A Revolution inMind June 2020
LegalDisclaimers 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, 2019 and the Company’s Quarterly Report on From 10-Q for the period ended September 30, 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. 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 chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy (“PoNS Treatment" TM ) and indicated as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. 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 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
Tongue Based Neuromodulation The neural network originating A mild-to-moderate traumatic T o restore balance and The PoNS ™ investigational in the tongue flows to the brain injury (“mmTBI”) function, the brain’s neural medical device gently brainstem, which is the body’s damages the brain’s neural network needs to be stimulates the surface of the control center. The tongue’s network and reduces its “rewired” as this tongue which excites the dense nerve endings make it ability to effectively reestablishes the proper flow neural network flowing to the ideal for stimulation. communicate with the body. of neural impulses to the brain. This neural activity is body. This “rewiring” is called believed to enable neuroplasticity. neuroplasticity which may restore lost function. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 3
PoNS - One SmartDevice Treatment Hypothesis • Researchers believe that targeted physical therapy performed during neurostimulation may promote neural network changes including rebuilding and reorganization (neuroplasticity) thereby restoring communication with the body and improving functionality such as balance Smart Device The PoNS™ is a smart device that tracks frequency, • duration and intensity of use Data Intelligence Capabilities Data captured is uploaded to the cloud for analysis, the • results of which support treatment decisions and also provide compliance profiles for payer reimbursement opportunities www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 4
Helius Earns Breakthrough Designation From FDA According to the FDA, the Breakthrough Devices Program is outlined as follows: • The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development • It offers manufacturers an opportunity to interact with the FDA's experts to efficiently address topics during the review phase • Manufacturers can also expect prioritized review of their submission. We plan to submit to the FDA for gait deficit tied to MS to address this high unmet medical need in the – second half of 2020. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 5
Regulatory Status Canada – PoNS received Marketing Authorization for treatment of gait deficit for people with MS in March 2020 based on: – The quality of the data included in our MS submission package to Health Canada – The existing published data – Real-world evidence gathered in Canada – High unmet medical need – PoNS already received marketing Authorization for balance deficit related to mild to moderate TBI PoNS is an authorized class II medical device. The device is intended for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is intended for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 6
Multiple Sclerosis Study – Mild and Moderate MS (EDSS score 3.5-6) Mean DGI* 8 wks home 12 wks home Study entry 4 wks home Two groups (10 each) : 10 Active 2 wks lab 1. “Active” PoNS + exercises 10 Control 2. Placebo PoNS + exercises * p < 0.05 ** p < 0.01 *** p < 0.005 DGI* Change • All 10 subjects in the active treatment group experienced at least a 4 point improvement from baseline to Week 14 in DGI. • only 3 of 10 (30%) subjects in the placebo control group experienced an improvement in DGI of at Clinically significant least 4 points from baseline to week 14. Weeks www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM Tyler et al. Journal of NeuroEngineering and Rehabilitation 2014, 11:79 7 *DGI = Dynamic Gait Index, a measure of the ability to walk
14 Multiple Sclerosis Study Evaluating PoNS on Balance Deficit 14 subjects, 7 non-stimulating PoNS Vs 7 active PoNS stimulation with concomitant physiotherapy • 90 80 70 Composite Scores SOT P=.001 Relative to Baseline ACTIVE 60 P= NS Relative to Baseline SHAM 50 ROLLOVER P=.015 Relative to Baseline 40 30 BASELINE 2 4 6 8 10 12 14 Weeks www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1 Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 8 9
26 fMRIChangesin Patients Treated with Active PoNS and PT vs Placebo PoNS and PT Group A Active Arm P=.01 P=.06 Group B Placebo Arm Active Arm Placebo Arm ActiveArm P=.02 Active Arm Placebo Arm www.heliusmedical.com | Nasdaq:HSDT | TSX:HSM 1 Multiple Sclerosis Journal Experimental, Translational and Clinical January-March 2017: 19 DOI: 10.1177/ 2055217317690561 9
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