0001558370-25-003619 | 10-K | XBRL Viewer | Helius Medical Technologies INC

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Document and Entity Information - USD ($)	12 Months Ended
Document and Entity Information - USD ($)	Dec. 31, 2024	Mar. 18, 2025	Jun. 30, 2024
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2024
Document Transition Report	false
Entity File Number	001-38445
Entity Registrant Name	HELIUS MEDICAL TECHNOLOGIES, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	36-4787690
Entity Address, Address Line One	642 Newtown Yardley Road, Suite 100
Entity Address, City or Town	Newtown
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	18940
City Area Code	215
Local Phone Number	944-6100
Title of 12(b) Security	Class A Common Stock, $0.001 par value per share
Trading Symbol	HSDT
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 3,094,103
Entity Common Stock, Shares Outstanding		6,126,778
Auditor Firm ID	23
Auditor Name	Baker Tilly US, LLP
Auditor Location	Minneapolis, Minnesota
Entity Central Index Key	0001610853
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Amendment Flag	false

INTANGIBLE ASSETS

12 Months Ended

Dec. 31, 2024

INTANGIBLE ASSETS

INTANGIBLE ASSETS

6.INTANGIBLE ASSETS

Intangible assets consist of the following (in thousands):


			December 31,
			2024						2023
							Net						Net
	Useful Life				Accumulated		Carrying				Accumulated		Carrying
	(in years)		Cost		Amortization		Value		Cost		Amortization		Value
Reacquired rights		3.87	$	447	$	(447)	$	—	$	486	$	(486)	$	—
Acquired proprietary software		5.00		134		(134)		—		145		(121)		24
Internally developed software		3.00		84		(84)		—		84		(84)		—
Total intangible assets			$	665	$	(665)	$	—	$	715	$	(691)	$	24

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2024

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

15.SUBSEQUENT EVENTS

Warrant inducement

On January 21, 2025, the Company entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain holders (the “Holders”) of its existing 2024 Public Warrants to purchase shares of the Company’s Class A common stock (the “Existing Warrants”), pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 4,971,110 shares of the Company’s common stock, in the aggregate, at a reduced exercise price of $0.751 per share, in exchange for the Company’s agreement to issue new Series C Warrants and Series D Warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants described below, to purchase up to 6,213,888 shares of the Company’s common stock (the “Inducement Warrant Shares”). The Company received aggregate gross proceeds of approximately $3.7 million from the exercise of the Existing Warrants by the

Holders. The Company engaged Roth to act as its financial advisor with the transactions summarized above and has paid Roth $0.2 million for its services, in addition to reimbursement for certain expenses along with other legal and regulatory expenses resulting in net proceeds of $3.4 million.

The Company has filed a registration statement on Form S-3 covering the resale of the Inducement Warrants Shares issued or issuable upon the exercise of the Inducement Warrants. In the Inducement Letters, the Company agreed not to issue any shares of common stock or common stock equivalents or to file any other registration statement with the SEC (in each case, subject to certain exceptions) for sixty (60) calendar days. The Company also has agreed not to effect or agree to effect any variable rate transaction (as defined in the Inducement Letters) for seventy-five (75) calendar days from the date of the Inducement Letters.

The Company has agreed to hold an annual or special meeting of stockholders on or prior to the date that is ninety (90) calendar days following the date of the Inducement Letters for the purpose of obtaining stockholder approval, with the recommendation of the Company’s board of directors that such proposals are approved. If the Company does not obtain stockholder approval at the first meeting, the Company has agreed to call a meeting to seek stockholder approval every ninety (90) calendar days until the date that the Inducement Warrants are no longer outstanding.

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Accrued and other current liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Accrued and other current liabilities
Insurance payable	$ 356	$ 446
Employees benefits	759	509
Professional services	24	52
Franchise tax		168
Other	100	85
Total accrued and other current liabilities	$ 1,239	$ 1,260

COMMITMENTS AND CONTINGENCIES

12 Months Ended

Dec. 31, 2024

COMMITMENTS AND CONTINGENCIES.

COMMITMENTS AND CONTINGENCIES

13.COMMITMENTS AND CONTINGENCIES

The Company is obligated under a license agreement with Advanced NeuroRehabilitation, LLC (“ANR”) to pay a 4% royalty on net revenue collected from the sale of devices covered by ANR’s patent pending technology, claims and knowhow. For the years ended December 31, 2024 and 2023, the Company recorded royalty expense from the sale of devices of approximately $19 thousand and $24 thousand, respectively, in its Consolidated Statements of Operations and Comprehensive Loss.

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
SUPPLEMENTAL BALANCE SHEET DISCLOSURES
Prepaid expenses	$ 603	$ 689
Inventory related	55	333
Deferred offering costs	7	140
Total prepaid expenses and other current assets	$ 665	$ 1,162

SEGMENT AND GEOGRAPHIC INFORMATION (Tables)

12 Months Ended

Dec. 31, 2024

SEGMENT AND GEOGRAPHIC INFORMATION

Schedule of revenue disaggregated by geographic area

The following table presents the Company’s revenue disaggregated by geographic area (in thousands):



	Years Ended
	2024		2023
Product sales, net:
United States	$	181	$	324
Canada		295		281
Total product sales, net		476		605
Other revenue		44		39
Total revenue	$	520	$	644

FIXED ASSET IMPAIRMENT (Details) - USD ($) $ in Thousands	3 Months Ended
FIXED ASSET IMPAIRMENT (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Sep. 30, 2023
FIXED ASSET IMPAIRMENT
Long-lived tangible assets impairment charges	$ 40	$ 159

LEASES (Tables)

12 Months Ended

Dec. 31, 2024

LEASES

Schedule of maturities of operating lease liabilities

Maturities of operating lease liabilities as of December 31, 2024 were as follows (in thousands):


2025	$	12
Total lease payments		12
Less: imputed interest		—
Total lease liabilities	$	12

The following table provides information on the lease term and discount rate for the operating lease as of December 31, 2024:


Remaining lease term (in years)	0.25
Discount rate	4.55	%

SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Schedule Of Significant Accounting Policies [Line Items]
Employee retention credit amount		$ 500
Employee retention credit receivable	$ 500
Advertising expenses	$ 651	$ 670
Furniture and fixtures
Schedule Of Significant Accounting Policies [Line Items]
Estimated useful life	7 years
Equipment \| Minimum
Schedule Of Significant Accounting Policies [Line Items]
Estimated useful life	5 years
Equipment \| Maximum
Schedule Of Significant Accounting Policies [Line Items]
Estimated useful life	15 years
Computer software and hardware \| Minimum
Schedule Of Significant Accounting Policies [Line Items]
Estimated useful life	3 years
Computer software and hardware \| Maximum
Schedule Of Significant Accounting Policies [Line Items]
Estimated useful life	5 years

STOCK-BASED COMPENSATION - Plan information (Details) - shares		12 Months Ended
	Jun. 27, 2024	Dec. 31, 2024	Jan. 01, 2025	Jul. 02, 2024
2022 Plan
STOCK-BASED COMPENSATION
Expiration period		10 years
Automatic increase to number of shares authorized for issuance, as a percentage of fully diluted shares of common stock outstanding	5.00%
Shares authorized for issuance	2,089,000	2,089,000	2,703,678	150,000
Shares of common stock available for issuance			637,237
2022 Plan \| Minimum
STOCK-BASED COMPENSATION
Vesting period		1 year
2022 Plan \| Maximum
STOCK-BASED COMPENSATION
Vesting period		3 years
Inducement Plan
STOCK-BASED COMPENSATION
Shares of common stock available for issuance		123,980
Inducement Plan \| Minimum
STOCK-BASED COMPENSATION
Vesting period		4 years
Inducement Plan \| Maximum
STOCK-BASED COMPENSATION
Vesting period		10 years

BASIC AND DILUTED LOSS PER SHARE - Computation (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Basic:
Net loss available to common stockholders - basic	$ (11,742)	$ (8,850)
Weighted average common shares outstanding - basic (in shares)	2,709,781	607,890
Loss per share - basic (in dollar per share)	$ (4.33)	$ (14.56)
Diluted:
Net loss available to common stockholders - diluted	$ (11,742)	$ (8,850)
Weighted average common shares outstanding - diluted (in shares)	2,709,781	607,890
Loss per share - diluted (in dollar per share)	$ (4.33)	$ (14.56)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

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- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

COMMON STOCK AND WARRANTS (Tables)

12 Months Ended

Dec. 31, 2024

COMMON STOCK AND WARRANTS

Schedule of estimate the fair value of the warrants


	December 31,			December 31,
	2024			2023
Stock price	$	0.67		$	8.04
Warrant term (in years)		2.61			3.61
Expected volatility		98.92	%		84.10	%
Risk-free interest rate		4.26	%		3.96	%
Dividend rate		0.00	%		0.00	%

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

SEGMENT AND GEOGRAPHIC INFORMATION (Details) - USD ($)	12 Months Ended
SEGMENT AND GEOGRAPHIC INFORMATION (Details) - USD ($)	Dec. 31, 2024	Dec. 31, 2023
Segment and Geographic Information
Product sales, net	$ 476,000	$ 605,000
Other revenue	44,000	39,000
Total revenue	$ 520,000	$ 644,000
Number of operating segments	1
Number of reportable segments	1
Net product sales \| Customer \| Two customers
Segment and Geographic Information
Number of customers	2	2
Concentration of risk (percent)	72.00%	65.00%
Accounts receivable, net \| Customer \| Single customer
Segment and Geographic Information
Concentration of risk (percent)		83.00%
Accounts receivable, net \| Credit \| Two customers
Segment and Geographic Information
Number of customers	2
Concentration of risk (percent)	100.00%
United States
Segment and Geographic Information
Product sales, net	$ 181,000	$ 324,000
Canada
Segment and Geographic Information
Product sales, net	295,000	$ 281,000
Long-lived assets	$ 0

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2024	Dec. 31, 2023
Consolidated Balance Sheets
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	150,000,000	150,000,000
Common stock, shares, issued (in shares)	3,728,172	714,590
Common stock, shares, outstanding (in shares)	3,728,172	714,590

COMMON STOCK AND WARRANTS

12 Months Ended

Dec. 31, 2024

COMMON STOCK AND WARRANTS

COMMON STOCK AND WARRANTS

8.COMMON STOCK AND WARRANTS

The Company may issue common stock in connection with underwritten public offerings, registered direct public offerings or other financing transactions. Such issuances of common stock may include the issuance or sale of warrants to purchase common stock. As of December 31, 2024, the Company reserves 146,271,828 shares of Class A Common Stock and 10,000,000 shares of unissued preferred stock for future issuances and future exercises of outstanding warrants and stock-based compensation awards.

Equity Transactions

Public Offering

On May 9, 2024, the Company closed on a registered public offering consisting of 704,999 shares of Common Stock (the “2024 Public Offering”), pre-funded warrants to purchase 2,147,222 shares of Common Stock (the “Pre-funded Warrants”) and accompanying Series A Warrants to purchase up to 2,852,221 shares of its Common Stock (“Series A Warrants”) and Series B Warrants to purchase up to 2,852,221 shares of its Common Stock (“Series B Warrants”, and together with the Series A Warrants, the “2024 Public Warrants”). The 2024 Public Offering price per share of Common Stock and accompanying Series A Warrants and Series B Warrants was $2.25, the public offering price per Pre-funded Warrant and accompanying Series A and Series B warrant was $2.249.

The Pre-funded Warrants have an exercise price of $0.001 per share and 1,076,445 were exercised on the closing date. Net proceeds from the 2024 Public Offering, after deducting placement agent fees and expenses and other offering costs, were approximately $5.5 million.

The 2024 Public Warrants have an exercise price of $2.25 per share and are exercisable upon issuance. The Series A Warrants will expire five years following the date of issuance and the Series B Warrants will expire twelve months following the date of issuance. The Pre-funded Warrants are exercisable upon issuance and may be exercised at any time until the Pre-funded Warrants are exercised in full.

At-The-Market Offering

On June 23, 2023, the Company entered into a Sales Agreement (the “Sales Agreement”) with Roth Capital Partners, LLC (“Roth”) to create an at-the-market offering program (“ATM”) under which the Company may offer and sell shares having an aggregate offering price of up to $2.0 million. Roth is entitled to a commission at a fixed commission rate equal to up to 3% of the gross proceeds pursuant to the Sales Agreement. As of December 31, 2024, 201,211 share issuances of securities have occurred in connection with the ATM generating net proceeds of $1.3 million and $0.4 million inclusive of share issuance costs in 2024 and 2023, respectively. On January 17, 2025, 93,300 shares were issued with the ATM, generating net proceeds of $0.1 million inclusive of share issuance costs.

Series B Preferred Stock

On March 23, 2023, the Board of Directors declared a dividend of one one-thousandth of a share of Series B Preferred Stock (“Series B Preferred Stock”) for each outstanding share of Common Stock held of record on April 3, 2023. The value of the Series B Preferred Stock issued in connection with the stock dividend was immaterial.

The outstanding shares of Series B Preferred Stock voted together with the outstanding shares of the Company’s Common Stock, as a single class, exclusively with respect to a proposal giving the Board of Directors the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the foregoing matters.

Each share of Series B Preferred Stock entitled the holder to 1,000,000 votes per share and each fraction of a share of Series B Preferred Stock had a ratable number of votes. The holder of Series B Preferred Stock, as such, are not entitled to receive dividends.

At the annual meeting of stockholders of the Company held on May 24, 2023, the Company’s stockholders approved an amendment to the Company’s Certificate of Incorporation to effect a reverse stock split of its outstanding Common Stock. All shares of Series B Preferred Stock that did not vote in person or by proxy were redeemed in whole by the Company. Shares of Series B Preferred Stock that did vote in person or by proxy will need to request redemption from the Company at a rate of $0.001 per share in cash. As of December 31, 2024, no shareholders of Series B Preferred Stock have requested such redemption.

Reverse Stock Split

At the annual meeting of stockholders on May 24, 2023, our stockholders voted to approve a reverse stock split of our outstanding Class A common stock at a ratio in the range of 1-for-10 to 1-for-80 to be determined at the discretion of the Board of Directors. On August 11, 2023, the Board approved a 1-for-50 reverse stock split of the Company’s issued and outstanding Common Stock (the “Reverse Stock Split”).

Warrants

August 2022 Warrants

In connection with the Company’s registered public offering that closed on August 9, 2022, the Company issued warrants to purchase an aggregate of 720,000 shares of common stock (“2022 Public Warrants”). The Company performed an analysis of the provisions of the Public Warrants and concluded that the Public Warrants did not meet the guidance for being classified as an equity instrument due to a potential price reset prompted by a change in an unrelated instrument’s conversion rate or, in the event of a fundamental transaction, settlement rights that differ from those of the underlying common stockholders.

The fair value of the derivative liability as of December 31, 2024 and 2023 was $0.2 million and $3.3 million, respectively. The change in the fair value of the derivative liability was recognized as a component of nonoperating income in the Company’s Consolidated Statements of Operations and Comprehensive Loss.

The fair value of the 2022 Public Warrants was determined using both a Monte Carlo simulation model, which uses multiple input variables to determine the probability of the occurrence of a price reset or a fundamental transaction and the Black-Scholes option pricing model. The following table includes the stock price and the inputs used to estimate the fair value of the warrants:


	December 31,			December 31,
	2024			2023
Stock price	$	0.67		$	8.04
Warrant term (in years)		2.61			3.61
Expected volatility		98.92	%		84.10	%
Risk-free interest rate		4.26	%		3.96	%
Dividend rate		0.00	%		0.00	%

The 603,690 of outstanding liability classified Public Warrants have an exercise price that was reset to $1.6163 per share as a result of the 2024 Public Offering are exercisable upon issuance and will expire five years following the date of issuance. 23,400 Public Warrants were exercised and the Company received gross proceeds of $0.2 million during the year ended December 31, 2024. No warrants were cancelled during the year ended December 31, 2024.

Equity-classified Warrants

The Company has outstanding equity-classified warrants to purchase 5,869,244 shares of common stock at a weighted average exercise price of $3.64, with expiration dates ranging from March 2025 to May 2029. The weighted average exercise price includes 12,222 Pre-funded Warrants with a nominal exercise price of $0.001 outstanding as of December 31, 2024. The weighted average exercise price excluding the outstanding Pre-funded Warrants is $3.65 as of December 31, 2024. During the year ended December 31, 2024, 2,135,000 Pre-funded Warrants were exercised for 2,134,754 common shares as the result of the cashless exercise provision and no warrants were cancelled due to expiration.

- Definition

The entire disclosure for equity.

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-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481112/505-10-50-18

+ Details

SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
SIGNIFICANT ACCOUNTING POLICIES (Policies)	Dec. 31, 2024
SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation	Principles of Consolidation The accompanying consolidated financial statements reflect the operations of Helius Medical Technologies, Inc. and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosure of contingent assets and liabilities. Significant estimates include the assumptions used in the valuation of the fair value-pricing model for stock-based compensation, liability classified warrants and deferred income tax asset valuation allowance. Financial statements include estimates, which, by their nature, are uncertain. Actual results could differ from those estimates.
Foreign Currency Translation	Foreign Currency Translation The local currency, or CAD$, is the functional currency of the Company’s foreign operating subsidiary, Helius Medical Technologies (Canada), Inc. All assets and liabilities are translated into United States dollars at the rate of exchange in effect at the balance sheet date. Income and expense items are translated at the weighted-average exchange rate prevailing during the period. The effects of foreign currency translation adjustments are deferred and reported in stockholders' equity as a component of “Accumulated Other Comprehensive Loss.” The effects of foreign currency transactions denominated in a currency other than an entity's functional currency are included in “Foreign Exchange (Loss) Gain” in the Consolidated Statements of Operations and Comprehensive Loss.
Revenue Recognition	Revenue Recognition The Company generates nearly all revenue from product sales directly to patients, its e-commerce partner in the United States and to clinics in Canada. Revenue from product sales is recognized at a point in time as the performance obligation is satisfied and when the customer obtains control of the product at the established transaction price. Taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue. The Company requires some customers in the United States to prepay the full product selling price, net of cash discount, prior to shipment. The Company records a contract liability for any customer prepayment received for which delivery had not yet occurred as of the end of the period.
Concentration of Credit Risk	Concentration of Credit Risk The Company deposits its cash and cash equivalents in demand commercial checking, unrestricted money market savings account, money market mutual funds, treasury bills or certificates of deposit at high-quality credit institutions. At times, such deposits may be in excess of federally insured limits. The Company has not experienced any losses.
Cash Equivalents	Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. Cash equivalents are valued at cost, which approximates fair value.
Accounts Receivable	Accounts Receivable Accounts receivable arise primarily from product sales in Canada and generally require payment within 30 days. The Company provides reserves against accounts receivable for estimated credit losses that may result from a customer’s inability to pay based on a combination of factors, such as the aging of accounts receivable past the due date, the customer’s financial strength and payment history. Amounts determined to be uncollectible are charged or written off against the reserve.
Employee Retention Credit	Employee Retention Credit The employee retention credit (“ERC”), as originally enacted through the Coronavirus Aid, Relief, and Economic Security Act, is a refundable credit against certain employment taxes equal to 50% of the qualified wages an eligible employer pays to employees from March 17, 2020 to December 31, 2020. The Disaster Tax Relief Act extended the ERC for qualified wages paid from January 1, 2021 to June 30, 2021 and the credit was increased to 70% of qualified wages an eligible employer pays to employees during the extended period. The American Rescue Plan Act of 2021, enacted on March 11, 2021, further extended the ERC through December 31, 2021. The Company qualified for the employee retention credit for the period from March 17, 2020 to September 30, 2021. The Company recognizes government credits for which there is a reasonable assurance of compliance with credit conditions and receipt of credits. The Company accounts for the ERC as government assistance and applies the grant accounting model by analogy to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance. Under this approach, the Company recognizes the credit when there is reasonable assurance that it will comply with the conditions of the grant and that the credit will be received. The Company recorded a credit of $0.5 million against operating expenses on the Consolidated Statement of Operations and Comprehensive Loss during the year ended December 31, 2023 and as a current asset on the consolidated balance sheets during the year ended December 31, 2024 and December 31, 2023 as an other receivable. The Company expects to receive the credit in the next twelve months.
Inventory	Inventory Inventories are stated at the lower of cost (average cost method) or net realizable value. The Company establishes inventory reserves for obsolescence based upon specific identification of expired or unusable units with a corresponding provision included in cost of revenue. The Company calculates provisions for excess inventory based on inventory on hand compared to anticipated sales or usage. Management uses its judgment to forecast sales or usage and to determine what constitutes a reasonable period. There can be no assurance that the amount ultimately realized for inventories will not be materially different than that assumed in the calculation of the reserves.
Property and Equipment	Property and Equipment Property and equipment are recorded at cost. Depreciation is calculated for financial reporting purposes on the straight-line method over the estimated useful lives of the related assets, which are seven years for furniture and fixtures, five to fifteen years for equipment and three to five years for computer software and hardware. Depreciation expense is recorded in selling, general and administrative expenses. Expenditures for repairs and maintenance, which do not improve or extend the expected useful life of the assets, are expensed as incurred.
Long-Lived Assets	Long-Lived Assets Management reviews the carrying amounts of definite-lived intangible assets and long-lived assets, including right-of-use (“ROU”) assets, property and equipment whenever events or circumstances indicate that the carrying amounts of an asset may not be recoverable. For purposes of assessing recoverability, definite-lived intangible assets and long-lived tangible assets are each deemed to be one asset group. The carrying amount of the asset group is compared to the estimated undiscounted future cash flows associated with it. If the sum of the expected future net cash flows is less than the carrying value of the asset group being evaluated, an impairment loss is calculated as the amount by which the carrying value of the asset group exceeds its estimated fair value.
Leases	Leases The Company has an operating lease for its corporate office. The Company determines whether a contract is, or contains, a lease at inception. ROU assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present value of unpaid lease payments. The Company's incremental borrowing rate is determined based on the estimated rate of interest for collateralized borrowing over a similar term as the associated lease. The Company’s lease arrangement does not have any lease and non-lease components.
Stock-Based Compensation	Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based awards based on estimated fair values. Stock-based awards consist of stock options and restricted stock units. Stock-based compensation expense is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period (vesting period) on a straight-line basis. Forfeitures are not estimated, but instead stock-based compensation expense is adjusted upon an actual forfeiture of a stock option. Upon exercise of stock options or vesting of restricted stock units, the Company issues common stock.
Income Taxes	Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance for deferred income tax assets is recorded when it is more likely than not that some portion or all of the deferred income tax assets will not be realized.
Selling, General and Administrative Expenses	Selling, General and Administrative Expenses Selling, general and administrative expenses are charged to expense when incurred. Advertising expenses were $651 thousand and $670 thousand for the years ended December 31, 2024 and 2023, respectively.
Research and Development Expenses	Research and Development Expenses Research and development costs are charged to expense when incurred.
Derivatives	Derivatives The Company does not engage in hedging activities. The Company evaluates its financial instruments and other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for. The result of this accounting treatment is that the fair value of the derivative is re-measured at each balance sheet date and recorded as a liability or asset and the change in fair value is recorded in the Consolidated Statements of Operations and Comprehensive Loss. Reclassifications or partial reclassifications to equity are recorded based on the fair value of the derivative on the transaction date. Refer to Note 8 for additional information about the derivative liability.
Basic and Diluted Loss per Share	Basic and Diluted Loss per Share Basic loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted loss per share is based on the weighted-average common shares outstanding during the period plus dilutive potential common shares calculated using the treasury stock method. Such potentially dilutive shares are excluded when the effect would be to reduce a net loss per share.
Recent Accounting Pronouncements	Recent Accounting Pronouncements Accounting Standards Adopted In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 modifies reportable segment disclosure requirements, primarily through enhanced disclosures about segment expenses categorized as significant or regularly provided to the CODM. In addition, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, and contain other disclosure requirements. The purpose of the amendments is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. This ASU is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024, with early adoption permitted. Refer to Note 14 for additional information regarding implementation of this new standard. Accounting Standards Not Yet Adopted In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires interim and annual tabular disclosure of disaggregated information for certain income statement expense captions. Specific expense categories required to be disclosed quantitatively include inventory purchases, employee compensation, depreciation, and intangible asset amortization, as well as other specified expense categories currently disclosed under existing disclosure requirements. Additionally, any remaining amounts that are not separately disaggregated are required to be described qualitatively. ASU 2024-03 also requires separate disclosure of total selling expenses incurred each reporting period, with annual disclosure of the entity's definition of selling expenses. The annual disclosures required by ASU 2024-03 are effective for the Company beginning in its fiscal year ending December 31, 2027, with interim disclosures effective beginning in its fiscal year ending December 31, 2028. The provisions of ASU 2024-03 are to be applied prospectively, although retrospective application is permitted. Early adoption is also permitted. The Company is currently evaluating the ASU to determine its impact on the Company’s disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance requires expanded annual disclosures including the standardization and disaggregation of income tax rate reconciliation categories and the amount of income taxes paid by jurisdiction. The guidance is effective for the Company beginning in its fiscal year ending December 31, 2025. The Company is currently evaluating the ASU to determine its impact on the Company’s disclosures. In March 2024, the SEC adopted rules under SEC Release No. 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors, which requires the disclosure of material Scope 1 and Scope 2 greenhouse gas emissions and other climate-related topics in annual reports and registration statements. For non-accelerated filers and smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027, subject to legal challenges and the SEC's voluntary stay of the disclosure requirements. The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures.

COMMON STOCK AND WARRANTS - Equity transactions (Details)							12 Months Ended
	Jan. 17, 2025 USD ($) shares	May 09, 2024 USD ($) $ / shares shares	Aug. 11, 2023	Jun. 23, 2023 USD ($)	May 24, 2023 $ / shares	Mar. 23, 2023 USD ($)	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) shares	May 31, 2024 $ / shares shares
Common stock and warrants
Share issuance costs \| $							$ 1,000,000	$ 65,000
Issuance cost allocated to equity \| $							1,132,000	65,000
Proceeds from issuance of common stock \| $							$ 2,961,000	$ 500,000
Reverse stock split			0.02
Public Warrants
Common stock and warrants
Exercise price \| $ / shares							$ 1.6163
Number of warrants exercised							23,400
Pre-funded Warrants
Common stock and warrants
Exercise price \| $ / shares							$ 0.001
Number of warrants exercised							2,135,000
Common Stock
Common stock and warrants
Shares issued							853,200	53,010
Additional Paid-In Capital
Common stock and warrants
Issuance cost allocated to equity \| $							$ 1,132,000	$ 65,000
Public Offering
Common stock and warrants
Net proceeds from issuance of common stock \| $		$ 5,500,000
Combined offering price (in dollars per share) \| $ / shares		$ 2.25							$ 2.25
Offering price per Pre-funded warrant and accompanying Public Warrants (in dollars per share) \| $ / shares		2.249							2.249
Public Offering \| Public Warrants
Common stock and warrants
Exercise price \| $ / shares		$ 2.25
Public Offering \| Series A Warrants
Common stock and warrants
Warrants expiration period		5 years
Shares of common stock purchasable with warrants		2,852,221
Public Offering \| Series B Warrants
Common stock and warrants
Warrants expiration period		12 months
Shares of common stock purchasable with warrants		2,852,221
Public Offering \| Pre-funded Warrants
Common stock and warrants
Exercise price \| $ / shares		$ 0.001					$ 0.001		$ 0.001
Shares of common stock purchasable with warrants		2,147,222							2,147,222
Number of warrants exercised		1,076,445					2,052,703
At-The-Market Offering
Common stock and warrants
Shares issued	93,300
Cumulative shares issued							201,211
Cumulative net proceeds \| $							$ 1,300,000	$ 400,000
Net proceeds from issuance of common stock \| $	$ 100,000
Aggregate offering amount \| $				$ 2,000,000
Maximum commission rate, percentage of gross proceeds pursuant to the Sales Agreement				3.00%
Series B Preferred Stock
Common stock and warrants
Dividend declared in shares of Series B Preferred Stock for each outstanding share of Class A common stock						0.001
Number of voting rights per share of preferred stock each holder is entitled to \| $						1,000,000
Preferred stock redemption rate (in dollars per share) \| $ / shares					$ 0.001
Class A Common Stock \| Minimum
Common stock and warrants
Reverse stock split					0.10
Class A Common Stock \| Maximum
Common stock and warrants
Reverse stock split					0.0125
Common Stock \| Public Offering
Common stock and warrants
Shares issued		704,999

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Cash flows from operating activities:
Net loss	$ (11,742)	$ (8,850)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of derivative liability	(2,981)	(2,966)
Stock-based compensation expense	2,522	1,629
Foreign exchange loss (gain)	999	(286)
Depreciation expense	36	45
Amortization expense	24	117
Fixed asset impairment	40	159
Provision for (reversal of) inventory reserve	28	(5)
Non-cash operating lease expense	41	52
Changes in operating assets and liabilities:
Accounts receivable	41	(44)
Other receivables	(46)	(247)
Inventory	(607)	137
Prepaid expense and other current assets	364	54
Operating lease liabilities	(45)	(53)
Accounts payable	344	(103)
Accrued and other current liabilities	(18)	(20)
Deferred revenue	(41)	(35)
Net cash used in operating activities	(11,041)	(10,416)
Cash flows from investing activities:
Purchase of property and equipment	(5)	(29)
Net cash used in investing activities	(5)	(29)
Cash flows from financing activities:
Proceeds from issuance of common stock	2,961	500
Proceeds from issuance of warrants	4,829
Proceeds from exercise of warrants	164	642
Share issuance costs	(1,000)	(65)
Net cash provided by financing activities	6,954	1,077
Effect of currency exchange rate changes on cash and cash equivalents	(2)	1
Net decrease in cash and cash equivalents	(4,094)	(9,367)
Cash and cash equivalents at beginning of period	5,182	14,549
Cash and cash equivalents at end of period	1,088	5,182
Non-cash investing and financing transactions:
Derivative warrant liability reclassified to equity on exercise of warrants	101	$ 628
Deferred offering costs reclassified to equity upon public offering	$ 132

STOCK-BASED COMPENSATION

12 Months Ended

Dec. 31, 2024

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

9.STOCK-BASED COMPENSATION

The Company may issue stock-based compensation awards under The Helius Medical Technologies, Inc. 2022 Equity Incentive Plan (“2022 Plan”) or the Helius Medical Technologies, Inc. 2021 Inducement Plan (as amended, the “Inducement Plan”). The 2022 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants. Options to purchase shares of the Company’s common stock granted under the 2022 Plan are awarded at a price equal to the fair market value at the date of grant based upon the closing price on that date. Options granted under the 2022 Plan generally vest over periods of between one to three years and expire no later than ten years from the date of grant.

On May 30, 2024, the Board adopted a First Amendment (the “Amendment”) to the 2022 Plan. On June 27, 2024, at the annual meeting of stockholders, the stockholders of the Company approved the Amendment. Pursuant to the terms and conditions of the Amendment, the 2022 Plan was amended to increase the aggregate number of shares of Common Stock that may be issued under the 2022 Plan to 2,089,000 new shares with an automatic increase on January 1st of each year by an amount equal to 5% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year. As of January 1, 2025, the number of shares authorized for issuance increased from 2,089,000 to 2,703,678 and there were 637,237 shares of common stock available for issuance under the 2022 Plan.

The Inducement Plan permits the grant of non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance stock and cash awards and other share‑based awards The Inducement Plan is used exclusively for grants of awards to individuals who were not previously employees or directors of the Company. Options granted under the Inducement Plan generally vest over four years and expire after ten years. The exercise price of each option is equal to the fair market value of the common stock at the date of grant. On July 2, 2024, the Company approved an amendment to the Inducement Plan pursuant to which, the Inducement Plan was amended to increase the

aggregate number of shares of Common Stock that may be issued under the Inducement Plan to 150,000 new shares. As of December 31, 2024, there were 123,980 shares of common stock available for issuance under the Inducement Plan.

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option valuation model that uses the assumptions noted in the following tables. The risk-free interest rate is estimated using the United States Treasury yield curve and is based on the expected term of the award. The expected term of stock option awards granted is estimated based on the “simplified” method described in the SEC Staff Accounting Bulletin, Topic 14: Share-Based Payment. Expected volatility is calculated using historical volatility over the expected term.

The Black-Scholes option pricing model was used with the following weighted-average assumptions for options granted during the years ended December 31, 2024 and 2023:


	Years Ended December 31, 2024
	2024			2023
Risk-free interest rate		4.38	%		3.93	%
Expected volatility		128.73	%		79.43
Expected term (years)		5.27			5.70
Expected dividend yield		0.00	%		0.00	%
Fair value, per share	$	0.84		$	10.17

During the year ended December 31, 2024 and 2023, 1,335,623 options with a total grant date fair value of $2.5 million and 86,580 options with a total grant date fair value of $1.6 million vested, respectively.

The fair value of restricted stock units granted during the years ended December 31, 2024 and 2023 was based on the closing price of the Company’s common stock on the Nasdaq Capital Market on the day of the grant.

Stock option activity during the year ended December 31, 2024 was as follows:


				Weighted Average	Aggregate
		Weighted		Remaining	Intrinsic
		Average		Contractual	Value
	Shares	Exercise Price		Term (in years)	(in thousands)
Outstanding as of December 31, 2023	245,830	$	76.28	9.03		5.00
Granted	1,856,000		0.96	—		—
Exercised	—		—	—		—
Expired	(5,747)		176.61	—		—
Forfeited	(3,622)		16.27	—		—
Outstanding as of December 31, 2024	2,092,461		9.30	9.33	$	—
Exercisable as of December 31, 2024	1,428,221		12.14	9.31	$	—

The following table summarizes nonvested restricted stock unit activity during the year ended December 31, 2024:


		Weighted Average
		Grant Date
	Shares	Fair Value
Nonvested as of December 31, 2023	2,228	$	7.81
Granted	—		—
Vested	(2,228)		7.81
Forfeited	—		—
Nonvested as of December 31, 2024	—	$	—

Total stock-based compensation expense was as follows (in thousands):


	Years Ended
	December 31,
	2024		2023
Cost of sales	$	28	$	18
Selling, general and administrative		2,008		1,320
Research and development		486		291
Total stock-based compensation expense	$	2,522	$	1,629

As of December 31, 2024, the total remaining unrecognized compensation expense related to nonvested stock options was $1.5 million which will be amortized over weighted-average remaining requisite service period of 0.7 years.

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Accounts receivable, net (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
SUPPLEMENTAL BALANCE SHEET DISCLOSURES
Allowance for credit losses	$ 0	$ 0

INTANGIBLE ASSETS (Tables)

12 Months Ended

Dec. 31, 2024

INTANGIBLE ASSETS

Schedule of intangible assets

Intangible assets consist of the following (in thousands):


			December 31,
			2024						2023
							Net						Net
	Useful Life				Accumulated		Carrying				Accumulated		Carrying
	(in years)		Cost		Amortization		Value		Cost		Amortization		Value
Reacquired rights		3.87	$	447	$	(447)	$	—	$	486	$	(486)	$	—
Acquired proprietary software		5.00		134		(134)		—		145		(121)		24
Internally developed software		3.00		84		(84)		—		84		(84)		—
Total intangible assets			$	665	$	(665)	$	—	$	715	$	(691)	$	24

INCOME TAXES - Loss Before Provision for Income Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
INCOME TAXES
U.S.	$ (11,303)	$ (8,689)
Non-U.S.	(439)	(161)
Loss before provision for income taxes	$ (11,742)	$ (8,850)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 280
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-Name Accounting Standards Codification
-Section 55
-Paragraph 48
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-URI https://asc.fasb.org/1943274/2147482785/280-10-55-48

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (f)
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-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 280
-SubTopic 10
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Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
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-Paragraph 1
-Subparagraph (i)
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-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 6: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
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-Paragraph 32
-Subparagraph (ee)
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-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 7: http://fasb.org/us-gaap/role/ref/otherTransitionRef
-Topic 280
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-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (c)
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 220
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(11))
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-URI https://asc.fasb.org/1943274/2147477250/944-220-S99-1

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Topic 280
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-Name Accounting Standards Codification
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-Paragraph 31
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-URI https://asc.fasb.org/1943274/2147482810/280-10-50-31

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
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-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
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-URI https://asc.fasb.org/1943274/2147477314/942-235-S99-1

Reference 11: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

COMMON STOCK AND WARRANTS - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Aug. 16, 2023	Aug. 09, 2022
Warrant activity
Fair value of derivative liability	$ 241	$ 3,323
Value of issuance allocated to equity	2,961	500
Derivative warrant liability reclassified to equity on exercise of warrants	$ 101	628
Public Warrants
Warrant activity
Number of warrants outstanding	603,690
Exercise price	$ 1.6163
Warrant expiration period			5 years
Number of warrants exercised	23,400
Number of warrants cancelled	0
Gross proceeds from exercise of warrants	$ 200
Equity-classified Warrants
Warrant activity
Shares of common stock purchasable with warrants	5,869,244
Number of warrants cancelled	0
Equity-classified Warrants \| Weighted Average
Warrant activity
Exercise price	$ 3.64
Equity-classified Warrants, excluding Pre-funded Warrants \| Weighted Average
Warrant activity
Exercise price	$ 3.65
Pre-funded Warrants
Warrant activity
Number of warrants outstanding	12,222
Exercise price	$ 0.001
Number of warrants exercised	2,135,000
Number of warrants settled	2,134,754
Common Stock
Warrant activity
Value of issuance allocated to equity	$ 1
August 9, 2022 registered public offering
Warrant activity
Fair value of derivative liability	$ 200
August 9, 2022 registered public offering \| 2022 Warrants
Warrant activity
Fair value of derivative liability		$ 3,300
Shares of common stock purchasable with warrants				720,000

LEASES (Details) $ in Thousands		12 Months Ended
LEASES (Details) $ in Thousands	Apr. 01, 2025 USD ($)	Dec. 31, 2024 USD ($) lease	Dec. 31, 2023 USD ($)
Leases
Number of operating leases \| lease		1
Lessee options to extend lease		false
Operating lease costs		$ 41	$ 54
Maturities of operating lease liabilities
2025		12
Total lease payments		12
Total lease liabilities		$ 12
Other disclosures
Weighted average remaining lease term (in years)		3 months
Weighted average discount rate		4.55%
Forecast
Leases
Amount of monthly rent expense	$ 4

COMMON STOCK AND WARRANTS - Other (Details)	Dec. 31, 2024 shares
COMMON STOCK AND WARRANTS
Class A Common Stock reserved for future issuance	146,271,828
Unissued preferred stock reserved for future issuances	10,000,000

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Thousands		12 Months Ended
	Jan. 21, 2025	Dec. 31, 2024	Dec. 31, 2023
Subsequent Events
Proceeds from exercise of warrants		$ 164	$ 642
Subsequent Event
Subsequent Events
Professional fees	$ 200
Subsequent Event \| Existing Warrants
Subsequent Events
Shares of common stock purchasable with warrants	4,971,110
Exercise price	$ 0.751
Proceeds from exercise of warrants	$ 3,700
Net proceeds from exercise of warrants	$ 3,400
Subsequent Event \| Inducement Warrants
Subsequent Events
Shares of common stock purchasable with warrants	6,213,888

SUPPLEMENTAL BALANCE SHEET DISCLOSURES (Tables)

12 Months Ended

Dec. 31, 2024

SUPPLEMENTAL BALANCE SHEET DISCLOSURES

Schedule of inventory, net

Inventory, net (in thousands)


	December 31,		December 31,
	2024		2023
Raw materials	$	576	$	351
Work-in-process		402		67
Finished goods		145		96
Inventory, gross		1,123		514
Inventory reserve		(87)		(57)
Inventory, net	$	1,036	$	457

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets (in thousands)


	December 31,		December 31,
	2024		2023
Prepaid expenses	$	603	$	689
Inventory related		55		333
Deferred offering costs		7		140
Total prepaid expenses and other current assets	$	665	$	1,162

Schedule of property and equipment, net

Property and equipment, net (in thousands)


	December 31, 2024		December 31, 2023
Furniture and fixtures	$	59	$	59
Equipment		247		243
Computer software and hardware		196		235
Property and equipment		502		537
Accumulated depreciation		(395)		(359)
Property and equipment, net	$	107	$	178

Schedule of accrued and other current liabilities

Accrued and other current liabilities (in thousands)


	December 31,		December 31,
	2024		2023
Insurance payable	$	356	$	446
Employees benefits		759		509
Professional services		24		52
Franchise tax		—		168
Other		100		85
Total accrued and other current liabilities	$	1,239	$	1,260

STOCK-BASED COMPENSATION - Nonvested Restricted Stock Unit Activity (Details) - Restricted stock units	12 Months Ended
	Dec. 31, 2024 $ / shares shares
Nonvested restricted stock unit activity, Shares
Nonvested, beginning of period (in shares) \| shares	2,228
Vested (in shares) \| shares	(2,228)
Nonvested restricted stock unit activity, Weighted Average Grant Date Fair Value
Nonvested, beginning of period (in dollars per share) \| $ / shares	$ 7.81
Vested (in dollars per share) \| $ / shares	$ 7.81

INCOME TAXES - Components of Deferred Income Tax Assets and Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Deferred tax assets
Net operating loss carryforwards	$ 32,635	$ 30,642
Stock-based compensation	3,967	3,316
Research and development	2,486	2,164
Tax credit carryforwards	1,419	1,267
Compensation and benefits	195	120
Unrealized foreign currency losses	320	33
Deferred revenue	31	45
Other	36	26
Total deferred tax assets	41,089	37,613
Deferred tax liabilities
Property and equipment	(4)	(16)
Other	(3)	(19)
Total deferred tax liabilities	(7)	(35)
Valuation allowance	$ (41,082)	$ (37,578)

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Deferred revenue (Details) - HTC - Exclusivity Agreement $ in Thousands		12 Months Ended
	Mar. 03, 2023 USD ($) item	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)
Deferred Revenue
Value of exclusivity right granted	$ 273
Number of additional terms \| item	1
Additional term	5 years
Period for written notice for renewal	60 days
Revenue recognized		$ 41	$ 35

STOCK-BASED COMPENSATION - Stock Option Activity (Details) - USD ($)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Stock option activity, Shares
Outstanding, beginning of period (in shares)	245,830
Granted (in shares)	1,856,000
Expired (in shares)	(5,747)
Forfeited (in shares)	(3,622)
Outstanding, end of period (in shares)	2,092,461	245,830
Exercisable (in shares)	1,428,221
Stock option activity, Weighted Average Exercise Price
Outstanding (in dollars per share)	$ 9.3	$ 76.28
Granted (in dollars per share)	0.96
Expired (in dollars per share)	176.61
Forfeited (in dollars per share)	16.27
Exercisable (in dollars per share)	$ 12.14
Additional information
Weighted Average Remaining Contractual Term, Outstanding	9 years 3 months 29 days	9 years 10 days
Weighted Average Remaining Contractual Term, Exercisable	9 years 3 months 21 days
Aggregate Intrinsic Value , Outstanding		$ 5,000

FAIR VALUE MEASUREMENTS

12 Months Ended

Dec. 31, 2024

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS

7.FAIR VALUE MEASUREMENTS

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value of an asset or liability considers assumptions that market participants would use in pricing the asset or liability, including consideration of non-performance risk. The inputs used to determine fair values are categorized in one of the following three levels of the fair value hierarchy:

Level 1 – Quoted market prices in active markets for identical assets or liabilities.

Level 2 – Inputs, other than quoted prices in active markets, that are observable, either directly or indirectly.

Level 3 – Unobservable inputs that are not corroborated by market data.

The Consolidated Financial Statements include financial instruments for which the fair market value of such instruments may differ from amounts reflected on a historical cost basis. Financial instruments of the Company as of December 31, 2024 and 2023 consist of cash equivalents, which were comprised of deposits of excess cash in an unrestricted money market savings account, money market mutual funds, treasury bills and a certificate of deposit. The carrying value of cash equivalents generally approximates fair value due to their short-term nature.

The Company’s derivative liability as of December 31, 2024 and 2023 is comprised of warrants issued in connection with the registered public offering completed in August 2022 discussed in Note 8. The derivative liability is classified as Level 3 within the fair value hierarchy and is required to be recorded at fair value on a recurring basis. See Note 8 for further information on the fair value of the derivative liability.

The majority of the Company’s non-financial instruments, which include intangible assets, lease assets, inventories and property and equipment, are not required to be carried at fair value on a recurring basis. However, if certain triggering events occur (or at least annually for indefinite-lived intangible assets), a non-financial instrument is required to be evaluated for impairment. If the Company determines that the non-financial instrument is impaired, the Company would be required to write down the non-financial instrument to its fair value. See Note 3 – Fixed Asset Impairment for further detail.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
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-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 940
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-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

BASIC AND DILUTED LOSS PER SHARE - Public Offering (Details) - $ / shares		12 Months Ended
	May 09, 2024	Dec. 31, 2024	May 31, 2024
Pre-funded Warrants
Public Offering
Exercise price		$ 0.001
Number of warrants exercised		2,135,000
Number of warrants outstanding		12,222
Public Offering
Public Offering
Combined offering price (in dollars per share)	$ 2.25		$ 2.25
Offering price per Pre-funded warrant and accompanying Public Warrants (in dollars per share)	$ 2.249		$ 2.249
Public Offering \| Pre-funded Warrants
Public Offering
Shares of common stock purchasable with warrants	2,147,222		2,147,222
Exercise price	$ 0.001	$ 0.001	$ 0.001
Number of warrants exercised	1,076,445	2,052,703
Number of warrants outstanding		12,222

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Class A Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Loss	Total
Beginning Balance, Shares at Dec. 31, 2022	564,094
Beginning Balance at Dec. 31, 2022	$ 1	$ 159,645	$ (151,107)	$ (388)	$ 8,151
Issuance of common stock in public offering, Shares	53,010
Issuance of common stock in public offering		500			500
Share issuance costs		(65)			(65)
Exercise of warrants, Shares	92,910
Exercise of warrants		1,270			1,270
Settlement of restricted stock units, Shares	4,576
Stock-based compensation		1,629			1,629
Other comprehensive gain (loss)				(285)	(285)
Net Income (Loss)			(8,850)		(8,850)
Ending Balance, Shares at Dec. 31, 2023	714,590
Ending Balance at Dec. 31, 2023	$ 1	162,979	(159,957)	(673)	2,350
Issuance of common stock in public offering, Shares	853,200
Issuance of common stock in public offering	$ 1	2,960			2,961
Issuance of warrants in public offering		4,829			4,829
Share issuance costs		(1,132)			(1,132)
Exercise of warrants, Shares	2,158,154
Exercise of warrants	$ 2	263			265
Settlement of restricted stock units, Shares	2,228
Stock-based compensation		2,522			2,522
Other comprehensive gain (loss)				1,006	1,006
Net Income (Loss)			(11,742)		(11,742)
Ending Balance, Shares at Dec. 31, 2024	3,728,172
Ending Balance at Dec. 31, 2024	$ 4	$ 172,421	$ (171,699)	$ 333	$ 1,059

STOCK-BASED COMPENSATION - Fair value assumptions and other (Details) - USD ($) $ / shares in Units, $ in Millions	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Additional information
Number of options vested	1,335,623	86,580
Fair value of options vested	$ 2.5	$ 1.6
Stock options
STOCK-BASED COMPENSATION
Risk-free interest rate	4.38%	3.93%
Expected volatility	128.73%	79.43%
Expected term	5 years 3 months 7 days	5 years 8 months 12 days
Expected dividend yield	0.00%	0.00%
Fair value, per share	$ 0.84	$ 10.17

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Property and equipment, net (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Property and equipment, net
Property and equipment	$ 502	$ 537
Accumulated depreciation	(395)	(359)
Property and equipment, net	107	178
Furniture and fixtures
Property and equipment, net
Property and equipment	59	59
Equipment
Property and equipment, net
Property and equipment	247	243
Computer software and hardware
Property and equipment, net
Property and equipment	$ 196	$ 235

STOCK-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
STOCK-BASED COMPENSATION
Stock based compensation expense	$ 2,522	$ 1,629
Share-Based Payment Arrangement, Nonvested Award	$ 1,500
Weighted-average remaining requisite service period	8 months 12 days
Cost of sales
STOCK-BASED COMPENSATION
Stock based compensation expense	$ 28	18
Selling, general and administrative
STOCK-BASED COMPENSATION
Stock based compensation expense	2,008	1,320
Research and development
STOCK-BASED COMPENSATION
Stock based compensation expense	$ 486	$ 291

INCOME TAXES - Tax credit carryforward (Details) - Research expenditure $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
United States federal \| 2034-2044
INCOME TAXES
Gross tax credit carryforward	$ 986
United States federal \| 2034-2044 \| Minimum
INCOME TAXES
Gross tax credit carryforward, expiration date	Dec. 31, 2034
United States federal \| 2034-2044 \| Maximum
INCOME TAXES
Gross tax credit carryforward, expiration date	Dec. 31, 2044
Canada federal \| 2034-2037
INCOME TAXES
Gross tax credit carryforward	$ 432
Canada federal \| 2034-2037 \| Minimum
INCOME TAXES
Gross tax credit carryforward, expiration date	Dec. 31, 2034
Canada federal \| 2034-2037 \| Maximum
INCOME TAXES
Gross tax credit carryforward, expiration date	Dec. 31, 2037

SUPPLEMENTAL BALANCE SHEET DISCLOSURES - Inventory, net (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Inventory
Raw materials	$ 576	$ 351
Work-in-process	402	67
Finished goods	145	96
Inventory, gross	1,123	514
Inventory reserve	(87)	(57)
Inventory, net	1,036	457
Inventory reserves charged against work-in-process inventory	$ 2	$ 16

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Current assets
Cash and cash equivalents	$ 1,088	$ 5,182
Accounts receivable, net	70	117
Other receivables	565	520
Inventory, net	1,036	457
Prepaid expenses and other current assets	665	1,162
Total current assets	3,424	7,438
Property and equipment, net	107	178
Intangible assets, net		24
Operating lease right-of-use asset, net	11	52
Total assets	3,542	7,692
Current liabilities
Accounts payable	873	531
Accrued and other current liabilities	1,239	1,260
Current portion of operating lease liabilities	12	45
Current portion of deferred revenue	39	43
Total current liabilities	2,163	1,879
Operating lease liabilities, net of current portion		12
Deferred revenue, net of current portion	79	128
Derivative liability	241	3,323
Total liabilities	2,483	5,342
Commitments and contingencies (Note 13)
Stockholders' equity
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 3,728,172 and 714,590 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively	4	1
Additional paid-in capital	172,421	162,979
Accumulated deficit	(171,699)	(159,957)
Accumulated other comprehensive loss	333	(673)
Total stockholders' equity	1,059	2,350
Total liabilities and stockholders' equity	$ 3,542	$ 7,692

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Revenue
Product sales, net	$ 476	$ 605
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	us-gaap:ProductMember	us-gaap:ProductMember
Other revenue	$ 44	$ 39
Total revenue	520	644
Cost of revenue
Cost of revenue	$ 582	$ 583
Cost, Product and Service [Extensible Enumeration]	us-gaap:ProductMember	us-gaap:ProductMember
Gross (loss) profit	$ (62)	$ 61
Operating expenses
Selling, general and administrative expenses	10,118	9,271
Research and development expenses	3,659	2,942
Amortization expense	24	117
Fixed asset impairment	40	159
Total operating expenses	13,841	12,489
Loss from operations	(13,903)	(12,428)
Nonoperating income
Interest (expense) income, net	(17)	257
Change in fair value of derivative liability	2,981	2,966
Foreign exchange (loss) gain	(1,006)	275
Other income, net	203	80
Nonoperating income, net	2,161	3,578
Loss before provision for income taxes	(11,742)	(8,850)
Provision for income taxes	0	0
Net loss	(11,742)	(8,850)
Other comprehensive income (loss)
Foreign currency translation adjustments	1,006	(285)
Comprehensive loss	$ (10,736)	$ (9,135)
Loss per share
Basic (in dollars per share)	$ (4.33)	$ (14.56)
Diluted (in dollars per share)	$ (4.33)	$ (14.56)
Weighted average number of common shares outstanding
Basic (in shares)	2,709,781	607,890
Diluted (in shares)	2,709,781	607,890

INTANGIBLE ASSETS - Summary (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Intangible Assets
Intangible assets, Cost	$ 665	$ 715
Intangible assets, Accumulated Amortization	$ (665)	(691)
Net Carrying Value		24
Reacquired rights
Intangible Assets
Intangible assets, Useful Life	3 years 10 months 13 days
Intangible assets, Cost	$ 447	486
Intangible assets, Accumulated Amortization	$ (447)	(486)
Acquired proprietary software
Intangible Assets
Intangible assets, Useful Life	5 years
Intangible assets, Cost	$ 134	145
Intangible assets, Accumulated Amortization	$ (134)	(121)
Net Carrying Value		24
Internally developed software
Intangible Assets
Intangible assets, Useful Life	3 years
Intangible assets, Cost	$ 84	84
Intangible assets, Accumulated Amortization	$ (84)	$ (84)

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

DESCRIPTION OF BUSINESS (Details) - USD ($) $ in Thousands	12 Months Ended
DESCRIPTION OF BUSINESS (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
DESCRIPTION OF BUSINESS
Cash and cash equivalents	$ 1,088	$ 5,182
Operating loss	13,903	12,428
Accumulated deficit	171,699	159,957
Product sales, net	$ 476	$ 605

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

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-Paragraph 41
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+ Details

LEASES

12 Months Ended

Dec. 31, 2024

LEASES

LEASES

5.LEASES

The Company has an operating lease for office space with lease terms that commenced in January 2022 and will expire in March 2025. The lease does not contain any options to extend. Operating lease costs for the years ended December 31, 2024 and 2023 were $41 thousand and $54 thousand, respectively.

On January 16, 2025, the Company entered into an agreement to extend the operating lease for the Newtown, PA office through March 31, 2026, at a rate of $4 thousand per month effective April 1, 2025.

Maturities of operating lease liabilities as of December 31, 2024 were as follows (in thousands):


2025	$	12
Total lease payments		12
Less: imputed interest		—
Total lease liabilities	$	12

The following table provides information on the lease term and discount rate for the operating lease as of December 31, 2024:


Remaining lease term (in years)	0.25
Discount rate	4.55	%

SUPPLEMENTAL BALANCE SHEET DISCLOSURES

12 Months Ended

Dec. 31, 2024

SUPPLEMENTAL BALANCE SHEET DISCLOSURES

SUPPLEMENTAL BALANCE SHEET DISCLOSURES

4.SUPPLEMENTAL BALANCE SHEET DISCLOSURES

Components of selected captions in the Consolidated Balance Sheets are as follows:

Accounts receivable, net

Accounts receivable is net of allowance for doubtful accounts of $0 as of December 31, 2024 and 2023.

Inventory, net (in thousands)


	December 31,		December 31,
	2024		2023
Raw materials	$	576	$	351
Work-in-process		402		67
Finished goods		145		96
Inventory, gross		1,123		514
Inventory reserve		(87)		(57)
Inventory, net	$	1,036	$	457

During the years ended December 31, 2024 and 2023, existing reserves of $2 thousand and $16 thousand were charged against inventory, respectively.

Prepaid expenses and other current assets (in thousands)


	December 31,		December 31,
	2024		2023
Prepaid expenses	$	603	$	689
Inventory related		55		333
Deferred offering costs		7		140
Total prepaid expenses and other current assets	$	665	$	1,162

Property and equipment, net (in thousands)


	December 31, 2024		December 31, 2023
Furniture and fixtures	$	59	$	59
Equipment		247		243
Computer software and hardware		196		235
Property and equipment		502		537
Accumulated depreciation		(395)		(359)
Property and equipment, net	$	107	$	178

Accrued and other current liabilities (in thousands)


	December 31,		December 31,
	2024		2023
Insurance payable	$	356	$	446
Employees benefits		759		509
Professional services		24		52
Franchise tax		—		168
Other		100		85
Total accrued and other current liabilities	$	1,239	$	1,260

Deferred revenue

Exclusive Distribution Agreement

Pursuant to an Exclusive Distribution Agreement with Health Tech Connex Inc. (“HTC”) (“Exclusivity Agreement”) entered into on March 3, 2023, subject to certain terms and conditions, the Company granted to HTC the exclusive right to provide PoNS Therapy® in the Fraser Valley and Vancouver metro regions of British Columbia. HTC is to purchase the PoNS devices for use in these regions exclusively from the Company and on terms no less favorable than the then-current standard terms and conditions. This Exclusivity Agreement replaced the previous Clinical Research and Co-Promotion Agreement (“Co-Promotion Agreement”) between the parties entered into in October 2019 that included a similar exclusive right provision. The exclusive right under the Exclusivity Agreement was granted for a fixed value of CAD$273 thousand, which is represented by the unamortized up-front payment under the former Co-Promotion

Agreement. The initial term of the Exclusivity Agreement expires on December 31, 2027, and is renewable by HTC for one additional five-year term upon sixty days’ written notice to the Company.

Deferred revenue as of both December 31, 2024 and 2023 is comprised of the remaining unamortized amount under these agreements. Revenue recognized is included in other revenue in the Consolidated Statements of Operations and Comprehensive Loss. Revenue recognized for the years ended December 31, 2024 and 2023 were $41 thousand and $35 thousand, respectively.

DEFINED CONTRIBUTION PLAN (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
DEFINED CONTRIBUTION PLAN
Percentage of first annual eligible compensation that employer matched	3.00%
Percentage of next annual eligible compensation that employer matched	2.00%
Percent of match	50.00%
Percentage of vesting	100.00%
Defined contribution plan expense	$ 137	$ 148

DEFINED CONTRIBUTION PLAN

12 Months Ended

Dec. 31, 2024

DEFINED CONTRIBUTION PLAN

DEFINED CONTRIBUTION PLAN

12.DEFINED CONTRIBUTION PLAN

The Company’s employees in the United States are eligible to participate in the Helius Medical Inc. Savings Plan, as amended, a safe harbor 401(k) plan (“401(k) Plan”). The 401(k) Plan allows eligible employees to make contributions through payroll deductions up to IRS limits. The Company matches the first 3% of the participant's annual eligible compensation contributed to the plan on a dollar-for-dollar basis and matches the next 2% of the participant's annual eligible compensation to the plan on a 50% basis. Pursuant to the 401(k) safe harbor provisions, the Company’s matching contributions are 100% vested. For the years ended December 31, 2024 and 2023, the Company’s defined contribution plan expense was $137 thousand and $148 thousand, respectively.

SEGMENT AND GEOGRAPHIC INFORMATION

12 Months Ended

Dec. 31, 2024

SEGMENT AND GEOGRAPHIC INFORMATION

SEGMENT AND GEOGRAPHIC INFORMATION

14.SEGMENT AND GEOGRAPHIC INFORMATION

Segment Information

Operating segments are components of an enterprise for which separate financial information is available and are evaluated regularly by the Company’s chief operating decision maker (“CODM”) in deciding how to allocate resources and assessing performance. The Company’s CODM is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is the business of development and commercialization of products related to PoNS® devices. The Company has a single reporting segment and the determination of the single segment is consistent with the information provided to the CODM. The CODM evaluates performance and allocates resources based on the Company’s consolidated financial results.

Geographic Information

The following table presents the Company’s revenue disaggregated by geographic area (in thousands):



	Years Ended
	2024		2023
Product sales, net:
United States	$	181	$	324
Canada		295		281
Total product sales, net		476		605
Other revenue		44		39
Total revenue	$	520	$	644

Two customers accounted for 72% and 65% of net product sales for the years ended December 31, 2024 and 2023, respectively. Two customers accounted for 100% of accounts receivable, net as of December 31, 2024 and a single customer accounted for 83% of accounts receivable, net as of December 31, 2023.

Long-lived assets are held in the United States and Canada with the majority of long-lived assets being held in the United States as of December 31, 2024 and 2023. As of December 31, 2024, the carrying value of long-lived assets held in Canada is $0.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2024

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

2.SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation

The accompanying consolidated financial statements reflect the operations of Helius Medical Technologies, Inc. and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosure of contingent assets and liabilities. Significant estimates include the assumptions used in the valuation of the fair value-pricing model for stock-based compensation, liability classified warrants and deferred income tax asset valuation allowance. Financial statements include estimates, which, by their nature, are uncertain. Actual results could differ from those estimates.

Foreign Currency Translation

The local currency, or CAD$, is the functional currency of the Company’s foreign operating subsidiary, Helius Medical Technologies (Canada), Inc. All assets and liabilities are translated into United States dollars at the rate of exchange in effect at the balance sheet date. Income and expense items are translated at the weighted-average exchange rate

prevailing during the period. The effects of foreign currency translation adjustments are deferred and reported in stockholders' equity as a component of “Accumulated Other Comprehensive Loss.” The effects of foreign currency transactions denominated in a currency other than an entity's functional currency are included in “Foreign Exchange (Loss) Gain” in the Consolidated Statements of Operations and Comprehensive Loss.

Revenue Recognition

The Company generates nearly all revenue from product sales directly to patients, its e-commerce partner in the United States and to clinics in Canada. Revenue from product sales is recognized at a point in time as the performance obligation is satisfied and when the customer obtains control of the product at the established transaction price. Taxes that the Company collects concurrent with revenue-producing activities are excluded from revenue.

The Company requires some customers in the United States to prepay the full product selling price, net of cash discount, prior to shipment. The Company records a contract liability for any customer prepayment received for which delivery had not yet occurred as of the end of the period.

Concentration of Credit Risk

The Company deposits its cash and cash equivalents in demand commercial checking, unrestricted money market savings account, money market mutual funds, treasury bills or certificates of deposit at high-quality credit institutions. At times, such deposits may be in excess of federally insured limits. The Company has not experienced any losses.

Cash Equivalents

The Company considers highly liquid investments with original maturities of three months or less to be cash equivalents. Cash equivalents are valued at cost, which approximates fair value.

Accounts Receivable

Accounts receivable arise primarily from product sales in Canada and generally require payment within 30 days. The Company provides reserves against accounts receivable for estimated credit losses that may result from a customer’s inability to pay based on a combination of factors, such as the aging of accounts receivable past the due date, the customer’s financial strength and payment history. Amounts determined to be uncollectible are charged or written off against the reserve.

Employee Retention Credit

The employee retention credit (“ERC”), as originally enacted through the Coronavirus Aid, Relief, and Economic Security Act, is a refundable credit against certain employment taxes equal to 50% of the qualified wages an eligible employer pays to employees from March 17, 2020 to December 31, 2020. The Disaster Tax Relief Act extended the ERC for qualified wages paid from January 1, 2021 to June 30, 2021 and the credit was increased to 70% of qualified wages an eligible employer pays to employees during the extended period. The American Rescue Plan Act of 2021, enacted on March 11, 2021, further extended the ERC through December 31, 2021.

The Company qualified for the employee retention credit for the period from March 17, 2020 to September 30, 2021. The Company recognizes government credits for which there is a reasonable assurance of compliance with credit conditions and receipt of credits. The Company accounts for the ERC as government assistance and applies the grant accounting model by analogy to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance. Under this approach, the Company recognizes the credit when there is reasonable assurance that it will comply with the conditions of the grant and that the credit will be received.

The Company recorded a credit of $0.5 million against operating expenses on the Consolidated Statement of Operations and Comprehensive Loss during the year ended December 31, 2023 and as a current asset on the consolidated balance

sheets during the year ended December 31, 2024 and December 31, 2023 as an other receivable. The Company expects to receive the credit in the next twelve months.

Inventory

Inventories are stated at the lower of cost (average cost method) or net realizable value. The Company establishes inventory reserves for obsolescence based upon specific identification of expired or unusable units with a corresponding provision included in cost of revenue. The Company calculates provisions for excess inventory based on inventory on hand compared to anticipated sales or usage. Management uses its judgment to forecast sales or usage and to determine what constitutes a reasonable period. There can be no assurance that the amount ultimately realized for inventories will not be materially different than that assumed in the calculation of the reserves.

Property and Equipment

Property and equipment are recorded at cost. Depreciation is calculated for financial reporting purposes on the straight-line method over the estimated useful lives of the related assets, which are seven years for furniture and fixtures, five to fifteen years for equipment and three to five years for computer software and hardware. Depreciation expense is recorded in selling, general and administrative expenses. Expenditures for repairs and maintenance, which do not improve or extend the expected useful life of the assets, are expensed as incurred.

Long-Lived Assets

Management reviews the carrying amounts of definite-lived intangible assets and long-lived assets, including right-of-use (“ROU”) assets, property and equipment whenever events or circumstances indicate that the carrying amounts of an asset may not be recoverable. For purposes of assessing recoverability, definite-lived intangible assets and long-lived tangible assets are each deemed to be one asset group. The carrying amount of the asset group is compared to the estimated undiscounted future cash flows associated with it. If the sum of the expected future net cash flows is less than the carrying value of the asset group being evaluated, an impairment loss is calculated as the amount by which the carrying value of the asset group exceeds its estimated fair value.

Leases

The Company has an operating lease for its corporate office. The Company determines whether a contract is, or contains, a lease at inception. ROU assets represent the Company’s right to use an underlying asset during the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present value of unpaid lease payments. The Company's incremental borrowing rate is determined based on the estimated rate of interest for collateralized borrowing over a similar term as the associated lease. The Company’s lease arrangement does not have any lease and non-lease components.

Stock-Based Compensation

The Company measures and recognizes compensation expense for all stock-based awards based on estimated fair values. Stock-based awards consist of stock options and restricted stock units. Stock-based compensation expense is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period (vesting period) on a straight-line basis. Forfeitures are not estimated, but instead stock-based compensation expense is adjusted upon an actual forfeiture of a stock option. Upon exercise of stock options or vesting of restricted stock units, the Company issues common stock.

Income Taxes

Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance for deferred income tax assets is recorded when it is more likely than not that some portion or all of the deferred income tax assets will not be realized.

Selling, General and Administrative Expenses

Selling, general and administrative expenses are charged to expense when incurred. Advertising expenses were $651 thousand and $670 thousand for the years ended December 31, 2024 and 2023, respectively.

Research and Development Expenses

Research and development costs are charged to expense when incurred.

Derivatives

The Company does not engage in hedging activities. The Company evaluates its financial instruments and other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for. The result of this accounting treatment is that the fair value of the derivative is re-measured at each balance sheet date and recorded as a liability or asset and the change in fair value is recorded in the Consolidated Statements of Operations and Comprehensive Loss. Reclassifications or partial reclassifications to equity are recorded based on the fair value of the derivative on the transaction date. Refer to Note 8 for additional information about the derivative liability.

Basic and Diluted Loss per Share

Basic loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted loss per share is based on the weighted-average common shares outstanding during the period plus dilutive potential common shares calculated using the treasury stock method. Such potentially dilutive shares are excluded when the effect would be to reduce a net loss per share.

Recent Accounting Pronouncements

Accounting Standards Adopted

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 modifies reportable segment disclosure requirements, primarily through enhanced disclosures about segment expenses categorized as significant or regularly provided to the CODM. In addition, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, and contain other disclosure requirements. The purpose of the amendments is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. This ASU is effective for annual periods beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024, with early adoption permitted. Refer to Note 14 for additional information regarding implementation of this new standard.

Accounting Standards Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires

interim and annual tabular disclosure of disaggregated information for certain income statement expense captions. Specific expense categories required to be disclosed quantitatively include inventory purchases, employee compensation, depreciation, and intangible asset amortization, as well as other specified expense categories currently disclosed under existing disclosure requirements. Additionally, any remaining amounts that are not separately disaggregated are required to be described qualitatively. ASU 2024-03 also requires separate disclosure of total selling expenses incurred each reporting period, with annual disclosure of the entity's definition of selling expenses. The annual disclosures required by ASU 2024-03 are effective for the Company beginning in its fiscal year ending December 31, 2027, with interim disclosures effective beginning in its fiscal year ending December 31, 2028. The provisions of ASU 2024-03 are to be applied prospectively, although retrospective application is permitted. Early adoption is also permitted. The Company is currently evaluating the ASU to determine its impact on the Company’s disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance requires expanded annual disclosures including the standardization and disaggregation of income tax rate reconciliation categories and the amount of income taxes paid by jurisdiction. The guidance is effective for the Company beginning in its fiscal year ending December 31, 2025. The Company is currently evaluating the ASU to determine its impact on the Company’s disclosures.

In March 2024, the SEC adopted rules under SEC Release No. 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors, which requires the disclosure of material Scope 1 and Scope 2 greenhouse gas emissions and other climate-related topics in annual reports and registration statements. For non-accelerated filers and smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027, subject to legal challenges and the SEC's voluntary stay of the disclosure requirements. The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures.

INCOME TAXES - Net operating losses (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($)
2032-2037 \| Domestic
INCOME TAXES
Net operating losses	$ 39,561
2032-2037 \| Domestic \| Minimum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2032
2032-2037 \| Domestic \| Maximum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2037
Indefinite \| Domestic
INCOME TAXES
Net operating losses	$ 83,378
Indefinite \| State
INCOME TAXES
Net operating losses	12,053
2033-2044 \| State
INCOME TAXES
Net operating losses	$ 74,624
2033-2044 \| State \| Minimum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2033
2033-2044 \| State \| Maximum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2044
2034-2044 \| Foreign
INCOME TAXES
Net operating losses	$ 6,384
2034-2044 \| Foreign \| Minimum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2034
2034-2044 \| Foreign \| Maximum
INCOME TAXES
Net operating losses, expiration date	Dec. 31, 2044

DESCRIPTION OF BUSINESS

12 Months Ended

Dec. 31, 2024

DESCRIPTION OF BUSINESS

DESCRIPTION OF BUSINESS

1.DESCRIPTION OF BUSINESS

Helius Medical Technologies, Inc. (together with its wholly owned subsidiaries the “Company”) conducts operations in the United States and Canada. The Company’s product, known as the Portable Neuromodulation Stimulator (“PoNS®”) has been commercially available in Canada since March 2019. The Company began accepting prescriptions for its PoNS product in the United States in the first quarter of 2022, and the first commercial sales began in April 2022. PoNS is authorized for sale as a Class IIa medical device in Australia. The Company is working to establish a distribution partner for Australia but has not yet had any commercial sales of PoNS in Australia.

Going Concern Uncertainty

As of December 31, 2024, the Company had cash and cash equivalents of $1.1 million. For the year ended December 31, 2024, the Company had an operating loss of $13.9 million, and as of December 31, 2024, its accumulated deficit was $171.7 million. For the year ended December 31, 2024, the Company had $0.5 million of net revenue from the commercial sale of products. The Company expects to continue to incur operating losses and net cash outflows until such time as it generates a level of revenue to support its cost structure. There is no assurance that the Company will achieve profitable operations, and, if achieved, whether it will be sustained on a continued basis. These factors indicate substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are filed. The Company’s consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and satisfaction of liabilities in the ordinary course of business; no adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern.

The Company intends to fund ongoing activities by utilizing its current cash and cash equivalents on hand, cash received from the sale of its PoNS device in the U.S. and Canada and by raising additional capital through equity or debt financings. There can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company. If the Company is unable to raise sufficient additional capital, the Company may be compelled to reduce the scope of its operations.

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2024

INCOME TAXES

Schedule of loss before provision for income taxes

The Company's loss before provision for income taxes was generated from operations in the United States and outside of the United States as follows (in thousands):


	Years Ended December 31,
	2024		2023
U.S.	$	(11,303)	$	(8,689)
Non-U.S.		(439)		(161)
	$	(11,742)	$	(8,850)

Reconciliation of United States federal statutory income tax rate to effective income tax rate

A reconciliation of the United States federal statutory income tax rate to the Company's effective income tax rate is as follows (in thousands):


	Years Ended December 31,
	2024		2023
Income tax benefit at United States federal statutory rate	$	(2,466)	$	(1,858)
Derivative liability		(626)		(623)
Share based payments		125		(791)
Tax credits		(189)		(142)
Foreign income taxed at foreign rate		(24)		(9)
Other permanent difference		119		126
Other		7		144
Increase in valuation allowance		3,054		3,153
Income tax expense	$	—	$	—

Schedule of components of deferred tax assets and liabilities

The components of deferred tax assets and liabilities are as follows (in thousands):


	As of December 31,
	2024		2023
Deferred tax assets
Net operating loss carryforwards	$	32,635	$	30,642
Stock-based compensation		3,967		3,316
Research and development		2,486		2,164
Tax credit carryforwards		1,419		1,267
Compensation and benefits		195		120
Unrealized foreign currency losses		320		33
Deferred revenue		31		45
Other		36		26
Total deferred tax assets		41,089		37,613
Deferred tax liabilities
Property and equipment		(4)		(16)
Other		(3)		(19)
Total deferred tax liabilities		(7)		(35)
Valuation allowance		(41,082)		(37,578)
Net deferred tax assets	$	—	$	—

Schedule of net operating loss carryforwards and related carryforward expiration periods


	As of December 31,
	2024		2023
Deferred tax assets
Net operating loss carryforwards	$	32,635	$	30,642
Stock-based compensation		3,967		3,316
Research and development		2,486		2,164
Tax credit carryforwards		1,419		1,267
Compensation and benefits		195		120
Unrealized foreign currency losses		320		33
Deferred revenue		31		45
Other		36		26
Total deferred tax assets		41,089		37,613
Deferred tax liabilities
Property and equipment		(4)		(16)
Other		(3)		(19)
Total deferred tax liabilities		(7)		(35)
Valuation allowance		(41,082)		(37,578)
Net deferred tax assets	$	—	$	—

Schedule of gross tax credit carryforwards and related carryforward expiration periods


		Carryforward
		Amount	Expiration
United States federal net operating losses	$	39,561	2032-2037
United States federal net operating losses		83,378	Indefinite
United States state net operating losses		74,624	2033-2044
United States state net operating losses		12,053	Indefinite
Canada federal net operating losses		6,384	2034-2044

The gross tax credit carryforwards and the related carryforward expiration periods as of December 31, 2024 are summarized as follows (in thousands):


		Carryforward
		Amount	Expiration
United States federal research expenditure tax credits	$	986	2034-2044
Canada federal research expenditure tax credits		432	2034-2037

BASIC AND DILUTED LOSS PER SHARE (Tables)

12 Months Ended

Dec. 31, 2024

BASIC AND DILUTED LOSS PER SHARE

Schedule of computation of basic and diluted loss per share

The table below presents the computation of basic and diluted loss per share (in thousands, except share and per share information):


	Years Ended
	December 31,
	2024		2023
Basic:
Net loss available to common stockholders — basic	$	(11,742)	$	(8,850)
Weighted average common shares outstanding — basic⁽¹⁾		2,709,781		607,890
Loss per share - basic	$	(4.33)	$	(14.56)

Diluted:
Net loss available to common stockholders — diluted ⁽²⁾	$	(11,742)	$	(8,850)
Weighted average common shares outstanding — diluted ⁽¹⁾		2,709,781		607,890
Loss per share — diluted	$	(4.33)	$	(14.56)

⁽¹⁾

In May 2024, in connection with the 2024 Public Offering, the Company issued and sold Pre-funded Warrants exercisable for an aggregate of 2,147,222 shares of Common Stock. The total price of the Pre-funded Warrants is $2.25 per share, $2.249 of which was pre-funded and paid to the Company upon issuance of the Pre-funded Warrants. The exercise price of the Pre-funded Warrants is $0.001 per share. The Pre-funded Warrants are immediately exercisable and do not expire. As of December 31, 2024, 2,052,703 Pre-funded Warrants were exercised and 12,222 Pre-funded Warrants remained outstanding. As the remaining shares underlying the Pre-funded Warrants are exercisable for nominal consideration of $0.001 per share, 12,222 in common shares underlying the unexercised Pre-funded Warrants were considered outstanding for purposes of the calculation of loss per share for the year ended December 31, 2024. Refer to Note 8 for additional information about the Pre-funded Warrants.

⁽²⁾	For the years ended December 31, 2024 and 2023, no adjustment was made to the numerator.

Schedule of anti-dilutive securities


	Years Ended
	December 31,
	2024	2023
Stock options	2,092,461	245,830
Restricted stock units	—	2,228
Warrants ⁽¹⁾	6,460,712	637,059

INCOME TAXES

12 Months Ended

Dec. 31, 2024

INCOME TAXES

INCOME TAXES

11.INCOME TAXES

The Company's loss before provision for income taxes was generated from operations in the United States and outside of the United States as follows (in thousands):


	Years Ended December 31,
	2024		2023
U.S.	$	(11,303)	$	(8,689)
Non-U.S.		(439)		(161)
	$	(11,742)	$	(8,850)

A reconciliation of the United States federal statutory income tax rate to the Company's effective income tax rate is as follows (in thousands):


	Years Ended December 31,
	2024		2023
Income tax benefit at United States federal statutory rate	$	(2,466)	$	(1,858)
Derivative liability		(626)		(623)
Share based payments		125		(791)
Tax credits		(189)		(142)
Foreign income taxed at foreign rate		(24)		(9)
Other permanent difference		119		126
Other		7		144
Increase in valuation allowance		3,054		3,153
Income tax expense	$	—	$	—

The components of deferred tax assets and liabilities are as follows (in thousands):


	As of December 31,
	2024		2023
Deferred tax assets
Net operating loss carryforwards	$	32,635	$	30,642
Stock-based compensation		3,967		3,316
Research and development		2,486		2,164
Tax credit carryforwards		1,419		1,267
Compensation and benefits		195		120
Unrealized foreign currency losses		320		33
Deferred revenue		31		45
Other		36		26
Total deferred tax assets		41,089		37,613
Deferred tax liabilities
Property and equipment		(4)		(16)
Other		(3)		(19)
Total deferred tax liabilities		(7)		(35)
Valuation allowance		(41,082)		(37,578)
Net deferred tax assets	$	—	$	—

Net operating loss carryforwards and the related carryforward expiration periods as of December 31, 2024 are summarized as follows (in thousands):


		Carryforward
		Amount	Expiration
United States federal net operating losses	$	39,561	2032-2037
United States federal net operating losses		83,378	Indefinite
United States state net operating losses		74,624	2033-2044
United States state net operating losses		12,053	Indefinite
Canada federal net operating losses		6,384	2034-2044

The gross tax credit carryforwards and the related carryforward expiration periods as of December 31, 2024 are summarized as follows (in thousands):


		Carryforward
		Amount	Expiration
United States federal research expenditure tax credits	$	986	2034-2044
Canada federal research expenditure tax credits		432	2034-2037

Under the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), the net operating loss carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Section 382 of the Code, as well as similar state provisions. This could substantially limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. Although a formal Section 382 analysis has not yet been completed, the Company believes it is possible ownership changes have occurred. The annual limitation may result in the expiration of United States net operating losses and credits before utilization; however, due to the valuation allowance against deferred tax assets as of December 31, 2024, the net effect of any limitation will have no impact on results of operations.

The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. As of both December 31, 2024 and 2023, the Company does not have an accrual relating to uncertain tax positions. It is not anticipated that unrecognized tax benefits would significantly increase or decrease within 12 months of the reporting date.

The Company files income tax returns in the United States and Canada. The Company’s tax returns are subject to tax examinations by United States federal and state tax authorities, or examinations by foreign tax authorities until the expiration of the respective statutes of limitation. The Company currently has no tax years under examination.

- Definition

The entire disclosure for income tax.

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+ Details

INCOME TAXES - Reconciliation of Income Tax Provision Computed at Statutory Rates (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
INCOME TAXES
Income tax benefit at United States federal statutory rate	$ (2,466)	$ (1,858)
Increase (decrease) in income tax recovery resulting from:
Derivative liability	(626)	(623)
Share based payments	125	(791)
Tax credits	(189)	(142)
Foreign income taxed at foreign rate	(24)	(9)
Other permanent difference	119	126
Other	7	144
Increase in valuation allowance	3,054	3,153
Income tax expense	$ 0	$ 0

BASIC AND DILUTED LOSS PER SHARE - Antidilutive securities (Details) - shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
Stock options
Anti-dilutive securities
Anti-dilutive outstanding securities not included in computation of diluted loss per share	2,092,461	245,830
Restricted stock units
Anti-dilutive securities
Anti-dilutive outstanding securities not included in computation of diluted loss per share		2,228
Warrants
Anti-dilutive securities
Anti-dilutive outstanding securities not included in computation of diluted loss per share	6,460,712	637,059

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (11,742)	$ (8,850)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(A))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 29: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(B))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 30: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iv))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(5))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 32: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-60B

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Topic 205
-SubTopic 20
-Name Accounting Standards Codification
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-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483499/205-20-50-7

Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
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-Section 45
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1B

Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

COMMON STOCK AND WARRANTS - Warrant fair value inputs (Details) - 2022 Warrants	Dec. 31, 2024	Dec. 31, 2023
Stock price
Fair value inputs
Derivative Liability, Measurement Input	0.67	8.04
Warrant term (in years)
Fair value inputs
Derivative Liability, Measurement Input	2.61	3.61
Expected volatility
Fair value inputs
Derivative Liability, Measurement Input	98.92	84.1
Risk-free interest rate
Fair value inputs
Derivative Liability, Measurement Input	4.26	3.96
Dividend rate
Fair value inputs
Derivative Liability, Measurement Input	0	0

FIXED ASSET IMPAIRMENT

12 Months Ended

Dec. 31, 2024

FIXED ASSET IMPAIRMENT

FIXED ASSET IMPAIRMENT

3.FIXED ASSETS IMPAIRMENT

In the fourth quarter of 2024, the Company made the decision to no longer utilize certain capitalized software associated with its enterprise resource planning system and as a result, impairment charges of $40 thousand were recorded in the fourth quarter of 2024 on its long-lived tangible assets.

In the third quarter of 2023, the Company identified an impairment indicator associated with its property and equipment and performed interim impairment tests on the long-lived tangible assets as a result of a planned change of the Company’s contract manufacturing partner to be completed in less than one year from September 30, 2023. The interim impairment tests were performed using estimated market prices. The Company had determined that the fair value of certain long-lived tangible assets was lower than the related book values. Additionally, for certain long-lived tangible assets, it is more likely than not that those long-lived assets will be disposed significantly before the end of their previously estimated useful lives. As a result, impairment charges of $159 thousand were recorded in the third quarter of 2023 on its long-lived tangible assets.

BASIC AND DILUTED LOSS PER SHARE

12 Months Ended

Dec. 31, 2024

BASIC AND DILUTED LOSS PER SHARE

BASIC AND DILUTED LOSS PER SHARE

10.BASIC AND DILUTED LOSS PER SHARE

The table below presents the computation of basic and diluted loss per share (in thousands, except share and per share information):


	Years Ended
	December 31,
	2024		2023
Basic:
Net loss available to common stockholders — basic	$	(11,742)	$	(8,850)
Weighted average common shares outstanding — basic⁽¹⁾		2,709,781		607,890
Loss per share - basic	$	(4.33)	$	(14.56)

Diluted:
Net loss available to common stockholders — diluted ⁽²⁾	$	(11,742)	$	(8,850)
Weighted average common shares outstanding — diluted ⁽¹⁾		2,709,781		607,890
Loss per share — diluted	$	(4.33)	$	(14.56)

⁽¹⁾

⁽²⁾	For the years ended December 31, 2024 and 2023, no adjustment was made to the numerator.

The following outstanding securities, presented based on amounts outstanding as of the end of each period, were not included in the computation of diluted loss per share for the periods indicated, as they would have been anti-dilutive due to the net loss in each period.


	Years Ended
	December 31,
	2024	2023
Stock options	2,092,461	245,830
Restricted stock units	—	2,228
Warrants ⁽¹⁾	6,460,712	637,059

COMMITMENTS AND CONTINGENCIES - License agreement (Details) - Advanced NeuroRehabilitation, LLC - License Agreement for Exclusive Right on Patent Pending Technology - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023
COMMITMENTS AND CONTINGENCIES
Percentage of royalty on net revenue	4.00%
Royalty expense	$ 19	$ 24

STOCK-BASED COMPENSATION (Tables)

12 Months Ended

Dec. 31, 2024

STOCK-BASED COMPENSATION

Schedule of weighted-average assumptions used in Black-Scholes option pricing model


	Years Ended December 31, 2024
	2024			2023
Risk-free interest rate		4.38	%		3.93	%
Expected volatility		128.73	%		79.43
Expected term (years)		5.27			5.70
Expected dividend yield		0.00	%		0.00	%
Fair value, per share	$	0.84		$	10.17

Summary of stock option activity


				Weighted Average	Aggregate
		Weighted		Remaining	Intrinsic
		Average		Contractual	Value
	Shares	Exercise Price		Term (in years)	(in thousands)
Outstanding as of December 31, 2023	245,830	$	76.28	9.03		5.00
Granted	1,856,000		0.96	—		—
Exercised	—		—	—		—
Expired	(5,747)		176.61	—		—
Forfeited	(3,622)		16.27	—		—
Outstanding as of December 31, 2024	2,092,461		9.30	9.33	$	—
Exercisable as of December 31, 2024	1,428,221		12.14	9.31	$	—

Summary of nonvested restricted stock unit activity


		Weighted Average
		Grant Date
	Shares	Fair Value
Nonvested as of December 31, 2023	2,228	$	7.81
Granted	—		—
Vested	(2,228)		7.81
Forfeited	—		—
Nonvested as of December 31, 2024	—	$	—

Schedule of stock-based compensation expense


	Years Ended
	December 31,
	2024		2023
Cost of sales	$	28	$	18
Selling, general and administrative		2,008		1,320
Research and development		486		291
Total stock-based compensation expense	$	2,522	$	1,629