Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (November 2021)
38 slides from Solana's investor presentation, Nov 29, 2021
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 November 23, 2021 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 in Canada for the treatment of gait deficit due to mild and mode
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: U.S. Clinical Progress and Future Opportunities
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 6 Subject to FDA authorization, targeted US commercialization for stroke Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 H1 24 GMED Audit / Maintained ISO13485:2016 and MDSAP Certifications Enhance
Slide 7: PoNS Therapy
PoNS Therapy™
Slide 8: PoNS Therapy Mechanism of Action
PoNS Therapy™ Mechanism of Action 8
Slide 9: PoNS Device: Empowering the Brain
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 Comprehensive Program
PoNS Therapy™ Comprehensive 14 Week PoNS Therapy Program Final Assessments Interim Interim Assessments Assessments
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 population MS patients are vocal and connected on social media MS patients are cared for by neurologists, a relatively discrete group (approx. 16,000 in USA1) 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 ~ 50-60 subjects with gait deficit due to m
Slide 16: U.S. Pre-Commercial Activities
U.S. Pre-Commercial Activities Building out go-to-market strategy (including licensing, territory identification, KOL engagement, etc.) and supporting infrastructure Activate key marketing strategies to generate awareness by way of conference attendance (ACTRIMS, AAN, CMSC), advocacy engagement, soc
Slide 17: Potential Addressable U.S. Opportunity in Multiple Sclerosis
1 million 41% Americans estimated to be affected by MS Report having difficulties walking, including 13% with an inability to walk at least 2x/week1 Potential Addressable U.S. Opportunity in Multiple Sclerosis 17 1. Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA”; E
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: MS Priority States
MS Priority States Published and maintained by the AMA (American Medical Association). Data Source = Purple Labs Claims Data Not necessarily indicative of where sales will first occur 19 Tier 1 Tier 2
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 December 1 – CMS HCPCS Public Meeting Evidence development is a multi-year endeavor Case by Case Coverage If granted,
Slide 21: PoNS Therapy for Symptoms Due to Stroke
PoNS Therapy™ for Symptoms Due to Stroke *PoNS is not authorized to treat individuals with stroke
Slide 22: 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 23: Potential Addressable U.S. Opportunity in Stroke
Potential Addressable U.S. Opportunity in Stroke 23 *PoNS is not authorized to treat individuals with stroke 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 Rehabilitat
Slide 24: Clinical Evidence: Stroke Pilot Randomized Controlled Trial
Clinical Evidence 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. Galea MP et al. Brain Stimul. 2017;10(6):1133-35. IQR = 9.5 Post-
Slide 25: Clinical Evidence: Multiple Sclerosis
Clinical Evidence: Multiple Sclerosis
Slide 26: Clinical Evidence: Multiple Sclerosis Study
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 Clinical Evidence Multiple Sclerosis Study – Mild and Moderate MS (EDSS score 3.5-6) Tyler et
Slide 27: Clinical Evidence: Multiple Sclerosis Study (continued)
Leonard et al. MSJ Experimental, Translational and Clinical January-March 2017:19 Change over time for Sensory Organization Test (SOT) composite scores Gait Imagery task revealed task-related activations in bilateral premotor and motor regions, and a higher BOLD signal in the left motor cortex 27 Cl
Slide 28: 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 Authorized in Canada for gait deficit due to symptoms of MS since March 2020 28 Promising results from initial real-world evidence gathere
Slide 29: 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 30: Capitalization & Ownership
Capitalization & Ownership
Slide 31: Capitalization, Ownership & Cash Position
Capitalization, Ownership & Cash Position (As of September 30, 2021) 31
Slide 32: Executive Leadership 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: Non-Executive 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: Non-Executive Directors: Experienced Leadership
Paul Buckman Director Founder and Co-Inventor of PoNS technology Co-founder of Wicab, Inc and former VP, Research and Development Lead Inventor of the BrainPort Balance Device Former University of Wisconsin Biomedical Engineering faculty member MS, Biomedical Engineering and Registered Professional
Slide 35: Helius MS Scientific Advisory Board and Key Opinion Leaders
Helius MS Scientific Advisory Board and Key Opinion Leaders 35
Slide 36: Extensive IP Portfolio
Extensive IP Portfolio 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 and 2040 Helius Patents Transferred to Chi
Slide 37: 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 US authorization in gait deficit due to MS MS launch targeted Q1’22 in US FDA Breakthrough Designation granted for the t
Slide 38: Thank you
)) Helius MEDICAL TECHNOLOGIES Thank you NASDAQ:HSDT
Helius Medical Technologies — Investor Presentation (November 2021) on 6ix