Helius Medical Technologies Announces DMEPOS Accreditation for PoNS

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— Crucial preliminary step towards US reimbursement —

NEWTOWN, Pa., June 20, 2023 (GLOBE NEWSWIRE) — Helius Medical Applied sciences, Inc. (Nasdaq:HSDT) (“Helius” or the “Firm”), a neurotech firm centered on delivering a novel therapeutic neuromodulation strategy for stability and gait deficits, at the moment introduced that its Moveable Neuromodulation Stimulator (PoNS®) gadget has been awarded Sturdy Medical Tools, Prosthetics, Orthotics and Provides (DMEPOS) accreditation by The Compliance Workforce (TCT), which is allowed by the Facilities for Medicare & Medicaid Providers (CMS) to accredit all DMEPOS services and products. The accreditation certifies that Helius has established processes that conform to TCT’s Exemplary Supplier® DMEPOS High quality Requirements.

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“We’re thrilled that PoNS has been awarded DMEPOS accreditation. Not solely does the certification underscore our dedication to high quality and affected person care, however it is usually a vital a part of our U.S. reimbursement technique. Organizations that want to invoice Medicare should have accreditation from an accepted company and it’s change into a typical with different funding sources as nicely,” stated Helius President and Chief Government Officer Dane Andreeff.

“DMEPOS accreditation has explicit relevance beneath the proposed Transitional Protection for Rising Applied sciences (TCET) laws. If handed as presently proposed, firms with a breakthrough designation might be lined by Medicare for as much as 4 years, permitting time to collect the required scientific knowledge to show the efficacy of their merchandise. PoNS has breakthrough designations in each a number of sclerosis and stroke within the U.S. and this certification establishes that Helius is an Exemplary Supplier® and our PoNS gadget has already met and exceeded CMS high quality requirements,” concluded Andreeff.

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TCT is a nationally acknowledged healthcare accreditation group that gives complete accreditation and certification companies to healthcare suppliers in all fifty states. TCT’s proprietary accreditation standing is named Exemplary Supplier Accreditation® and its industry-leading accreditation mannequin options healthcare’s first complete set of plain language, operations-driven high quality requirements with expert-led implementation steerage.

About Helius Medical Applied sciences, Inc.

Helius Medical Applied sciences is a number one neurotech firm within the medical gadget area centered on neurologic deficits utilizing non-implantable platform applied sciences that amplify the mind’s skill to compensate and promote neuroplasticity, bettering the lives of individuals coping with neurologic illnesses. The Firm’s first industrial product is the Moveable Neuromodulation Stimulator (PoNS®) gadget. For extra details about the PoNS® or Helius Medical Applied sciences, go to www.heliusmedical.com.

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Concerning the PoNS Gadget and PoNS Remedy

The Moveable Neuromodulation Stimulator (PoNS) is an modern non-surgical medical gadget, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the floor of the tongue to enhance stability and gait. The PoNS gadget is indicated to be used in the USA as a short-term remedy of gait deficit resulting from mild-to-moderate signs from a number of sclerosis (“MS”) and is for use as an adjunct to a supervised therapeutic train program in sufferers 22 years of age and over by prescription solely.

PoNS can be approved on the market in Canada for 3 indications: (i) to be used as a short-term remedy (14 weeks) of continual stability deficit resulting from mild-to-moderate traumatic mind damage (“mmTBI”) and is for use along with bodily remedy; and (ii) to be used as a short-term remedy (14 weeks) of gait deficit resulting from gentle and average signs from MS and is for use along with bodily remedy; and (iii) to be used as a short-term remedy (14 weeks) of gait deficit resulting from gentle and average signs from stroke, for use along with bodily remedy. PoNS can be approved on the market in Australia for brief time period use by healthcare professionals as an adjunct to a therapeutic train program to enhance stability and gait. For extra data go to www.ponstherapy.com.

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Cautionary Disclaimer Assertion

Sure statements on this information launch are usually not based mostly on historic information and represent forward-looking statements or forward-looking data throughout the which means of the U.S. Non-public Securities Litigation Reform Act of 1995 and Canadian securities legal guidelines. All statements aside from statements of historic truth included on this information launch are forward-looking statements that contain dangers and uncertainties. Ahead-looking statements are sometimes recognized by phrases similar to “consider,” “count on,” “proceed,” “will,” “aim,” “intention” and related expressions. Such forward-looking statements embrace, amongst others, statements relating to the Firm’s skill to acquire reimbursement for the PoNS gadget, and the potential for TCET to be accepted.

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There could be no assurance that such statements will show to be correct and precise outcomes and future occasions may differ materially from these expressed or implied by such statements. Essential components that might trigger precise outcomes to vary materially from the Firm’s expectations embrace uncertainties related to the Firm’s capital necessities to realize its enterprise goals, disruptions within the banking system and monetary markets, lingering impacts of the COVID-19 pandemic, the impact of macroeconomic situations and the Firm’s skill to entry capital markets, the Firm’s skill to coach bodily therapists within the supervision of using the PoNS Therapy, the Firm’s skill to safe contracts with rehabilitation clinics, the Firm’s skill to acquire nationwide Medicare protection and to acquire a reimbursement code in order that the PoNS gadget is roofed by Medicare and Medicaid, the Firm’s skill to construct inside industrial infrastructure, safe state distribution licenses, construct a industrial workforce and construct relationships with Key Opinion Leaders, neurology consultants and neurorehabilitation facilities, market consciousness of the PoNS gadget, availability of funds, manufacturing, labor scarcity and provide chain dangers, our skill to take care of and implement our mental property rights, scientific trials and the scientific growth course of, the product growth course of, the regulatory submission evaluate and approval course of, our working prices and use of money, and our skill to realize vital revenues, ongoing authorities regulation, and different dangers detailed once in a while within the “Danger Elements” part of the Firm’s Annual Report on Type 10-Ok for the yr ended December 31, 2022, and its different filings with the USA Securities and Change Fee and the Canadian securities regulators, which could be obtained from both at www.sec.gov or www.sedar.com.

The reader is cautioned to not place undue reliance on any forward-looking assertion. The forward-looking statements contained on this information launch are made as of the date of this information launch and the Firm assumes no obligation to replace any forward-looking assertion or to replace the explanation why precise outcomes may differ from such statements besides to the extent required by legislation.

Investor Relations Contact

Lisa M. Wilson, In-Web site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

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