The Last Frontier in Healthcare Empowering the Natural Healing Process of the Brain September 2020
LegalDisclaimers 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 or whether the agencies may require that the Company conduct future clinical trials; future economic, competitive, reimbursement and regulatory conditions; new product introductions; ability to commercialize its PoNS Treatment™; demographic trends; the intellectual property landscape; financial market conditions; continued availability of capital and financing, including its ability to continue as a going concern; and future business and strategic decisions made by the Company and its competitors. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward looking statements include the impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and regulatory subimssion and approval process, and other risks described in the “Risk Factors” section of Company’s Annual Report on Form 10-K for the year ended December 31, 2019 and the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as well as those set forth from time to time in the Company’s other filings with the securities and exchange commission and the Canadian securities regulators available at http://www.sec.gov or www.sedar.com The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Certain data in this presentation was obtained from various external sources. Neither the Company nor its affiliates, advisers or representatives have verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives make any representations as to the accuracy or completeness of that data or commits to update such data after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors. The Company’s first product, known as the Portable Neuromodulation Stimulator (“PoNS" TM ), is an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy (“PoNS Treatment" TM ). It is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”), and it is currently under review for clearance by the FDA for use in gait dysfunction due to MS and AUS Therapeutic Goods Administration. PoNS Treatment™ is not currently commercially available in the United States, the European Union orAustralia. The Company has withdrawn its application from the EU marketing process due to uncertainty in Europe due to the switch from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the withdrawal of Lloyd’s Register Quality Assurance, the Company’s notified body, from the notified body business. The Company will reconsider submitting to the EU when conditions stabilize. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 2
InvestmentHighlights Large Lifetime PoNS Treatment™ Platform Technology Addressable Markets • First-in-Class, non-implantable • MS in Canada and US: ~1.2M • “Portable Neuromodulation neurotechnology with the • TBI in Canada and US: ~6.9M Stimulator” with a controller & opportunity to evolve with • Other Neurological Disease/ Trauma mouthpiece connected by a cord advancements in AI, compliance • CP and data collection technologies • Stroke • Electrodes on the mouthpiece • Parkinson’s send mild signals to the surface of • Broad potential in treating the tongue exciting the neural symptoms of neurological disease, • Cognitive and Human Performance network that flows to the brain trauma, and potentially wellness and human performance • Wellness • Mild stimulation combined with physical therapy may enhance • High barrier to entry due to • Enhancement to the technology to neuroplasticity development timelines further drive market adoption Undervalued asset poised for growth: science-backed neurotechnology with ready-to-scale operation www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 3
InvestmentHighlights cont'd Regulatory Progress Clinical Evidence Commercial Robust IP Portfolio • Commercial infrastructure • FDA Breakthrough Device • Publications and real-world • Exclusively licensed from established evidence showing Designation; FDA submission inventors improvements in gait or balance for de novo classification and • Sales & Marketing success in MS clearance related to MS • 29 US and 41 Foreign in Canada pending patents issued and owned • Multiple publications showing by Helius statistically significant • Research, Regulatory and • Authorization for gait deficits improvements in balance/gait in Quality systems due to mild and moderate • Patents expire between TBI symptoms of MS in Canada established 2026 and 2040 in March 2020 • Real world evidence appears to • Scale manufacturing and complement findings in RCTs • 3 Chinese Design Patents • Authorization for balance supply chain deficit due to TBI in Canada • Add’l studies in stroke, CP, to be • Independent Verification of in Oct 2018 • Reimbursement strategies developed Patents and Freedom to in development for US • TGA pending operate • Engagement of renowned KOLs • ISO / MDSAP Certification • China partners and SAB www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 4
Helius Leadership Team: Experienced Leadership With Healthcare and Commercialization Expertise Dane Joyce Dr. Jonathan Mark LaViscount Sackier Andreeff Leno Chief MedicalOfficer Chief Financial Officer Interim CEO and VP, General Manager, and Chief Operating Member, Board of Canadian Operations Officer Directors • 20+ years at Maple Leaf Partners as 30+ years in the health sciences 30+ years in the health • 17+ years in the medical devices • • the General Partner and Portfolio industry sciences industry industry manager, a value-based hedge fund Accomplished Trained surgeon and pioneer of • Sales and Marketing Director, • • which grew to over $2b in assets under pharmaceutical/healthcare public new medical technologies Boston Scientific Canada management. company CAO Has helped build several • National Sales Manager, Canada • • Board member and trusted advisor to Former COO and CFO at MM companies including medical Johnson & Johnson • Helius Medical Technologies, Inc for Pharmaceutical Solutions technology, research and product- • Former Media Relations and over 3 years and HDL Therapeutics, design and medical contract sales Former Executive Director/Group Marketing executive for Blue Jays • Inc for over 15 years organizations Controller at Aptalis & NHL • Owns approximately 3.4% of the Pharmaceuticals company through Maple Leaf Partners and affiliates www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 5
Recommend
More recommend
