A Revolution in Mind May 2019
Legal Disclaimers This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, including 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 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 risks described in the “Risk Factors” section of Company’s Annual Report on Form 10-K for the period ended December 31, 2018 and the Company’s Quarterly Report on From 10-Q for the period ended March 31, 2019, as well as those set forth from time to time in the Company’s other SEC filings, available at http://www.sec.gov. 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. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 2
We are a neurotech company in the medical device industry focused on neurological wellness. 3 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM
Helius Leadership Team: Experienced Leadership With Healthcare and Commercialization Expertise Philippe Joyce Dr. Jonathan Jennifer Deschamps LaViscount Sackier Laux President, Chief Financial Officer Chief Medical Officer Chief Commercial Chief Executive and Chief Operating Officer Officer & Chairman Officer 30+ years in the health 22+ years in the health sciences • • 29+ years in the health sciences 30+ years in the health • • sciences industry industry industry sciences industry Former CEO at MediMedia Former VP of Commercial at Inovio • • Accomplished Trained surgeon and • • Health Pharmaceuticals pharmaceutical/healthcare pioneer of new medical Former President and CEO at public company CAO technologies Former VP of Cardiovascular • • GSW Worldwide (Division of Marketing at Boehringer Ingelheim Former COO and CFO at MM Has helped build several • • inVentiv Health) Pharmaceutical Solutions companies including medical Former Executive Director of • Former Director of technology, research and Cardiovascular Franchise at Merck • Former Executive • Neuroscience Marketing at product-design and medical Director/Group Controller at Bristol-Myers Squibb contract sales organizations Aptalis Pharmaceuticals www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 4
Investment Highlights Platform Technology • First in class, non-invasive neurotechnology with broad potential for treating symptoms of neurological disease and trauma Large Initial Market • Over 350K people with chronic balance deficit caused by mild-to- moderate traumatic brain injury (mmTBI) in Canada 1 • “First mover advantage” with demonstrated safety and efficacy in PoNS Treatment™ a market with few viable treatment options • Cleared in Canada. EU and TGA submissions under review. Regulatory Progress Efforts to resubmit to FDA in process. • Pilot studies completed in Stroke, Multiple Sclerosis, and Clinical Pipeline Cerebral Palsy Robust IP • Method Patent portfolio coverage extends to 2028; utility and design patents to 2035 www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 5
Large and Growing Addressable Market Chronic balance >1.5M ~420K US deficit is a long-term disability associated ~13K CA with neuro trauma and disease > 350K Functional status, capacity to return to work, and quality of life is frequently People worldwide who People living with New cases annually of affected in individuals experience new TBI chronic balance deficit chronic balance deficit with balance deficit cases annually 1 following an mmTBI in caused by mmTBI in the US 2 and Canada 3 the US 4 and Canada 5 After the initial medical event, mmTBI can present significant long-term disabilities and challenges to the individual, family, and society www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 6
Clinical Support for PoNS Treatment™: RCT Enrollment Criteria for Mild-to-Moderate TBI with Chronic Balance Deficit • Safety and efficacy of PoNS Treatment demonstrated in two double-blind randomized controlled trials (RCTs) 1 • Enrollment criteria included patients with persisting balance deficit, despite treatment with physical therapy (PT), the current standard of care Inclusion Criteria Aged 18-65 years at screening Balance disorder as a result of mmTBI ≥ 1 -year since mmTBI Plateaued in recovery with current PT rehabilitation regimen SOT score > 16 points below normal PT = physical therapy; SOT = Sensory Organization Test; TBI = traumatic brain injury. 7
Clinical Support for PoNS Treatment™: Significant, Sustained Improvement In patients with Long-term Treatment Study in mmTBI mmTBI, mean Sensory Organization Test (SOT) Score Comparison balance scores were 12 weeks washout – no stimulation 90 Normal significantly better at Range 80 SOT Score 2 Weeks, 14 Weeks 70 and 26 Weeks ∆ 33.8 ∆ 29.8 60 ∆ 21.0 50 SOT The majority of 40 those patients 30 maintained normal 20 SOT scores during 10 12 week washout 0 period. Baseline Week 2 Week 14 Week 26 HFP+PT N=22 1 1 Patients treated with high frequency pulse (HFP) device. Low frequency pulse (LFP) data not shown since it was not statistically different from HFP. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 8
Global Regulatory Strategy Canada: • Canadian authorization received 10/17/18 • The PoNS™ device is intended for use as an acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI), and is to be used in conjunction with physical therapy (PT). The device is limited to prescription use. EU: • EU: Submitted CE Mark application 12/7/18 Australia: • Australia: Therapeutic Goods Administration (TGA) filing submitted 5/6/19 US: FDA declined request for de novo classification April 2019 • FDA recognized there were no device-related serious adverse events in either RCT and acknowledged that participants in both arms of the study demonstrated • improvements from baseline in all pre-specified clinical endpoints FDA noted that it did not have sufficient information to discern the relative independent contributions of the PoNS Device and physical therapy on the improvements • from baseline in the effectiveness endpoints observed in the Company’s clinical studies Efforts to resubmit to FDA ongoing • www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 9
Commercializing PoNS Treatment™ in Canada (Slide 1/2) • Cleared by Health Canada 10/17/18 • Patients began treatment in Q1 2019 • Over 350K people living with chronic balance deficit due to mmTBI 1 • Regulatory, quality management and post-market surveillance systems for PoNS Treatment™ in place • Heuro Canada established to develop network of neuroplasticity clinics • Partnership with HTC to deliver PoNS Treatment™ • Two neuroplasticity clinics established in Montreal and Surrey • Expect to add three additional neuroplasticity clinics in Canada during 2019 Focused on expanding commercial efforts and treating patients in Canada www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 10
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