Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Rhea-AI Summary

Helius Medical Technologies has received a significant boost with the issuance of U.S. Patent No. 11,197,994, enhancing its Portable Neuromodulation Stimulator (PoNS) device. This patent allows for wired communication between the mouthpiece and the controller, paving the way for next-generation PoNS therapy. Currently, Helius holds 34 U.S. and 46 foreign patents, and PoNS is approved for treating gait deficits in MS patients in the U.S., while authorized for use in Canada and Australia for similar conditions. The advancements position Helius strongly in the neurotech market.

Positive

• Issuance of U.S. Patent No. 11,197,994 allows wireless communication in PoNS device.
• Helius now holds 34 U.S. and 46 foreign patents, strengthening its intellectual property.
• PoNS device authorized for use in treating gait deficit from MS in the U.S. and other conditions in Canada and Australia.

Negative

• None.

Patent Readies Company for Next Generation of PoNS Therapy

NEWTOWN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,197,994, which is directed to systems for providing non-invasive neurorehabilitation of a patient. The patent is similar in scope to prior Helius patents for the Portable Neuromodulation Stimulator (PoNS) device but expressly recites that the communications between the mouthpiece and controller are done wirelessly.

“We are pleased to announce our new patent, which will allow for a wireless connection between the mouthpiece and controller of our PoNS device,” said Dane Andreeff, President and Chief Executive Officer of Helius. “PoNS is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma, and this patent is an important building block for future generations of PoNS therapy.”

Helius now owns 34 U.S. and 46 foreign patents expiring between 2026 and 2036, and exclusively licenses nine U.S. medical method patents expiring between 2029 and 2031.

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) PoNS is authorized 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) PoNS is authorized 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.

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.

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,” “future,” “goal,” “aim” and similar expressions.

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 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, 2020, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 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

FAQ

What is U.S. Patent No. 11,197,994 related to HSDT?

U.S. Patent No. 11,197,994 pertains to systems for providing non-invasive neurorehabilitation, specifically allowing wireless communication between the mouthpiece and controller of the PoNS device.

What are the key features of the Portable Neuromodulation Stimulator (PoNS)?

The PoNS is a non-surgical medical device that delivers electrical stimulation to the tongue, aimed at improving balance and gait, specifically for patients with mild-to-moderate symptoms from multiple sclerosis.

How many patents does Helius Medical Technologies hold?

Helius Medical Technologies currently holds 34 U.S. and 46 foreign patents, with an additional nine U.S. medical method patents under exclusive license.

What indications does PoNS have in Canada?

In Canada, PoNS is authorized for treating chronic balance deficits due to mild-to-moderate traumatic brain injury and gait deficits due to mild and moderate MS symptoms.

What advancements are planned for PoNS therapy under HSDT?

Helius Medical Technologies is focused on advancing PoNS therapy through ongoing post-approval research and the recently launched Therapeutic Experience Program.