Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (July 2021)
28 slides from Solana's investor presentation, Jul 13, 2021
Slide 1: Empowering the Neuroplasticity of the Brain
Empowering the Neuroplasticity of the Brain 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: 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 5: PoNS Treatment Program
PoNS Treatment™ Comprehensive 14 Week PoNS Treatment™ Program Base Final Assessments Assessments Initial Week Consultation in-Clinic Phase]
Slide 6: PoNS Treatment Mechanism of Action
PoNS Treatment™ Mechanism of Action 6
Slide 7: 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 8: 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 9: 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 Approved in Canada for gait deficit due to symptoms of MS since March 2020 9 Promising results from initial real-world evidence gathered t
Slide 10: 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 11: U.S. Clinical Progress and Future Opportunities
Stroke (7M People; 795K new each year) 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) Parkin
Slide 12: Current Strategies for Managing Neurological Disorders
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 12
Slide 13: 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 13 1. Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA”; E
Slide 14: 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 15: FDA Breakthrough Designation Program
FDA program to address unmet medical needs. Provides interactive and timely communications with the FDA Achieved Breakthrough Designation and worked interactively with the FDA under the program to achieve market authorization Potential expedited reimbursement pathway under MCIT rule for breakthrough
Slide 16: MCIT – Medicare Coverage for Innovative Technologies
MCIT – Medicare Coverage for Innovative Technologies – accelerated coverage pathway for innovative products 4 years CMS reimbursement for products with a breakthrough designation and FDA clearance Alignment of coverage with launch date 60 million people in the US are covered under Medicare. 16
Slide 17: 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 18: Helius MS Scientific Advisory Board and Key Opinion Leaders
Helius MS Scientific Advisory Board and Key Opinion Leaders 18
Slide 19: International Opportunities
EUROPE: Evaluating appropriate timing for submission AUSTRALIA: Awaiting decision from Therapeutic Goods Administration (TGA) CHINA: Strategic Agreement with China Medical Systems (“CMS”) for development and commercialization of PoNS in China plus 4 territories Transferred ownership of Asian patents
Slide 20: Next Neurological Market Opportunity: Stroke
795k US individuals have a stroke each year1 50% of stroke survivors 65 and over suffer from reduced mobility2 Walking is the most frequently reported activity at the time of a fall in stroke survivors3 In post-stroke patients, the cerebral cortex becomes impaired while the spinal cord is preserved.
Slide 21: 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 22: 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 22 Potential trials on TBI and Stroke Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q2 22 2H 22 GMED Audit / Maintained ISO13485:2016 and
Slide 23: Capitalization & Ownership
Capitalization & Ownership As of June 30, 2021 23
Slide 24: First-in-Class Neurotech
First-in-Class Neurotech First and only treatment authorized to improve lost 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 FDA cleara
Slide 25: Management Team
Dane Andreeff President & CEO Dr. Jonathan Sackier Medical Advisor Joyce LaViscount Chief Operating 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, My
Slide 26: Management Team (continued)
Frederick Fantazzia VP, Sales & Marketing North America 25+ years combined experience in Medical Device and Pharmaceutical Sales 16+ years in the medical devices industry with extensive commercialization expertise in neuromodulation sales and marketing Former VP of North America Sales and Marketing,
Slide 27: 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 28: Thank you
Thank you (NASDAQ:HSDT | TSX:HSM) 28
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