Helius Medical Technologies and HealthTech Connex Announce Exclusive Distribution Agreement for the Portable Neuromodulation Stimulator (PoNS®) Device

— Agreement extends existing partnership —
— Collaboration makes HealthTech Connex the exclusive provider of PoNS Therapy in the Vancouver area and will greatly strengthen Helius’s presence in the region —

NEWTOWN, Pa., March 22, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, and HealthTech Connex Inc. (“HTC”), a leading health technology company specializing in neurotechnology innovations, announced today that they have entered into an exclusive distribution agreement.

This agreement, which replaces Helius and HTC’s prior clinical research and co-promotion agreement, grants HTC the exclusive right to purchase, market, sell, and distribute Helius’s PoNS device throughout the metropolitan Vancouver and Fraser Valley regions of British Columbia, Canada, subject to established minimums. The initial term is for five years, with the possibility to extend to ten years.

“HTC has been an important partner for Helius and we are delighted to extend this valuable collaboration. PoNS is the perfect fit for HTC’s leading-edge neurorehabilitation clinics and this agreement will allow Helius to establish a strong presence in the greater Vancouver area while continuing to help HTC empower patients who suffer from gait and balance impairment improve their daily lives,” said Helius President and Chief Executive Officer Dane Andreeff.

“We’re thrilled to announce the collaboration with Helius that gives HTC exclusive rights to purchase, market, sell, and distribute Helius’s PoNS device throughout the metropolitan Vancouver and Fraser Valley regions of British Columbia. This will allow HTC to continue providing groundbreaking treatment using the PoNS device to make a positive impact in the lives of countless people in British Columbia,” stated Kirk Fisher, Chief Executive Officer of HTC.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS®) device. For more information about the PoNS® or Helius Medical Technologies, visit www.heliusmedical.com.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device 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. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) 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 (ii) 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 HealthTech Connex Inc.

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 located in the Health and Technology District in Surrey, British Columbia. The company is focused on delivering translational neuroscience innovations to care sectors and communities worldwide. Its trademark product, the NeuroCatch^® Platform, consists of EEG electrodes embedded in a mesh cap. It interfaces with a custom software platform to elicit desired brain responses within just six minutes. 

About NeuroCatch Inc:

NeuroCatch Inc. is a neuro-health technology company focused on translating neuroscience research innovations into real-world medical devices and consumer products. It is located within the Health and Technology District in Surrey, British Columbia and is a wholly owned subsidiary of HealthTech Connex Inc. Its medical device, the NeuroCatch^® Platform, conducts a rapid six-minute scan at the point of care to measure and report on cognitive brain function. The three different brain responses it measures, also known as event-related potentials (ERPs), are termed the ABCs of NeuroCatch^® and are derived from the scientific framework of brain vital signs. 

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 Company’s partnership with HTC.

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, the impact of the COVID-19 pandemic, 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, future clinical trials and the clinical development process, manufacturing and supply chain risks, the product development process and FDA regulatory submission review and approval process, other development activities, 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