Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2024 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-4787690 ...

--Revelation Neuro, Inc. is focused on advancing development of a Non-Implantable Artificial Intelligence ("AI") Powered BCI Technology-- --Helius' existing IP portfolio and extensive data warehouse provides a solid foundation for AI algorithm development-- --Helius to Present at the 37th Annual ROTH Conference on Monday, March 17 at 12:00pm PT-- NEWTOWN, Pa., March 13, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) ("Helius" or the "Company"), a neurotech company focused on delive ...

--Revelation Neuro, Inc. is focused on advancing development of a Non-Implantable Artificial Intelligence (“AI”) Powered BCI Technology-- --Helius’ existing IP portfolio and extensive data warehouse provides a solid foundation for AI algorithm development-- --Helius to Present at the 37th Annual ROTH Conference on Monday, March 17 at 12:00pm PT-- NEWTOWN, Pa., March 13, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delive ...

--Anthem Blue Cross Blue Shield approves claim for PoNS Device at out-of-network adjusted list price-- --Provides further validation of PoNS pricing-- NEWTOWN, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- 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 its first reimbursement payment from a major healthcare provider, Anthem Blue Cross Blue Shield, for ...

--PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy on gait deficit improvement in people with Multiple Sclerosis-- --Statistically significant findings in DGI (Dynamic Gait Index) during Phase 1 and Phase 2 among the 38 subjects who completed the treatment protocol showing a total mean improvement of 5.00 (4.1 to 5.9, p<0.001) at week 14-- NEWTOWN, Pa., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Hel ...

Transaction Details - Helius Medical Technologies has entered into agreements with certain warrant holders to exercise outstanding warrants for 4,971,110 shares of common stock at a reduced exercise price of $0.751 per share, generating approximately $3.7 million in gross proceeds [1] - The new warrants will be exercisable for up to 6,213,888 shares of common stock, with 3,728,333 warrants exercisable for five years and 2,485,555 warrants exercisable for two years after stockholder approval [3] - Roth Capital Partners is acting as the financial advisor for this transaction [2] PoNS Device and Therapy - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece to improve balance and gait, primarily used at home with physical rehabilitation exercises [5] - PoNS is indicated in the US for short-term treatment of gait deficit due to mild-to-moderate multiple sclerosis symptoms and is used as an adjunct to supervised therapeutic exercise programs for patients aged 22 and over [5] - In Canada, PoNS is authorized for sale in three indications: gait deficit due to stroke, chronic balance deficit due to mild-to-moderate traumatic brain injury, and gait deficit due to multiple sclerosis, all used in conjunction with physical therapy [6] - PoNS is also authorized for sale in Australia for short-term use by healthcare professionals as an adjunct to therapeutic exercise programs to improve balance and gait [6] Company Overview - Helius Medical Technologies is a leading neurotech company focused on neurologic deficits using an orally applied technology platform that amplifies the brain's ability to engage physiologic compensatory mechanisms and promote neuroplasticity [7] - The company's first commercial product is the Portable Neuromodulation Stimulator (PoNS) [8]

--128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants-- --150 maximum participant enrollment projected by end of January-- --The stroke registrational program is intended to demonstrate the safety and effectiveness of the novel Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors-- --On track for FDA submission for stroke authorization in the second quarter of 2025-- NEWTOWN, Pa., Jan. 21, 2025 (GLOBE NEWSWIRE) -- H ...

NEWTOWN, Pa., Dec. 23, 2024 (GLOBE NEWSWIRE) -- 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 first PoNS System sale to the VA Healthcare System. The PoNS System sale through our distributor, Lovell Government Services ("Lovell"), was at the contracted price of $23,844, comprised of $16,499 for the PoNS Controller and $7,345 for the PoNS Mou ...

NEWTOWN, Pa., Nov. 18, 2024 (GLOBE NEWSWIRE) -- 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 provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator (PoNS) device and announced plans to host a business update call today at 9:00am ET.   “We disagree with the proposed pricing for the PoNS Mouthpiece and are ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. | --- | --- | |----------------------------------------------------------------- ...