Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (August 2021)
32 slides from Solana's investor presentation, Aug 24, 2021
Slide 1: Empowering Neuroplasticity: Disruptive Technology for Healthcare
Empowering Neuroplasticity Disruptive Technology for Healthcare (NASDAQ:HSDT | TSX:HSM) Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements, including statements about: 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 de
Slide 3: The Portable Neuromodulation Stimulator PoNS Device
The first and only patented treatment 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 m
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 gait deficit due to symptoms of MS Closed on $11m public offering MCIT strategy submitted to CMS 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 Au
Slide 7: PoNS Treatment
PoNS Treatment™
Slide 8: PoNS Treatment Mechanism of Action
PoNS Treatment™ Mechanism of Action 8
Slide 9: PoNS Device: Empowering the brain
PoNS™ Device Empowering the brain and improvement during PoNS Treatment™ 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 phys
Slide 10: PoNS Treatment Comprehensive Program
PoNS Treatment™ Comprehensive 14 Week PoNS Treatment™ Program Base Final Assessments Assessments Initial Week Consultation in-Clinic Phase]
Slide 11: PoNS Treatment for Symptoms Due to Stroke
PoNS Treatment™ for Symptoms Due to Stroke *PoNS is not authorized to treat individuals with stroke
Slide 12: 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 Treatment to be used as an adjunct to a supervise
Slide 13: Potential Addressable U.S. Opportunity in Stroke
Potential Addressable U.S. Opportunity in Stroke 13 *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 14: PoNS Treatment for Symptoms of Multiple Sclerosis
PoNS Treatment™ for Symptoms of Multiple Sclerosis
Slide 15: 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 16: 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 16 1. Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA”; E
Slide 17: 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 18: Clinical Evidence: fMRI Changes in Treated Patients
Clinical Evidence fMRI Changes in Patients Treated with Active PoNS and PT vs non-stimulating Placebo PoNS and PT 26 Group A: Active Arm Group B: Placebo Arm Active Arm Placebo Arm Active Arm Active Arm Placebo Arm 1Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 20
Slide 19: 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 19 Promising results from initial real-world evidence gathere
Slide 20: Media Coverage of PoNS
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 21: Current Strategies for Managing Neurological Disorders
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 21
Slide 22: Commercialization and Reimbursement
Commercialization and Reimbursement
Slide 23: MCIT - Medicare Coverage for Innovative Technologies
MCIT – Medicare Coverage for Innovative Technologies – accelerated coverage pathway for innovative products 4 years CMS reimbursement from the date of clearance for products with a breakthrough designation and FDA clearance Alignment of coverage with launch date 60 million people in the US are cover
Slide 24: 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 Finalizing distribution model of the PoNS device Targeting commercial launch in Q1’22 with initial cash pay customers, while pursuing
Slide 25: Capitalization & Ownership
Capitalization & Ownership
Slide 26: Capitalization & Ownership
Capitalization & Ownership As of June 30, 2021 26
Slide 27: Management Team
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 28: Board of Directors
Sherrie Perkins Director Mitch Tyler 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,
Slide 29: Helius MS Scientific Advisory Board and Key Opinion Leaders
Helius MS Scientific Advisory Board and Key Opinion Leaders 29
Slide 30: 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 31: First-in-Class Neurotech
First-in-Class Neurotech Unique and innovative treatment 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 Potential CMS reimbursement for 4 years with
Slide 32: Thank you
Thank you (NASDAQ:HSDT | TSX:HSM)
Helius Medical Technologies — Investor Presentation (August 2021) on 6ix