Test (SOT) composite scores Statistical analysis of SOT week 14 scores vs pre - training reveals that improvement in the active group is significant (p<0.001) whereas sham group difference did not reach statistical significance (p<0.06) Gait i magery reveale
Slide 43: Patients with MS Treated with PoNS in Canada
42 Patients with MS treated with PoNS in Canada 58.3% Patients had achieved at least a 4 - point improvement in their functional gait assessment (FGA) PoNS ™ Device 1 Authorized in Canada for gait deficit due to symptoms of MS since March 2020 43 Promising results from initial real - world evidence
Slide 44: Real-World Evidence Poster Presentation
Real - World Evidence Poster Presentation 44 Visit ponstherapy.com to view the poster online
Helius Medical Technologies — Investor Presentation (January 2023) on 6ix