Full Press Release Details
Empowering Neuroplasticity
PoNS Therapy for Balance and Gait Deficits in Patients with Neurological Disorders
Legal Disclaimers This presentation contains forward-looking statements, including statements regarding the Company's future strategic and operational execution, the next phase of the Company's market development activities, clinical and regulatory development plans for the PoNS device, and the timing and success of the Company's commercialization efforts in the United States. 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 uncertainties regarding the Company's capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Company's ability to secure contracts with rehabilitation clinics, the Company's ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company's ability to obtain FDA clearance for stroke, the Company's ability to build internal commercial infrastructure, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks described in the "Risk Factors" section of Company's Annual Report on Form 10-K for the year ended December 31, 2021 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, PoNS, is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. The PoNS device is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS device is authorized for sale in Australia as a non-implantable neurostimulator intended for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. 2
The first and only patented therapy 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 for the treatment of gait deficit due to mild and moderate symptoms of MS and chronic balance deficit due to mild and moderate traumatic brain injury ("mmTBI") Authorized for the treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis ("MS")
FDA Breakthrough Designation granted for the treatment of gait
deficit due to symptoms of MS
FDA Breakthrough Designation granted for the temporary treatment
of dynamic gait and balance deficits following a stroke
3 Authorized for use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.
4 A Path to Commercialization: FDA Breakthrough Designation Breakthrough Designation granted for the treatment of gait deficit due to symptoms of MS May 2020 Breakthrough Designation granted for the treatment of dynamic gait and balance deficits following a stroke March 2021 Received FDA marketing authorization
Only medical device cleared in the U.S. for this indication August 2021 Next Milestones Pivotal trial
Potential FDA marketing authorization STROKE
Stroke (7M People) Cerebral Palsy (764K People) Indication and Target Population - US Potential for Future
Development Ongoing Evaluation Multiple Sclerosis (1M People) Pilot Studies Conducted Studies Completed; Additional Study Planned Traumatic Brain Injury (6.8M People) Parkinson's Disease (1M People; 60K new each year) Future Studies Needed FDA Breakthrough Designation Large Potential Addressable Markets
U.S. Clinical Progress and Future Opportunities 5 Authorized for gait deficit due to symptoms of MS Pilot Study Conducted
Additional Study in Development FDA Breakthrough Designation
Recent Milestones and Anticipated Value Creation Events Authorized in the US for MS
Closed on $11m public offering
GMED Audit / Maintained ISO13485:2016 and MDSAP Certifications
Enhanced and expanded senior leadership team 6 Subject to FDA authorization, targeted US commercialization for stroke H1 21 H2 21 Q1 22 Q2 22 H2 22 Y 24 Expansion of resources to support US commercialization*
Launch clinical adoption studies
FDA Breakthrough Designation granted for stroke
Authorized in Australia to improve balance and gait
Initiated Therapeutic Experience Program
Closed on $11.1m public offering
Initiated inventory build for commercial launch
Established total of 40 clinics in Canada
Initial outreach with KOLs and strategic partners
US commercial launch for MS
Deploy reimbursement strategies
Training transitioned to online platform
Established List Pricing for PoNS Therapy (US)
Initiate pivotal trial in stroke
Achieve 10-12 TEP sites
Preliminary data from TEP
Begin enrollment in MUSC stroke pilot
= Target * = Ongoing Initial US commercial sales
Start enrollment of TEP
Establish additional TEP sites
Y 23 Full enrollment of MUSC stroke pilot
Data from MUSC stroke pilot
Reimbursement policies (US)
8 Blood oxygen level-dependent (BOLD) signal
Empowering the brain and improvement during PoNS Therapy
Mouthpiece electrodes stimulate the tongue surface, sending signals to the brain
The stimulation produced by PoNS is believed to help strengthen the neural connections associated with balance and walking when combined with physical rehabilitation
Current Strategies for Managing Neurological Disorders Prescription Drugs Therapy Surgery Medical Devices 11
PoNS Therapy for Symptoms of Multiple Sclerosis
Understanding the "MS" Market Opportunity in US MS is a well-characterized chronic disease with a fast-growing diagnosed population1 MS patients are vocal and connected on social media MS patients are cared for by neurologists, a relatively discrete group
(approx. 16,000 in USA) Gait dysfunction is a common and distressing symptom experienced by MS patients1 MS patients actively seek out new and promising treatments 13 Larocca, Nicholas G. "Impact of walking impairment in multiple sclerosis: perspectives of patients and care partners." The patient vol. 4,3 (2011): 189-201. doi:10.2165/11591150-000000000-00000
Commercialization and Reimbursement
Therapeutic Experience Program Helius sponsored open-label, interventional, observational, clinical study
Evaluating PoNS on-label therapy in target population (Multiple Sclerosis) aiming to investigate patients' adherence to PoNS Therapy regimen
Enrolling ~ 40-50 subjects with gait deficit due to mild-moderate MS at Centers of Excellence across the US (10-12 sites)
Expected to start enrollment in Q2' 22 and continue through Q4' 22
1st Center of Excellence announced (NYU Langone Health)
U.S. Commercial Activities Actively identifying and onboarding neuro rehab clinics currently treating MS patients to provide therapy
Training evolved to online platform to facilitate ease and convenience
Pursuing commercial and government reimbursement programs with initial cash pay option
Ongoing CMS engagement to obtain HCPCS codes and coverage
Prescriptions received in March with initial shipments anticipated in April
Exploring tele-medicine / prescription fulfillment
Implement key marketing strategies to generate awareness
Social and digital presence
Conference attendance (ACTRIMS, CMSC, ACRM)
1 million 70% Americans estimated to be affected by MS1 Report having difficulties walking2 Potential Addressable U.S. Opportunity in Multiple Sclerosis 17 1. Wallin, Mitchell T et al. "The prevalence of MS in the United States: A population-based estimate using health claims data." Neurology vol. 92,10 (2019): e1029-e1040. doi:10.1212/WNL.0000000000007035
2. Williams, Angela E et al. "Symptoms and Association with Health Outcomes in Relapsing-Remitting Multiple Sclerosis: Results of a US Patient Survey." Multiple sclerosis international vol. 2014 (2014): 203183. doi:10.1155/2014/203183
Addressable Market 5 Year Avg All States: 127,532 patients 5 Year Avg Top 10 States: 71,331 patients
Abnormalities of gait and mobility R26
R26.1 Paralytic gait
R26.2 Difficulty in walking, not elsewhere classified
R26.8 Other abnormalities of gait and mobility
R26.81 Unsteadiness on feet
R26.89 Other abnormalities of gait and mobility
R26.9 Unspecified abnormalities of gait and mobility
18 * Data Source = Purple Labs Patient Data
PoNS Established US List Pricing
Cash pay option available
Discounted modestly below anticipated reimbursement rate
Direct to consumer financing option through a 3rd party
Link to National MS Society for potential financial assistance
20 US Market Access Key Coding & Payment Milestones and Timelines Commercial Payers have their own fee schedules; Medicare is often benchmark Launch with Unlisted DME Codes 2022 2023 Evidence development is a multi-year endeavor Case by Case Coverage Ongoing engagement with CMS to obtain HCPCS code Payer Meetings Develop market access toolkit for patients and providers Develop pricing crosswalk for Medicare and US payers Work with patient advocacy groups, societies and KOLs 20 Q4
Clinical Evidence: Multiple Sclerosis
Two groups (10 each):
Active Group: PoNS + PT
Control Group: Placebo PoNS + PT DGI = Dynamic Gait Index, a measure of the ability to walk
Change In DGI Score Versus Time Within The Study Period Improvement in Dynamic Gait Index scores for the Active Group Mean avg of 7.95 All 10 subjects in the active treatment group experienced at least a 4-point improvement from baseline to Week 14 in DGI. Mean avg of 3.45 Only 3 of 10 (30%) subjects in the placebo control group experienced an improvement in DGI of at least 4 points from baseline to week 14. 100% Clinical Evidence1 Multiple Sclerosis Study - Gait Deficit in Mild and Moderate MS (EDSS score 3.0-6*) *Error on publication regarding EDSS Score9
**One visit per week was in-clinic
1. Tyler, Mitchell E et al. "Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial." Journal of neuroengineering and rehabilitation vol. 11 79. 1 May. 2014, doi:10.1186/1743-0003-11-79
PoNS Therapy: Imaging Data1 Multiple Sclerosis Study - Gait Deficit in Mild and Moderate MS (EDSS score 3.0-6*) Gait Imagery task revealed task-related activations in bilateral premotor and motor regions Gait Imagery fMRI in MS Patients *Error on publication regarding EDSS Score10 1. Leonard, Gabriel et al. "Noninvasive tongue stimulation combined with intensive cognitive and physical rehabilitation induces neuroplastic changes in patients with multiple sclerosis: A multimodal neuroimaging study." Multiple sclerosis journal - experimental, translational and clinical vol. 3,1 2055217317690561. 1 Feb. 2017, doi:10.1177/2055217317690561
42 Patients with MS treated
58.3% Patients had achieved at least a 4-point improvement in their functional gait assessment (FGA) PoNS Device1
Authorized in Canada for gait deficit due to symptoms of MS since March 2020
24 Promising results from initial real-world evidence gathered through 12.31.2019 which was used in FDA regulatory submission Currently evaluating additional data gathered on MS patients for commercial and medical insights and publication 1. Helius Medical, Inc. Data on file: 001_Helius Medical Inc_PoNS_Direct DeNovo Request_08042020.pdf. August 2020.
PoNS Therapy for Symptoms Due to Stroke
FDA Breakthrough Designation for Treatment of Symptoms Due to Stroke Announced receipt of FDA Breakthrough Designation on August 17, 2021