Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (April 2022)
36 slides from Solana's investor presentation, Apr 1, 2022
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 April 2022 NASDAQ:HSDT Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements, including statements regarding the Company’s future strategic and operational execution, the next phase of the Company’s market development activities, clinical and regulatory development plans for the PoNS device, and the timi
Slide 3: The Portable Neuromodulation Stimulator (PoNS) Device
The first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma. The Portable Neuromodulation Stimulator “PoNS” Device Authorized for the treatment of gait deficit due to mild and moderate sympt
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 marketing a
Slide 5: Indication and Target Population - US
Stroke (7M People) Cerebral Palsy (764K People) Indication and Target Population - US Potential for Future Development Ongoing Evaluation Multiple Sclerosis (1M People) Pilot Studies Conducted Studies Completed; Additional Study Planned Traumatic Brain Injury (6.8M People) Parkinson’s Disease (1M Pe
Slide 6: Recent Milestones and Anticipated Value Creation Events
Recent Milestones and Anticipated Value Creation Events Authorized in the US for MS Closed on $11m public offering GMED Audit / Maintained ISO13485:2016 and MDSAP Certifications Enhanced and expanded senior leadership team 6 Subject to FDA authorization, targeted US commercialization for stroke H1 2
Slide 7: PoNS Therapy
PoNS Therapy™
Slide 8: PoNS Therapy Mechanism of Action
PoNS Therapy™ Mechanism of Action 8 Blood oxygen level-dependent (BOLD) signal
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 physica
Slide 10: PoNS Therapy
PoNS Therapy™ Final In-Clinie yyy yyy yey yy 2
Slide 11: Current Strategies for Managing Neurological Disorders
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 11
Slide 12: PoNS Therapy for Symptoms of Multiple Sclerosis
PoNS Therapy™ for Symptoms of Multiple Sclerosis
Slide 13: 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 population1 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 dysfunction is
Slide 14: Commercialization and Reimbursement
Commercialization and Reimbursement
Slide 15: Therapeutic Experience Program
Therapeutic Experience Program Helius sponsored open-label, interventional, observational, clinical study Evaluating PoNS on-label therapy in target population (Multiple Sclerosis) aiming to investigate patients’ adherence to PoNS Therapy regimen Enrolling ~ 40-50 subjects with gait deficit due to m
Slide 16: U.S. Commercial Activities
U.S. Commercial Activities Actively identifying and onboarding neuro rehab clinics currently treating MS patients to provide therapy Training evolved to online platform to facilitate ease and convenience Pursuing commercial and government reimbursement programs with initial cash pay option Ongoing C
Slide 17: Potential Addressable U.S. Opportunity in Multiple Sclerosis
1 million 70% Americans estimated to be affected by MS1 Report having difficulties walking2 Potential Addressable U.S. Opportunity in Multiple Sclerosis 17 1. Wallin, Mitchell T et al. “The prevalence of MS in the United States: A population-based estimate using health claims data.” Neurology vol. 9
Slide 18: Addressable Market
Addressable Market 5 Year Avg All States: ≈ 127,532 patients 5 Year Avg Top 10 States: ≈ 71,331 patients Abnormalities of gait and mobility R26 Codes: R26.0 Ataxic gait R26.1 Paralytic gait R26.2 Difficulty in walking, not elsewhere classified R26.8 Other abnormalities of gait and mobility R26.81 Un
Slide 19: 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 Link to National MS Society for potential financial assistance 19
Slide 20: US Market Access: Key Coding & Payment Milestones and Timelines
20 US Market Access Key Coding & Payment Milestones and Timelines Commercial Payers have their own fee schedules; Medicare is often benchmark Launch with Unlisted DME Codes 2022 2023 Evidence development is a multi-year endeavor Case by Case Coverage Ongoing engagement with CMS to obtain HCPCS code
Slide 21: Clinical Evidence: Multiple Sclerosis
Clinical Evidence: Multiple Sclerosis
Slide 22: Clinical Evidence: Multiple Sclerosis Study – Gait Deficit
Two groups (10 each): Active Group: PoNS + PT 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 Improvement in Dynamic Gait Index scores for the Active Group Mean avg of 7.95 All 10 subjects in the acti
Slide 23: PoNS Therapy: Imaging Data
PoNS Therapy: Imaging Data1 Multiple Sclerosis Study – Gait Deficit in Mild and Moderate MS (EDSS score 3.0-6*) Gait Imagery task revealed task-related activations in bilateral premotor and motor regions Gait Imagery fMRI in MS Patients *Error on publication regarding EDSS Score10 1. Leonard, Gabrie
Slide 24: 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™ Device1 Authorized in Canada for gait deficit due to symptoms of MS since March 2020 24 Promising results from initial real-world evidence gather
Slide 25: Media coverage of PoNS Therapy
Healt insight Heath aight =u =u The Power of lasti PONS Tr in People with MS PONS therapy helps Ontario woman recover from brain injury Could Help Canadian MS Patients with Chronic Gait Deficit MS PATIENT BENEFITS FROM NEW DEVICE.
Slide 26: PoNS Therapy for Symptoms Due to Stroke
PoNS Therapy™ for Symptoms Due to Stroke
Slide 27: 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 supervised
Slide 28: Potential Addressable U.S. Opportunity in Stroke
Potential Addressable U.S. Opportunity in Stroke 28 7 million 80% Dobkin BH, Dorsch A. New evidence for therapies in stroke rehabilitation. Curr Atheroscler Rep. 2013;15(6):331.doi:10.1007/s11883-013-0331-y. Carmen M. Cirstea. Gait Rehabilitation After Stroke, Should we re-evaluate our practice? Str
Slide 29: Clinical Evidence: Stroke – Pilot Randomized Controlled Trial
Clinical Evidence1 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. IQR = 9.5 P
Slide 30: Capitalization & Ownership
Capitalization & Ownership
Slide 31: Capitalization, Ownership & Cash Position
Capitalization, Ownership & Cash Position 31
Slide 32: Management Team and Board
Dane Andreeff President & CEO Dr. Antonella Favit-Van Pelt 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 Solutions for 4 ye
Slide 33: 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 member B
Slide 34: 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 Transferred to Ch
Slide 35: 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 and comme
Slide 36: Thank you
)) Helius MEDICAL TECHNOLOGIES Thank you NASDAQ:HSDT
Helius Medical Technologies — Investor Presentation (April 2022) on 6ix