Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (January 2021)
28 slides from Solana's investor presentation, Jan 5, 2021
Slide 1: Empowering the Healing Process of the Brain
Empowering the Healing Process 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: uncertainties regarding the FDA regulatory approval process (including the FDA Breakthrough Designation), uncertainties regarding the regulatory approval process in China and Australia, whether the r
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 chronic balance deficit due to mmTBI and gait de
Slide 4: Large Potential Addressable Markets: 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 Submitted to FDA for de novo classification and clearance Ongoing Evaluation Multiple Sclerosis (1M People) Pilot Studies Completed Studies Completed; Additional
Slide 5: Breakthrough Designation Program
Breakthrough Designation Program Helius is working interactively with the FDA under the program Advantages Focused on addressing high unmet needs in gait deficit for MS patients Prioritized review of the submission under Breakthrough Designation Interacting with FDA to efficiently address topics as
Slide 6: Potential CMS reimbursement for breakthrough designation
Potential first 4 years reimbursement under the pending CMS policy for companies with a breakthrough designation and FDA clearance. 70 million people in the US are covered under Medicare and Medicaid, which PoNS will have access to if qualified. 6
Slide 7: Recent Milestones and Anticipated Value Creation Events
Authorized in Canada for the treatment of balance deficit due to mmTBI Recent Milestones and Anticipated Value Creation Events Q4’18 Q1’19 Initiated Canadian commercialization - first 10 Canadians treated in 2 clinics Q4’19 7 PoNS Clinics established across Canada Q1’20 Authorized in Canada for the
Slide 8: Executive Team
Dane Andreeff Interim CEO and Member, Board of Directors Dr. Jonathan Sackier Chief Medical Officer Joyce LaViscount Chief Financial Officer & Chief Operating Officer Mark Leno VP, General Manager, Canadian Operations Executive Team Experienced Leadership With Healthcare and Commercialization Expert
Slide 9: Board of Directors
Blane Walter Chairman of the Board Ed Straw Director Jeff Mathiesen, CPA Director Mitch Tyler Director Board of Directors Experienced Leadership With Healthcare and Commercialization Expertise Partner, Talisman Capital Partners Vice Chair of InVentive Health Chair of the Governor of Ohio’s Executive
Slide 10: PoNS Device
PoNS™ Device Empowering the brain and recovery during PoNS Treatment PoNS controller and mouthpiece are connected by a cord Mouthpiece electrodes stimulate the tongue surface, sending signals to the brain 10
Slide 11: PoNS Treatment Mechanism of Action
PoNS Treatment™ Mechanism of Action 11
Slide 12: Clinical Evidence: fMRI Changes in Patients Treated
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 13: 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 14: 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 15: Current Strategies for Managing Neurological Disorders
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 15
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 “Impact of Walking Impairment in Multiple Sclerosis Perspectives of Patients and Care P
Slide 17: The Current MS Gait Deficit Care in US: Competitive Landscape
Leading MS Treatment Competitor annual sales reached over $543 million prior to losing patent exclusivity Leading MS Treatment Competitor Annual Sales The Current MS Gait Deficit Care in US Competitive Landscape 17 Acorda Therapeutics Annual 10K (2010 – 2019) “Acorda Therapeutics Announces Pricing a
Slide 18: 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 19: Patients with MS treated with PoNS in Canada
42 Patients with MS treated with PoNS in Canada 58.3% Patients had an overall average improvement in their functional gait assessment (FGA) PoNS Device - Health Canada approved for gait deficit due to symptoms of MS since March 2020 19 Promising results from initial real world evidence gathered thro
Slide 20: PoNS Treatment Could Help Canadian MS Patients
PoNS Treatment™ Could Help Canadian MS Patients with Chronic Gait Deficit The Restorative Power of Neuroplasticity in People with MS PONS therapy helps Ontario woman recover from brain injury MS PATIENT BENEFITS FROM NEW DEVICE.
Slide 21: Multiple Sclerosis Opportunity
Multiple Sclerosis “MS” Opportunity 93,500 patients MS Society of Canada 1,000,000 patients National MS Society MS patients are highly motivated and linked on social media High urgency to treat High Patient awareness Specialty clinic system BOTH 21
Slide 22: Helius MS Scientific Advisory Board
Helius MS Scientific Advisory Board 22
Slide 23: International Strategy
CHINA: Strategic Agreement with China Medical Systems (“CMS”) for development and commercialization of PoNS in China plus 4 territories Transferred ownership of Asian patents, patent applications and granted exclusive license to market, promote distribute and sell the technology CMS assumed all deve
Slide 24: 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 25: Next Neurological Market Opportunity Continued
Next Neurological Market Opportunity Continued Mild-to-Moderate TBI 6.8m CerebralPalsy 764k Baby Boomers Balance 78m Neurological Wellness 1b 25 Parkinson’s Disease 1m
Slide 26: Capitalization & Ownership
Capitalization & Ownership As of January 4, 2021 28
Slide 27: Neurotech company focused on neurological wellness
We are a neurotech company in the medical device industry focused on neurological wellness. FDA Breakthrough Designation and pending US clearance in MS Potential to obtain CMS reimbursement for 4 years – 70M covered lives Building on success/knowledge/infrastructure developed in two years of commerc
Slide 28: Thank you
Thank you (NASDAQ:HSDT | TSX:HSM)
Helius Medical Technologies — Investor Presentation (January 2021) on 6ix