Full Press Release Details
Fact Sheet: May 15, 2017
Developer of the Portable Neuromodulation Stimulator (PoNSTM)
Helius Medical Technologies is a United States-based medical device company developing and commercializing the PoNSTM Therapy platform, a powerful wearable direct current stimulation technology to treat movement and gait disorders in patients with traumatic brain injury (TBI) and chronic neurological disease. The
first targeted application of the PoNSTM is for balance disorder tied to mild to moderate TBI. The US neurostimulation device market is forecast to grow to $4 billion in 2018.
Features of the PoNSTM therapy platform:
Helius is led by an experienced
management team. CEO Phil Deschamps, CFO & COO Joyce LaViscount and CMO Jonathan Sackier each bring over 30+ years of experience in Health Sciences industry with a focus on development and commercialization of healthcare products.
The company is nearing completion of a 120 patient double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNSTM device for cranial nerve noninvasive neuromodulation in subjects with a chronic balance deficit due to mild to moderate TBI. The Company plans to submit for FDA, Health Canada and CE Mark and TGA
regulatory approval of the PoNSTM device in 2H 2017.
In addition to over $7 million in grants raised
by the inventors, the Company has raised $36 million in equity capital since June 2014, and has received $1.8 million in funding from the U.S. Army in support of PoNSTM clinical development, with a further $1 million expected later in 2017.
The Company filed a registration statement on Form S-3 in January 2017 establishing a $100 million shelf; $9.5
million was taken down in the February 2017 registered offering.
currently traded on the Toronto Stock Exchange (symbol: HSM) & Over-The-Counter Bulletin Board in the U.S. (symbol: HSDT) with a goal to be listed on a US national securities exchange.
The Company has received ISO 13485 Certification which permits submission to Health Canada, CE Mark in Europe and TGA in Australia.
Helius Medical s PoNS Therapy
The PoNS device delivers specially-patterned electrical stimulation developed to mirror nerve impulses to the brain
through 143-gold-plated electrodes on the mouthpiece which is placed on the tongue;
Stimulation of the brain and brain-stem via cranial nerve innervation
of the tongue is hypothesized to encourage neuroplasticity, or a re-routing , enabling the damaged brain to compensate for lost function due to trauma or disease, by recruiting existing working neurons;
PoNSTM, when used in combination with specialized physical or cognitive therapy, has been shown to
improve symptoms of patients with chronic neurological symptoms caused by disease or trauma;
Relative to most neurological drug and device treatments,
shorter clinical timelines, fewer study subjects and a shortened regulatory pathway offer relatively lower-cost opportunities to bring new indications to market;
Key near-term focus is the ongoing FDA registrational trial for PoNS Therapy for the treatment of balance deficit associated with mild to moderate TBI.
Investment Highlights for Helius Medical Technologies
One of the few pure-play medical device company in the large and growing neuromodulation market. The neuromodulation market is estimated at nearly $6
billion worldwide by 2020 and is expected to grow in the double digits on a percentage basis annually. Significant industry consolidation by large, diversified medical device companies has left few pure-play companies developing and commercializing
novel therapies. Differentiated technologies like the PoNSTM device capture market share relatively quickly post-launch.
Helius has a number of compelling milestones. The company has a goal to have its shares listed on a US national securities exchange, a critical
component in potentially broadening the US institutional investor base. Data from the 120 patient double-blind, randomized, sham-controlled trial in TBI is expected to read out in early 2H2017. Assuming FDA clearance, the 510(k)-de Novo to Class II
device classification could allow for commercial launch as early as 1H2018.
PoNSTM Therapy could
play a unique role in the treatment paradigm for multiple neurological deficits. The unique and non-invasive neuromodulation approach, in conjunction with physical or cognitive therapy, as well as pharmacotherapies, could allow for potential
broad applicability across a range of indications beyond TBI. Positive outcomes with PoNSTM Therapy could reduce the cost of pharmaceutical and rehabilitation treatments for patients that are
incurred with today s care plans.
Flexible business model. If the PoNSTM Therapy is approved
for commercialization, the combination of the wearable pulse generator and disposable mouthpiece could result in a recurring revenue stream. The service model is expected to launch in a clinic setting initially, with potential expansion to
home-based therapy care plan support model, with existing reimbursement for treatment. The de Novo device classification affords for relatively short clinical trials with a small number of subjects, translating to relatively low cost development to
expand into additional indications.
Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks are discussed
more fully in the Risk Factors section of our Transition Report on Form 10-K for the period ended December 31, 2016, which we filed with the SEC on April 3, 2017. These risks include the following:
Forward-Looking Statements
This fact sheet contains
forward-looking statements and forward-looking information as such terms are defined under applicable U.S. federal securities and Canadian securities legislation. All statements other than statements of historical fact contained in this fact sheet
constitute forward-looking statements and forward-looking information, including, without limitation, statements containing the words believe , may , plan , should , predict ,
potential , will , estimate , continue , anticipate , intend , expect , seek , mission , goal and similar words, variations, expressions
or the negative thereof. Forward-looking statements are necessarily based on estimates and assumptions made by management of the Helius Medical Technologies, Inc. ( Helius , we or the Company ) in light of experience
and perception of historical trends, current conditions and expected future developments, as well as the factors management of the Company believes are appropriate. Forward-looking statements and information in this fact sheet include but are not
limited to statements relating to:
statements reflect management of the Company s current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the
Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future
results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others, those risks described in Risk Factors above and the risks described in our SEC filings, including our
Transition Report on Form 10-K for the period ended December 31, 2016 and our other SEC filings from time to time.
This fact sheet speaks as of its
date and we, our advisors, and our and their affiliates and representatives undertake no obligation to update, revise or correct the information contained herein, except as required by law.
Industry and Market Data
This fact sheet contains
industry and market data that we obtained from independent industry publications. We have not independently confirmed this data and, although we believe it is generally reliable, it involves a number of assumptions and limitations, it is inherently
imprecise, and you are cautioned not to place undue reliance on it.