HSDT Helius Medical Technologies Inc

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the publication of a white paper demonstrating that rehabilitative treatment with the Portable Neuromodulation Stimulator (“PoNS®”) can drastically improve return-to-work (“RTW”) outcomes for patients suffering from TBI. The report, entitled “Evaluating the Real-World Impact of PoNS Therapy™ on Return-to-Work Outcomes in Individuals on Long-Term Disability due to Traumatic Brain Injury,” was co-sponsored by Pacific Blue Cross (“PBC”) and HealthTech Connex (“HTC”), and performed at the Surrey Neuroplasticity Clinic. The Centre for Neurology Studies collected and analyzed the data and released it in a white paper, which can be found on HTC’s website.

Nearly seven million people in North America suffer from chronic balance deficit and other disabilities related to TBI, which negatively affects a person’s ability to work and their overall quality of life. Rehabilitation therapy is the current standard of care. However, its efficacy varies widely, and many patients reach plateaus over time or even lose some function regained through rehabilitation. As a result, the RTW rate, at approximately 40%, is relatively low, and a significant percentage of patients end up on long-term disability, often permanently.

Because PoNS Therapy has demonstrated the ability to improve balance and gait significantly in this underserved population, PBC contracted HTC to deliver treatment with PoNS to nine patients suffering from long-term TBI-related disabilities. The program participants included patients who were at least two years post-injury, who did not respond to standard rehabilitation treatments, and for whom RTW was not expected. The study was designed to track and report occupational performance and durable (over six months) RTW status for the nine patients who received PoNS Therapy, which is administered by using a PoNS device to deliver mild electrical impulses to branches of the trigeminal and facial nerves via the tongue while the patient performs a set of rehabilitation exercises as instructed by a physical therapist.

Key findings of the study include:

• Five out of nine (56%) participants returned to work
• Four of those five (80%) returned to their prior occupations full-time for at least six months
• Six of the nine (67%) study participants experienced a clinically significant improvement in balance and gait
• Eight of nine (89%) said that balance and gait was no longer a barrier to return to work
• Three of six (50%) participants who indicated headaches were a barrier to work saw a reduction in the severity of their headaches
• PBC estimated that the five individuals who returned to work saved the provider approximately $1.6 million in long-term disability claims

“In my 31 years as a physiotherapist, I have never seen clinical results like this,” said Tanja Yardley, Vice President of Clinical Innovation at HTC. “One participant described PoNS Therapy as a ‘life changing experience.’ Not only did PoNS give these patients their lives back, but it also reduced the financial burden to the insurance provider and brought much-needed technology advancements to the patients who could benefit most.”

“These results demonstrate the significant impact PoNS Therapy can have on the lives of people suffering from TBI. All participants to the study were deemed unlikely to work again and, remarkably, more than half resumed their former occupations for an extended length of time,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer. “In addition to significant improvements in balance and gait disability, PoNS Therapy helped with headache, cognitive, and mental health symptoms. We are pleased to have contributed to this impactful study with our innovative PoNS Therapy and proud of the role this treatment plays in improving the health of TBI patients.”

About Helius Medical Technologies, Inc. 

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information visit www.heliusmedical.com.  

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, 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.

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use 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; and (iii) 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. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com. 

About Pacific Blue Cross

Pacific Blue Cross is a Health Benefits Society and British Columbia’s number one health benefits provider. Based in Burnaby, BC, the not-for-profit organization provides health, dental, life, disability and travel coverage for 1 in 3 British Columbians through group benefits and individual plans. As part of its mission to improve health and wellbeing for British Columbians, Pacific Blue Cross proactively supports charitable organizations across the province working to improve health outcomes. More information: pac.bluecross.ca.

About HealthTech Connex

HealthTech Connex connects science and R&D to product breakthroughs utilizing state-of-the-art brain health technology. The team comprises recognized health, science, and business leaders with extensive experience in leveraging healthcare advances fueled by agile partnerships through its headquarters in Surrey, British Columbia. Based on the business model MEASURE, TEST, and TREAT, the company strives to optimize brain health through its three divisions: NeuroCatch Inc., Centre for Neurology Studies, and Surrey Neuroplasticity Clinic. HealthTech Connex is dedicated to deliver translational neuroscience innovations to care sectors and communities worldwide. More information: healthtechconnex.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the success of the Company’s commercialization efforts including those related to the project between PBC and HTC and the uses and effectiveness of PoNS and PoNS Therapy.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, lingering impacts of the COVID-19 pandemic, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, 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 build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com. 

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law. 

Investor Relations Contact Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com