Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (September 2020)
24 slides from Solana's investor presentation, Sep 9, 2020
Slide 1: The Last Frontier in Healthcare
Exhibit 99.1 The Last Frontier in Healthcare Empowering the Natural Healing Process of the Brain September 2020
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, whether the results of our clinical trials will be sufficient to support an FDA, CE Mark or TGA approval of the PoNS™ device for marketing
Slide 3: Investment Highlights
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Investment Highlights Platform Technology Undervalued asset poised for growth: science-backed neurotechnology with ready-to-scale operation Large Lifetime Addressable Markets PoNS Treatment™ First-in-Class, non-implantable neurotechnology with the opport
Slide 4: Commercial Investment Highlights cont'd
Commercial www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Investment Highlights cont'd Clinical Evidence Regulatory Progress Robust IP Portfolio FDA Breakthrough Device Designation; FDA submission for de novo classification and clearance related to MS pending Authorization for gait deficits due to mi
Slide 5: Helius Leadership
Dane Andreeff Interim CEO and Member, Board of Directors Dr. Jonathan Sackier Chief Medical Officer Joyce LaViscount Chief Financial Officer and Chief Operating Officer 17+ years in the medical devices industry Sales and Marketing Director, Boston Scientific Canada National Sales Manager, Canada Joh
Slide 6: Helius Leadership (continued)
Harry Kovelman, VP, Medical Affairs Ellyn Ito, VP, Human Resources Larry Picciano VP, Quality & Regulatory Affairs 20+ years in clinical and research-oriented neurorehab physical therapy Neuromodulation research collaborator and Clinical Trial Manager at Univ Wisconsin Former Director, PT and Clinic
Slide 7: Board of Directors
Blane Walter Chairman of the Board, Member, Audit Committee, Nominating and Governance Committee Ed Straw Member, Compensation Committee, Nominating Committee Mitch Tyler Board Member Founder and Co-Inventor of PoNS™ technology Co-founder of Wicab, Inc and former VP, Research and Development Lead In
Slide 8: Company Overview (as of June 30, 2020)
Company Overview (as of June 30, 2020) Listed on the Nasdaq Capital Market since April 2018 (HSDT) - Market cap of $20M Class A Common Stock shares issued and outstanding: 45.1M $5.3M Cash and no long-term debt as of June 30, 2020 China Medical Systems - 5.5% (ownership and development of PoNS asset
Slide 9: Large Lifetime Addressable Market: Indications and Target Populations
Balance Maintenance in Baby Boomers (78M people) Neurological Wellness (1 billion people) Human Performance Stroke (7M People; 795K new each year) Cerebral Palsy (764K People) Indication and Target Population - US* Potential for Future Development Large Lifetime Addressable Market Additional Clinica
Slide 10: Large Lifetime Addressable Market and Strategic Vision
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 2020 - 2023 +$10bn 2021 - 2027 2025 - 2030 $1.5tn(2) Wellness / Betterment Preventative and Personalized Medicine Human Performance Improvement Cognitive Maintenance / Enhancement, Balance and Mobility, Neuro Recovery, Fall Prevention Medical Application
Slide 11: The PoNS Device and PoNS Treatment
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Smart Device The PoNS™ is a smart device that tracks frequency, duration and intensity of use PoNS Treatment ™ The PoNS™ Device Data Intelligence Capabilities Data is uploaded to the cloud for analysis, the results of which provide compliance profiles fo
Slide 12: PoNS Treatment Mechanism of Action
~14MM pulses per 20-minute session Feels like champagne or carbonated water bubbles Trigeminal and Facial Cranial Nerve Branches25 Translingual Neurostimulation provides neuromodulation of the cranial nerves via the tongue Neuromodulation is the modification of nerve activity through delivery of a t
Slide 13: Regulatory Progress: FDA Submission under Breakthrough Device Designation
Regulatory Progress FDA Submission under the Breakthrough Device Designation Published studies earned PoNS™ Breakthrough Device Designation for the treatment of gait deficits due to symptoms of Multiple Sclerosis On August 4th, 2020, the Company filed its application to FDA for de novo classificatio
Slide 14: Evolution of Our Regulatory Strategy in Canada
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Regulatory Progress Evolution of Our Regulatory Strategy in Canada We received label expansion for MS by Health Canada on March 26, 2020 MS market characteristics 93,500 MS patients in Canada Strong advocacy for MS (MS Society) Urgency to treat Similar t
Slide 15: 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 a
Slide 16: Real-World Evidence in MS Patients Treated with PoNS in Canada
Clinical Evidence Real-World Evidence in MS Patients Treated with PoNS™ in Canada 42 patients with MS were treated with PoNS in Canada between March 2019 and September 2019 in a validated electronic database capture system and Participant Disposition, Demographics, and Clinical Characteristics refle
Slide 17: Clinical Evidence: TBI-001 SOT Responders
Clinical Evidence TBI-001: SOT Responders at 5 Weeks in Pooled and HFP Population While the trial included both high and low frequency groups, there was no statistical difference between patients between groups so the data was pooled. 67.2 0 20 40 60 80 100 Pooled SOT responders,a % HFP = high-frequ
Slide 18: Long-term Treatment Study in mild-to-moderate TBI
In patients with mmTBI, balance improvements shown at 2 Weeks, 14 Weeks and 26 Weeks 0 10 20 30 40 50 60 70 80 90 SOT Baseline Week 26 ∆ 29.8 ∆ 21.0 ∆ 33.8 Normal Range SOT Score Week 14 N=221 12-week washout period – no stimulation On average, patients with mmTBI improved from an impaired SOT score
Slide 19: Commercialization: Canadian Market Opportunity
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 350,000 patients in Canada 19 Clinic Locations Target of 25 at end of 2020 Engagement w/ Toronto Rehabilitation Mild-to-Moderate Traumatic Brain Injury (“mmTBI”) 93,500 patients in Canada High urgency to treat High Patient Awareness Specialty clinic syst
Slide 20: Commercialization: Canadian Strategic Focus
Establish robust network of Canadian Clinics to deploy PoNS 19 established clinic locations to date Additional 6 clinics to target 25 by year-end New neuro-centric clinics in Ontario, Western Canada & Quebec Label expansion for MS approved in March 2020 Gain KOL support through clinical experience p
Slide 21: International Regulatory Status: Australia, EU, China
AUSTRALIA: Awaiting decision from Therapeutic Goods Administration (TGA) Submission review in process – we supplemented our submission and responded to all follow-up questions to date EU: Company withdrew its CE Mark Application Decision made due to EU’s move to Medical Device Regulation (MDR) from
Slide 22: Extensive IP Portfolio
www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Extensive IP Portfolio A Significant Barrier to Competitor Entry 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 Forei
Slide 23: Thank You
THANK YOU www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM
Slide 24: References
References Slide 9: Disease State Prevalence MS https://www.nationalmssociety.org/What-is-MS/MS-FAQ-s Cerebral Palsy: http://www.cerebralpalsy.org/about-cerebral-palsy/prevalence-and-incidence Stroke – http://www.strokeassociation.org/STROKEORG/LifeAfterStroke/Life-After-Stroke_UCM_308546_SubHomePag
Helius Medical Technologies — Investor Presentation (September 2020) on 6ix