For general inquiries, call 1 877-564-0008 or [email protected]. Fax PoNS device prescriptions to 1 (215) 754-4903.

– Training for physical therapists treating patients with multiple sclerosis (MS) is now available on demand –

NEWTOWN, Pa., July 12, 2022 (GLOBE NEWSWIRE) – Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the launch of its online training module for physical therapists seeking to treat gait deficit in adults with mild to moderate symptoms of multiple sclerosis (“MS”).

“We are pleased to introduce our online PoNS Therapy training curriculum. In the past, physical therapists treating gait deficit in patients with MS received PoNS training through an in-person, multi-day course. Our new online module allows training to be completed in three hours, or less, at the therapist’s own pace. Prior to implementing the software, we could only train five to ten people at a time and already we have fifty-five therapists in the queue in the United States, and another twenty in Canada. By standardizing the process and reducing training time, we expand access to training and facilitate physical therapists’ specialization in PoNS Therapy to provide a meaningful therapeutic intervention for MS patients in the United States who suffer from walking impairment,” stated Dane Andreeff, President and Chief Executive Officer of Helius.

PoNS Therapy training modules are now live for registrants to complete at their own pace. Providers who are interested may visit https://ponstreatment.com/training/ or contact Helius at [email protected] to learn more. Online training for therapists in Canada will be available later in July.

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 promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, 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) designed to partner with neurologists and neurorehabilitation therapists at 10-12 US centers of excellence, who express an interest in becoming “early adopters” of PoNS Therapy. The Company has also initiated its Patient Therapy Access Program (“PTAP”), which provides qualifying patients access to on-label PoNS Therapy at a significantly reduced price. PTAP is expected to run through December 31, 2022.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.

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 expected scope and duration of PTAP, patients’ ability to qualify for PTAP, and availability of online PoNS training for physical therapists in Canada.

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, and ability to raise capital, 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, 2021 and Quarterly Report on Form 10-Q for the three months ended March 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: [email protected]

By submitting this form, you agree to receive future updates and communication regarding the PoNS® device and other Helius products, services, programs or topics of interest. Your consent is not required as a condition of receiving any goods or services from Helius. You may choose unsubscribe and choose not to receive further information from Helius by emailing [email protected]

IMPORTANT SAFETY INFORMATION

No serious adverse events related to the PoNS device were reported in the MS RCTs or in use in clinical rehabilitation settings to treat balance and gait disorders.

Some individuals have reported headaches, fatigue, and excess salivation. Excess salivation during training sessions often occurs but generally improves as patients get used to wearing the mouthpiece.

Indication
The PoNS® device is indicated for use as a short term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis and is to be used as an adjunct to a supervised therapeutic exercise program for adults 22 years of age and over by prescription only.

Contraindications
The PoNS® device delivers electrical stimulation directly to the surface of the tongue. Precautions for use are similar to those for transcutaneous electrical nerve stimulation (TENS).

Electrical stimulation should not be used:

  • If there is an active or suspected malignant tumor
  • In areas of recent bleeding or open wounds
  • In areas that lack normal sensation

The PoNS® has not been tested on, and thus should not be used by individuals who are pregnant. Do not use the PoNS® if you are sensitive to nickel, gold or copper.

Use with caution
Electrical stimulation should only be used after seeking professional medical advice, and with caution in patients with any of the following:

  • Implanted electronic devices, including:
    • Cardiac pacemakers
    • Cardioverter defibrillators
    • Deep Brain Stimulators
    • Vagal Nerve Stimulators
    • Sacral nerve stimulators
    • Cochlear Implants
  • Metal in the mouth (e.g. piercings, braces, retainers, or other orthodontic appliance)
  • Seizure disorders
  • Epilepsy

Ready to get started with PoNS?

Patients who are seeking more information on how to get PoNS can email us at [email protected], or fill out our contact form: