Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission File Number 001-38109

MYOMO, INC.

(Exact name of Registrant as Specified in its Charter)


Delaware		47-0944526
(State or Other Jurisdiction of		(I.R.S. Employer
Incorporation or Organization)		Identification No.)

137 Portland St., 4th Floor, Boston, Massachusetts		02114
(Address of principal executive offices)		(Zip Code)

(617) 996-9058

Registrant’s Telephone Number, Including Area Code

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	MYO	NYSE American

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes: ☒ No: ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

At August 1, 2024, the registrant has 30,225,752 shares of common stock, par value $0.0001 per share, outstanding.

Summary of the Material Risks Associated with Our Business

•

We have a history of operating losses. Factors both within and outside of our control could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis.

•

Our strategy to maximize revenues by focusing our efforts on patients whose insurance has reimbursed for the MyoPro in the past has resulted in a concentration of revenues with patients covered by a particular insurer. Adverse changes in that insurer’s reimbursement policy regarding the MyoPro could have an adverse effect on our business.

•

We currently rely, and in the future will rely, on sales of our MyoPro products for our revenue, and we may not be able to achieve or maintain market acceptance.

•

We may not be able to maintain adequate levels of third-party payer reimbursement, including reimbursement by Medicare, for our products.

•

We depend on a single third-party to manufacture key subassemblies for the MyoPro, and a limited number of third-party suppliers for certain components of the MyoPro.

•

We sell to orthotics and prosthetics providers and distributors who are free to market products that compete with the MyoPro, and we rely on these distributors to market and promote our products in accordance with their U.S. Food and Drug Administration, or FDA, listings, select appropriate patients and provide adequate follow-on care.

•

The market for myoelectric braces is new and the rate of adoption is uncertain, and important assumptions about the potential market for our products may be inaccurate.

•

Defects in our products or the software that drives them could adversely affect the results of our operations.

•

We are subject to extensive governmental regulations relating to the design, development, manufacturing, labeling and marketing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.

•

Our internal computer systems, or those of our customers, collaborators or other contractors, may be subject to cyber-attacks or security breaches, which could result in a material disruption of our product development programs.

•

Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products.

•

The market price of our common stock has been and may continue to be volatile.

•

Since we sell products in several overseas markets, we are subject to foreign currency fluctuations in value, which may reduce our revenue per unit in dollars.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q constitutes forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms or other comparable terminology.

You should not place undue reliance on forward looking statements. The cautionary statements set forth in this Quarterly Report on Form 10-Q, including in “Risk Factors” and elsewhere, identify important factors which you should consider in evaluating our forward-looking statements. These factors include, among other things:

•

our ability to achieve reimbursement from third-party payers for our products;

•

our dependence upon external sources for the financing of our operations;

•

our ability to obtain and maintain our strategic collaborations and to realize the intended benefits of such collaborations;

•

our ability to effectively execute our business plan;

•

our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products;

•

our expectations as to our clinical research program and clinical results;

•

our ability to improve our products and develop new products;

•

our ability to manage the growth of our operations over time;

•

our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;

•

our ability to gain and maintain regulatory approvals;

•

our ability to maintain relationships with existing customers and develop relationships with new customers;

•

our ability to compete and succeed in a highly competitive and evolving industry; and

•

other risks and uncertainties, including those listed under the captain “Risk Factors” in this Quarterly Report on Form 10-Q.

Although the forward-looking statements in this Quarterly Report on Form 10-Q, are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this Quarterly Report on Form 10-Q, or otherwise make public statements updating our forward-looking statements.

TABLE of CONTENTS


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (interim periods unaudited)			1

Condensed Consolidated Balance Sheets at June 30, 2024 and December 31, 2023 (audited)			1

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023			2

Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2024 and 2023			3

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023			4

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023			5

Notes to Unaudited Condensed Consolidated Financial Statements			6

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			16

Item 3. Quantitative and Qualitative Disclosures About Market Risk			22

Item 4. Controls and Procedures			22

PART II. OTHER INFORMATION

Item 1. Legal Proceedings			23

Item 1A. Risk Factors			23

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities			43

Item 5 Other Information			43

Item 6. Exhibits			44

Signatures			45

Part 1. FINANCIAL INFORMATION

Item 1. Financial statements

MYOMO, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	June 30,			December 31,
	2024			2023
	(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents	$	5,846,100		$	6,871,306
Short-term investments		3,135,801			1,994,662
Accounts receivable, net		2,526,361			2,382,658
Inventories, net		2,601,104			1,803,507
Prepaid expenses and other current assets		1,032,323			598,850
Total Current Assets		15,141,689			13,650,983
Operating lease assets with right of use, net		539,498			663,554
Equipment, net		289,303			175,794
Other assets		219,891			91,237
Total Assets	$	16,190,381		$	14,581,568
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable and accrued expenses		5,868,407			4,885,944
Current operating lease liability		316,600			486,143
Income taxes payable		268,310			96,461
Deferred revenue		12,015			8,510
Total Current Liabilities		6,465,332			5,477,058
Non-current operating lease liability		47,338			115,160
Total Liabilities		6,512,670			5,592,218
Commitments and Contingencies		—			—
Stockholders’ Equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding		—			—
Common stock par value $0.0001 per share, 65,000,000 shares authorized; 30,201,354 and 27,135,061 shares issued as of June 30, 2024 and December 31, 2023, respectively; and 30,201,327 and 27,135,034 shares outstanding at June 30, 2024 and December 31, 2023, respectively		3,021			2,715
Additional paid-in capital		111,430,314			105,840,239
Accumulated other comprehensive income		138,888			83,669
Accumulated deficit		(101,888,048	)		(96,930,809	)
Treasury stock, 27 shares at cost		(6,464	)		(6,464	)
Total Stockholders’ Equity		9,677,711			8,989,350
Total Liabilities and Stockholders’ Equity	$	16,190,381		$	14,581,568

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)


	For the Three Months ended						For the Six Months Ended
	June 30,						June 30,
	2024			2023			2024			2023
Revenue
Product revenue	$	7,520,767		$	4,243,624		$	11,275,156		$	7,690,332
License revenue		—			1,714,920			—			1,714,920
		7,520,767			5,958,544			11,275,156			9,405,252

Cost of revenue		2,195,255			1,677,488			3,650,601			2,816,594
Gross profit		5,325,512			4,281,056			7,624,555			6,588,658
Operating expenses:
Research and development		1,007,224			564,235			1,963,438			1,041,225
Selling, clinical and marketing		2,777,135			2,271,937			5,138,980			4,302,488
General and administrative		2,656,217			2,547,890			5,525,968			5,018,947
		6,440,576			5,384,062			12,628,386			10,362,660

Loss from operations		(1,115,064	)		(1,103,006	)		(5,003,831	)		(3,774,002	)

Other (income) expense, net
Interest income		(107,242	)		(103,439	)		(242,535	)		(189,753	)
Other expense, net		—			5,631			—			5,631
Loss on equity investment		—			12,514			—			29,716
		(107,242	)		(85,294	)		(242,535	)		(154,406	)
Loss before income taxes		(1,007,822	)		(1,017,712	)		(4,761,296	)		(3,619,596	)
Income tax expense (benefit)		113,785			(3,562	)		195,943			38,849
Net loss	$	(1,121,607	)	$	(1,014,150	)	$	(4,957,239	)	$	(3,658,445	)

Weighted average number of common shares outstanding:
Basic and diluted		37,368,488			27,992,928			37,060,543			26,000,216
Net loss per share attributable to common stockholders
Basic and diluted	$	(0.03	)	$	(0.04	)	$	(0.13	)	$	(0.14	)

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)


	For the Three Months Ended						For the Six Months Ended
	June 30,						June 30,
	2024			2023			2024			2023
Net loss	$	(1,121,607	)	$	(1,014,150	)	$	(4,957,239	)	$	(3,658,445	)
Other comprehensive (loss) income, net of tax:
Foreign currency translation adjustments		(9,241	)		(71,357	)		52,410			(5,569	)
Unrealized gain on short-term investments		618			1,634			2,809			1,634
Other comprehensive (loss) income		(8,623	)		(69,723	)		55,219			(3,935	)
Comprehensive loss	$	(1,130,230	)	$	(1,083,873	)	$	(4,902,020	)	$	(3,662,380	)

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited)


	For the Three and Six Months Ended June 30, 2024 and 2023
	Common stock		Additional Paid-in	Accumulated Comprehensive	Accumulated	Treasury Stock		Total Stockholders’
	Shares	Amount	Capital	Income (Loss)	Deficit	Shares	Amount	Equity
Balance, January 1, 2024	27,135,061	$2,715	$105,840,239	$83,669	$(96,930,809)	27	$(6,464)	$8,989,350
Proceeds from sale of common stock in registered direct offering, net of offering costs of $547,257	1,354,218	135	4,598,636	—	—	—	—	4,598,771
Proceeds from sale of 224,730 pre-funded warrants in registered direct offering, net of offering costs of $90,814			763,138					763,138
Common stock issued upon vesting of restricted stock units	300,544	31	(31)	—	—	—	—	—
Stock-based compensation	—	—	320,288	—	—	—	—	320,288
Other comprehensive (loss)/income	—	—	—	63,842	—	—	—	63,842
Net loss	—	—	—	—	(3,835,632)	—	—	(3,835,632)
Balance, March 31, 2024	28,789,823	$2,881	$111,522,270	$147,511	$(100,766,441)	27	$(6,464)	$10,899,757
Common stock issued upon vesting of restricted stock units	636,801	63	(63)	—	—	—	—	—
Stock-based compensation	—	—	(91,893)	—	—	—	—	(91,893)
Exercise of pre-funded warrants	774,730	77						77
Other comprehensive (loss)/income	—	—	—	(8,623)	—	—	—	(8,623)
Net loss	—	—	—	—	(1,121,607)	—	—	(1,121,607)
Balance, June 30, 2024	30,201,354	$3,021	$111,430,314	$138,888	$(101,888,048)	27	$(6,464)	$9,677,711

Balance, January 1, 2023	7,750,635	$775	$95,105,071	$43,227	$(88,783,244)	27	$(6,464)	$6,359,365
Common stock issued upon vesting of restricted stock units	2,821	—	—	—	—	—	—	—
Proceeds from sale of common stock in public offering, net of offering costs of $663,856	13,169,074	1,317	3,614,777	—	—	—	—	3,616,094
Proceeds from sale of 6,830,926 pre-funded warrants, net of offering costs of $155,356	—	—	2,064,012	—	—	—	—	2,064,012
Stock-based compensation	—	—	171,027	—	—	—	—	171,027
Other comprehensive (loss)/income	—	—	—	65,788	—	—	—	65,788
Net loss	—	—	—	—	(2,644,295)	—	—	(2,644,295)
Balance, March 31, 2023	20,922,530	$2,092	$100,954,887	$109,015	$(91,427,539)	27	$(6,464)	$9,631,991
Common stock issued upon vesting of restricted stock units, net of 16,744 shares withheld for employee taxes	169,499	18	$(8,165)					(8,147)
Stock-based compensation			280,061					280,061
Unrealized loss on foreign currency				(71,357)				(71,357)
Other comprehensive (loss)/income				1,634				1,634
Net loss					(1,014,150)			(1,014,150)
Balance, June 30, 2023	21,092,029	$2,110	$101,226,783	$39,292	$(92,441,689)	27	$(6,464)	$8,820,032

The accompanying notes are an integral part of the consolidated unaudited financial statements.

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)


For the Six Months Ended June 30,	2024			2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(4,957,239	)	$	(3,658,445	)
Adjustments to reconcile net loss to net cash used in operations:
Depreciation		65,663			100,622
Stock-based compensation		228,395			451,088
Accretion of discount on short-term investments		(108,999	)		—
Credit losses		5,257			13,000
Loss on equity investment		—			29,716
Amortization of right-of-use assets		124,057			209,625
Other non-cash charges		44,631			(10,786	)
Changes in operating assets and liabilities:
Accounts receivable		(102,234	)		235,877
Inventories		(816,055	)		68,907
Prepaid expenses and other current assets		(363,375	)		(212,438	)
Other assets		(214,937	)		—
Accounts payable and accrued expenses		990,973			888,594
Income taxes payable		176,235			34,774
Operating lease liabilities		(237,365	)		(232,467	)
Deferred revenue		3,505			(20,280	)
Net cash used in operating activities		(5,161,488	)		(2,102,213	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of short-term investments		(5,482,757	)		(3,198,634	)
Maturities of short-term investments		4,450,000			250,000
Purchases of equipment		(179,173	)		(60,058	)
Net cash used in investing activities		(1,211,930	)		(3,008,692	)
CASH FLOWS FROM FINANCING ACTIVITIES
Net proceeds from common stock offering		4,598,771			3,708,045
Net settlement of vested restricted stock units to fund related employee statutory tax withholding		—			(8,147	)
Proceeds from sale of pre-funded warrants, net of offering costs		763,138			2,064,012
Net cash provided by financing activities		5,361,909			5,763,910

Effect of foreign exchange rate changes on cash		(13,697	)		7,311

Net (decrease) increase in cash and cash equivalents		(1,025,206	)		660,316

Cash and cash equivalents, beginning of period		6,871,306			5,345,967

Cash and cash equivalents, end of period	$	5,846,100		$	6,006,283

SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES
Deferred offering costs incurred in a prior period to additional paid-in capital	$	—		$	(91,952	)
Unrealized gain from mark to market on short-term investments	$	2,809		$	1,634

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

MYOMO, INC.

NOTES TO CONDENSED CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS

Note 1 — Description of Business

Myomo Inc. (“Myomo” or the Company”) is a wearable medical robotics company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to Orthotics and Prosthetics ("O&P") providers around the world, the Veterans Health Administration, and distributors in Europe and Australia. The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Boston, Massachusetts.

Note 2 — Liquidity

The Company incurred net losses of approximately $4,957,200 and $3,658,400 during the six months ended June 30, 2024 and 2023, respectively, and has an accumulated deficit of approximately $101,888,000 and $96,930,800 at June 30, 2024 and December 31, 2023, respectively. Cash used in operating activities was approximately $5,161,500 and $2,102,200 for the six months ended June 30, 2024 and 2023, respectively. The Company's historical losses and cash used in operations are indicators of substantial doubt regarding the Company's ability to continue as a going concern.

Based upon its current cash, cash and cash equivalents, and short-term investments, as well as the future expected cash flows, the Company believes that its available cash, cash equivalents, and short-term investments will fund its operations for at least the next twelve months from the issuance date of these financial statements.

The Company has historically funded its operations through financing activities, including raising equity and debt. On July 11, 2024, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, which provides the Company the ability to borrow up to $4.0 million against eligible accounts receivable. See Note 10 - Subsequent Events for further discussion. On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants to purchase common stock at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. On August 29, 2023, the Company completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants to purchase common stock at $0.60 per share or at $0.5999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $3.9 million. On January 17, 2023, the Company completed a public equity offering, selling 13,169,074 shares of common stock and 6,830,926 to pre-funded warrants to purchase common stock at $0.325 per share or at $0.3249 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.7 million. See Note 7 - Common Stock and Warrants for further discussion. Financing activities, such as the line of credit and the recently completed registered direct equity offering, are enabling the Company to sustain its operations.

Management's operating plans are primarily focused on increasing its clinical, reimbursement and manufacturing capacity in order to serve a higher volume of Medicare Part B patients in 2024 and beyond. Based on the final fees published by the Centers for Medicare and Medicaid Services (“CMS”) for the Company’s products, which became effective on April 1, 2024, if its supply chain is able to meet its volume requirements without disruption, the Company believes it can achieve cash flow breakeven on a quarterly basis by the fourth quarter of 2024. In addition, the Company believes that it has access to capital resources through the use of its line of credit, possible public or private equity offerings, exercises of outstanding warrants, or other means. Based on the Company's latitude as to the timing and amount of certain expenses, its current cash position and operating plans, the Company believes that the substantial doubt is alleviated as of the issuance date of these financial statements. However, there can be no assurance that the Company will be successful in implementing its operating plans.

Note 3 — Summary of Significant Accounting Policies

Interim Financial Statements

The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2024, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2023 and 2022 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Basis of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated.

Comprehensive Income (Loss)

Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There was a reclassification which management does not consider to be material out of accumulated other comprehensive income (loss) to other (income) expense related to realized gains or losses on short-term investments in the three and six months ended June 30, 2024. There were no reclassifications in the three and six months ended June 30, 2023.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s significant estimates include deferred tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for slow-moving inventory.

Cash, Cash Equivalents and Short-Term Investments

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at June 30, 2024 and December 31, 2023.

The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of June 30, 2024 and December 31, 2023 consists of commercial paper, U.S. Treasury Bills and short-term corporate debt securities, which are classified as held-to-maturity, and certificates of deposit totaling approximately $3,135,800 and $1,994,700 as of June 30, 2024, and December 31, 2023, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at each balance sheet date. All of the Company's U.S. Treasury Bills mature within the subsequent twelve months from the date of purchase.

Accounts Receivable and Allowance for Credit Losses

The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At June 30, 2024, and December 31, 2023, the Company recorded an allowance for credit losses accounts which was immaterial to the condensed consolidated financial statements.

Joint Venture

On March 28, 2022, the Company invested cash consideration of $199,000 for a 19.9% ownership stake in Jiangxi Myomo Medical Assistive Appliance Co. Ltd. (the "JV Company"), a company headquartered in China that is majority-owned by Beijing Ryzur Medical Investment Co., Ltd. (“Ryzur Medical”). The JV Company will manufacture and sell the Company’s current and future products in greater China, including Hong Kong, Macau and Taiwan. The Company accounts for its investment in the JV Company under the equity method because the Company exerts significant influence over its management. The investment was fully written off as of December 31, 2023, due to the recording of the Company's share of the losses of the JV Company in prior periods, which were recorded to other expense (income) in the condensed consolidated statement of operations, the Company has no obligation to fund any losses incurred by the JV Company.

Revenue Recognition

The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all of the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time.

The Company recognizes revenue after applying the following five steps:

Identification of the contract, or contracts, with a customer,

Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract,

Determination of the transaction price, including the constraint on variable consideration,

Allocation of the transaction price to the performance obligations in the contract, and

Recognition of revenue when, or as, performance obligations are satisfied.

Revenue is recognized when control of these services is transferred to our customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.

Product Revenue

Increasingly, the Company derives its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans Administration (“VA”). Under direct billing, the Company recognizes revenue when all of the following criteria are met:

(i)

The product has been delivered to the patient, including completion of initial instruction on its use,

(ii)

Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it is notified that insurance intends to pay and a payment amount is provided, and

(iii)

The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606.

For revenue derived from certain insurance companies where the Company has demonstrated sufficient payment history, the Company recognizes revenue when it receives a pre-authorization from the insurance company and control passes to the patient upon delivery of the device in an amount that reflects the consideration the Company expects to receive in exchange for the device. These insurers represented 27% and 53% of direct billing channel revenue during the three months ended June 30, 2024 and 2023, respectively. These insurers represented 35% and 57% of direct billing channel revenue during the six months ended June 30, 2024 and June 30, 2023, respectively. During the three months ended June 30, 2024, revenues from patients covered by Medicare Part B were recorded at the time the payment amount was known.

Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended June 30, 2024 and 2023, the Company recognized revenue of approximately $1,865,800 and $403,900, respectively, and during the six months ended June 30, 2024 and 2023, the Company recognized revenue of approximately $1,745,000 and $1,898,200, respectively, from third-party payers for which costs related to the completion of the Company’s performance obligations were not recorded in the current period.

For revenues derived from O&P providers and the VA, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable.

The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.

License Revenue

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer, the customer is able to use and benefit from the license, and collectability is deemed probable.

On January 21, 2021, the Company entered into a definitive agreement with Ryzur Medical to form the JV Company to manufacture and sell the Company's current and future products in greater China, including Hong Kong, Macau and Taiwan (the “JV Agreement”). Under the JV Agreement, the Company is entitled to receive an upfront license fee of $2.7 million. As of June 30, 2023, the final portion of the initial license fee has been paid in full and recognized as license revenue. In addition, the Company is entitled to receive a guaranteed minimum payment for purchase of MyoPro Control Units for a period of ten years from the effective date of the JV Agreement. The Company will recognize revenue on these amounts upon invoicing of the JV Company as long as the collectability is deemed to be assured.

Contract Balances

The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had $12,000 of deferred revenue

as of June 30, 2024, and approximately $8,500 of deferred revenue as of December 31, 2023, the outstanding deferred revenue is expected to be recognized by the end of the third quarter of 2024.

Disaggregated Revenue from Contracts with Customers

The following table presents revenue by major source:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Direct to patient	$	5,829,407	$	3,304,113	$	8,059,833	$	5,718,727
Clinical/Medical providers		1,691,360		939,511	$	3,215,323	$	1,971,605
License revenue		—		1,714,920		—		1,714,920
Total revenue from contracts with customers	$	7,520,767	$	5,958,544	$	11,275,156	$	9,405,252

Geographic Data

The Company generated 86% of its total revenue from the United States and 14% from Germany for the three months ended June 30, 2024. The Company generated 63% of its total revenue from the United States, 29% from China, 8% from Germany and an immaterial amount from other international locations, for the three months ended June 30, 2023.

During the six months ended June 30, 2024, the Company generated 82% of its total revenues from the United States, 17% from Germany and 1% from other international locations. During the six months ended June 30, 2023, the Company generated 70% of its total revenues from the United States, 18% from China, 11% from Germany, and 1% from other international locations. Excluding license revenue during the six months ended June 30, 2023, the Company generated 85% of its product revenues from the United States, 14% from Germany and 1% from other international locations.

Cost of Revenue

In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from third-party payers, after which revenue is recognized. For the three and six months ended June 30, 2024, the Company recorded cost of goods sold of approximately $121,800 and $144,600, respectively, without corresponding revenue. For the three and six months ended June 30, 2023, the Company recorded cost of goods sold of $265,600 and $366,800, respectively, without corresponding revenue. Direct billing fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25, as a cost of obtaining a contract. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to measure, fit and deliver the device to patients are expensed to cost of revenue.

Advertising

The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $849,600 and $846,400 for the three months ended June 30, 2024 and 2023, respectively, and approximately $1,636,900 and $1,537,900 during the six months ended June 30, 2024 and 2023, respectively.

Foreign Currency Translation

The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive (loss) gain. The Company recorded losses of approximately $9,200 and $71,400 during the three months ended June 30, 2024 and 2023, respectively, and a gain of approximately $52,400 and a loss of approximately $5,600 during the six months ended June 30, 2024 and 2023, respectively, which are included in accumulated other comprehensive income in the condensed consolidated balance sheet. Transaction and translation foreign exchange gains and losses from a foreign currency to the functional currency are included in cost of goods sold in the consolidated statements of operations. Such amounts were immaterial for the three months ended June 30, 2024 and 2023. The balance sheet is translated using the spot rate on the day of reporting and the statement of operations is translated monthly using the average rate for the month.

Net Loss per Share

Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock,

restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three months ended June 30, 2024 and 2023, and as a result, all potentially dilutive common shares are considered antidilutive for these periods.

Potential dilutive common shares issuable consist of the following at:


	June 30,
	2024		2023
Stock options		23,629		26,138
Restricted stock units		1,275,862		1,608,615
Other warrants		668,250		668,250
Total		1,967,741		2,303,003

Due to their nominal exercise price of $0.0001 per share, a total of 7,721,519 and 6,830,926 outstanding pre-funded warrants as of June 30, 2024 and 2023, respectively are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying condensed consolidated statements of operations as of the closing dates of the Company's public equity offerings in January 2023, August 2023, and January 2024, respectively.

Recently Adopted Accounting Standards

In September 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2022-04, “Liabilities - Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations”, that requires entities that use supplier finance programs in connection with the purchase of goods and services to disclose the key terms of the programs and information about obligations outstanding at the end of the reporting period, including a rollforward of those obligations. The guidance does not affect the recognition, measurement or financial statement presentation of supplier finance program obligations. The new standard’s requirements to disclose the key terms of the programs and information about obligations outstanding are effective for fiscal years, including interim periods, beginning after December 15, 2022, except for the requirement to disclose a rollforward of obligations outstanding will be effective for fiscal years beginning after December 15, 2023. The Company adopted this new standard on January 1, 2024, which did not have a material impact on its financial position and results of operations.

In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations.

In December 2023, the FASB issued ASU 2023-09, “Accounting Standards Update, Income Taxes (Topic 740: Improvements to Income Tax Disclosures”. ASU 2023-09 focuses on income tax disclosures around effective tax rates and cash income taxes paid. This amendment in the ASU will become effective for public companies as of December 15, 2024 and effective to all other companies as of December 15, 2025. The Company will adopt these new standards when they become effective, which is not expected to have a material impact on its financial position and results of operations.

Note 4 — Inventories

Inventories consist of the following at:


	June 30, 2024		December 31, 2023
Finished goods	$	800,305	$	321,484
Work in process		146,945		6,589
Parts and subassemblies		1,653,854		1,475,434
Inventories, net	$	2,601,104	$	1,803,507

Note 5 — Fair Value of Financial Instruments

The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820, “Fair Value Measurement” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements.

ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

•

Level 1 — Quoted prices available in active markets for identical assets or liabilities.

•

Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

•

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.

The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents consist of money market funds that limit their investments to only short-term U.S. Treasury Securities and repurchase agreements related to these securities. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the condensed consolidated balance sheets at amortized cost which approximates fair value.

Cash equivalents and short-term investments measured at fair value on a recurring basis at June 30, 2024 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Cash equivalents
Money market funds		4,754,628	$	—	$	—	$	4,754,628
	$	4,754,628	$	—	$	—	$	4,754,628
Short-term investments
US government agency debt securities		—		499,705		—		499,705
Commercial paper		—		2,240,060		—		2,240,060
Corporate debt securities		—		396,036		—		396,036
	$	—	$	3,135,801	$	—	$	3,135,801

Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2023 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Money market funds	$	4,893,387	$	—	$	—	$	4,893,387
Commercial paper		—	$	746,762		—	$	746,762
Short-term investments		—	$	1,994,662		—	$	1,994,662

Note 6 - Accounts Payable and Other Accrued Expenses

Accounts Payable and Other Accrued Expenses consists of the following at:


	June 30, 2024		December 31, 2023
Trade payables	$	1,369,978	$	1,073,405
Accrued compensation and benefits		2,174,382		1,964,487
Accrued insurance		349,909		95,680
Accrued professional services		60,276		52,202
Warranty reserve		160,104		231,108
Customer deposits		1,595,300		1,114,979
Other		158,458		354,083
	$	5,868,407	$	4,885,944

Note 7 — Common Stock and Warrants

On January 17, 2023, the Company completed a public equity offering, selling 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share or at $0.3249 per warrant, generating proceeds after fees and expenses of approximately $5.7 million. As of June 30, 2024, 5,801,519 pre-funded warrants remain exercisable. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.

On August 29, 2023, the Company completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants at $0.60 per share, or at $0.5999 per warrant, generating proceeds after fees and expenses of approximately $3.9 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share. All of these pre-funded warrants remain exercisable at June 30, 2024.

On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or at $3.7999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share. All of these pre-funded warrants were exercised during the three months ended June 30, 2024.

As of June 30, 2024 there were 7,721,519 pre-funded warrants outstanding.

On August 2, 2022, the Company entered into an ATM Facility with Alliance Global Partners on (“AGP”). Under the ATM Facility, the Company may sell up to an aggregate of $15 million of the Company’s common stock from time to time and shall pay to AGP cash commissions of 3.0% of the gross proceeds of sales of common stock under the ATM Facility. There were no sales under the ATM Facility during the three and six months ended June 30, 2024 and 2023, respectively. In conjunction with the public equity offering in August 2023, the Company reduced the amount available to sell under the ATM Facility to $1,000. This amount remains available for sale at June 30, 2024.

No shares of common stock were issued through the exercise of stock options during the three and six months ended June 30, 2024 and June 30, 2023, respectively.

During the three and six months ended June 30, 2024, 774,730 and 937,345 restricted stock units vested, respectively. During the three and six months ended June 30, 2023, 169,499 and 172,320 restricted stock units vested, respectively.

Note 8 — Stock Award Plans and Stock-Based Compensation

As of June 30, 2024, there were 493,970 shares available for issuance under the Myomo, Inc. 2018 Stock Option and Incentive Plan (the “2018 Plan”). On January 1 of each year, the number of shares of common stock reserved and available for issuance under the 2018 Plan will cumulatively increase by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee of the Board of Directors. On January 1, 2024, 1,085,401 shares were added to the share reserve under the 2018 Plan.

Recipients of awards of restricted stock units typically sell shares in the open market to cover their individual tax liabilities and remit the proceeds to the Company, which offsets withholding taxes paid by the Company. In certain circumstances, stock awards may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. In such instances, these payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. There were no stock awards that were net share settled during the three and six months ended June 30, 2024. There were 16,744 restricted stock units that were withheld as part of net share settlement transactions during the three and six months ended June 30, 2023.

Share-Based Compensation Expense

The Company accounts for stock awards to employees and non-employees based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award.

The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period.

The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:


	For the Three Months Ended					For the Six Months Ended
	June 30,					June 30,
	2024			2023		2024		2023
Cost of goods sold	$	(10,591	)	$	22,114	$	12,796	$	42,593
Research and development		8,719			34,308		32,964		(35,419	)
Selling, clinical and marketing		7,190			49,592		53,251		91,448
Selling, general and administrative		(97,211	)		174,047		129,384		352,466
Total	$	(91,893	)	$	280,061	$	228,395	$	451,088

As of June 30, 2024, there was approximately $13,300 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 0.97 years.

As of June 30, 2024, there was approximately $2,802,300 of unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 2.66 years.

Note 9 — Commitments and Contingencies

Litigation

The Company may be involved from time to time in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. During 2022, a former employee who was terminated in 2021 brought an age discrimination claim against the Company. During the fourth quarter of 2023, the Company settled the claim with the former employee. The Company deemed it probable that its insurance company would pay its share of the claim. As a result of this assumed gain contingency, the Company reduced its accrual to an amount that is not expected to be covered by insurance, and recorded a liability of approximately $55,000 for severance and legal expenses as of December 31, 2023. The settlement was paid and all insurance proceeds were received during the three months ended March 31, 2024. There is no other material litigation against the Company at this time.

Operating Leases

The Company has a non-cancelable sublease agreement for its corporate headquarters in Boston, Massachusetts, which expires in January 2025 and a lease agreement for office space in Fort Worth, TX. which expires in December 2025. Termination options are either not included, or have expired, for the Company’s existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the condensed consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.

As of June 30, 2024, operating lease assets were approximately $539,500. The amount and the maturity of the Company’s operating lease liabilities as of June 30, 2024, are as follows:


	June 30, 2024
2024		289,220
2025		102,841
2026		—
2027		—
Thereafter		—
Total future minimum lease payments		392,061
Less imputed interest		28,123
Total operating lease liabilities	$	363,938
Included in the condensed consolidated balance sheet:
Current operating lease liabilities	$	316,600
Non-current operating lease liabilities		47,338
Total operating lease liabilities	$	363,938

For the three and six months ended June 30, 2024 and 2023, the total lease cost is comprised of the following amounts:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Operating lease expense		87,835		125,650		175,671		251,299
Short-term lease expense		1,608		—		3,268		—
Total lease expense	$	89,443	$	125,650	$	178,939	$	251,299

The following summarizes additional information related to operating leases:


	June 30, 2024			December 31, 2023
Weighted-average remaining lease term (in years)		0.79			1.20
Weighted-average discount rate		23.3	%		23.3	%

Major Customers

For the three and six months ended June 30, 2024 and 2023, there were no customers which accounted for more than 10% of product revenues. For the three and six months ended June 30, 2024, a U.S. insurance payer represented 20% and 24% of product revenues, respectively. For the three and six months ended June 30, 2024, patients with Medicare Part B coverage represented 47% and 35% of product revenues, respectively. For the three and six months ended June 30, 2023, a U.S. insurance payer represented 41% and 42% of product revenues, respectively.

At June 30, 2024 and December 31, 2023, one insurance payer and its affiliates accounted for approximately 37% and 38% of accounts receivable, respectively.

For the three and six months ended June 30, 2024, approximately 26% and 30% of the Company's product revenues, respectively, were derived from patients with Medicare Advantage insurance plans. For the three and six months ended June 30, 2023, approximately 63% and 59% of the Company's product revenues were derived from patients with Medicare advantage insurance plans, respectively.

Supplier Finance Program Obligations

The Company finances its Directors and Officers Insurance policy, which requires the Company to make a down payment, followed by equal payments over a defined term. During the year ended December 31, 2023, the Company completed its payment obligation associated with its 2022-2023 policy and entered into a new policy covering the twelve-month period ending June 2024. Under this financing arrangement, the Company made a down payment of approximately $29,000 during the three months ended June 30, 2023 and made nine equal monthly payments of approximately $27,000, starting in July 2023. During the three and six months ended June 30, 2024, the Company completed its payment obligation associated with its 2023-2024 policy and entered into a new policy covering the twelve-month period ending June 2025. Under this new financing arrangement, the Company made a down payment of approximately $39,000 during the three months ended June 30, 2024, and is making nine equal monthly payments of approximately $39,000, starting in July 2024. Changes in the Company's supplier finance obligations were as follows:



For the Six Months Ended June 30,	2024			2023
Balance January 1	$	142,217		$	56,603
Increase		—			128,692
Expensed		(80,109	)		(132,988	)
Balance March 31,	$	62,108		$	52,307
Increase		349,909			375,824
Expensed		(78,593	)		(155,076	)
Balance June 30,	$	333,424		$	273,055

No assets are pledged as security under this arrangement.

Note 10 — Subsequent Events

Line of Credit

On July 11, 2024 (the “Effective Date”), the Company, entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (the “Bank”).

The Loan Agreement provides for a revolving line of credit whereby the Company may borrow up to $4,000,000 (the “Revolving Line”) , which Revolving Line may be increased to $5,500,000 at the Bank’s sole discretion upon the occurrence of certain events. Amounts advanced by the Bank are based on 80% of “eligible accounts”, which includes all receivables in the United States, reduced by aged amounts and customers and insurance payers with concentrations in excess of defined limits, among other deductions. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) 8.50% and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period plus one-half percent (0.50%). The Revolving Line is secured on a first priority basis by all of Company’s assets other than intellectual property and certain customary exceptions. Any newly formed or acquired subsidiary of the Company or any guarantor under the Loan Agreement, will either join the Loan Agreement as a co-borrower or become a guarantor under the Loan Agreement, as determined by the Bank in its sole discretion. The Company intends to use the Revolving Line for working capital and general business purposes.

The Revolving Line terminates, and any outstanding principal amount of all advances made thereunder, and any accrued and unpaid interest thereon, become immediately due and payable on the two year anniversary of the Effective Date. The Company must also pay Bank (i) a commitment fee of $20,000, (ii) an “Anniversary Fee” of 0.50% of the Revolving Line and (iii) an “Unused Revolving Line Facility Fee” of 0.50% per annum of the average unused portion of the Revolving Line. In addition, upon termination of the Loan Agreement or the Revolving Line prior to the two year anniversary of the Effective Date, the Company must pay a termination fee of 1.00% of the Revolving Line, subject to certain exceptions.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with our condensed consolidated financial statements and the related notes contained elsewhere in this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission filings. The following discussion may contain predictions, estimates, and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors”, “Cautionary Statement Regarding Forward-Looking Statements” and elsewhere in this Quarterly Report on Form 10-Q. These risks could cause our actual results to differ materially from any future performance suggested below.

Overview

We are a wearable medical robotics company, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders. We develop and market the MyoPro product line, which is a myoelectric-controlled upper limb brace, or orthosis. The orthosis is a rigid brace used for the purpose of supporting a patient’s weak or deformed arm to enable and improve functional activities of daily living (“ADLs”), in the home and community. It is custom constructed by a trained professional during a custom fabrication process for each individual user to meet their specific needs. Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders.

We have relationships with physicians and therapists who generate patient referrals, and we utilize digital ads on various platforms as well as television ads to reach patients who are potential candidates for our product. Once the prospective patient contacts us or is referred to us, either our trained clinical staff or a trained Orthotics and Prosthetics (“O&P”) provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are often conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate. Prior to delivering our device to a Medicare patient or obtaining authorizations from commercial insurance companies, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and a prescription is always obtained from a physician. Once these documents are obtained, a pre-authorization request is submitted to the patient’s commercial insurer. If we receive a pre-authorization, we proceed to measure the patient’s arm, a process we refer to as shape capture. For a Medicare patient, we will commence shape capture once we are in possession of all relevant medical records and have assessed that the patient meets our inclusion criteria. Beginning in 2022, arm measurements are being done in some cases using a digital measurement kit supplied to the patient. We then use those measurements to 3D print orthotic parts, which are used to fabricate the MyoPro, and then deliver it to the patient. Since we are directly providing the device to the patient and then billing insurance ourselves, we refer to this process as direct billing. We also call on O&P practices in the United States, Europe and Australia that provide our products to their patients as well as generate indirect sales. The MyoPro product line has been approved by the Veterans Administration (“VA”) for impaired veterans, and nearly 130 VA facilities have ordered devices for their patients.

Our myoelectric orthoses have been clinically shown in peer reviewed published research studies to help regain the ability to complete functional tasks by supporting the affected joint and enabling individuals to self-initiate and control movement of their partially paralyzed limbs by using their own muscle signals. Our technology was originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. Myomo was incorporated in 2004.

Other historical milestones include:

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In 2012, we introduced the MyoPro. The primary business focus shifted from developing devices that were designed for rehabilitation therapy and sold to hospitals to providing an assistive device through O&P providers to patients who are otherwise impaired for use at home, work, and in the community that facilitates ADLs.

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During 2015, we extended our basic MyoPro for the elbow with the introduction of the MyoPro Motion W, a multi-articulated non-powered wrist and the MyoPro Motion G, which includes a powered grasp. The MyoPro Motion W allows the user to use their sound arm to adjust the device and then, for instance, open a refrigerator door, carry a shopping bag, hold a cell phone, or stabilize themselves to avoid a fall and potential injury. The MyoPro Motion G model allows users with severely weakened or clenched hands, such as seen in certain stroke survivors, to open and close their hands and perform a large number of ADLs.

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On June 9, 2017, we completed our initial public offering (“IPO”) and a private offering concurrent with the IPO, generating net proceeds of $6.9 million in the aggregate.

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On July 31, 2017, we met the criteria to apply the CE Mark for the MyoPro. This has enabled us to sell the MyoPro to individuals in the European Union (the “EU”).

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In November 2018, we announced that the Centers for Medicare and Medicaid Services, (“CMS”), had published two new codes (L8701, L8702) pursuant to our application for Healthcare Common Procedure Coding System (“HCPCS”) codes which become effective in early 2019. The assignment of unique L-Codes, if followed by appropriate payment terms, offers greater access to the MyoPro for Medicare beneficiaries.

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In 2019, we transitioned our business to become a direct provider of the MyoPro to patients and bill insurance companies directly.

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In July 2021, we became accredited as a Medicare provider.

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In January 2022, we introduced MyoPro 2+ and began in-house fabrication of the device.

China Joint Venture

On January 21, 2021, we entered into a definitive agreement with Beijing Ryzur Medical Investment Co., Ltd. (“Ryzur Medical”), a medical device manufacturer based in Beijing, to form a joint venture (the “JV”) to manufacture and sell our current and future products in greater China, including Hong Kong, Macau and Taiwan (the “JV Agreement”).

Majority ownership in the joint venture, named Jiangxi Myomo Medical Assistive Appliance Co., Ltd., (the "JV Company") is held by Ryzur Medical with minority ownership by Wuxi Chinaleaf Investment Management Limited Partnership, a private fund that invests in growth opportunities in new technologies. We own a minimum 19.9% stake in the JV Company. Ryzur Medical and its partners have committed to invest a minimum of $8 million and up to $20 million in the JV Company over five years.

The JV Company was established on August 12, 2021. On December 29, 2021, we entered into an amendment to the JV Agreement, as well as a Technology License Agreement and a Trademark License Agreement (collectively, the “Agreements”). Under the Agreements, we and the JV Company have entered into a ten-year agreement to license our intellectual property, including recently issued patents in China and Hong Kong, and purchase MyoPro Control System units from us. Pursuant to the Agreements, the JV Company has agreed to an escalating purchase commitment for a minimum of $10.75 million in MyoPro Control System Units during the next ten years, subject to receipt of regulatory approvals necessary to permit sales of the product in the greater China territory.

Recent Developments

Equity Offerings

On January 19, 2024 we completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants to purchase common stock at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. Net proceeds from the offering were used to hire 50 to 60 people through the second quarter of 2024 in order to increase our clinical, reimbursement and manufacturing capacity to serve a growing number of patients, including Medicare Part B beneficiaries. On August 29, 2023, we completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants to purchase common stock at $0.60 per share, or at $0.5999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $3.9 million. In January 2023, we completed a public equity offering, whereby we sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants to purchase common stock at $0.325 per share, or $0.3249 per pre-funded warrant. Each pre-funded warrant in the above offerings entitles the holder to one share of common stock upon exercise at a nominal exercise price of $0.0001 per share. See section titled “Liquidity” for further discussion.

CMS Status

On November 1, 2023, CMS issued a final rule that results in a change in the benefit category associated with products billed under the HCPCS codes for our products from durable medical equipment rental to a brace, which would permit reimbursement of MyoPro sales on a lump sum basis. The rule became effective on January 1, 2024. On February 29, 2024, CMS published final average payment determinations for the HCPCS codes describing our products of approximately $33,500 for L8701, the MyoPro Motion W, and approximately $65,900 for L8702, the MyoPro Motion G, which became effective on April 1, 2024. We are being paid by CMS at approximately 80% of the published fees, with the remaining 20% from either the patient directly or their secondary insurance, if any.

Beginning January 1, 2024, we began deliveries to Medicare Part B patients for lump sum reimbursement under the brace benefit category. During the three and six months ended June 30, 2024, revenues from Medicare Part B beneficiaries represented 47% and 35% of product revenues, respectively.

Results of Operations

We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue as we focus our efforts on continuing to expand our sales and marketing efforts by increasing the breadth of our marketing activities, increasing our investment in the German and other international markets, investing in development of the pediatric version of the MyoPro, the MyoPal, and the funding of resources focused on obtaining reimbursement from insurance companies.

The following table sets forth our revenue, cost of revenue, gross profit and gross margin for each of the periods presented.


	For the Three Months Ended June 30,		Period- to-Period Change		For the Six Months Ended June 30,		Period- to-Period Change
	2024	2023	$	%	2024	2023	$	%
Product revenue	$7,520,767	$4,243,624	$3,277,143	77%	$11,275,156	$7,690,332	$3,584,824	47%
License revenue	—	1,714,920	(1,714,920)	(100)%	-	1,714,920	(1,714,920)	(100)%
Total revenue	7,520,767	5,958,544	1,562,223	26%	11,275,156	9,405,252	1,869,904	20%
Cost of revenue	2,195,255	1,677,488	517,767	31%	3,650,601	2,816,594	834,007	30%
Gross profit	$5,325,512	$4,281,056	$1,044,456	24%	$7,624,555	$6,588,658	$1,035,897	16%
Gross margin %	70.8%	71.8%		-1.0%	67.6%	70.1%		-2.5%

Revenues

We derive revenue primarily from providing devices directly to patients and billing insurance companies or Medicare directly. We also sell our products to O&P providers in the U.S, Europe and Australia, to the VA, and to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.

Total revenue increased by approximately $1,562,000 and $1,869,900, or 26% and 20%, for the three and six months ended June 30, 2024, as compared to the same periods in 2023. Product revenue increased by approximately $3,277,100 and $3,584,800, or 77% and 47%, for the three and six months ended June 30, 2024 as compared to the same periods in 2023. Higher product revenues in the three months ended June 30, 2024 were due to a higher number of revenue units, driven by deliveries to Medicare Part B patients and a higher average selling price as a result of the recently published fees for the MyoPro by CMS.

Cost of Revenue and Gross Margin

Cost of revenue consists of direct costs for the manufacturing, printing of orthotic parts, fabrication and fitting of our products, changes in inventory and warranty reserves, and costs for our quality and fulfillment organizations.

Gross margin was 70.8% and 67.6% for the three and six months ended June 30, 2024 respectively, compared to 71.8% and 70.1% for the three and six months ended June 30, 2023, respectively. Gross margin for product revenue was 70.8% and 67.6% for the three and six months ended June 30, 2024 respectively, compared to 60.5% and 63.4% for the three and six months ended June 30,2023, respectively. The increase in gross margin from product revenue were primarily due to a higher average selling price, fixed cost absorption, and a prior year inventory write-down, offset by an increased manufacturing overhead as we are adding capacity in support of planned revenue growth in 2024 and higher material costs.

Operating expenses

The following table sets forth our operating expenses for each of the periods presented.


	For the Three Months Ended June 30,		Period-to-Period Change		For the Six Months Ended June 30,		Period-to-Period Change
	2024	2023	$	%	2024	2023	$	%
Research and development	$1,007,224	$564,235	$442,989	79%	$1,963,438	$1,041,225	$922,213	89%
Selling, clinical and marketing	2,777,135	2,271,937	505,198	22%	5,138,980	4,302,488	836,492	19%
General and administrative	2,656,217	2,547,890	108,327	4%	5,525,968	5,018,947	507,021	10%
Total operating expenses	$6,440,576	$5,384,062	$1,056,514	20%	$12,628,386	$10,362,660	$2,265,726	22%

Research and development

Research and development (“R&D”) expenses consist of costs for our R&D personnel, including salaries, benefits, bonuses and stock-based compensation, product development costs, clinical studies, and the cost of certain third-party contractors and travel expense. R&D costs are expensed as they are incurred. We intend to enhance our existing products in 2024 and expect R&D costs to increase on an annual basis.

R&D expenses increased by approximately $443,000 and $922,200, or 79% and 89%, during the three and six months ended June 30, 2024, respectively, as compared to the same periods in 2023. The increases were primarily due to higher costs for payroll as we are adding headcount in order to accelerate our sustaining engineering and product development efforts as a result of coverage by Medicare, partially offset by lower stock-based compensation expense.

Selling, clinical and marketing

Selling, clinical, and marketing (“SC&M”) expenses consist of costs for our field clinical staff, clinical training organization, and marketing personnel, including salaries, benefits, bonuses, stock-based compensation and sales commissions, costs of advertising, marketing and promotional events, corporate communications, product marketing and travel expenses. Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense in the period in which the measurable work is performed. We expect SC&M expenses to increase in 2024 as we plan to add clinical capacity in support of serving Medicare Part B patients.

SC&M expenses increased by approximately $505,200 and $836,500 or 22% and 19%, during the three and six months ended June 30, 2024, respectively, as compared to the same periods in 2023. The increases were primarily due to higher payroll costs due to increased headcount in our clinical functions to support higher expected sales volume in 2024, higher travel costs and the effect on payroll costs from a headcount decrease in the first quarter of 2023.

General and administrative

General and administrative (“G&A”) expenses consist primarily of costs for administrative, reimbursement, and finance personnel, including salaries, benefits, bonuses and stock-based compensation, professional fees associated with legal matters, consulting expenses, costs for pursuing insurance reimbursements for our products and costs required to comply with the regulatory requirements of the SEC, as well as costs associated with accounting systems, insurance premiums and other corporate expenses. We expect that general and administrative expenses will increase in 2024 as we plan to add headcount in our human resources and reimbursement functions in support of serving Medicare Part B patients.

G&A increased by approximately $108,300 and $507,000, or 4% and 10%, during the three and six months ended June 30, 2024, respectively, as compared to the same periods in 2023. The increases were primarily due to increased payroll costs due to increased headcount in our clinical, reimbursement and human resource functions as part of our plan to increase our reimbursement capacity in 2024 in order to serve Medicare Part B patients, and the effect on payroll costs from a headcount decrease in the first quarter of 2023, as well as an increase in legal fees, offset by lower stock based compensation expense.

Other (income), net

The following table sets forth our other income, net for each of the periods presented:


	For the Three Months Ended June 30,						Period-to-Period Change						For the Six Months Ended June 30,						Period-to-Period Change
	2024			2023			$			%			2024			2023			$			%
Interest income		(107,242	)		(103,439	)		(3,803	)		4	%		(242,535	)		(189,753	)		(52,782	)		28	%
Other expense, net		-			5,631			(5,631	)		(100	)%		-			5,631			(5,631	)		(100	)%
Loss on equity investment		-			12,514			(12,514	)		(100	)%		-			29,716			(29,716	)		(100	)%
Total other income, net	$	(107,242	)	$	(85,294	)	$	(21,948	)		26	%	$	(242,535	)	$	(154,406	)	$	(88,129	)		57	%

Other income, net was approximately $107,200 and $242,500 for the three and six months ended June 30, 2024, respectively, compared to approximately $85,300 and $154,400 for the same periods in 2023, respectively. The increases in other income were due primarily to higher interest income as a result of higher average investment balance compared to the prior year period.

Income tax expense

Income tax expense recorded during the three and six months ended June 30, 2024 and 2023 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. Income tax expense increased in the three and six months ended June 30, 2024 as a result of higher taxable income compared to the same periods in 2023.

Adjusted EBITDA

We believe that the presentation of Adjusted EBITDA, a non-GAAP financial measure, provides investors with additional information about our financial results. Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.

We define Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization adjusted for, stock-based compensation and other unusual items.

Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. As a non-GAAP measure, Adjusted EBITDA has limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP. In particular:

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Adjusted EBITDA does not reflect the amounts we paid in taxes or other components of our tax provision;

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Adjusted EBITDA does not include interest income;

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Adjusted EBITDA does not include depreciation expense from fixed assets;

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Adjusted EBITDA does not include the impact of stock-based compensation;

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Adjusted EBITDA does not include the loss on investment in minority interest;

Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S. GAAP.

The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the periods indicated:


	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2024			2023			2024			2023
GAAP net loss	$	(1,121,607	)	$	(1,014,150	)	$	(4,957,239	)	$	(3,658,445	)
Adjustments to reconcile to Adjusted EBITDA:
Interest income		(107,242	)		(103,439	)		(242,535	)		(189,753	)
Depreciation expense		35,979			51,989			65,663			100,622
Stock-based compensation		(91,893	)		280,061			228,395			451,088
Loss on investment in minority interest		—			12,514			—			29,716
Income tax (benefit) expense		113,785			(3,562	)		195,943			38,849
Adjusted EBITDA	$	(1,170,978	)	$	(776,587	)	$	(4,709,773	)	$	(3,227,923	)

Liquidity and Capital Resources

Liquidity

We measure our liquidity in a number of ways, including the following:


	June 30, 2024		December 31, 2023
Cash and cash equivalents	$	5,846,100	$	6,871,306
Short-term investments		3,135,801		1,994,662
Total		8,981,901		8,865,968
Working capital	$	8,676,357	$	8,173,925

As of June 30, 2024, we had working capital of approximately $8.7 million and stockholders’ equity of approximately $9.7 million. We used approximately $5.2 million in cash for operating activities during the six months ended June 30, 2024. Our historical losses and cash used in operations are indicators of substantial doubt regarding our ability to continue as a going concern. Considering our cash, cash equivalents, and short-term investment balances as of June 30, 2024 and our plans to grow our revenues in 2024 by serving Medicare Part B beneficiaries, we believe there is sufficient cash, cash equivalents, and short-term investments to fund our operations and capital expenditures for the next 12 months from the date of this report.

We have historically funded our operations through financing activities, including raising equity and debt capital. On July 11, 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. In January 2024, we completed a registered direct equity offering, pursuant to which we sold 1,354,218 shares of common stock and 224,730 pre-funded warrants to purchase common stock at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. In August 2023, we completed a public equity offering pursuant to which we sold 5,413,334 shares of common stock and 1,920,000 pre-funded warrants to purchase common stock at $0.60 per share, or at $0.5999 per warrant, generating proceeds after fees and expenses of approximately $3.9 million. In January 2023, we completed an equity offering under which we sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants to purchase common stock at $0.325 per share, or at $0.3249 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.7 million.

Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by Statutory Health Insurance plans in Germany, which could prevent our revenues from growing to the level necessary to achieve cash flow breakeven. We believe that we have access to capital resources, if necessary, through usage of our line of credit, potential public or private equity offerings, exercises of outstanding warrants, debt financings, or other means. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. We may also explore strategic alternatives for the purpose of maximizing stockholder value. There can be no assurance we will be successful in implementing our plans to sustain our operations and continue to conduct our business.

Our operating plans are primarily focused on increasing our clinical, reimbursement and manufacturing capacity and increasing our advertising spending in the second half of 2024, in order to educate patients and clinicians regarding the MyoPro and to serve a higher volume of patients in 2025 and beyond. We believe that based on the final fees published by the CMS for our products, which became effective on April 1, 2024, if our supply chain is able to meet our volume requirements without disruption, and we are able to compensate for the additional advertising spending, we believe we can achieve cash flow breakeven on a quarterly basis by the fourth quarter of 2024. Based on our latitude as to the timing and amount of certain expenses, our current cash position and operating plans, we believe that the substantial doubt is alleviated as of the issuance date of these financial statements.

Cash Flows


	Six Months Ended June 30,
	2024			2023
Net cash used in operating activities	$	(5,161,488	)	$	(2,102,213	)
Net cash used in investing activities		(1,211,930	)		(3,008,692	)
Net cash provided by financing activities		5,361,909			5,763,910
Effect of foreign change rate changes on cash		(13,697	)		7,311
Net increase (decrease) in cash, cash equivalents and restricted cash	$	(1,025,206	)	$	660,316

Operating Activities. The net cash used in operating activities for the six months ended June 30, 2024 was primarily used to fund a net loss of approximately $5.0 million, adjusted for non-cash expenses in the aggregate amount of approximately $0.4 million and by approximately $0.6 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to an increase in inventory and prepaid expenses and other current assets, offset by an increase in accounts payable and accrued expenses.

The net cash used in operating activities for the six months ended June 30, 2023 was primarily used to fund a net loss of approximately $3.7 million, adjusted for non-cash expenses in the aggregate amount of approximately $0.8 million and by approximately $0.8 million of cash generated by net changes in the levels of operating assets and liabilities, primarily related to an increase in accounts payable and accrued expenses and a decrease in accounts receivable, offset by an increase in prepared expenses and other current assets.

Investing Activities. During the six months ended June 30, 2024, and 2023, our cash used in investing activities of $1.2 million and $3.0 million respectively, was primarily related to our purchase, net of maturities, of short-term investments and purchases of equipment.

Financing Activities. There was $5.4 million and $5.8 million in cash generated from financing activities during the six months ended June 30, 2024 and 2023, respectively, due entirely to the net proceeds from our equity offerings in January 2024 and January 2023.

Critical Accounting Policies and Estimates

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from those estimates. Our significant estimates include deferred tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for credit losses and slow-moving inventory.

Other

There have been no material changes to our critical accounting policies from those described in our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.

Recent Accounting Standards

Information regarding new accounting standards is included in Note 3 — Recently Adopted Accounting Standards to our unaudited condensed consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

This item is not applicable to us as a smaller reporting company.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer, our principal executive officer, and our Chief Financial Officer, our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2024. Based upon such evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of such date.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation of our internal control that occurred during the quarter ended June 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Part II. OTHER INFORMATION

Item 1. Legal Proceedings

The Company may be involved in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. During the fourth quarter of 2023, the Company settled an age discrimination claim by a former employee. The settlement was paid and all insurance proceeds were received during the three months ended March 31, 2024. There is no material litigation against the Company at this time that is required to be disclosed under Item 103 of Regulation S-K.

Item 1A. Risk Factors

The following important factors, among others, could cause our actual operating results to differ materially from those indicated or suggested by forward-looking statements made in this Form 10-Q or presented elsewhere by management from time to time. Investors should carefully consider the risks described below before making an investment decision. The risks described below are not the only ones we face. Additional risks not presently known to us or that we currently believe are not material may also significantly impair our business operations. Our business could be harmed by any of these risks. The trading price of our common stock could decline due to any of these risks, and investors may lose all or part of their investment.

Risks Associated with Our Business

Risks Related to Our Operating and Financial Results

We have a history of operating losses. Factors both within and outside of our control could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis.

We have a history of losses since inception. For the three and six months ended June 30, 2024, we incurred net losses of $1.1 million and $5.0 million, respectively. For the year ended December 31, 2023, we incurred a net loss of $8.1 million. At June 30, 2024, we had an accumulated deficit of approximately $101.9 million. The extent and duration of future operating and net losses will depend on our ability to grow our revenues and absorb the headcount and additional clinical, reimbursement and manufacturing capacity we added in the first half of 2024, as well as the ability of our supply chain to meet our volume requirements without disruption. We believe it is achievable to be cash flow breakeven on a quarterly basis by the fourth quarter of 2024. However, there can be no assurance that we can cost effectively grow our revenues without requiring additional capital.

Our cash, cash equivalents and short-term investments at June 30, 2024 were approximately $9.0 million. On July 11, 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“Silicon Valley Bank”), which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. On January 19, 2024, we completed a registered direct offering of our common stock and pre-funded warrants, generating net proceeds of approximately $5.4 million. We believe that our existing cash, cash equivalents, and short-term investments at June 30, 2024 will be sufficient to fund our operations for the twelve months from the date of this report. If we encounter obstacles such as those that have been referred to above, the timing of our ability to achieve cash flow breakeven could extend beyond the fourth quarter of 2024 and additional capital may be required.

Our strategy to maximize revenues by focusing our efforts on patients whose insurance has reimbursed for the MyoPro in the past has resulted in a concentration of revenues with patients covered by a single insurer. Adverse changes in that insurer’s reimbursement policy regarding the MyoPro could have an adverse effect on our business.

In order to maximize revenues and minimize cash used for operations, we focus on patients with insurers who have previously reimbursed for the MyoPro. Beginning in September 2021, a large insurer that has historically reimbursed for the MyoPro began denying claims after having granted a pre-authorization and after we delivered the devices to patients, and these post-service denials currently continue. Revenues from patients insured by this payer represented 20% and 24% of total revenue during the three and six months ended June 30, 2024, respectively. With a small number of exceptions, appeals filed with the payer have been successful and these claims have ultimately been paid. This payer also continues to provide us with pre-authorizations to serve new patients. If this payer were to start regularly denying appeals on filed claims, reduce the number of MyoPro’s that it will authorize for its insured patients, or delays payments pending resolution of the denial and appeals process, our revenues and cash flows would be negatively impacted, which would have an adverse effect on our business.

We may experience significant fluctuations in our quarterly and annual results.

Fluctuations in our quarterly and annual financial results have resulted and will continue to result from numerous factors, including:

•

timing, number and dollar value of reimbursements of our products by insurance payers;

•

changes in the mix of products we sell;

•

strategic actions by us, such as acquisitions of businesses, products, or technologies;

•

effects of domestic and foreign economic conditions and exchange rates on our industry and/or customers;

•

the divestiture or discontinuation of a product line or other revenue generating activity;

•

the relocation and integration of manufacturing operations and other strategic restructuring;

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regulatory actions which may necessitate recalls of our products or warning letters that negatively affect the markets for our products;

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costs incurred by us in connection with the termination of contractual and other relationships, including distributorships;

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our ability to collect outstanding accounts receivable;

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the expiration or exhaustion of deferred tax assets such as net operating loss carryforwards;

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increased product and price competition, due to reimbursement of our products by Medicare, the regulatory landscape, market conditions or other factors;

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technology changes to enhance individual data privacy that could negatively impact our ability to market our products to prospective candidates and could result in increased advertising costs;

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market reception of our new or improved product offerings; and

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the loss of any significant customer.

These factors, some of which are not within our control, may cause the price of our common stock to fluctuate substantially. If our quarterly operating results fail to meet or exceed the expectations of securities analysts or investors, our stock price could drop suddenly and significantly. We believe quarterly comparisons of our financial results are not always meaningful and should not be relied upon as an indication of our future performance.

Risks related to our Reliance on Third Parties

We may not be able to obtain third-party payer reimbursement, including reimbursement by Medicare, for our products.

Sales of our device depend, in part, on the extent to which our products are covered by third-party payers, such as government health programs, commercial insurance and managed healthcare organizations. See section titled “Business Section – Government Regulation – Health Insurance Reimbursement, in our December 31,2023 annual report on Form 10-K.” Third-party payers are increasingly challenging the prices charged, examining the medical necessity and creating additional restrictions on coverage, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payers may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a particular indication. In addition, CMS may issue local or national coverage determinations which could result in more restrictive coverage for our products. The coverage determination process is often a time-consuming and costly process that requires us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage and adequate reimbursement will be obtained. In addition, the absence of in-network contracts with Medicare Advantage plans or commercial insurers could result in utilization management for out-of-network patients. Currently, we are almost entirely dependent on third parties to cover the cost of our products to patients and rely on their reimbursement for the cost of our products. If the U.S. Department of Veterans Affairs, (the “VA”) health insurance companies and other third-party payers do not provide adequate coverage or reimbursement for our products, then our sales will be limited to clinical facilities and individuals who can pay for our devices without reimbursement. To our knowledge, through the year ended December 31, 2023, fewer than 50 units have been self-paid or funded by non-profit foundations. Some commercial health insurance plans have published statements that they will not cover the cost of the MyoPro for their members. In the event we are unsuccessful in obtaining additional coverage and adequate reimbursement for our products from third-party payers, our sales will be significantly constrained. Currently, reimbursement for the cost of our products is obtained primarily on a case-by-case basis until such time, if any, we obtain broad coverage policies with Medicare and third-party payers. There can be no assurance that we will be able to obtain these broad coverage policies or that Medicare or its local administrative billing contractors will not establish more restrictive coverage requirements for the MyPro in the future (for example, in the form of a local or national coverage

determination). See section titled “Business Section – Government Regulation – Health Insurance Reimbursement, in our December 31,2023 annual report on Form 10-K.”

In connection with Medicare reimbursement, in November 2023 CMS reclassified the MyoPro from the durable medical equipment benefit to the brace benefit category effective January 1, 2024, thereby allowing for lump sum reimbursement. Such lump sum reimbursements based on the fees posted by CMS, are now being made. CMS published final average payment determinations for the MyoPro Motion W (L8701) of approximately $33,500 and the MyoPro Motion G (L8702) of approximately $65,900, effective April 1, 2024. It is possible that our claims could be evaluated on a case-by-case basis during the remainder of 2024.

There can be no assurance that the final fees will be sufficient to permit us to generate gross margin required to allow us to operate on a profitable basis. Third-party payers also may continue to deny or limit coverage, limit reimbursement or reduce their levels of payment, or our costs of production may increase faster than increases in reimbursement levels. In addition, we may not obtain coverage and reimbursement approvals in a timely manner. Our failure to operate profitably could negatively impact market acceptance of MyoPro.

If CMS amends, restricts, or retracts coverage requirements, its billing contractors and insurers offering Medicare Advantage insurance plans may restrict what they reimburse for the MyoPro, which would have an adverse effect on our business.

Revenues from patients who are covered by Medicare Advantage insurance plans have become a significant portion of our overall revenues. Approximately 26% and 63% of our product revenues were derived from patients with Medicare Advantage insurance plans for the three months ended June 30, 2024 and 2023, respectively. Revenues from Medicare Part B patients represented 47% and 35% of total revenue for the three and six months ended June 30, 2024, respectively. If CMS amends, restricts, or retracts its November 2023 rule classifying MyoPro as a brace, amends or retracts any published fees, or establishes more restrictive inclusion criteria for coverage, our Medicare revenues could be negatively impacted and insurers offering Medicare Advantage insurance plans may no longer cover or adequately reimburse for the MyoPro. As a result, our overall revenues and cash flows would be negatively impacted, which could have an adverse effect on our business. See “Risks Related to our Reliance on Third Parties—We may not be able to obtain third-party payer reimbursement, including reimbursement by Medicare, for our products” for additional information about CMS coverage decisions.

We currently rely, and in the future will rely, on sales of our MyoPro products for our revenue, and we may not be able to expand market acceptance or grow revenues in the orthotics and prosthetics channel.

We currently rely, and in the future will rely, on sales of our MyoPro products for our revenue. MyoPro products are relatively new products, and continuing market acceptance and adoption will depend on educating people with limited upper extremity mobility and healthcare providers as to the distinct features, ease-of-use, improved quality of life and other benefits of MyoPro systems compared to alternative technologies and treatments. Our products may not be perceived to have sufficient potential benefits compared with these alternatives, which include rehabilitation therapy or amputation with a prosthetic replacement. Also, healthcare providers such as orthotics and prosthetics ("O&P") practices and the VA want to see good outcomes for their patients and certainty of third-party reimbursement. Accordingly, healthcare providers may not recommend the MyoPro until there is sufficient evidence to convince them to alter the treatment methods they typically recommend. This evidence may include prominent healthcare providers or other key opinion leaders in the upper extremity paralysis community recommending the MyoPro as effective in providing identifiable immediate and long-term health benefits, and the publication of additional peer-reviewed clinical studies demonstrating its value. Additionally, because the MyoPro is a prescription device, patients require the prescription of a healthcare provider to access our products and to have the device reimbursed by insurance.

Expanding market acceptance of MyoPro products could be negatively impacted by many other factors, including, but not limited to:

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patient outcomes not meeting expectations;

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lack of sufficient evidence supporting the benefits of MyoPro over competitive products or other available treatment, or lifestyle management to accommodate the disability;

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patient resistance to wearing an external device or making required insurance co-payments;

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limitations on the ability of patients to complete evaluations and fittings, including adverse changes in their health, or other environmental, social and economic barriers to patient access;

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results of clinical studies relating to MyoPro or similar products;

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claims that MyoPro, or any component thereof, infringes on patent or other intellectual property rights of third parties;

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perceived risks associated with the use of MyoPro or similar products or technologies;

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the introduction of new competitive products or greater acceptance of competitive products;

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adverse regulatory or legal actions relating to MyoPro or similar products or technologies; and

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problems arising from the insourcing of our manufacturing capabilities, or our existing manufacturing and supply relationships with third parties.

Any factors that negatively impact sales of MyoPro would adversely affect our business, financial condition and operating results.

We depend on a single third-party to manufacture key subassemblies for the MyoPro and a limited number of third-party suppliers for certain components of the MyoPro.

While we are the manufacturer of record with the U.S. Food and Drug Administration, (the “FDA”) for the MyoPro device we sell, we have contracted with Cogmedix, Inc., or Cogmedix, a contract manufacturer with expertise in the medical device industry, for the contract manufacture of all of our products and the sourcing of all of our components and raw materials. Pursuant to this contract, Cogmedix manufactures the MyoPro pursuant to our specifications at its facility in West Boylston, Massachusetts. As the manufacturer of the MyoPro, we ultimately remain responsible to the FDA for overseeing Cogmedix’s manufacturing activities to ensure that they conform with product specifications and applicable laws and regulations, including FDA’s good manufacturing practice requirements for medical devices. Any failure to effectively oversee the regulatory compliance of the product and contract manufacturing activities by Cogmedix can lead to potential enforcement actions, including civil or criminal liabilities, as well as recalls with the FDA. We may terminate our relationship with Cogmedix at any time upon sixty (60) days’ written notice. For our business strategy to be successful, Cogmedix must be able to manufacture our products in sufficient quantities, and to source raw materials and components, in compliance with regulatory requirements and quality control standards, in accordance with agreed upon specifications, at acceptable costs and on a timely basis. Increases in our product sales, whether forecasted or unanticipated, or supply chain constraints that may arise for any number of reasons, could strain the ability of Cogmedix to manufacture an increasingly large supply of our current or future products in a manner that meets these various requirements. In addition, although we are not restricted from engaging an alternative manufacturer, the process of moving our manufacturing activities would be time consuming and costly, and may limit our ability to meet our sales commitments, which could harm our reputation and could have a material adverse effect on our business. Further, any new contract manufacturer would need to be compliant with FDA regulations and International Organization for Standardization, (“ISO”), standard 13485.

We also rely on third-party suppliers, including AB Corp, for 3D printed orthotic components. Some third-party suppliers contract directly with Cogmedix, to supply certain components of the MyoPro products. Cogmedix does not have long-term supply agreements with most of their suppliers and, in many cases, makes purchases on a purchase order basis. We do not have any long-term supply agreements directly with Cogmedix’s suppliers. Our ability and Cogmedix’s ability to secure adequate quantities of such products may be limited. Suppliers may encounter problems that limit their ability to manufacture components for our products, including financial difficulties or damage to their manufacturing equipment or facilities. If we, or Cogmedix, fail to obtain sufficient quantities of high-quality components to meet demand on a timely basis, or fail to effectively oversee the regulatory compliance of the supply chain, we could face regulatory enforcement, have to conduct recalls, lose customer orders, our reputation may be harmed, and our business could suffer.

Cogmedix generally uses a small number of suppliers for the MyoPro products. Depending on a limited number of suppliers exposes us to risks, including limited control over pricing, availability, quality and delivery schedules. If any one or more of our suppliers ceases to provide sufficient quantities of components in a timely manner or on acceptable terms, Cogmedix would have to seek alternative sources of supply. It may be difficult to engage additional or replacement suppliers in a timely manner. Failure of these suppliers to deliver products at the level our business requires would limit our ability to meet our sales commitments, which could harm our reputation and could have a material adverse effect on our business. Cogmedix also may have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other regulatory agencies, and the failure of Cogmedix’s suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including warning letters, product recalls, termination of distribution, product seizures or civil penalties. It could also require Cogmedix to cease using the components, seek alternative components or technologies and we could be forced to modify our products to incorporate alternative components or technologies, which could result in a requirement to seek additional regulatory approvals. Any disruption of this nature or increased expenses could harm our commercialization efforts and adversely affect our operating results.

We also rely on a limited number of suppliers for the batteries used by the MyoPro and do not maintain any long-term supply agreement with respect to batteries. If we fail to obtain sufficient quantities of batteries in a timely manner, our reputation may be harmed and our business could suffer.

While we currently believe we have sufficient inventory in our supply chain in the near term, if we, or any third parties in our supply chain for materials which are used in either the manufacture of our products are adversely impacted by infections or restrictions from public heath crises, or other factors, our supply chain may be disrupted and our ability to manufacture and ship our products may be limited. While many companies continue to experience shortages of certain electronic components, so far we and our contract manufacturing partners have been able to procure the electronic components necessary for the manufacture of our products, but we are dealing with longer lead times and delivery delays for certain critical components. There can be no assurance that such supplies will become less constrained in the future.

Risks Related to Limited Operating History and Capital Requirements

Our limited operating history makes it difficult for us to evaluate our future business prospects and make decisions based on those estimates of our future performance.

Since inception through June 30, 2024, we have delivered more than 2,700 units for use by patients at home and at clinical facilities. Our latest product line, the MyoPro, was introduced to the market in fiscal year 2012 and we have delivered nearly 2,400 units since such time. As a result, we have a limited operating history. It is difficult to forecast our future results based upon our historical data. Because of the uncertainties related to our limited historical operations, we may be hindered in our ability to anticipate and timely adapt to increases or decreases in revenues or expenses.

We may not have sufficient funds to meet our future capital requirements.

Our cash, cash equivalents and short term investments at June 30, 2024 was approximately $9.0 million. On July 11, 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. On January 19, 2024, we completed a registered direct offering of our common stock and pre-funded warrants, generating net proceeds of approximately $5.4 million.

Our ability to grow our business is dependent on our ability to generate sufficient cash flows from operations or to raise additional capital to meet our obligations, if necessary. We believe that our existing cash, cash equivalents, and short-term investments will be sufficient to enable us to achieve cash flow breakeven on a quarterly basis, which we believe is achievable by the fourth quarter of 2024, assuming that we are able to grow revenues as planned, and our supply chain is able to meet our volume requirements without disruption. If additional capital is required to achieve cash flow breakeven, we may be unable to obtain additional funds on reasonable terms, or at all. Our ability to secure financing and the cost of raising such capital are dependent on numerous factors, including general economic and capital markets conditions, credit availability from lenders, investor confidence and the existence of regulatory and tax incentives that are conducive to raising capital. Uncertainty in the financial markets has caused banks and financial institutions to decrease the amount of capital available for lending and has significantly increased the risk premium of such borrowings. In addition, such turmoil and uncertainty has significantly limited the ability of companies to raise funds through the sale of equity or debt securities. If we are unable to raise additional funds, we may need to delay, modify or abandon some or all of our business plans or cease operations. If we raise funds through the issuance of debt, the amount of any indebtedness that we may raise in the future may be substantial, and we may be required to secure such indebtedness with our assets and may have substantial interest expenses. If we default on any future indebtedness, our lenders could declare all outstanding principal and interest to be due and payable and our secured lenders may foreclose on the facilities securing such indebtedness. The incurrence of indebtedness could require us to meet financial and operating covenants, which could place limits on our operations and ability to raise additional capital, decrease our liquidity and increase the amount of cash flow required to service our debt. If we raise funds through the issuance of equity securities, such issuance could result in dilution to our stockholders and the newly issued securities may have rights senior to those of the holders of our common stock.

Continued inflation may materially impact our financial operations or results of operations.

Inflation has and is expected to remain elevated for the near future. Inflationary factors, such as increases in the cost of our raw materials, manufacturing, interest rates and overhead costs may adversely affect our operating results. The price and availability of key components used to manufacture our products has been increasing and may continue to fluctuate significantly. In addition, the cost of labor internally or at our third-party manufacturers could increase significantly due to regulation or inflationary pressures. Additionally, the cost of logistics and transportation fluctuates in large part due to the price of oil, and availability can be limited due to political and economic issues. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some effect in the near future, especially if inflation rates continue to rise.

Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.

In July 2024, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank. Pursuant to the terms of the Loan Agreement, we may request advances on a revolving line of credit whereby we may borrow up to $4 million (the “Revolving Line”), which Revolving Line may be increased to $5.5 million at Silicon Valley Bank’s sole discretion upon the occurrence of certain events. The Revolving Line is secured on a first priority basis by all of our assets other than intellectual property and certain customary exceptions. To the extent we use the Revolving Line, such indebtedness may create additional financing risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing our outstanding debt obligations at maturity. This indebtedness could also have important negative consequences, including the fact that:

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we will need to repay our indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance our operations; and

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our failure to comply with the restrictive covenants under the Loan Agreement could result in an event of default that, if not cured or waived, would accelerate our obligation to repay this indebtedness, and Silicon Valley Bank could seek to enforce our security interest in the assets securing such indebtedness.

Risks Related to Competitors and Our Market

The industries in which we operate are highly competitive and subject to rapid technological change. If our competitors are better able to develop and market products that are safer, more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to compete effectively with other companies.

Industrial and medical robotics is characterized by intense competition and rapid technological change, and we will face competition on the basis of product features, clinical outcomes, price, services and other factors. Publication of fees by CMS under our Healthcare Common Procedures Coding System (“HCPCS”) billing codes L8701 and L8702 is also expected to attract competition. Competitors may include large medical device and other companies, some of which have significantly greater financial and marketing resources than we do, and firms that are more specialized than we are with respect to particular markets. Our competition may respond more quickly to new or emerging technologies, undertake more extensive marketing campaigns, and have greater financial, marketing and other resources than we do or may be more successful in attracting potential customers, employees and strategic partners.

Our competitive position will depend on multiple complex factors, including our ability to maintain and grow market acceptance for our products, develop new products, implement production and marketing plans, secure regulatory clearances or approvals, if necessary, for products under development and protect our intellectual property. In some instances, competitors may also offer, or may attempt to develop, alternative therapies for disease states that may be delivered without a medical device. The development of new or improved products, processes or technologies by other companies may render our products or proposed products obsolete or less competitive. The entry into the market of manufacturers located in low-cost manufacturing locations may also create pricing pressure, particularly in developing markets. Our future success depends, among other things, upon our ability to compete effectively against current technology, as well as to respond effectively to technological advances, and upon our ability to successfully implement our marketing strategies and execute our research and development plans.

We sell to O&P providers and distributors who are free to market products that compete with the MyoPro, and we rely on these parties to market and promote our products in accordance with their FDA listings, select appropriate patients and provide adequate follow-on care.

We rely on our relationships with qualified O&P providers and our distribution arrangements to market and sell our products. We believe that a meaningful percentage of our sales will continue to be generated through these channels in the future. However, none of these partners are required to sell or provide our products exclusively. If a key independent O&P provider were to cease to distribute our products, our sales could be adversely affected. In such a situation, we may need to seek alternative independent providers or increase our reliance on our other independent providers or our direct field representatives, which may not prevent our sales from being adversely affected. Additionally, to the extent that we enter into additional arrangements with independent distributors to perform sales, marketing, or distribution services, the terms of the arrangements could cause our profit margins to be lower than if we directly marketed and sold our products.

If these independent O&P providers or distributors do not follow our inclusion/exclusion criteria for patient selection or do not provide adequate follow-on care, then our reputation may be harmed by patient dissatisfaction. This could also lead to product returns and adversely affect our financial condition. When issues with distributors have arisen in the past, we have supplied additional training and documentation and/or ended the distributor relationship.

The sales and marketing of medical devices is under increased scrutiny by the FDA and other enforcement bodies. If our sales and marketing activities fail to comply with FDA regulations, such as regulations for the labeling and advertising of our products, or other applicable laws, we may be subject to warnings or enforcement actions from the FDA or other enforcement bodies. For example, we are restricted from promoting our products for any use that is beyond the scope of their applicable FDA classification regulation. Such promotion could result in enforcement action by the FDA, which may include, but is not limited to untitled letters or warning letters, injunctions, recall or seizure of our products, and imposition of FDA’s premarket clearance or approval requirements.

The market for myoelectric braces is new and the rate of adoption is uncertain, and important assumptions about the potential market for our products may be inaccurate.

The market for myoelectric braces, or orthotics, is new and the rate of adoption is uncertain. Our estimates of market size are derived from statistics regarding the number of individuals with paralysis, but not necessarily limited to their upper extremities. Accordingly, it is difficult to predict the future size and rate of growth of the market. We cannot be certain whether the market will continue to develop or if orthotics will achieve and sustain a level of market acceptance and demand sufficient for us to continue to generate revenue and achieve profitability.

Limited sources exist to obtain reliable market data with respect to the number of mobility-impaired individuals and the occurrence of upper extremity paralysis in our target markets. In addition, there are no third-party reports or studies regarding what percentage of those with upper extremity paralysis would be able to use orthotics in general, or our current or planned future products in particular. In order to use our current products marketed to those with upper extremity paralysis, users must meet a set of inclusion criteria and not have a medical condition which disqualifies them from being an appropriate candidate. Future products for those with upper extremity paralysis may have the same or other restrictions. Our business strategy is based, in part, on our estimates of the number of upper extremity impaired individuals and the incidence of upper extremity injuries in our target markets and the percentage of those groups that would be able to use our current and future products. Our assumptions and estimates may be inaccurate and may change.

If the upper extremity orthotics market fails to develop or develops more slowly than we expect, or if we have relied on sources or made assumptions or estimates that are not accurate, our business could be adversely affected.

In addition, because we operate in a new market, the actions of our competitors could adversely affect our business. Adverse events such as product defects or legal claims with respect to competing or similar products could cause reputational harm to the market on the whole. Further, adverse regulatory findings or reimbursement-related decisions with respect to other products could negatively impact the entire market and, accordingly, our business.

Risks Related to Our Products

We may receive a significant number of warranty claims or our MyoPro may require significant amounts of service after sale.

Sales of MyoPro products generally include a three-year warranty for parts and labor, other than for normal wear and tear. As the number and complexity of the features and functionalities of our products increase, we may experience a higher level of warranty claims. If product returns or warranty claims are significant or exceed our expectations, we could incur unanticipated expenditures for parts and services, which could have a material adverse effect on our operating results.

Defects in our products or the software that drives them could adversely affect the results of our operations.

The design, manufacture and marketing of the MyoPro products involve certain inherent risks. Manufacturing or design defects, unanticipated use of the MyoPro, or inadequate disclosure of risks relating to the use of MyoPro products can lead to injury or other adverse events. In addition, because the manufacturing of our products is outsourced to Cogmedix, we may not always be aware of manufacturing defects that could occur and corrective or preventive actions implemented by Cogmedix may not be effective at resolving such defects. Such adverse events could lead to recalls or safety alerts relating to MyoPro products (either voluntary or required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of MyoPro products from the market. A recall could result in significant costs. To the extent any manufacturing defect occurs, our agreement with Cogmedix contains a limitation on Cogmedix’s liability, and therefore we could be required to incur the majority of related costs. A defect in connection with the fabrication of our products may result in significant costs in connection with lawsuits or refunds. Product defects or recalls could also result in negative publicity, damage to our reputation or, in some circumstances, delays in new product approvals.

MyoPro users may not use MyoPro products in accordance with safety protocols and training, which could enhance the risk of injury. Any such occurrence could cause delay in market acceptance of MyoPro products, damage to our reputation, additional regulatory filings, product recalls, increased service and warranty costs, product liability claims and loss of revenue relating to such hardware or software defects.

The medical device industry has historically been subject to extensive litigation over product liability claims. We have not been subject to such claims to date, but we may become subject to product liability claims alleging defects in the design, manufacture or labeling of our products in the future. A product liability claim, regardless of its merit or eventual outcome, could result in significant legal defense costs and high punitive damage payments. Although we maintain product liability insurance, the coverage is subject to deductibles and limitations, and may not be

adequate to cover future claims. Additionally, we may be unable to maintain our existing product liability insurance in the future at satisfactory rates or in adequate amounts.

While there is long-term clinical data supporting the safety of our existing MyoPro products, updates to our products inherently have uncertain safety risks as they enter the market.

While clinical data have established the safety of MyoPro products, our products undergo periodic updates for various reasons, including performance and reliability improvements and cost reductions. For example, in January 2022, we announced the availability of MyoPro2+. Because MyoPro users generally do not have feeling in their upper extremities, they may not immediately notice adverse effects from updates to the MyoPro, which could exacerbate their impact. If MyoPro products are shown to present new risks or to be unsafe or cause such unforeseen effects in the future, our business and reputation could be harmed, including through field corrections, withdrawals, removals, mandatory product recalls, suspension or withdrawal of FDA registration, significant legal liability or harm to our business reputation.

Risks Related to Collaborations and Licensing Agreements

We may enter into collaborations, licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues.

In the ordinary course of our business, in the future we may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships to develop the MyoPro and to pursue new markets. We are selling the MyoPro in several European countries, as well as Australia. In January 2021, we announced that we had entered into a joint venture (the “JV”) with Beijing Ryzur Medical Investment Co., Ltd. (“Ryzur Medical”), to manufacture and sell the products containing our technology in China, including Hong Kong, Taiwan and Macau. The company is named Jiangxi Myomo Medical Assistive Appliance Co., Ltd. (the “JV Company”). In December 2021, we entered into a technology license agreement and a trademark license agreement with the JV Company, under which we were entitled to receive a license fee of $2.7 million and the JV Company will commit to purchase a minimum of $10.75 million of MyoPro control units over the next ten years. During 2023, we received full payment of the $2.7 million initial license fee and have received payment for MyoPro control units of $50,000. This and any other of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. In addition, proposing, negotiating and implementing collaborations, licensing arrangements, joint ventures, strategic alliances or partnerships may be a lengthy and complex process. We may not identify, secure, or complete any such transactions or arrangements in a timely manner, on a cost-effective basis, on acceptable terms or at all. We have limited institutional knowledge and experience with respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement. In particular, these collaborations may not result in the development of products that achieve commercial success or result in significant revenues and could be terminated prior to developing any products. Any delays in entering into new strategic partnership agreements related to our products could delay the development and commercialization of our products in certain geographies, which would harm our business prospects, financial condition and results of operations.

If we pursue collaborations, additional licensing arrangements and joint ventures, strategic alliances or partnerships, we may not be able to consummate them, or we may not be in a position to exercise sole decision decision-making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on decisions, and our collaborators may have economic or business interests or goals that are, or that may become, inconsistent with our business interests or goals. It is possible that conflicts may arise with our collaborators. Our collaborators may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us. Any such disputes could result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the applicable agreements.

Risks Related to Our Business Operations and Management

If we fail to properly manage our anticipated growth, including in O&P channel and international markets, our business could suffer.

As we grow our revenues from Medicare Part B patients and expand the number of locations which provide the MyoPro products, including O&P practices in the U.S., and future planned international distribution, we expect that it will place significant strain on our management team and on our financial resources. Failure to manage our growth effectively could cause us to mis-allocate management or financial resources and result in losses or weaknesses in our infrastructure, systems, processes and controls, which could materially adversely affect our business. Additionally, our anticipated growth will increase the demands placed on our suppliers, resulting in an increased need for us to manage our suppliers and monitor for quality assurance.

Moreover, there are significant costs and risks inherent in selling our products, particularly in international markets, including: (a) time and difficulty in building a widespread network of distribution partners; (b) increased shipping and distribution costs, which could increase our expenses and reduce our margins; (c) potentially lower margins in some regions; (d) longer collection cycles in some regions; (e) compliance

with foreign laws and regulations; (f) compliance with anti-bribery, anti-corruption, and anti-money laundering laws, such as the Foreign Corrupt Practices Act and the Office of Foreign Assets Control regulations, by us, our employees, and our business partners; (g) currency exchange rate fluctuations and related effects on our results of operations; (h) economic weakness, including inflation, or political instability in foreign economies and markets; (i) compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; (j) workforce uncertainty in countries where labor unrest is more common than in the United States; (k) business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires; and (l) other costs and risks of doing business internationally, such as new tariffs which may be imposed. For example, we have entered into a joint venture with Beijing Ryzur Medical Investment Co., Ltd., to manufacture and sell the products containing the Company’s technology in China, including Hong Kong, Taiwan and Macau. In connection with this joint venture, we may encounter challenges in working with our joint venture partners, including with respect to compliance with local laws and domestic laws related to foreign operations.

These and other factors could harm our ability to implement planned growth in international operations and, consequently, harm our business, results of operations, and financial condition. Further, we may incur significant operating expenses as a result of our planned expansion activities, and they may not be successful. We have limited experience with regulatory environments and market practices internationally, and we may not be able to penetrate or successfully operate in new markets. We may also encounter difficulty growing the O&P channel while simultaneously being a direct provider to patients in the U.S. and expanding into international markets because of limited brand recognition. These factors my lead to delayed or limited acceptance of our products by patients in these markets. Accordingly, if we are unable to expand O&P channel revenues in the U.S., expand internationally or manage our international operations successfully, we may not achieve the expected benefits of this expansion and our financial condition and results of operations could be harmed.

We depend on the knowledge and skills of our senior management.

We have benefited substantially from the leadership and performance of our senior management and other key employees. We do not carry key person insurance. Our success will depend on our ability to retain our current management and key employees. Competition for these key persons in our industry is intense and we cannot guarantee that we will be able to retain our personnel. The loss of the services of certain members of our senior management or key employees could prevent or delay the implementation and completion of our strategic objectives or divert management’s attention to seeking qualified replacements.

We may seek to grow our business through acquisitions of complementary products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could have a material adverse effect on our business, financial condition and operating results.

From time to time, we may consider opportunities to acquire other products or technologies that may enhance our products or technology or advance our business strategies. Potential acquisitions involve numerous risks, including:

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problems assimilating the acquired products or technologies;

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issues maintaining uniform standards, procedures, controls and policies;

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unanticipated costs associated with acquisitions;

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diversion of management’s attention from our existing business;

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risks associated with entering new markets in which we have limited or no experience; and

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increased legal and accounting costs relating to the acquisitions or compliance with regulatory matters.

We have no current commitments with respect to any acquisition and no current plans to seek acquisitions; however, depending on industry and market conditions, we may consider acquisitions in the future. If we do proceed with acquisitions, we do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired products or technologies. Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business, operating results and financial condition.

Risks Related to Government Regulation

Risks Related to Healthcare Industry

We are subject to extensive governmental regulations relating to the design, development, manufacturing, labeling and marketing, delivery and billing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.

Our products are regulated as medical devices in the United States under the FFDCA, as implemented and enforced by the FDA. Under the FFDCA, medical devices are classified into one of three classes–Class I, Class II or Class III–depending on the degree of risk associated with the medical device, what is known about the type of device, and the extent of control needed to provide reasonable assurance of safety and effectiveness. Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA pre-market review. This determination is required prior to marketing the device. See section titled “Business — Government Regulation, in our December 31,2023 annual report on Form 10-K.”

In 2012, we listed the MyoPro device as a Class I, 510(k)-exempt, limb orthosis with the FDA. From time to time, the FDA may disagree with the classification regulation under which a registrant lists their device. For example, the FDA may disagree with a registrant’s determination to classify their device as a Class I medical device. Instead, the FDA may determine the device to be a Class II or Class III device requiring the submission of a premarket notification, or 510(k), or a premarket approval, (“PMA”) application for premarket clearance or approval. As the FDA is now giving more attention to the differentiated performance of myoelectric controlled orthotics, we elected to change our device listing to be under a Class II classification regulation for biofeedback devices. Under the classification regulation, we believe our device remains 510(k)-exempt as a prescription battery powered external limb orthosis that is indicated for functional improvement, a device which is generally 510(k)-exempt under the classification regulation. In the event that the FDA determines that our devices, whether by functionality or marketing claims, exceed the limitations on 510(k)-exemption such that premarket clearance or approval is required (i.e., that our device is intended for a use different from the intended use of a legally marketed device in the generic type of device under the applicable classification regulation or that our modified device operates using a different fundamental scientific technology than such a legally marketed device), should be classified as Class II devices or Class III devices requiring premarket clearance or approval, or should FDA decide to reclassify our device as a Class II or Class III device requiring premarket clearance or approval, we could be precluded from marketing our devices for clinical use within the United States for months or longer depending on the requirements of the classification. Obtaining premarket clearance or approval could significantly increase our regulatory costs, including expense associated with required pre-clinical (animal) and clinical (human) trials, more extensive mechanical and electrical testing and other costs.

We are registered with the FDA as a manufacturer for medical devices. We are also subject to regulation by foreign governmental agencies in connection with international sales. The agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising, marketing and distribution, and market surveillance of our medical device products. Following the introduction of a product, the governmental agencies will periodically review our product development methodology, quality management systems, and product performance. We are under a continuing obligation to ensure that all applicable regulatory requirements, such as the FDA’s medical device good manufacturing practice / Quality System Regulation, (“QSR”), requirements and the FDA’s medical device reporting requirements for certain device-related adverse events and malfunction, continue to be met. Our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QSR, and comparable foreign regulations.

The process of complying with the applicable QSR, medical device reporting, and other requirements can be costly and time consuming, and could delay or prevent the production, manufacturing or sale of the MyoPro. If the FDA determines that we fail to comply with applicable regulatory requirements, they may issue an inquiry or an untitled or warning letter with one or more citations of non-compliance. These inquiries or letters, if not closed promptly, can result in fines, delays or suspensions of regulatory clearances, closure of manufacturing sites, seizures or recalls of products and damage to our reputation. Similarly, if we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. Recent changes in enforcement practice by the FDA and other agencies have resulted in increased enforcement activity, which increases the compliance risk that we and other companies in our industry are facing.

In addition, governmental agencies of the United States or other countries may impose new requirements regarding registration, labeling or prohibited materials that may require us to modify or re-register the MyoPro once it is already on the market or otherwise impact our ability to market the MyoPro in the United States or other countries. For example, on February 2, 2024, the FDA published a final rule to amend its QSR requirements to align more closely with the international consensus standards for medical devices by converging with quality management system, (“QMS”), requirements used by other regulatory authorities from other countries. Specifically, the final rule does so primarily by incorporating by reference the 2016 edition of the ISO 13485 standard. The amended regulation is referred to as the Quality Management System Regulation, (“QMSR”), and is effective February 2, 2026. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing authorization that we may have obtained, which could have a material adverse effect on our business, prospects, results of operations, financial condition and

our ability to achieve or sustain profitability. The process of complying with these governmental regulations can be costly and time consuming, and could delay or prevent the production, manufacturing or sale of the MyoPro. For instance, the FDA may issue mandates, known as 522 orders, requiring us to conduct post-market surveillance studies of our devices. Failure to comply could result in enforcement of the FFDCA against us or our products including an agency request that we recall our MyoPro products.

Our relationships with healthcare providers and physicians and third-party payers will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

We are subject to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which we sell, market and distribute our products. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry (e.g., healthcare providers, physicians and third-party payers), are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. We are also subject to patient information and privacy and security regulation by both the federal government and the states and foreign jurisdictions in which we conduct business. See section titled “Business – Government Regulation – Healthcare Privacy Laws and Regulations, in our December 31,2023 annual report on Form 10-K”.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies often scrutinize interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business.

The failure to comply with any of these laws or regulatory requirements subject entities to possible legal or regulatory action. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities, could, despite efforts to comply, be subject to challenge under one or more of such laws. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. Depending on the circumstances, failure to meet applicable regulatory requirements can result in civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs, contractual damages, reputational harm and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause us to incur significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way. Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. In addition, the commercialization of any of our products outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

If we or our third-party manufacturers or key suppliers fail to comply with the FDA’s Quality System Regulation, our manufacturing operations could be interrupted.

We and our third-party manufacturers and key suppliers are also required to comply with the FDA’s QSR which covers the methods and documentation of the production, control, quality assurance, labeling, packaging, storage and shipping of our products. We, Cogmedix, our electromechanical kit manufacturer, and other key suppliers are also subject to the regulations of foreign jurisdictions regarding the manufacturing process with respect to the market for our products abroad.

We continue to monitor our quality management, as well as that of our third-party manufacturers and suppliers to improve our overall level of compliance. Our facilities and those of our third-party manufacturers and key suppliers are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QSR and comparable foreign regulations. If our facilities or the facilities of our third-party manufacturers and suppliers are found to be in violation of applicable laws and regulations, or if we or our third-party manufacturers and suppliers fail to take satisfactory corrective action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following sanctions:

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untitled letters, warning letters, Form 483 findings (results from quality system inspections), fines, injunctions, consent decrees and civil penalties;

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customer notifications or repair, replacement or refunds;

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detention, recalls or seizure of our products;

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operating restrictions or partial suspension or total shutdown of production;

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withdrawing our FDA registration;

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refusing to provide certificates to foreign governments with respect to exports; and

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pursuing criminal prosecution.

Any of these sanctions could impair our ability to produce the MyoPro in a cost-effective and timely manner in order to meet our customers’ demands and could have a material adverse effect on our reputation, business, results of operations and financial condition. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits.

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business, financial condition and results of operations.

We face risks in connection with the Affordable Care Act (“ACA”) or its possible replacement or modifications and other ongoing healthcare legislative and regulatory reform measures.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could affect our ability to profitably sell our products. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.

Payers, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies. In the United States, there have been and continue to be a number of legislative and regulatory initiatives and judicial challenges to contain healthcare costs. See section titled “Business – Government Regulations – Current and Future Legislation, in our December 31,2023 annual report on Form 10-K.”

We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, lower reimbursement, and new payment methodologies. This could lower the price that we receive for our products. Any denial or narrowing of coverage or reduction in reimbursement from Medicare or other government-funded programs may result in a similar denial or reduction in payments from private payers, including Medicare Advantage plans, which may prevent us from being able to generate sufficient revenue, attain profitability or commercialize our products. Litigation and legislative efforts to change or repeal the ACA are likely to continue, with unpredictable and uncertain results. It is not clear how these developments, or other future potential changes to the ACA, will change the reimbursement model and market outlook for O&P devices such as the MyoPro. We intend to monitor industry trends relative to the ACA to assist in our determination of how the MyoPro can fit into patient care protocols with providers such as rehabilitation hospitals and surgery centers. If reimbursement policies change significantly, the demand for MyoPro products may be impacted.

Risks Related to Cybersecurity and Data Protection

Our internal computer systems, or those of our customers, collaborators or other contractors, may be subject to cyber-attacks, compromises or security breaches, which could result in a material disruption of our product development programs.

Despite the implementation of security measures, our internal computer systems and infrastructures and those of our customers, collaborators, contractors, or other third parties are vulnerable to damage, compromise or interruption from computer viruses, unauthorized access, misuse, or other security compromises or breaches. Cyber-attacks are increasing in their frequency, sophistication and intensity, and have become

increasingly difficult to detect. Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, wrongful conduct by employees, vendors, or other third parties, hostile foreign governments, industrial espionage, social engineering and business email compromises, and other means to affect service reliability and threaten or compromise the security, confidentiality, integrity and availability of systems and information. Cyber-attacks also could include phishing attempts or e-mail fraud to cause payments or information to be transmitted to an unintended recipient. We have in the past experienced threats and security incidents related to our data and systems, and we may in the future experience other threats, compromises, breaches, or incidents. A cyber-attack or security compromise or breach could cause interruptions in our operations and could result in a material disruption of our business operations, damage to our reputation or a loss of revenues.

In the ordinary course of our business, we collect and store confidential and/or proprietary information or other sensitive information, including, among other things, personal information about our employees and patients, intellectual property, and proprietary business information. Any cyber-attack or security compromise or breach that leads to unauthorized access, use, disclosure, loss, corruption or other compromise of confidential and/or proprietary information or other sensitive information could harm our reputation, cause us not to comply with federal and/or state breach notification laws and foreign law equivalents and otherwise subject us to liability under laws and regulations, including those that protect the privacy and security of personal information. In addition, we could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information technology systems, infrastructure, and networks of our company and our vendors, including personal information of our employees, and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate our systems and infrastructure or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems. If a breach or compromise of our information technology systems or infrastructure or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged.

We could be required to expend significant amounts of money and other resources to detect, mitigate and respond to these threats, compromises, or breaches and to repair or replace information technology systems infrastructure or networks and could suffer financial loss or the loss of valuable confidential and/or proprietary information. In addition, we could be subject to regulatory actions, inquiries, investigations, orders, penalties, fines, and/or claims made by individuals and groups in private litigation, including those involving privacy and security issues related to data collection and use practices and other data privacy and security laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process designed to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, instances of unauthorized access to our computer systems have occurred in the past, though these events have not resulted in financial loss or disruption to our operations. The possibility of these events occurring in the future cannot be eliminated entirely. There can be no assurance that any measures we take will prevent or adequately address cyber-attacks or security compromises or breaches that could adversely affect our business.

We, our collaborators and our service providers may be subject to a variety of privacy and data protection laws, regulations and contractual obligations, which may require us to incur substantial compliance costs, and any failure or perceived failure by us to comply with them could expose us to fines or other penalties and otherwise harm our business and operations.

In the United States, several layers of federal and state data protection laws and regulations may apply to our business, including HIPAA, the Federal Trade Commission (“FTC”) Act and state consumer privacy and health data privacy laws. For example, the California Consumer Privacy Act, (“CCPA”), is a comprehensive law that creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information. The CCPA went into effect on January 1, 2020 and the California State Attorney General became empowered to commence enforcement actions against violators as of July 1, 2020. Further, as of January 1, 2023, the California Privacy Rights Act (“CPRA”), created additional obligations with respect to processing and storing personal information.

Similar consumer privacy laws have passed or come into force in numerous U.S. states. Like the CCPA, these laws grant consumers rights in relation to their personal information and impose new obligations on regulated businesses, including, in some instances, broader data security requirements. In addition, federal and state legislators and regulators have signaled their intention to further regulate health and other sensitive information, and new and strengthened requirements relating to this information could impact our business. At the state level, some states have passed or proposed laws to specifically regulate health information. For example, Washington’s My Health My Data Act, which went into effect in March 2024, requires regulated entities to obtain consent to collect health information, grants consumers certain rights, including to request deletion, and provides for robust enforcement mechanisms, including enforcement by the Washington state attorney-general and a private right of action for consumer claims. At the federal level, the FTC has used its authority over “unfair or deceptive acts or practices” to impose stringent requirements on the collection and disclosure of sensitive categories of personal information, including health information.

Moreover, the FTC’s expanded interpretation of a “breach” under its Health Breach Notification Rule could impose new disclosure obligations that would apply in the event of a qualifying breach.

European data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

The collection and use of personal data, including personal health data in the European Economic Area, (“EEA”) and the UK is governed by the provisions of the EU General Data Protection Regulation, (“EU GDPR”) (with regards to the EEA) and the UK General Data Protection Regulation, (“UK GDPR”), (with regards to the UK), as well as applicable data protection laws in effect in the member states of the EEA and in the UK (including the UK Data Protection Act 2018). In this Annual Report on Form 10-K, “GDPR” refers to both the EU GDPR and the UK GDPR, unless specified otherwise. The GDPR applies to the processing of personal data by any company established in the EEA/UK and to companies established outside the EEA/UK to the extent they process personal data in connection with the offering of goods or services to data subjects in the EEA/UK or the monitoring of the behavior of data subjects in the EEA/UK. The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, such as including requirements relating to having legal bases or conditions for processing personal data relating to identifiable individuals and transferring such information outside the EEA/UK , including to the U.S., providing details to those individuals regarding the processing of their personal data, implementing safeguards to keep personal data secure, having data processing agreements with third parties who process personal data, providing information to individuals regarding data processing activities, responding to individuals’ requests to exercise their rights in respect of their personal data, where required obtaining consent of the individuals to whom the personal data relates, reporting security and privacy breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping. In the event of any non-compliance with the GDPR and any supplemental EEA Member State or UK national data protection laws, we could be subject to warning letters, mandatory audits, orders to cease/change the use of data, and financial penalties, including fines of up to €20,000,000 (£17.5 million for the UK GDPR) or 4% of total annual global revenue, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.

The GDPR imposes strict rules on the transfer of personal data outside of the EEA or the UK to countries that do not ensure an adequate level of protection, like the United States in certain circumstances unless adequate safeguards (such as the European Commission approved standard contractual clauses , (“SCCs”), or the UK International Data Transfer Agreement/Addendum, (“IDTA”) and transfer impact assessments carried out when relying on the SCCs and UK IDTA. The international transfer obligations under the EU data protection laws will require significant effort and cost and may result in us needing to make strategic considerations around where EEA and UK personal data is transferred and which service providers we can utilize for the processing of EEA and UK personal data. Any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our ability to conduct trials and may adversely affect our business and financial position. Although the UK is regarded as a third country under the EU GDPR, the European Commission (“EC”) has now issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EEA to the UK remain unrestricted. Like the EU GDPR, the UK GDPR restricts personal data transfers outside the UK to countries not regarded by the UK as providing adequate protection. The UK government has confirmed that personal data transfers from the UK to the EEA remain free flowing.

The UK’s data protection regime is independent from but aligned to the EU’s data protection regime. However, following the UK’s exit (“Brexit”) from the European Union (“EU”), there will be increasing scope for divergence in application, interpretation and enforcement of the data protection laws between these territories. For example, the UK Government has introduced a Data Protection and Digital Information Bill, (“Data Reform Bill”) into the UK legislative process to reform the UK’s data protection regime following Brexit. If passed, the final version of the Digital Information Bill may have the effect of further altering the similarities between the UK and EEA data protection regimes and threaten the UK adequacy decision from the EU Commission, which may lead to additional compliance costs and could increase our overall risk. The respective provisions and enforcement of the EU GDPR and UK GDPR may further diverge in the future and create additional regulatory challenges and uncertainties. This lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, complexity and cost to our handling of European personal data and our privacy and data security compliance programs, and could require us to implement different compliance measures for the UK and the EEA.

Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with any European and UK-based activities.

Risks Related to Our Intellectual Property

Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products.

Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products. We seek to protect our intellectual property through a combination of patents, trademarks, confidentiality and assignment agreements with our employees and certain of our contractors and confidentiality agreements with certain of our consultants, scientific advisors and other vendors and contractors. In addition, we rely on trade secrets law to protect our proprietary software and product candidates or products in development.

The patent position of myoelectric orthotic inventions can be highly uncertain and involves many new and evolving complex legal, factual and technical issues. Patent laws and interpretations of those laws are subject to change and any such changes may diminish the value of our patents or narrow the scope of protection. In addition, we may fail to apply for or be unable to obtain patents necessary to protect our technology or products or enforce our patents due to lack of information about the exact use of technology or processes by third parties. Also, we cannot be sure that any patents will be granted in a timely manner or at all with respect to any of our patent pending applications or that any patents that are granted will be adequate to protect our intellectual property for any significant period of time or at all.

Litigation to establish or challenge the validity of patents, or to defend against or assert against others infringement, unauthorized use, enforceability or invalidity claims, can be lengthy and expensive and may result in our patents being invalidated or interpreted narrowly and our not being granted new patents related to our pending patent applications. Even if we prevail, litigation may be time consuming and force us to incur significant costs, and any damages or other remedies awarded to us may not be valuable and management’s attention could be diverted from managing our business. In addition, U.S. patents and patent applications may be subject to interference proceedings, and U.S. patents may be subject to re-examination and review in the U.S. Patent and Trademark Office. Foreign patents may also be subject to opposition or comparable proceedings in the corresponding foreign patent offices. Any of these proceedings may be expensive and could result in the loss of a patent or denial of a patent application, or the loss or reduction in the scope of one or more of the claims of a patent or patent application.

In addition, we seek to protect our trade secrets, know-how and confidential information that is not patentable by entering into confidentiality and assignment agreements with our employees and certain of our contractors and confidentiality agreements with certain of our consultants, scientific advisors and other vendors and contractors. However, we may fail to enter into the necessary agreements, and even if entered into, these agreements may be breached or otherwise fail to prevent disclosure, third-party infringement or misappropriation of our proprietary information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure or use of proprietary information. Enforcing a claim that a third-party illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. We also have taken precautions to initiate reasonable safeguards to protect our information technology systems. However, these measures may not be adequate to safeguard our proprietary information, which could lead to the loss or impairment thereof or to expensive litigation to defend our rights against competitors who may be better funded and have superior resources. In addition, unauthorized parties may attempt to copy or reverse engineer certain aspects of our products that we consider proprietary or our proprietary information may otherwise become known or may be independently developed by our competitors or other third parties. If other parties are able to use our proprietary technology or information, our ability to compete in the market could be harmed. Further, unauthorized use of our intellectual property may have occurred, or may occur in the future, without our knowledge.

If we are unable to obtain or maintain adequate protection for intellectual property, or if any protection is reduced or eliminated, competitors may be able to use our technologies, resulting in harm to our competitive position.

We are not able to protect our intellectual property rights in all countries.

Filing, prosecuting, maintaining and defending patents on each of our products in all countries throughout the world would be prohibitively expensive, and thus our intellectual property rights outside the United States are currently limited to selected countries in the EU, including China, including Hong Kong, and Japan. In addition, the laws of some foreign countries, especially developing countries, do not protect intellectual property rights to the same extent as federal and state laws in the United States. Also, it may not be possible to effectively enforce intellectual property rights in some countries at all or to the same extent as in the United States and other countries. Consequently, we are unable to prevent third parties from using our inventions in all countries, or from selling or importing products made using our inventions in the jurisdictions in which we do not have (or are unable to effectively enforce) patent protection. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop, market or otherwise commercialize their own products, and we may be unable to prevent those competitors from importing those infringing products into territories where we have patent protection, but enforcement is not as strong as in the United States. These products may compete with our products and our patents and other intellectual property rights may not be effective or sufficient to prevent them from competing in those jurisdictions. Moreover, competitors or others in the chain of commerce may raise legal challenges against our intellectual property rights or may infringe upon our intellectual property rights, including through means that may be difficult to prevent or detect.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. Proceedings to enforce our patent rights in the United States or foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert patent infringement or other claims against us. We may not prevail

in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights in the United States and around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license from third parties.

We may be subject to patent infringement claims, which could result in substantial costs and liability and prevent us from commercializing our current and future products.

The medical device industry is characterized by competing intellectual property and a substantial amount of litigation over patent rights. In particular, our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in competing technologies, have been issued patents and filed patent applications with respect to their products and processes and may apply for other patents in the future. The large number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent litigation.

Determining whether a product infringes a patent involves complex legal and factual issues and the outcome of patent litigation is often uncertain. Even though we have conducted research of issued patents, no assurance can be given that patents containing claims covering our products, technology or methods do not exist, have not been filed or could not be filed or issued. In addition, because patent applications can take years to issue and because publication schedules for pending applications vary by jurisdiction, there may be applications now pending of which we are unaware and may result in issued patents which our current or future products infringe. Also, because the claims of published patent applications can change between publication and patent grant, published applications may issue with claims that potentially cover our products, technology or methods.

Infringement actions and other intellectual property claims brought against us, with or without merit, may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of management and harm our reputation. We cannot be certain that we will successfully defend against any allegations of infringement. If we are found to infringe another party’s patents, we could be required to pay damages. We could also be prevented from selling our products that infringe, unless we could obtain a license to use the technology covered by such patents or could redesign our products so that they do not infringe. A license may be available on commercially reasonable terms or none at all, and we may not be able to redesign our products to avoid infringement. Further, any modification to our products could require us to conduct clinical trials and revise our filings with the FDA and other regulatory bodies, which would be time consuming and expensive. In these circumstances, we may not be able to sell our products at competitive prices or at all, and our business and operating results could be harmed.

We rely on trademark protection to distinguish our products from the products of our competitors.

We rely on trademark protection to distinguish our products from the products of our competitors. We have registered the trademarks “MyoPro” (Registration No. 4,532,331), “MYOMO” (Registration No. 4,451,445), “MyoPal” (Registration No. 6,086,533) and “MyoCare” (Registration No. 6,579,736) in the United States. The MyoPro mark is registered in Canada and in selected EU countries with pending registration. In jurisdictions where we have not yet registered our trademark and are using it, and as permitted by applicable local law, we seek to rely on common law trademark protection where available. Third parties may oppose our trademark applications, or otherwise challenge our use of the trademarks, and may be able to use our trademarks in jurisdictions where they are not registered or otherwise protected by law. If our trademarks are successfully challenged or if a third-party is using confusingly similar or identical trademarks in particular jurisdictions before we do, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote additional resources to marketing new brands. If others are able to use our trademarks, our ability to distinguish our products may be impaired, which could adversely affect our business. Further, we cannot assure you that competitors will not infringe upon our trademarks, or that we will have adequate resources to enforce our trademarks.

We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.

Some of our employees were previously employed at other medical device companies, including our competitors or potential competitors, and we may hire employees in the future that are so employed. We could in the future be subject to claims that these employees, or we, have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. If we fail in defending against such claims, a court could order us to pay substantial damages and prohibit us from using technologies or features that are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. If any of these technologies or features are important to our products, this could prevent us from selling those products and could have a material adverse effect on our business. Even if we are successful in defending against these claims, such litigation could result in substantial costs and divert the attention of management.

Risks Related to our Securities

Risks Related to Ownership of Our Securities

Our stockholders will experience significant dilution upon the issuance of common stock if the shares of our common stock underlying our warrants are exercised or converted.

We have a significant number of securities convertible into, or allowing the purchase of, our common stock. Investors could be subject to increased dilution upon the conversion or exercise of these securities. For example, in conjunction with equity offerings in January 2024, August 2023 and January 2023, we issued 224,730, 1,920,000 and 6,830,926 pre-funded warrants, respectively. Each pre-funded warrant is exercisable for one share of common stock at the nominal exercise price of $0.0001 per share. As of June 30, 2024, we had 7,721,519 shares issuable upon the exercise of pre-funded warrants with an exercise price of $0.0001 per share, 668,250 shares issuable upon the exercise of other warrants, with a weighted-average exercise price of $7.50 per share and 1,275,862 unvested restricted stock units outstanding. In addition, we had 23,629 shares issuable upon the exercise of stock options under our equity incentive plans, with a weighted-average exercise price of $42.38 per share.

We may not be able to maintain a listing of our common stock on the NYSE American.

We must meet certain financial and liquidity criteria to maintain such listing. If we fail to meet any of the NYSE American’s listing standards, our common stock may be delisted. In addition, our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A delisting of our common stock from the NYSE American may materially impair our stockholders’ ability to buy and sell our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock. A delisting of our common stock could significantly impair our ability to raise capital.

There is no public market for our warrants or pre-funded warrants to purchase common stock.

There is no established public trading market for our warrants or pre-funded warrants and we do not expect a market to develop. In addition, we do not intend to apply for listing of such warrants on any securities exchange. Without an active market, the liquidity of such warrants will be limited.

Holders of our warrants and pre-funded warrants have no rights as a common stockholder until such holders exercise their warrants and acquire our common stock.

Until holders of our warrants and pre-funded warrants exercise such warrants, they will have no rights with respect to the shares of our common stock underlying such warrants. Upon exercise of such warrants, the holders thereof will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

The market price of our common stock has been and may continue to be volatile.

The stock market in general, and the market price of our common stock in particular will likely be subject to fluctuation, whether due to, or irrespective of, our operating results, financial condition and prospects. For example, from June 30, 2023 to June 30, 2024, the high and low sales price of our common stock on the NYSE American has fluctuated from a low of $0.48 to a high of $5.63 per share. During the period from July 1, 2024 to the date of the filing of this report, our stock price has ranged from $2.81 to $5.63.

Our financial performance, our industry’s overall performance, changing consumer preferences, technologies, government regulatory action, tax laws and market conditions in general could have a significant impact on the future market price of our common stock. Some of the other factors that could negatively affect our share price or result in fluctuations in our share price include:

•

actual or anticipated variations in our periodic operating results;

•

increases in market interest rates that lead purchasers of our common stock to demand a higher investment return;

•

changes in earnings estimates;

•

changes in market valuations of similar companies;

•

actions or announcements by our competitors;

•

adverse market reaction to any increased indebtedness we may incur in the future;

•

additions or departures of key personnel;

•

actions by stockholders;

•

speculation in the media, online forums, or investment community; and

•

our intentions and ability to maintain our common stock on the NYSE American.

We do not expect to declare or pay dividends in the foreseeable future.

We do not expect to declare or pay dividends in the foreseeable future, as we anticipate that we will invest future earnings in the development and growth of our business. In addition, pursuant to the terms of our Loan Agreement, we are prohibited from paying cash dividends without the prior written consent of Silicon Valley Bank. Therefore, holders of our common stock will not receive any return on their investment unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all.

If securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our common stock could be negatively affected.

Any trading market for our common stock will be influenced in part by any research reports that securities industry analysts publish about us. We do not have any control over these analysts. We currently have limited research coverage by securities industry analysts and we may be unable to maintain analyst coverage or have analysts initiate coverage on us. If securities industry analysts cease coverage of us, the market price and market trading volume of our common stock could be negatively affected. In the event we are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage on us, the market price and market trading volume of our common stock could be negatively affected.

Future issuances of our common stock or equity-related securities could cause the market price of our common stock to decline and would result in the dilution of your holdings.

Future issuances of our common stock or securities convertible into our common stock could cause the market price of our common stock to decline. We cannot predict the effect, if any, of future issuances of our common stock or securities convertible into our common stock on the price of our common stock. In all events, future issuances of our common stock would result in the dilution of your holdings. In addition, the perception that new issuances of our common stock, or other securities convertible into our common stock, could occur, could adversely affect the market price of our common stock.

Future issuances of debt securities, which would rank senior to our common stock upon our bankruptcy or liquidation, and future issuances of preferred stock, which could rank senior to our common stock for the purposes of dividends and liquidating distributions, may adversely affect our common stock price.

In the future, we may attempt to increase our capital resources by offering debt securities. Upon bankruptcy or liquidation, holders of our debt securities, and lenders with respect to other borrowings we may make, would receive distributions of our available assets prior to any distributions being made to holders of our common stock. Moreover, if we issue preferred stock, the holders of such preferred stock could be entitled to preferences over holders of common stock in respect of the payment of dividends and the payment of liquidating distributions. Because our decision to issue debt or preferred securities in any future offering, or borrow money from lenders, will depend in part on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any such future offerings or borrowings. Holders of our common stock must bear the risk that any future offerings we conduct or borrowings we make may adversely affect the level of return they may be able to achieve from an investment in our common stock.

If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not retain a listing on the NYSE American or another national securities exchange and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.

Provisions in our amended and restated certificate of incorporation and bylaws may have the effect of delaying or preventing a change in control or changes in our management. Our amended and restated certificate of incorporation and bylaws include provisions that:

•

authorize our board of directors to issue preferred stock, without further stockholder action and with voting liquidation, dividend and other rights superior to our common stock;

•

establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for director nominees;

•

establish that our board of directors is divided into three classes, with directors in each class serving three-year staggered terms;

•

require the approval of holders of two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or amend or repeal the provisions of our certificate of incorporation regarding the election and removal of directors and the ability of stockholders to take action by written consent or call a special meeting;

•

prohibit cumulative voting in the election of directors; and

•

provide that vacancies on our board of directors may be filled only by the vote of a majority of directors then in office, even though less than a quorum or by the holders of at least sixty-six and two-thirds percent (66 2/3%) of the issued and outstanding shares of common stock.

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, (“DGCL”), which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three years following the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limit the price that investors might be willing to pay in the future for shares of our common stock, and they could deter potential acquirers of our company, thereby reducing the likelihood that you would receive a premium for your common stock in an acquisition.

Risks Related to Internal Controls

We are a "smaller reporting company” under the reporting rules set forth under the Exchange Act. For so long as we remain a “smaller reporting company,” we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not “smaller reporting companies”.

We are a “smaller reporting company,”. For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not “smaller reporting companies,” including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (so long as we remain a non-accelerated filer) and reduced disclosure obligations regarding executive compensation in the Annual Report on Form 10-K and our periodic reports and proxy statements.

We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

We are obligated to develop and maintain a system of effective internal control over financial reporting. We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may harm investor confidence in our company and, as a result, the value of our common stock.

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, (“Section 404”), to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting in the annual and quarterly reports we file with the SEC. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. However, our auditors are not required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer a “smaller reporting company” as set forth under the Exchange Act.

We will need to continue to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial

reporting. As we continue to grow as a public company, we may need to add additional finance staff. We may not be able to remediate any future material weaknesses, or to complete our evaluation, testing and any required remediation in a timely fashion. During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective. If we are unable to assert that our internal control over financial reporting is effective, or if our auditors are unable to express an opinion on the effectiveness of our internal controls when they are required to issue such opinion, investors could lose confidence in the accuracy and completeness of our financial reports, which could harm our stock price.

The preparation of our financial statements involves the use of estimates, judgments and assumptions, and our financial statements may be materially affected if such estimates, judgments or assumptions prove to be inaccurate.

Financial statements prepared in accordance with accounting principles generally accepted in the United States typically require the use of estimates, judgments and assumptions that affect the reported amounts. Often, different estimates, judgments and assumptions could reasonably be used that would have a material effect on such financial statements, and changes in these estimates, judgments and assumptions may occur from period to period over time. Significant areas of accounting requiring the application of management’s judgment include, but are not limited to, determining the fair value of assets and the timing and amount of cash flows from assets. These estimates, judgments and assumptions are inherently uncertain and, if our estimates were to prove to be wrong, we would face the risk that charges to income or other financial statement changes or adjustments would be required. Any such charges or changes could harm our business, including our financial condition and results of operations and the price of our securities. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of the accounting estimates, judgments and assumptions that we believe are the most critical to an understanding of our financial statements and our business.

We are incurring increased costs as a public company and our management team is required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, and particularly after we are no longer a “small reporting company,” we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the NYSE American and other applicable securities rules and regulations impose various requirements on public companies. Our management and other personnel will need to devote a substantial amount of time to compliance with these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

Risks Related to Tax Laws

We may be subject to adverse legislative or regulatory changes in tax laws that could negatively impact our financial condition.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the U.S. Internal Revenue Service, (“IRS”) and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect our stockholders or us. In recent years, many such changes have been made and changes are likely to occur in the future. We cannot predict whether, when, in what form, or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or decided, which could result in an increase in our, or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize increases in our tax liability.

Our ability to use net operating losses and research and development credits to offset future taxable income may be subject to certain limitations.

As of December 31, 2023, we had U.S. federal and state net operating loss (“NOL”) carryforwards of $77.4 million and $72.7 million, respectively, which begin to expire in the year 2028 and 2024 through 2044, respectively. Additionally, we had U.S. federal and state research and development tax credits, (“tax credits”) of $0.4 million and $0.2 million, respectively, which begin to expire in the year 2026 and 2033, respectively. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future taxable income or tax liabilities, respectively. In addition, in general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, (the “Code”), and corresponding provisions of state law, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOL carryforwards or tax credits, (“NOLs”) or credits, to offset future taxable income. For these purposes, an ownership change generally occurs where the aggregate stock ownership of one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. We have determined that such ownership changes have occurred in prior years. The result of these ownership changes is that we have a $64,000 annual limitation on our ability to utilize pre-ownership change NOLs and approximately $20.0 million of our federal NOLs and $48.0 million of our state NOLs will expire unutilized. There may have been an ownership change associated with our equity offerings in August 2023 and January 2024. We may undergo an ownership change in connection with future changes in our stock ownership (many of which are outside of our control), whereby our ability to utilize NOLs or credits could be further limited by Sections 382 and 383 of the Code or under corresponding provisions of state law. Furthermore, our ability to utilize our NOLs or tax credits is conditioned upon our attaining profitability

and generating U.S. federal and state taxable income. As described above under “Risk factors— Risks Associated with Our Business,” we have incurred net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future; and therefore, we do not know whether or when we will generate the U.S. federal or state taxable income necessary to utilize our NOLs or tax credits that are subject to limitation by Sections 382 and 383 of the Code. Under current law, U.S. federal NOL carryforwards generated in taxable years beginning after December 31, 2017 will not be subject to expiration, but the amount of such NOL carryforwards that we are permitted to deduct in a taxable year beginning after December 31, 2020 will be limited to 80% of our taxable income in each such year to which the NOL carryforwards are applied.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities

None.

Item 5. Other Information

None

Item 6. Exhibits

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibits Index, which is incorporated by reference.

Exhibits Index


Exhibit No.		Exhibit Description
3.1		Eighth Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 2.3 contained in the Registrant’s Form 1-A filed on January 6, 2017)

3.2		Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.4 contained in the Registrant’s Form 1-A filed on January 6, 2017)

3.3		Certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on January 30, 2020 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on January 30, 2020)

3.4		Second certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on June 10, 2021 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on June 15, 2021)

31.1*		Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*		Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1+		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2+		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS*		Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH*		Inline XBRL Taxonomy Extension Schema Document with embedded linkbase documents.
104*		Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Filed herewith.

+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date August 6, 2024


	Myomo, Inc.

	/s/ David A. Henry
	David A. Henry
	Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 31.1

Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934

I, Paul R. Gudonis, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Myomo, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 06, 2024

    /s/ Paul R. Gudonis

   

    Paul R. Gudonis

   

    President and Chief Executive Officer
(Principal Executive Officer)

Exhibit 31.2

Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934

I, David A. Henry, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Myomo, Inc.;

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 06, 2024

    /s/ David A. Henry

   

    David A. Henry

   

    Chief Financial Officer
(Principal Financial Officer)

Exhibit 32.1

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

I, Paul R. Gudonis, President and Chief Executive Officer of Myomo, Inc. (the “Company”), certify, pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that:

(1) the Quarterly Report on Form 10-Q of the Company for the three months ended June 30, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 780(d)); and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: August 06, 2024

    /s/ Paul R. Gudonis

   

    Paul R. Gudonis

   

    President and Chief Executive Officer
(Principal Executive Officer)

Exhibit 32.2

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

I, David A. Henry, Chief Financial Officer of Myomo, Inc. (the “Company”), certify, pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, that:

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: August 06, 2024

    /s/ David A. Henry

   

    David A. Henry

   

    Chief Financial Officer
(Principal Financial Officer)

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2024	Aug. 01, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Trading Symbol	MYO
Entity Registrant Name	MYOMO, INC.
Entity Central Index Key	0001369290
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Shell Company	false
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		30,225,752
Entity File Number	001-38109
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Tax Identification Number	47-0944526
Entity Address, Address Line One	137 Portland St.
Entity Address, Address Line Two	4th Floor
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02114
City Area Code	617
Local Phone Number	996-9058
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Security Exchange Name	NYSEAMER
Entity Incorporation, State or Country Code	DE
Document Quarterly Report	true
Document Transition Report	false

Condensed Consolidated Balance Sheets - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 5,846,100	$ 6,871,306
Short-term investments	3,135,801	1,994,662
Accounts receivable, net	2,526,361	2,382,658
Inventories, net	2,601,104	1,803,507
Prepaid expenses and other current assets	1,032,323	598,850
Total Current Assets	15,141,689	13,650,983
Operating lease assets with right of use, net	539,498	663,554
Equipment, net	289,303	175,794
Other assets	219,891	91,237
Total Assets	16,190,381	14,581,568
Current Liabilities:
Accounts payable and accrued expenses	5,868,407	4,885,944
Current operating lease liabilities	316,600	486,143
Income taxes payable	268,310	96,461
Deferred revenue	12,015	8,510
Total Current Liabilities	6,465,332	5,477,058
Non-current operating lease liabilities	47,338	115,160
Total Liabilities	6,512,670	5,592,218
Commitments and Contingencies	0	0
Stockholders’ Equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding	0	0
Common stock par value $0.0001 per share, 65,000,000 shares authorized; 30,201,354 and 27,135,061 shares issued as of June 30, 2024 and December 31, 2023, respectively; and 30,201,327 and 27,135,034 shares outstanding at June 30, 2024 and December 31, 2023, respectively	3,021	2,715
Additional paid-in capital	111,430,314	105,840,239
Accumulated other comprehensive income	138,888	83,669
Accumulated deficit	(101,888,048)	(96,930,809)
Treasury stock, 27 shares at cost	(6,464)	(6,464)
Total Stockholders’ Equity	9,677,711	8,989,350
Total Liabilities and Stockholders’ Equity	$ 16,190,381	$ 14,581,568

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	65,000,000	65,000,000
Common stock, shares issued	30,201,354	27,135,061
Common stock, shares outstanding	30,201,327	27,135,034
Treasury shares at cost	27	27

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Revenue	$ 7,520,767	$ 5,958,544	$ 11,275,156	$ 9,405,252
Cost of revenue	2,195,255	1,677,488	3,650,601	2,816,594
Gross profit	5,325,512	4,281,056	7,624,555	6,588,658
Operating expenses:
Research and development	1,007,224	564,235	1,963,438	1,041,225
Selling, clinical and marketing	2,777,135	2,271,937	5,138,980	4,302,488
General and administrative	2,656,217	2,547,890	5,525,968	5,018,947
Total operating expenses	6,440,576	5,384,062	12,628,386	10,362,660
Loss from operations	(1,115,064)	(1,103,006)	(5,003,831)	(3,774,002)
Other (income) expense, net
Interest income	(107,242)	(103,439)	(242,535)	(189,753)
Other expense, net	0	5,631	0	5,631
Loss on equity investment	0	12,514	0	29,716
Total other expense (income), net	(107,242)	(85,294)	(242,535)	(154,406)
Loss before income taxes	(1,007,822)	(1,017,712)	(4,761,296)	(3,619,596)
Income tax expense (benefit)	113,785	(3,562)	195,943	38,849
Net loss	$ (1,121,607)	$ (1,014,150)	$ (4,957,239)	$ (3,658,445)
Weighted average number of common shares outstanding:
Basic	37,368,488	27,992,928	37,060,543	26,000,216
Diluted	37,368,488	27,992,928	37,060,543	26,000,216
Net loss per share attributable to common stockholders
Basic	$ (0.03)	$ (0.04)	$ (0.13)	$ (0.14)
Diluted	$ (0.03)	$ (0.04)	$ (0.13)	$ (0.14)
Product revenue
Revenue	$ 7,520,767	$ 4,243,624	$ 11,275,156	$ 7,690,332
License revenue
Revenue	$ 0	$ 1,714,920	$ 0	$ 1,714,920

Condensed Consolidated Statements of Comprehensive Loss (unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Statement of Comprehensive Income [Abstract]
Net loss	$ (1,121,607)	$ (1,014,150)	$ (4,957,239)	$ (3,658,445)
Other comprehensive income, net of tax:
Foreign currency translation adjustments	(9,241)	(71,357)	52,410	(5,569)
Unrealized gain on short-term investments	618	1,634	2,809	1,634
Other comprehensive income	(8,623)	(69,723)	55,219	(3,935)
Comprehensive loss	$ (1,130,230)	$ (1,083,873)	$ (4,902,020)	$ (3,662,380)

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Total	Common Stock	Additional Paid-in Capital [Member]	Accumulated Comprehensive Income [Member]	Accumulated Deficit [Member]	Treasury Stock [Member]
Beginning balance at Dec. 31, 2022	$ 6,359,365	$ 775	$ 95,105,071	$ 43,227	$ (88,783,244)	$ (6,464)
Beginning balance, shares at Dec. 31, 2022		7,750,635				27
Common stock issued upon vesting of restricted stock units, Shares		2,821
Proceeds from sale of common stock in public offering costs, value	3,616,094	$ 1,317	3,614,777
Proceeds from sale of common stock in public offering costs, shares		13,169,074
Proceeds from sale of pre-funded warrants, value	2,064,012		2,064,012
Stock-based compensation	171,027		171,027
Other comprehensive (loss)/income	65,788			65,788
Net loss	(2,644,295)				(2,644,295)
Ending balance at Mar. 31, 2023	9,631,991	$ 2,092	100,954,887	109,015	(91,427,539)	$ (6,464)
Ending balance, shares at Mar. 31, 2023		20,922,530				27
Beginning balance at Dec. 31, 2022	6,359,365	$ 775	95,105,071	43,227	(88,783,244)	$ (6,464)
Beginning balance, shares at Dec. 31, 2022		7,750,635				27
Net loss	(3,658,445)
Ending balance at Jun. 30, 2023	8,820,032	$ 2,110	101,226,783	39,292	(92,441,689)	$ (6,464)
Ending balance, shares at Jun. 30, 2023		21,092,029				27
Beginning balance at Mar. 31, 2023	9,631,991	$ 2,092	100,954,887	109,015	(91,427,539)	$ (6,464)
Beginning balance, shares at Mar. 31, 2023		20,922,530				27
Common stock issued upon vesting of restricted stock units	(8,147)	$ 18	(8,165)
Common stock issued upon vesting of restricted stock units, Shares		169,499
Stock-based compensation	280,061		280,061
Other comprehensive (loss)/income	1,634			1,634
Unrealized gains (loss) on foreign currency adjustments	(71,357)			(71,357)
Net loss	(1,014,150)				(1,014,150)
Ending balance at Jun. 30, 2023	8,820,032	$ 2,110	101,226,783	39,292	(92,441,689)	$ (6,464)
Ending balance, shares at Jun. 30, 2023		21,092,029				27
Beginning balance at Dec. 31, 2023	8,989,350	$ 2,715	105,840,239	83,669	(96,930,809)	$ (6,464)
Beginning balance, shares at Dec. 31, 2023		27,135,061				27
Common stock issued upon vesting of restricted stock units		$ 31	(31)
Common stock issued upon vesting of restricted stock units, Shares		300,544
Proceeds from sale of common stock in public offering costs, value	4,598,771	$ 135	4,598,636
Proceeds from sale of common stock in public offering costs, shares		1,354,218
Proceeds from sale of pre-funded warrants, value	763,138		763,138
Stock-based compensation	320,288		320,288
Other comprehensive (loss)/income	63,842			63,842
Net loss	(3,835,632)				(3,835,632)
Ending balance at Mar. 31, 2024	10,899,757	$ 2,881	111,522,270	147,511	(100,766,441)	$ (6,464)
Ending balance, shares at Mar. 31, 2024		28,789,823				27
Beginning balance at Dec. 31, 2023	8,989,350	$ 2,715	105,840,239	83,669	(96,930,809)	$ (6,464)
Beginning balance, shares at Dec. 31, 2023		27,135,061				27
Net loss	(4,957,239)
Ending balance at Jun. 30, 2024	9,677,711	$ 3,021	111,430,314	138,888	(101,888,048)	$ (6,464)
Ending balance, shares at Jun. 30, 2024		30,201,354				27
Beginning balance at Mar. 31, 2024	10,899,757	$ 2,881	111,522,270	147,511	(100,766,441)	$ (6,464)
Beginning balance, shares at Mar. 31, 2024		28,789,823				27
Exercise of pre-funded warrants, value	77	$ 77
Exercise of pre-funded warrants, share		774,730
Common stock issued upon vesting of restricted stock units		$ 63	(63)
Common stock issued upon vesting of restricted stock units, Shares		636,801
Stock-based compensation	(91,893)		(91,893)
Other comprehensive (loss)/income	(8,623)			(8,623)
Net loss	(1,121,607)				(1,121,607)
Ending balance at Jun. 30, 2024	$ 9,677,711	$ 3,021	$ 111,430,314	$ 138,888	$ (101,888,048)	$ (6,464)
Ending balance, shares at Jun. 30, 2024		30,201,354				27

Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($)	3 Months Ended
	Mar. 31, 2024	Jun. 30, 2023	Mar. 31, 2023
Common stock issued upon vesting of restricted stock units		16,744
Pre-funded Warrants [Member]
Offering cost from sale of stock	$ 90,814		$ 155,356
Warrants Outstanding	224,730		6,830,926
Common Stock
Offering cost from sale of stock	$ 547,257		$ 663,856

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (4,957,239)	$ (3,658,445)
Adjustments to reconcile net loss to net cash used in operations:
Depreciation	65,663	100,622
Stock-based compensation	228,395	451,088
Accretion of discount on short-term investments	(108,999)	0
Credit losses	5,257	13,000
Loss on equity investment	0	29,716
Amortization of right-of-use assets	124,057	209,625
Other non-cash charges	44,631	(10,786)
Changes in operating assets and liabilities:
Accounts receivable	(102,234)	235,877
Inventories	(816,055)	68,907
Prepaid expenses and other current assets	(363,375)	(212,438)
Other assets	(214,937)	0
Accounts payable and accrued expenses	990,973	888,594
Income taxes payable	176,235	34,774
Operating lease liabilities	(237,365)	(232,467)
Deferred revenue	3,505	(20,280)
Net cash used in operating activities	(5,161,488)	(2,102,213)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of short-term investments	(5,482,757)	(3,198,634)
Maturities of short-term investments	4,450,000	250,000
Purchases of equipment	(179,173)	(60,058)
Net cash used in investing activities	(1,211,930)	(3,008,692)
CASH FLOWS FROM FINANCING ACTIVITIES
Net proceeds from common stock offering	4,598,771	3,708,045
Net settlement of vested restricted stock units to fund related employee statutory tax withholding	0	(8,147)
Proceeds from sale of pre-funded warrants, net of offering costs	763,138	2,064,012
Net cash provided by financing activities	5,361,909	5,763,910
Effect of foreign exchange rate changes on cash	(13,697)	7,311
Net (decrease) increase in cash and cash equivalents	(1,025,206)	660,316
Cash and cash equivalents, beginning of period	6,871,306	5,345,967
Cash and cash equivalents, end of period	5,846,100	6,006,283
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES
Deferred offering costs incurred in a prior period to additional paid-in capital	0	(91,952)
Unrealized gain from mark to market on short-term investments	$ 2,809	$ 1,634

Description of Business

6 Months Ended

Jun. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business

Note 1 — Description of Business

Liquidity

6 Months Ended

Jun. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Liquidity

Note 2 — Liquidity

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2024

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Note 3 — Summary of Significant Accounting Policies

Interim Financial Statements

Basis of Consolidation

Comprehensive Income (Loss)

Use of Estimates

Cash, Cash Equivalents and Short-Term Investments

Accounts Receivable and Allowance for Credit Losses

Joint Venture

Revenue Recognition

The Company recognizes revenue after applying the following five steps:

Identification of the contract, or contracts, with a customer,

Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract,

Determination of the transaction price, including the constraint on variable consideration,

Allocation of the transaction price to the performance obligations in the contract, and

Recognition of revenue when, or as, performance obligations are satisfied.

Product Revenue

(i)

The product has been delivered to the patient, including completion of initial instruction on its use,

(ii)

(iii)

The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606.

The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.

License Revenue

Contract Balances

as of June 30, 2024, and approximately $8,500 of deferred revenue as of December 31, 2023, the outstanding deferred revenue is expected to be recognized by the end of the third quarter of 2024.

Disaggregated Revenue from Contracts with Customers

The following table presents revenue by major source:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Direct to patient	$	5,829,407	$	3,304,113	$	8,059,833	$	5,718,727
Clinical/Medical providers		1,691,360		939,511	$	3,215,323	$	1,971,605
License revenue		—		1,714,920		—		1,714,920
Total revenue from contracts with customers	$	7,520,767	$	5,958,544	$	11,275,156	$	9,405,252

Geographic Data

Cost of Revenue

Advertising

Foreign Currency Translation

Net Loss per Share

Potential dilutive common shares issuable consist of the following at:


	June 30,
	2024		2023
Stock options		23,629		26,138
Restricted stock units		1,275,862		1,608,615
Other warrants		668,250		668,250
Total		1,967,741		2,303,003

Recently Adopted Accounting Standards

Inventories

6 Months Ended

Jun. 30, 2024

Inventory Disclosure [Abstract]

Inventories

Note 4 — Inventories

Inventories consist of the following at:


	June 30, 2024		December 31, 2023
Finished goods	$	800,305	$	321,484
Work in process		146,945		6,589
Parts and subassemblies		1,653,854		1,475,434
Inventories, net	$	2,601,104	$	1,803,507

Fair Value of Financial Instruments

6 Months Ended

Jun. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value of Financial Instruments

Note 5 — Fair Value of Financial Instruments

•

Level 1 — Quoted prices available in active markets for identical assets or liabilities.

•

Cash equivalents and short-term investments measured at fair value on a recurring basis at June 30, 2024 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Cash equivalents
Money market funds		4,754,628	$	—	$	—	$	4,754,628
	$	4,754,628	$	—	$	—	$	4,754,628
Short-term investments
US government agency debt securities		—		499,705		—		499,705
Commercial paper		—		2,240,060		—		2,240,060
Corporate debt securities		—		396,036		—		396,036
	$	—	$	3,135,801	$	—	$	3,135,801

Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2023 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Money market funds	$	4,893,387	$	—	$	—	$	4,893,387
Commercial paper		—	$	746,762		—	$	746,762
Short-term investments		—	$	1,994,662		—	$	1,994,662

Accounts Payable and Other Accrued Expenses

6 Months Ended

Jun. 30, 2024

Payables and Accruals [Abstract]

Accounts Payable and Other Accrued Expenses

Note 6 - Accounts Payable and Other Accrued Expenses

Accounts Payable and Other Accrued Expenses consists of the following at:


	June 30, 2024		December 31, 2023
Trade payables	$	1,369,978	$	1,073,405
Accrued compensation and benefits		2,174,382		1,964,487
Accrued insurance		349,909		95,680
Accrued professional services		60,276		52,202
Warranty reserve		160,104		231,108
Customer deposits		1,595,300		1,114,979
Other		158,458		354,083
	$	5,868,407	$	4,885,944

Common Stock and Warrants

6 Months Ended

Jun. 30, 2024

Equity [Abstract]

Common Stock and Warrants

Note 7 — Common Stock and Warrants

As of June 30, 2024 there were 7,721,519 pre-funded warrants outstanding.

No shares of common stock were issued through the exercise of stock options during the three and six months ended June 30, 2024 and June 30, 2023, respectively.

Stock Award Plans and Stock-based Compensation

6 Months Ended

Jun. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock Award Plans and Stock-based Compensation

Note 8 — Stock Award Plans and Stock-Based Compensation

Share-Based Compensation Expense

The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period.


	For the Three Months Ended					For the Six Months Ended
	June 30,					June 30,
	2024			2023		2024		2023
Cost of goods sold	$	(10,591	)	$	22,114	$	12,796	$	42,593
Research and development		8,719			34,308		32,964		(35,419	)
Selling, clinical and marketing		7,190			49,592		53,251		91,448
Selling, general and administrative		(97,211	)		174,047		129,384		352,466
Total	$	(91,893	)	$	280,061	$	228,395	$	451,088

Commitments and Contingencies

6 Months Ended

Jun. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 9 — Commitments and Contingencies

Litigation

Operating Leases

As of June 30, 2024, operating lease assets were approximately $539,500. The amount and the maturity of the Company’s operating lease liabilities as of June 30, 2024, are as follows:


	June 30, 2024
2024		289,220
2025		102,841
2026		—
2027		—
Thereafter		—
Total future minimum lease payments		392,061
Less imputed interest		28,123
Total operating lease liabilities	$	363,938
Included in the condensed consolidated balance sheet:
Current operating lease liabilities	$	316,600
Non-current operating lease liabilities		47,338
Total operating lease liabilities	$	363,938

For the three and six months ended June 30, 2024 and 2023, the total lease cost is comprised of the following amounts:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Operating lease expense		87,835		125,650		175,671		251,299
Short-term lease expense		1,608		—		3,268		—
Total lease expense	$	89,443	$	125,650	$	178,939	$	251,299

The following summarizes additional information related to operating leases:


	June 30, 2024			December 31, 2023
Weighted-average remaining lease term (in years)		0.79			1.20
Weighted-average discount rate		23.3	%		23.3	%

Major Customers

At June 30, 2024 and December 31, 2023, one insurance payer and its affiliates accounted for approximately 37% and 38% of accounts receivable, respectively.

Supplier Finance Program Obligations



For the Six Months Ended June 30,	2024			2023
Balance January 1	$	142,217		$	56,603
Increase		—			128,692
Expensed		(80,109	)		(132,988	)
Balance March 31,	$	62,108		$	52,307
Increase		349,909			375,824
Expensed		(78,593	)		(155,076	)
Balance June 30,	$	333,424		$	273,055

No assets are pledged as security under this arrangement.

Subsequent Events

6 Months Ended

Jun. 30, 2024

Subsequent Events [Abstract]

Subsequent Events

Note 10 — Subsequent Events

Line of Credit

Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2024

Accounting Policies [Abstract]

Interim Financial Statements

Basis of Consolidation

Comprehensive Income (Loss)

Use of Estimates

Cash, Cash Equivalents and Short-Term Investments

Accounts Receivable and Allowance for Credit Losses

Joint Venture

Revenue Recognition

The Company recognizes revenue after applying the following five steps:

Identification of the contract, or contracts, with a customer,

Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract,

Determination of the transaction price, including the constraint on variable consideration,

Allocation of the transaction price to the performance obligations in the contract, and

Recognition of revenue when, or as, performance obligations are satisfied.

Product Revenue

(i)

The product has been delivered to the patient, including completion of initial instruction on its use,

(ii)

(iii)

The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606.

The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.

License Revenue

Contract Balances

as of June 30, 2024, and approximately $8,500 of deferred revenue as of December 31, 2023, the outstanding deferred revenue is expected to be recognized by the end of the third quarter of 2024.

Disaggregated Revenue from Contracts with Customers

The following table presents revenue by major source:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Direct to patient	$	5,829,407	$	3,304,113	$	8,059,833	$	5,718,727
Clinical/Medical providers		1,691,360		939,511	$	3,215,323	$	1,971,605
License revenue		—		1,714,920		—		1,714,920
Total revenue from contracts with customers	$	7,520,767	$	5,958,544	$	11,275,156	$	9,405,252

Geographic Data

Cost of Revenue

Advertising

Foreign Currency Translation

Net Loss per Share

Potential dilutive common shares issuable consist of the following at:


	June 30,
	2024		2023
Stock options		23,629		26,138
Restricted stock units		1,275,862		1,608,615
Other warrants		668,250		668,250
Total		1,967,741		2,303,003

Recently Adopted Accounting Standards

Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2024

Accounting Policies [Abstract]

Summary of Revenue by Major Source

The following table presents revenue by major source:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Direct to patient	$	5,829,407	$	3,304,113	$	8,059,833	$	5,718,727
Clinical/Medical providers		1,691,360		939,511	$	3,215,323	$	1,971,605
License revenue		—		1,714,920		—		1,714,920
Total revenue from contracts with customers	$	7,520,767	$	5,958,544	$	11,275,156	$	9,405,252

Summary of Potential Common Shares Issuable

Potential dilutive common shares issuable consist of the following at:


	June 30,
	2024		2023
Stock options		23,629		26,138
Restricted stock units		1,275,862		1,608,615
Other warrants		668,250		668,250
Total		1,967,741		2,303,003

Inventories (Tables)

6 Months Ended

Jun. 30, 2024

Inventory Disclosure [Abstract]

Schedule of Inventories

Inventories consist of the following at:


	June 30, 2024		December 31, 2023
Finished goods	$	800,305	$	321,484
Work in process		146,945		6,589
Parts and subassemblies		1,653,854		1,475,434
Inventories, net	$	2,601,104	$	1,803,507

Fair Value of Financial Instruments (Tables)

6 Months Ended

Jun. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of Cash Equivalents and Short-term Investments Measured at Fair Value on Recurring Basis

Cash equivalents and short-term investments measured at fair value on a recurring basis at June 30, 2024 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Cash equivalents
Money market funds		4,754,628	$	—	$	—	$	4,754,628
	$	4,754,628	$	—	$	—	$	4,754,628
Short-term investments
US government agency debt securities		—		499,705		—		499,705
Commercial paper		—		2,240,060		—		2,240,060
Corporate debt securities		—		396,036		—		396,036
	$	—	$	3,135,801	$	—	$	3,135,801

Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2023 were as follows:


	In Active Markets for Identical Assets or Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Money market funds	$	4,893,387	$	—	$	—	$	4,893,387
Commercial paper		—	$	746,762		—	$	746,762
Short-term investments		—	$	1,994,662		—	$	1,994,662

Accounts Payable and Other Accrued Expenses (Tables)

6 Months Ended

Jun. 30, 2024

Payables and Accruals [Abstract]

Summary of Accounts Payable and Other Accrued Expenses

Accounts Payable and Other Accrued Expenses consists of the following at:


	June 30, 2024		December 31, 2023
Trade payables	$	1,369,978	$	1,073,405
Accrued compensation and benefits		2,174,382		1,964,487
Accrued insurance		349,909		95,680
Accrued professional services		60,276		52,202
Warranty reserve		160,104		231,108
Customer deposits		1,595,300		1,114,979
Other		158,458		354,083
	$	5,868,407	$	4,885,944

Stock Award Plans and Stock-based Compensation (Tables)

6 Months Ended

Jun. 30, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Stock-based Compensation Expense


	For the Three Months Ended					For the Six Months Ended
	June 30,					June 30,
	2024			2023		2024		2023
Cost of goods sold	$	(10,591	)	$	22,114	$	12,796	$	42,593
Research and development		8,719			34,308		32,964		(35,419	)
Selling, clinical and marketing		7,190			49,592		53,251		91,448
Selling, general and administrative		(97,211	)		174,047		129,384		352,466
Total	$	(91,893	)	$	280,061	$	228,395	$	451,088

Commitments and Contingencies (Tables)

6 Months Ended

Jun. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Summary of Maturity of Operating Lease Liabilities

The amount and the maturity of the Company’s operating lease liabilities as of June 30, 2024, are as follows:


	June 30, 2024
2024		289,220
2025		102,841
2026		—
2027		—
Thereafter		—
Total future minimum lease payments		392,061
Less imputed interest		28,123
Total operating lease liabilities	$	363,938
Included in the condensed consolidated balance sheet:
Current operating lease liabilities	$	316,600
Non-current operating lease liabilities		47,338
Total operating lease liabilities	$	363,938

Summary of Operating Lease Cost

For the three and six months ended June 30, 2024 and 2023, the total lease cost is comprised of the following amounts:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2024		2023		2024		2023
Operating lease expense		87,835		125,650		175,671		251,299
Short-term lease expense		1,608		—		3,268		—
Total lease expense	$	89,443	$	125,650	$	178,939	$	251,299

Summary of Additional Information Related to Operating Leases

The following summarizes additional information related to operating leases:


	June 30, 2024			December 31, 2023
Weighted-average remaining lease term (in years)		0.79			1.20
Weighted-average discount rate		23.3	%		23.3	%

Schedule Of Changes In The Companys Supplier Finance Obligations

Changes in the Company's supplier finance obligations were as follows:



For the Six Months Ended June 30,	2024			2023
Balance January 1	$	142,217		$	56,603
Increase		—			128,692
Expensed		(80,109	)		(132,988	)
Balance March 31,	$	62,108		$	52,307
Increase		349,909			375,824
Expensed		(78,593	)		(155,076	)
Balance June 30,	$	333,424		$	273,055

Liquidity - Additional Information (Detail) - USD ($)				6 Months Ended
Liquidity - Additional Information (Detail) - USD ($)	Jan. 19, 2024	Aug. 29, 2023	Jan. 17, 2023	Jun. 30, 2024	Jun. 30, 2023	Jul. 11, 2024	Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Net loss				$ 4,957,200	$ 3,658,400
Accumulated deficit				101,888,000			$ 96,930,800
Cash used in operating activities				$ 5,161,500	$ 2,102,200
Sale of stock number of shares issued in transaction	1,354,218	5,413,334	13,169,074
Sales of prefunded warrants	224,730	1,920,000	6,830,926
Price per share	$ 3.8	$ 0.6	$ 0.325
Per sale price of warrants	$ 3.7999	$ 0.5999	$ 0.3249
Amount borrowed against account receivable						$ 4,000,000
Sale of stock consideration received on transaction	$ 5,400,000	$ 3,900,000	$ 5,700,000

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)		3 Months Ended		6 Months Ended
	Mar. 28, 2022	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Summary of Significant Accounting Policies [Line Items]
Percentage of direct billing channel revenue insures represent		27.00%	53.00%	35.00%	57.00%
Revenue		$ 7,520,767	$ 5,958,544	$ 11,275,156	$ 9,405,252
Deferred revenue		12,000		12,000		$ 8,500
Cost of goods sold		121,800	265,600	144,600	366,800
Advertising expense		849,600	846,400	1,636,900	1,537,900
Restructuring Reserve, Foreign Currency Translation Gain (Loss)		$ 9,200	$ 71,400	$ 52,400	$ 5,600
Warrants exercise price		$ 0.0001		$ 0.0001
Common stock equivalents, pre-funded warrants		7,721,519	6,830,926	7,721,519	6,830,926
Short-Term Investments		$ 3,135,800		$ 3,135,800		$ 1,994,700
Product Revenue [Member] \| Geographic Concentration Risk [Member] \| United States [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage		86.00%	63.00%	82.00%	70.00%
Product Revenue [Member] \| Geographic Concentration Risk [Member] \| China [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			29.00%		18.00%
Product Revenue [Member] \| Geographic Concentration Risk [Member] \| Germany [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage		14.00%	8.00%	17.00%	11.00%
Product Revenue [Member] \| Geographic Concentration Risk [Member] \| Other International Locations [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage				1.00%	1.00%
Beijing Ryzur Medical Investment Co., Ltd
Summary of Significant Accounting Policies [Line Items]
Upfront license fee				$ 2,700,000
License revenue
Summary of Significant Accounting Policies [Line Items]
Revenue		$ 0	$ 1,714,920	0	$ 1,714,920
License revenue \| Product Revenue [Member] \| Geographic Concentration Risk [Member] \| United States [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage					85.00%
License revenue \| Product Revenue [Member] \| Geographic Concentration Risk [Member] \| Germany [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage					14.00%
License revenue \| Product Revenue [Member] \| Geographic Concentration Risk [Member] \| Other International Locations [Member]
Summary of Significant Accounting Policies [Line Items]
Concentration Risk, Percentage					1.00%
O&P Providers or Third Party Payors [Member]
Summary of Significant Accounting Policies [Line Items]
Revenue recognized		$ 1,865,800	$ 403,900	$ 1,745,000	$ 1,898,200
Jiangxi Myomo Medical Assistive Appliance Co. Ltd
Summary of Significant Accounting Policies [Line Items]
Cash consideration paid	$ 199,000
Ownership percentage	19.90%

Summary of Significant Accounting Policies - Summary of Revenue by Major Source (Detail) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Disaggregation of Revenue [Line Items]
Total revenue from contracts with customer	$ 7,520,767	$ 5,958,544	$ 11,275,156	$ 9,405,252
Direct to Patient [Member]
Disaggregation of Revenue [Line Items]
Total revenue from contracts with customer	5,829,407	3,304,113	8,059,833	5,718,727
Clinical/Medical Providers [Member]
Disaggregation of Revenue [Line Items]
Total revenue from contracts with customer	1,691,360	939,511	3,215,323	1,971,605
License Revenue [Member]
Disaggregation of Revenue [Line Items]
Total revenue from contracts with customer	$ 0	$ 1,714,920	$ 0	$ 1,714,920

Summary of Significant Accounting Policies - Summary of Potential Common Shares Issuable (Detail) - shares	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	1,967,741	2,303,003
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	23,629	26,138
Restricted Stock Units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	1,275,862	1,608,615
Other Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	668,250	668,250

Inventories - Schedule of Inventories (Detail) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Finished goods	$ 800,305	$ 321,484
Work in process	146,945	6,589
Parts and subassemblies	1,653,854	1,475,434
Inventories, net	$ 2,601,104	$ 1,803,507

Fair Value of Financial Instruments - Schedule of Cash Equivalents and Short-term Investments Measured at Fair Value on Recurring Basis (Detail) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents	$ 4,754,628
Short-term investments	3,135,801	$ 1,994,662
Money market funds [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents	4,754,628	4,893,387
US government agency debt securities [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Short-term investments	499,705
Commercial Paper [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents		746,762
Short-term investments	2,240,060
Corporate debt securities [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Short-term investments	396,036
In Active Markets for Identical Assets or Liabilities (Level 1) [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents	4,754,628
In Active Markets for Identical Assets or Liabilities (Level 1) [Member] \| Money market funds [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents	4,754,628	4,893,387
Significant Other Observable Inputs (Level 2) [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Short-term investments	3,135,801	1,994,662
Significant Other Observable Inputs (Level 2) [Member] \| US government agency debt securities [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Short-term investments	499,705
Significant Other Observable Inputs (Level 2) [Member] \| Commercial Paper [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Cash equivalents		$ 746,762
Short-term investments	2,240,060
Significant Other Observable Inputs (Level 2) [Member] \| Corporate debt securities [Member]
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
Short-term investments	$ 396,036

Accounts Payable and Other Accrued Expenses - Summary of Accounts Payable and Other Accrued Expenses (Detail) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Trade payables	$ 1,369,978	$ 1,073,405
Accrued compensation and benefits	2,174,382	1,964,487
Accrued insurance	349,909	95,680
Accrued professional services	60,276	52,202
Warranty reserve	160,104	231,108
Customer deposits	1,595,300	1,114,979
Other	158,458	354,083
Total	$ 5,868,407	$ 4,885,944

Common Stock and Warrants - Additional Information (Details)					3 Months Ended		6 Months Ended
	Jan. 19, 2024 USD ($) $ / shares shares	Aug. 29, 2023 USD ($) $ / shares shares	Jan. 17, 2023 USD ($) $ / shares shares	Aug. 02, 2022 USD ($)	Jun. 30, 2024 USD ($) $ / shares shares	Jun. 30, 2023 shares	Jun. 30, 2024 USD ($) $ / shares shares	Jun. 30, 2023 USD ($) shares	Dec. 31, 2023 USD ($) shares
Class of Stock [Line Items]
Sale of stock number of shares issued in transaction	1,354,218	5,413,334	13,169,074
Sales of prefunded warrants	224,730	1,920,000	6,830,926
Per Sale Price of warrants \| $ / shares	$ 3.7999	$ 0.5999	$ 0.3249
Sale Of Stock Consideration Received On Transaction \| $	$ 5,400,000	$ 3,900,000	$ 5,700,000
Nominal Exercise Value \| $ / shares	$ 0.0001	$ 0.0001	$ 0.0001
Common stock equivalents, pre-funded warrants					7,721,519	6,830,926	7,721,519	6,830,926
Common stock, shares outstanding					30,201,327		30,201,327		27,135,034
Shares value \| $					$ 3,021		$ 3,021		$ 2,715
Price per share \| $ / shares	$ 3.8	$ 0.6	$ 0.325
Common stock warrants, exercise price per share \| $ / shares					$ 0.0001		$ 0.0001
Proceeds from exercise of warrants \| $							$ 4,598,771	$ 3,708,045
Number of shares, Vested					774,730	169,499	937,345	172,320
A T M Facility [Member]
Class of Stock [Line Items]
Number of shares offer and sell \| $				$ 1,000
Percentage of gross proceeds from sales of common stock				0.03
Stock issued during period					0	0	0	0
Common stock issued for the exercise of common stock options, Shares					0		0	0
A T M Facility [Member] \| Maximum [Member]
Class of Stock [Line Items]
Proceeds from issuance of common stock \| $				$ 15,000,000
Underwriter Warrants [Member]
Class of Stock [Line Items]
Sales of prefunded warrants							5,801,519

Stock Award Plans and Stock-based Compensation - Additional Information (Detail) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock award net share settled paid for withholding taxes	0	16,744	0	16,744
Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation cost	$ 13,300		$ 13,300
Weighted-average remaining contractual term			11 months 19 days
Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation cost	$ 2,802,300		$ 2,802,300
Weighted-average remaining contractual term			2 years 7 months 28 days
2018 Stock Option and Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares available for future grant	493,970		493,970
Number of common shares reserved for issuance	1,085,401		1,085,401
Percentage increase in number of shares of common stock reserved and available for issuance			4.00%

Stock Award Plans and Stock-based Compensation - Schedule of Stock-based Compensation Expense (Detail) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share based compensation expense	$ (91,893)	$ 280,061	$ 228,395	$ 451,088
Cost of Goods Sold [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share based compensation expense	(10,591)	22,114	12,796	42,593
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share based compensation expense	8,719	34,308	32,964	(35,419)
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share based compensation expense	(97,211)	174,047	129,384	352,466
Selling, clinical, and marketing [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share based compensation expense	$ 7,190	$ 49,592	$ 53,251	$ 91,448

Related Party Transactions - Additional Information (Detail) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Related Party Transactions [Abstract]
Cost of goods sold	$ 121,800	$ 265,600	$ 144,600	$ 366,800

Commitments and Contingencies - Additional Information (Detail)	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2024 USD ($) Customer	Jun. 30, 2023 USD ($)	Jun. 30, 2024 USD ($) Insurer	Jun. 30, 2023 USD ($) Customer	Dec. 31, 2023 USD ($) Insurer	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
Commitments And Contingencies [Line Items]
Description of operating lease agreement for office space			The Company has a non-cancelable sublease agreement for its corporate headquarters in Boston, Massachusetts, which expires in January 2025 and a lease agreement for office space in Fort Worth, TX. which expires in December 2025. Termination options are either not included, or have expired, for the Company’s existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the condensed consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.
Operating Lease Right Of Use Assets	$ 539,500		$ 539,500
Finance program obligations	333,424	$ 273,055	333,424	$ 273,055	$ 142,217	$ 62,108	$ 52,307	$ 56,603
Loss Contingency					$ 55,000
Directors and Officers Insurance Member
Commitments And Contingencies [Line Items]
Finance program obligations	39,000	29,000	$ 39,000	$ 29,000
Equal monthly payment made	$ 39,000	$ 27,000
Sales Revenue, Net [Member]
Commitments And Contingencies [Line Items]
Number of customers \| Customer	0			0
Accounts Receivable [Member]
Commitments And Contingencies [Line Items]
Number of customers \| Insurer			1		1
Customer Concentration Risk [Member] \| Sales Revenue, Net [Member] \| One U.S. Insurance Payer [Member]
Commitments And Contingencies [Line Items]
Concentration Risk, Percentage	20.00%	41.00%	24.00%	42.00%
Customer Concentration Risk [Member] \| Sales Revenue, Net [Member] \| Patients with Medicare Advantage Insurance Plans [Member]
Commitments And Contingencies [Line Items]
Concentration Risk, Percentage	26.00%	63.00%	30.00%	59.00%
Customer Concentration Risk [Member] \| Sales Revenue, Net [Member] \| Patients With Medicare Part B Coverage [Member]
Commitments And Contingencies [Line Items]
Concentration Risk, Percentage	47.00%		35.00%
Customer Concentration Risk [Member] \| Accounts Receivable [Member] \| One Insurer [Member]
Commitments And Contingencies [Line Items]
Concentration Risk, Percentage			37.00%		38.00%

Commitments and Contingencies - Summary of Maturity of Operating Lease Liabilities (Detail) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2024	$ 289,220
2025	102,841
2026	0
2027	0
Thereafter	0
Total future minimum lease payments	392,061
Less imputed interest	28,123
Total operating lease liabilities	363,938
Included in the condensed consolidated balance sheet:
Current operating lease liabilities	316,600	$ 486,143
Non-current operating lease liabilities	47,338	$ 115,160
Total operating lease liabilities	$ 363,938

Commitments and Contingencies - Summary of Operating Lease Cost (Detail) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Lease, Cost [Abstract]
Operating lease expense	$ 87,835	$ 125,650	$ 175,671	$ 251,299
Short-term lease expense	1,608	0	3,268	0
Total lease expense	$ 89,443	$ 125,650	$ 178,939	$ 251,299

Commitments and Contingencies - Summary of Additional Information Related to Operating Leases (Detail)	Jun. 30, 2024	Dec. 31, 2023
Leases [Abstract]
Weighted-average remaining lease term (in years)	9 months 14 days	1 year 2 months 12 days
Weighted-average discount rate	23.30%	23.30%

Commitments and Contingencies - Schedule Of Changes In The Companys Supplier Finance Obligations (Details) - USD ($)	3 Months Ended
	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2023	Mar. 31, 2023
Commitments and Contingencies Disclosure [Abstract]
Opening January 1	$ 62,108	$ 142,217	$ 52,307	$ 56,603
Increase	349,909	0	375,824	128,692
Expensed	(78,593)	(80,109)	(155,076)	(132,988)
Ending	$ 333,424	$ 62,108	$ 273,055	$ 52,307

Subsequent Events (Additional Information) (Details) - Subsequent Event [Member] - Revolving Credit Line [Member] - Silicon Valley Bank [Member]	Jul. 11, 2024 USD ($)
Subsequent Event [Line Items]
Company's maximum borrowing capacity	$ 4,000,000
Debt instrument, face amount	$ 5,500,000
Debt instrument interest rate	80.00%
Basis spread on variable rate	8.50%
Commitment fee	$ 20,000
Unused Revolving Line Facility Fee	0.50%
Percentage OfTermination fee	1.00%
Percentage Of Anniversary Fee	0.50%
Debt Instrument, Interest Rate, Stated Percentage	0.50%

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