Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 01, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MYO | ||
Entity Registrant Name | MYOMO, INC. | ||
Entity Central Index Key | 0001369290 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Shell Company | false | ||
Entity Ex Transition Period | false | ||
Entity Common Stock, Shares Outstanding | 6,875,056 | ||
Entity Public Float | $ 60,192,401 | ||
Entity File Number | 001-38109 | ||
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, $0.0001 par value per share | ||
Security Exchange Name | NYSEAMER | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | Marcum, LLP | ||
Auditor Firm ID | 688 | ||
Auditor Location | New York, NY, USA | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Part III of this Form 10-K incorporates information by reference from the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year ended December 31, 2021. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 15,524,378 | $ 12,241,261 |
Accounts receivable, net | 1,960,037 | 924,916 |
Inventories, net | 808,308 | 707,114 |
Prepaid expenses and other current assets | 894,494 | 572,684 |
Total Current Assets | 19,187,217 | 14,445,975 |
Equipment, net | 275,289 | 95,023 |
Operating lease assets with right-of-use | 632,906 | 168,784 |
Total Assets | 20,095,412 | 14,709,782 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 3,949,784 | 2,848,904 |
Current operating lease liability | 333,380 | 18,289 |
Deferred revenue | 249 | 2,512 |
Total Current Liabilities | 4,283,413 | 2,869,705 |
Other long-term liabilities | 118,060 | |
Non-current operating lease liability | 401,622 | 155,148 |
Deferred revenue | 1,246 | 1,495 |
Total Liabilities | 4,686,281 | 3,144,408 |
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; 6,869,753 and 4,593,184 shares issued as of December 31, 2021 and 2020, respectively, and 6,869,726 and 4,593,157 shares outstanding as of December 31, 2021 and 2020, respectively. | 687 | 457 |
Additional paid-in capital | 93,537,807 | 79,273,964 |
Accumulated other comprehensive loss | (60,677) | (12,690) |
Accumulated deficit | (78,062,222) | (67,689,893) |
Treasury stock, at cost; 27 shares of common stock | (6,464) | (6,464) |
Total Stockholders’ Equity | 15,409,131 | 11,565,374 |
Total Liabilities and Stockholders’ Equity | $ 20,095,412 | $ 14,709,782 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
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 | 6,869,753 | 4,593,184 |
Common stock, shares outstanding | 6,869,726 | 4,593,157 |
Treasury shares at cost | 27 | 27 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Revenue | $ 13,856,374 | $ 7,583,371 |
Cost of revenue | 3,544,097 | 2,600,375 |
Gross profit | 10,312,277 | 4,982,996 |
Operating expenses: | ||
Research and development | 2,557,367 | 1,669,188 |
Selling, general and administrative | 18,022,975 | 13,816,494 |
Total operating expenses | 20,580,342 | 15,485,682 |
Loss from operations | (10,268,065) | (10,502,686) |
Other expense (income) | ||
Change in fair value of derivative liabilities | (122,706) | |
Interest and other expense, net | 15,336 | 255,906 |
Non-cash interest expense, debt discount | 218,803 | |
Loss of early extinguishment of debt | 709,222 | |
Total other expense (income) | 15,336 | 1,061,225 |
Loss before income taxes | (10,283,401) | (11,563,911) |
Income tax expense | 88,928 | |
Net loss | (10,372,329) | (11,563,911) |
Deemed dividend on discounting and repricing of warrants | (639,953) | (670,632) |
Net loss attributable to common stockholders | $ (11,012,282) | $ (12,234,543) |
Weighted average number of common shares outstanding: | ||
Basic and diluted | 5,830,353 | 3,329,868 |
Net loss per share available to common stockholders: | ||
Basic and diluted | $ (1.89) | $ (3.67) |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (10,372,329) | $ (11,563,911) |
Other comprehensive (loss), net of tax: | ||
Foreign currency translation loss | (47,987) | (12,690) |
Other comprehensive loss | (47,987) | (12,690) |
Comprehensive loss | $ (10,420,316) | $ (11,576,601) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Comprehensive (Loss) Income [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] |
Beginning balance at Dec. 31, 2019 | $ 6,425,885 | $ 57 | $ 57,957,097 | $ (56,125,982) | $ (6,464) | |
Beginning balance, shares at Dec. 31, 2019 | 574,524 | 27 | ||||
Proceeds from public offering, net of offering costs | 13,475,535 | $ 166 | 13,475,369 | |||
Proceeds from public offering, net of offering costs, shares | 1,660,000 | |||||
Proceeds from issuance of pre-funded warrants in conjunction with public offering | 48 | $ 48 | ||||
Proceeds from issuance of pre-funded warrants in conjunction with public offering, shares | 483,000 | |||||
Proceeds from issuances under at-market sales facility, net of offering costs | 4,917,575 | $ 118 | 4,917,457 | |||
Proceeds from issuances under at-market sales facility, net of offering costs, shares | 1,181,096 | |||||
Issuances of common stock to repay debt | 2,150,405 | $ 54 | 2,150,351 | |||
Issuances of common stock to repay debt, shares | 544,526 | |||||
Exercise of Warrants | 161,250 | $ 10 | 161,240 | |||
Exercise of Warrants, shares | 118,835 | |||||
Common stock issued upon vesting of restricted stock units | (1,852) | $ 3 | (1,855) | |||
Common stock issued upon vesting of restricted stock units, Shares | 30,561 | |||||
Restricted stock vested | $ 1 | $ 1 | ||||
Restricted stock vested, shares | 489 | 588 | ||||
Exercise of common stock options | $ 3 | 3 | ||||
Exercise of stock options, shares | 421 | 123 | ||||
Adjustment due to reverse stock split | (69) | |||||
Stock-based compensation | $ 614,302 | 614,302 | ||||
Unrealized gain/(loss) on foreign currency | (12,690) | $ (12,690) | ||||
Deemed dividend on discounting and repricing of warrants | (670,632) | |||||
Net loss | (11,563,911) | (11,563,911) | ||||
Ending balance at Dec. 31, 2020 | 11,565,374 | (12,690) | $ 457 | 79,273,964 | (67,689,893) | $ (6,464) |
Ending balance, shares at Dec. 31, 2020 | 4,593,184 | 27 | ||||
Proceeds from issuances under at-market sales facility, net of offering costs | 1,099,800 | $ 11 | 1,099,789 | |||
Proceeds from issuances under at-market sales facility, net of offering costs, shares | 107,500 | |||||
Exercise of Warrants | $ 12,067,865 | $ 204 | 12,067,661 | |||
Exercise of Warrants, shares | 2,015,243 | |||||
Common stock issued upon vesting of restricted stock units | $ 15 | (15) | ||||
Common stock issued upon vesting of restricted stock units, Shares | 153,357 | |||||
Restricted stock vested, shares | 30 | |||||
Exercise of stock options, shares | 439 | 439 | ||||
Stock-based compensation | $ 1,096,408 | 1,096,408 | ||||
Unrealized gain/(loss) on foreign currency | (47,987) | (47,987) | ||||
Deemed dividend on discounting and repricing of warrants | (639,953) | |||||
Net loss | (10,372,329) | (10,372,329) | ||||
Ending balance at Dec. 31, 2021 | $ 15,409,131 | $ (60,677) | $ 687 | $ 93,537,807 | $ (78,062,222) | $ (6,464) |
Ending balance, shares at Dec. 31, 2021 | 6,869,753 | 27 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Offering cost from sale of stock | $ 1,499,370 | |
Prior period offering cost from sale of stock | $ 161,253 | |
Net withheld for employee taxes | 489 | |
Common stock issued for warrants exercised net of offering costs | $ 349,400 | |
At-market Sales Facility [Member] | ||
Offering cost from sale of stock | $ 152,853 | $ 131,976 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (10,372,329) | $ (11,563,911) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Depreciation | 145,995 | 105,382 |
Stock-based compensation | 1,096,408 | 614,302 |
Loss on disposal of asset | 202 | 547 |
Bad debt expense | 9,839 | |
Non-cash interest expense, debt discount | 218,803 | |
Amortization of original issue discount | 161,869 | |
Amortization of right-of-use assets | 189,968 | 3,288 |
Loss of early extinguishment of debt | 709,222 | |
Change in fair value of derivative liabilities | (122,706) | |
Other non-cash charges | (19,929) | (18,446) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,046,282) | (522,944) |
Inventories | (118,222) | (271,545) |
Prepaid expenses and other current assets | (323,644) | 248,464 |
Other assets | 57,987 | |
Accounts payable and accrued expenses | 1,113,235 | 1,217,929 |
Operating lease liabilities | (92,525) | 1,365 |
Deferred revenue | (2,512) | (401) |
Other liabilities | (118,060) | 118,060 |
Net cash used in operating activities | (9,547,695) | (9,032,896) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of equipment | (326,462) | (45,752) |
Net cash used in investing activities | (326,462) | (45,752) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Repayment of debt | (1,703,552) | |
Payment of prepayment penalty on debt | (255,533) | |
Net proceeds from common stock offering | 13,504,812 | |
Net settlement of vested restricted stock units to fund related employee statutory tax withholding | (1,855) | |
Proceeds from exercise of stock options | 3 | |
Proceeds from exercise of warrants | 12,067,865 | 161,298 |
Proceeds from at the market offering, net of offering costs | 1,099,801 | 5,049,551 |
Proceeds from payments under grants | 25,852 | |
Net cash provided by financing activities | 13,167,666 | 16,780,576 |
Effect of foreign exchange rate changes on cash | (10,392) | (1,122) |
Net increase in cash and cash equivalents | 3,283,117 | 7,700,806 |
Cash and cash equivalents beginning of year | 12,241,261 | 4,540,455 |
Cash and cash equivalents end of year | 15,524,378 | 12,241,261 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH INTEREST, INVESTING, AND FINANCING ACTIVITIES | ||
Inventory capitalized as sales demo equipment | 2,743 | |
Sales demo equipment transferred to rental inventory | 2,514 | |
Deferred issuance costs to additional paid-in capital paid in prior period | 161,253 | |
Issuance of common stock for debt | 2,150,405 | |
Right of use assets obtained in exchange for lease obligations | $ 654,091 | $ 172,072 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 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 Food and Drug Administration as a Class II medical device. The Company provides the device to patients and bills their insurance companies directly, sometimes utilizing the clinical services of orthotics and prosthetics (“O&P”) providers for which they are paid a fee. The Company sells the product to O&P providers around the world, the Veterans Health Administration (VA), 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. Pursuant to an amended and restated certificate of incorporation, the Company is authorized to issue up to 75,000,000 shares of stock, consisting of 65,000,000 shares of common stock, par value $0.0001 and 10,000,000 shares of undesignated Preferred Stock, par value of $0.0001. Follow-on Public Offering In February 2020, the Company completed a follow-on offering of 1,660,000 shares of its common stock and 1,660,000 investor warrants to purchase one share of the Company’s common stock at a combined offering price of $7.00 per share (“February 2020 Offering”). In addition, the Company sold 483,000 pre-funded warrants and 483,000 investor warrants to purchase one share of the Company’s common stock at a combined offering price of $6.999 per share. The offering generated approximately $13.5 million in net proceeds to the Company. See Note 8 – Preferred and Common Stock, for further information. Shelf Registration Statement On May 14, 2021, the Company filed a Registration Statement on Form S-3 (the “Shelf”) with the Securities and Exchange Commission in relation to the registration of common stock, preferred stock, warrants and/or units or any combination thereof the Company (collectively, the “Securities”) having an aggregate price of up to $100 million, subject to the limitations of the Shelf. On June 25, 2021, the Company entered into an At Market Issuance Sales Agreement (the “ATM”) with Alliance Global Partners “(AGP”), as sales agent, to provide for the offering, issuance and sale by the Company of up to an aggregate amount of $15 million of the Company’s common stock from time to time in “at-the-market” offerings under the Shelf and subject to the limitations thereof. The Company shall pay to the sales agent cash commissions of 3.0% of the gross proceeds of sales of common stock under the ATM. See Note 8 – Preferred and Common Stock, for further information. Liquidity The Company incurred net losses of approximately $10,372,000 and $11,564,000 during the years ended December 31, 2021 and 2020, respectively, and has an accumulated deficit of approximately $78,062,000 and $67,690,000 Management’s operating plans are primarily focused on scaling up its operations, increasing the proportion of patients carrying commercial health insurance with payers that have historically reimbursed for the Company’s products, and continued work with the Centers for Medicare and Medicaid Services, or CMS, and their billing contractors regarding reimbursement of its products. In addition, the Company believes that it has access to capital resources through payment of a license fee associated with the Company’s entry into a joint venture and technology license agreement with Beijing Ryzur Medical Investment Co. Ltd., possible public or private equity offerings, including usage of its ATM facility (approximately $13.7 million remaining availability as of December 31, 2021), exercises of outstanding warrants, additional debt financings, or other means. Additional debt financing may contain t erms that are not favorable to the Company or its stockholders. Historical losses, quantitatively, give rise to substantial doubt regarding the Company’s ability to continue to operate as a going concern. However, based on the company's latitude as to the timing and amount of certain expenses, and its current cash position, the C ompany believes that substantial doubt about its liquidity is mitigated for at least twelve months from the issuance date of these financial statements . In October 2021, the Company completed a transaction to incentivize the exercise of the warrants issued in its February 2020 Offering by reducing the exercise price to $5.00 per share. The Company generated $4.8 million of net proceeds from this transaction (See Note 10 – Warrants). In addition, the Company generated net proceeds of $1.1 million from sales of common stock under ATM facility during 2021 (See Note 8 – Preferred and Common Stock). Based upon its expected cash flows, including the expected payment of the license fee by the joint venture partner in China, and net proceeds from the aforementioned transactions, the Company believes that its available cash will fund its operations for at least the next twelve months from the issuance date of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 — Summary of Significant Accounting Policies Basis of Consolidation The 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 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. There were no reclassifications out of accumulated other comprehensive loss in the years ended December 31, 2021 and 2020. 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. The Company’s estimates include the allowance for doubtful accounts, deferred tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for slow-moving inventory. Cash and Cash Equivalents 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 December 31, 2021 and 2020. Accounts Receivable and Allowance for Doubtful Accounts The Company reports accounts receivable at invoiced amounts less an allowance for doubtful accounts. The Company evaluates its accounts receivable on a continuous basis, and if necessary, establishes an allowance for Inventories Inventories are recorded at the lower of average cost or net realizable value. Average cost approximates valuation on a first-in, first-out basis. The Company reduces the carrying value of inventory for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technology developments or other economic factors. In addition, the carrying value of consigned inventories is reduced by the value of MyoPro devices that will not be sold based on historical experience. Equipment Equipment is stated at historical cost, net of accumulated depreciation and is depreciated using the straight-line method over the estimated useful lives of the related assets, generally three years. Leasehold improvements are depreciated using the straight-line method over the shorter of the lease term or the estimated useful life. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life, are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Demonstration units are sometimes provided by the Company’s to its indirect sales channel for marketing and patient evaluation purposes. These units are manufactured by the Company and are expensed in the statements of operations to selling, general, and administrative expense. During the years ended December 31, 2021 and 2020, the Company charged to operations approximately $22,200 and $61,700, respectively, for these units. Demonstrations units provided to its own sales force are capitalized as equipment on the Company’s balance sheet. Test units are provided to research and development staff to use in their development process and to end users who are given free units to act as testers so that research and development staff can evaluate and understand their use by patients. A primary objective of these units is to determine when and under what conditions they fail, at which time they are analyzed for cause of failure and then scrapped. These units are expensed in the statements of operations as part of research and development expense. During the year ended December 31, 2021 and 2020 the Company charged to operations approximately $17,400 and $15,400, respectively, of these units. Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, including equipment when there are indications that the assets might be impaired. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated undiscounted cash flows, the Company records an impairment charge for the difference. Based on its assessments, the Company did not record any impairment charges for the years ended December 31, 2021 and 2020. Leases The Company accounts for leases under Accounting Standards Topic 842 (“ASC 842”). The Company assesses whether a contract is or contains a lease at inception of the contract and recognizes right-of-use assets and corresponding lease liabilities at the lease commencement date, except for short-term leases, which are under one year, and leases of low value. For these leases, the Company recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease. Revenue Recognition The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all 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: 1) Identification of the contract, or contracts, with a customer, 2) Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract 3) Determination of the transaction price, including the constraint on variable consideration 4) Allocation of the transaction price to the performance obligations in the contract 5) Recognition of revenue when, or as, performance obligations are satisfied Revenue is recognized when control of these services is transferred to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. 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 U.S. and internationally, the Veterans Administration (“VA”), and distributors in Europe and Australia. 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. (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 expect to receive in exchange for the device. During the fourth quarter of 2020, the Company made such a determination for certain insurers. These insurers represented approximately 39% and 40% of direct billing channel revenue in 2021 and 2020, respectively. 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 on an ongoing basis. During the year ended December 31, 2021 and 2020, the Company recognized revenue of approximately $2,050,345 and $490,800, respectively, from O&P providers or third-party payers for which costs related to the completion of the Company’s performance obligations were recorded in a prior period. For revenues derived from O&P providers, the VA, and distributors, 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, which 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. In certain cases, the Company ships its products to O&P providers pending reimbursement from non-government, third party payers. As a result of this arrangement, elements of the revenue recognition criteria have not been met upon shipment. In this instance, the Company recognizes revenue when payment has been received, as then all of the revenue recognition criteria has been met. 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. 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 approximately $1,500 and $4,000 of deferred revenue as of December 31, 2021 and 2020, respectively. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: 2021 2020 Clinical/medical providers $ 3,186,248 $ 2,255,263 Direct-to-patient 10,670,126 5,328,108 Total revenue from contracts with customers $ 13,856,374 $ 7,583,371 Geographic Data The Company generated 89% of its revenue from the United States, 10% from Germany, and 1% from other international locations for the year ended December 31, 2021. The Company generated 92% of its revenue from the United States and 8% from international locations for the year ended December 31, 2020. 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, such as when the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from certain third party payers, which triggers revenue recognition. For the years ended December 31, 2021 and December 31, 2020, the Company recorded cost of goods sold of approximately $21,400 and $216,100, respectively without corresponding revenue. The cost of clinical services by O&P providers for which they are paid a fee in conjunction with devices being sold directly to patients and billing their insurance companies directly 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, with the remaining costs associated with the patient being expensed to cost of revenue. Shipping and Handling Costs Shipping and handling costs paid by customers are netted against the related shipping costs we incur. The net cost is recorded in cost of revenues. Historically, such costs have not been material. Income Taxes The Company accounts for income taxes under Accounting Standards Codification ASC 740 Income Taxes (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the financial statement in the period in which the law is enacted. ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Tax benefits claimed or expected to be claimed on a tax return are recorded in the Company’s financial statements. A tax benefit from an uncertain tax position is only recognized if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution. The Company files income tax returns in federal and state jurisdictions and is no longer subject to examinations by tax authorities for years prior to 2018. Currently, there are no income tax audits in process. Stock-Based Compensation The Company accounts for stock awards to employees by measuring the cost of services received in exchange for the award of equity instruments 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. Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Net foreign currency gains and losses during the year ended December 31, 2021 were immaterial and included in accumulated other comprehensive loss in the consolidated balance sheets. Transaction foreign exchange gains and losses are included in net loss. Foreign exchange translation gains and losses from the functional currency of Myomo Europe GmbH, which is the euro, to USD are captured in other comprehensive loss. The balance sheet is translated using the spot date on the day of reporting and the income statement is translated monthly using the average rate for the month. Net Loss per Share Basic 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 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 years ended December 31, 2021 and 2020, respectively, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potentially common shares issuable at December 31, 2020 and 2019 consist of: 2021 2020 Options 31,725 24,088 Warrants 693,643 2,709,159 Restricted stock units 292,473 276,568 Restricted stock — 30 Total 1,017,841 3,009,845 Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $3,587,300 and $841,300 in 2021 and 2020, respectively. Research and Development Costs The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and benefits, facility and overhead costs, and outsourced research activities. Recent Accounting Standards In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU 2019-12 “Income Taxes (Topic 740) -- Simplifying the Accounting for Income Taxes. This ASU modifies certain provisions of ASC 740 to simplify the accounting for income taxes. The amendments in ASU 2019-12 are effective for public business entities for fiscal years beginning after December 15, 2020, including interim periods therein. The Company adopted ASU 2019-12 in the first quarter of 2021. The guidance did not have a material impact on our consolidated financial statements. In May 2021, the FASB issued ASU 2021-04 Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early application is permitted, including in an interim period as of the beginning of the fiscal year that includes that interim period. The Company adopted the provisions of ASU 2021-04 in the fourth quarter of 2021. The implementation resulted in a deemed dividend of approximately $640,000 on the discounting of certain warrants. Subsequent Events The Company evaluates whether there have been subsequent events through the date the financial statements were issued and determines whether subsequent events exist that would require recognition in the financial statements or disclosure in the notes of the financial statements. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 3 — Inventories Inventories consist of the following at December 31: 2021 2020 Finished goods $ 176,082 $ 40,682 Work in Process 23,161 18,000 Rental units 62,531 62,531 Parts and subassemblies 584,996 603,443 846,770 724,656 Less: Reserve for rental units (38,462 ) (17,542 ) Inventories, net $ 808,308 $ 707,114 |
Equipment, net
Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Equipment, net | Note 4 — Equipment, net Equipment consists of the following at December 31: 2021 2020 Computer equipment $ 180,979 $ 119,780 Sales demonstration units 186,951 187,179 R&D tools and molds 52,644 52,644 Leasehold improvements 246,268 4,900 Furniture and fixtures 40,341 17,965 707,183 382,468 Less: accumulated depreciation (431,894 ) (287,445 ) Equipment, net $ 275,289 $ 95,023 Depreciation expenses was approximately $146,000 and $105,400 for the years ended December 31, 2021 and 2020, respectively. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 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 Measurements and Disclosures” (“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 are a money market fund that limits its investments to only short-term U.S. Treasury securities and repurchase agreements related to these securities. Cash equivalents, which are measured at fair value, were as follows At December 31, 2021: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2021 Total Cash equivalents $ 14,803,456 — — $ 14,803,456 Cash equivalents, which are measured at fair value, were as follows at December 31, 2020: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2020 Total Cash equivalents $ 11,718,319 — — $ 11,718,319 |
Accounts Payable and other Accr
Accounts Payable and other Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
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 December 31: 2021 2020 Trade payables $ 723,352 $ 180,499 Accrued compensation and benefits 2,188,869 1,843,402 Accrued professional services 108,417 92,399 Deferred payroll taxes under CARES Act 113,423 118,060 Warranty reserve 176,281 119,713 Customer Deposits 192,501 300 Other 446,941 494,531 $ 3,949,784 $ 2,848,904 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 7 – Debt On October 22, 2019, the Company entered into a Note Purchase Agreement, Senior Note and Security Agreement (collectively, the “Term Loan”) with Chicago Venture Partners (“CVP”). Under the Term Loan, the Company received gross proceeds of $3.0 million (excluding fees and expenses). Including an original issue discount the Company repaid CVP $3.3 million. The Term Loan carried an interest rate of 10%. On May 12, 2020 (the “Issuance Date”), the Company entered an amendment to its Term Loan with CVP to provide for the conversion of outstanding amounts into shares of common stock in satisfaction of its repayment obligations (as amended, the convertible instrument is referred to herein as the “Note”) in which the Company, at its option, could pay monthly redemptions in either cash or shares of common stock. If the Company made a redemption payment to CVP in shares of common stock, the number of shares issued was based on the redemption amount divided by the product of (x) 91%, and (y) the lowest daily volume weighted average price over the ten preceding trading days. Interest expense under the Term Loan and the Note, including amortization of the debt discount was approximately $492,600, |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common Stock | Note 8 — Common Stock During the year ended December 31, 2020, During the year ended December 31, 2021 and 2020, the Company issued 439 and 123 shares of common stock through the exercise of stock options. During the years ended December 31, 2021 and 2020, the Company issued 153,357 and 30,561 shares of common stock, net of During the year ended December 31, 2021 and 2020, the Company issued 30 and 588 shares of common stock upon the vesting of restricted stock awards, respectively. |
Stock Award Plans and Stock-Bas
Stock Award Plans and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Award Plans and Stock-Based Compensation | Note 9 — Stock Award Plans and Stock-Based Compensation Equity Incentive Plan On June 19, 2018, the Company’s Shareholders and the Board of Directors approved the Myomo, Inc. 2018 Stock Options 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. On January 1, 2021 and 2020, the number of shares reserved and available for issuance under the 2018 Plan increased by 183,726 and 22,980 shares, respectively. At December 31, 2021, there were 96,868 shares available for future grant under the 2018 Plan. Under the terms of the 2018 Plan, incentive stock options (ISOs) may be granted to officers and employees and non-qualified stock options and awards may be granted to directors, consultants, officers and employees of the Company. The exercise price of ISOs cannot be less than the fair market value of the Company’s Common Stock on the date of grant. The options vest over a period determined by the Company’s Board of Directors, ranging from immediate to four years, and expire not more than ten years from the date of grant. Stock Option Awards Stock option activity under the Stock Option Plans during the years ended December 31, 2021 and 2020 is as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Life (years) Intrinsic Value Balance at January 1, 2020 21,805 $ 63.0000 7.83 $ 17,581 Granted 5,000 4.4700 Adjustment due to reverse stock split 28 63.0000 Forfeited or cancelled (123 ) 0.0500 Expired (2,201 ) 58.6600 Exercised (421 ) 80.5500 Balance at December 31, 2020 24,088 51.2900 7.51 $ 23,194 Granted 9,250 17.0700 Forfeited or cancelled (1,174 ) 50.9600 Expired - - Exercised (439 ) 0.0500 Balance at December 31, 2021 31,725 $ 40.5800 Options exercisable at December 31, 2020 14,998 $ 68.0300 6.58 $ 11,894 Options exercisable at December 31, 2021 17,390 $ 63.2600 5.97 $ 12,392 The Company uses the Black-Scholes option pricing model to estimate the grant date fair value of its stock options. There was no income tax benefit recognized in the financial statements for share-based compensation arrangements for the years ended December 31, 2021 and 2020. The weighted-average grant date fair value per share was $8.32 and $3.73 for the years ended December 31, 2021 and 2020, respectively. The following weighted average assumptions underlying the calculation of grant date fair value are as follows: 2021 2020 Volatility 111.90% 110.14% Risk-free interest rate 1.15% 0.54% Weighted-average expected option term (in years) 6.25 6.25 Dividend yield 0% 0% The stock price volatility for the Company’s options was determined using a blend of the Company’s historical volatility since its initial public offering in June 2017 and the historical volatilities for industry peers. The risk-free interest rate was derived from U.S. Treasury rates existing on the date of grant for the applicable expected option term. The expected term represents the period of time that options are expected to be outstanding. Because the Company has only very limited historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. The expected dividend yield assumption is based on the fact that the Company has never paid, nor has any intention to pay, cash dividends. Restricted Stock Awards Restricted stock activity for the years ended December 31, 2021 and 2020 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as January 1, 2020 659 $ 109.91 0.97 Awarded - - Vested (609 ) 102.41 Canceled (20 ) 202.50 Outstanding as December 31, 2020 30 202.50 0.62 Awarded - - Vested (30 ) 202.50 Canceled - Outstanding as of December 31, 2021 - $ - - Restricted Stock Units Restricted stock unit “RSU” activity for the years ended December 31, 2021 and 2020 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as of January 1, 2020 18,395 $ 25.00 1.65 Awarded 294,530 3.70 Vested (31,050 ) 9.65 Canceled (5,307 ) 15.57 Outstanding as of December 31, 2020 276,568 4.22 2.36 Awarded 194,095 13.29 Vested (153,357 ) 5.18 Canceled (22,833 ) 5.10 Outstanding as of December 31, 2021 294,473 $ 9.56 2.27 In 2021 and 2020, the Company granted an aggregate of 79,600 and 160,500 RSU’s to executive officers, respectively, which vest over a period of three years. In 2021 and 2020, the Company granted 11,780 and 45,330 RSU’s to independent members of the board of directors, which vest in four equal quarterly installments. The Company determined the fair value of these grants based on the closing price of the Company’s common stock on the respective grant dates. The compensation expense is being amortized over the respective vesting periods. During the year ended December 31, 2021, the Company’s compensation committee granted certain executives a performance-based stock grant with a target of 52,900 RSU’s, a maximum of 105,800, and a minimum of 0. The number of RSU’s earned is dependent on the total shareholder return of the Company’s common stock compared to a set of peer companies from the grant date through March 9, 2024. Any RSU’s earned will vest in their entirety on June 9, 2024. As these grants are subject to market-based vesting criteria, the Company is recognizing compensation expense for these awards subject to market-based vesting conditions regardless of whether it becomes probable that these conditions will be achieved or not, and compensation expense for share-settled awards is not reversed if vesting does not actually occur. The Company recognizes compensation expense based on the fair value on the date of grant as determined by a Monte Carlo valuation model over the expected vesting period. Awards of RSU’s are frequently 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. These payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. Share-Based Compensation Expense The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and time-based and performance-based restricted stock units to employees and directors, and restricted stock units to employees in the statements of operations as follows: 2021 2020 Cost of goods sold $ 53,130 $ 32,367 Research and development 132,610 81,033 Selling, general and administrative 910,668 500,902 Total $ 1,096,408 $ 614,302 As of December 31, 2021, there was approximately $125,100 of unrecognized compensation cost related to unvested stock options which is expected to be recognized over a weighted-average period of 2.6 years. As of December 31, 2021, there was approximately $1,996,300 of unrecognized compensation cost related to unvested restricted stock unit awards which is expected to be recognized over a weighted-average period of 2.3 years. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants | Note 10 — Warrants On February 12, 2019, the Company issued to the underwriter of its public equity offering a warrant (the “Underwriter Warrant”) to purchase 12,113 shares of common stock. The Underwriter Warrant has an exercise price of $52.50 per share and may be exercised on a cashless basis in certain circumstances as specified in the Underwriter Warrant. The Underwriter Warrant is exercisable six months from the date of issuance and expires on February 12, 2023. The Underwriter Warrant provides for adjustment in the number and price of such Underwriter Warrant (and the shares of common stock underlying such Underwriter Warrant) in the event of a recapitalization, merger or other fundamental transaction. In the event of a fundamental transaction, the warrant may be payable to the holder in cash in certain circumstances. The following table presents the Company’s common stock warrant activity for the years ended December 31, 2021 and 2020: Warrants Weighted Average Exercise Price Outstanding Exercisable Outstanding Exercisable Balance, Jan 1, 2020 181,176 181,176 $ 86.40 $ 86.40 Issued 2,694,823 2,694,823 7.46 7.46 Expired (48,005 ) (48,005 ) 198.98 198.98 Exercised (118,835 ) (118,835 ) 1.36 1.36 Balance, Dec 31, 2020 2,709,159 2,709,159 7.77 7.77 Issued — — — — Expired (273 ) (273 ) 194.10 194.10 Exercised (2,015,243 ) (2,015,243 ) 7.40 7.40 Balance, Dec 31, 2021 693,643 693,643 $ 8.76 $ 8.76 The weighted average remaining contractual life of warrants outstanding and exercisable at December 31, 2021 was 3.0 years. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11 — Related Party Transactions The Company sells its products to an orthotics and prosthetics practice whose ownership includes an individual who was both a shareholder and executive officer of the Company. The executive resigned his position with the Company effective March 31, 2021. As a result, the orthotics and prosthetics practice is no longer a related party effective April 1, 2021. Sales to this related party were sold at standard list prices. During the years ended December 31, 2021 (the portion of the year the party was related to the Company) and 2020 revenue recognized on sales to this orthotics and prosthetics practice amounted to approximately $25,900 and $175,900, respectively. Accounts receivable from the related party were $44,900 The Company also obtains consulting and fabrication services, reported in cost of goods sold, from the same previously related party. Charges for these services amounted to approximately $112,900 and $457,200 during the years ended December 31, 2021 (the portion of the year the party was related to the Company) and 2020, respectively. Included in accounts payable and accrued expenses at December 31, 2020 is approximately $29,600 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 12 — Commitments and Contingencies Litigation 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. Currently, there is no litigation against the Company. Operating Leases On January 1, 2020, the Company adopted Topic 842. There was no impact to retained earnings upon adoption of Topic 842. The Company has a non-cancelable lease agreement for its corporate headquarters in Boston, MA expiring in 2023, and it has a non-cancelable lease agreement for its office space in Fort Worth, TX expiring in 2025 with early termination available at the company’s discretion in 2023. Termination options were not included in the lease term for the Company's existing operating lease. Certain of the 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 consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term. As of December 31, 2021, operating lease assets were approximately $633,000 and operating lease liabilities were approximately $735,000. The maturity of the Company’s operating lease liabilities as of December 31, 2020, are as follows: As of December 31, 2021 2022 454,774 2023 312,014 2024 57,852 2025 59,459 Thereafter — Total future minimum lease payments 884,099 Less imputed interest 149,097 Total operating lease liabilities $ 735,002 Included in the consolidated balance sheet: Current operating lease liabilities $ 333,380 Non-current operating lease liabilities 401,622 Total operating lease liabilities $ 735,002 For the twelve months ended December 31, 2020, the total lease cost is comprised of the following amounts: Years ended December 31, 2021 2020 Operating lease expense 372,114 9,072 Short-term lease expense 29,759 631,433 Total lease expense $ 401,873 $ 640,505 The following summarizes additional information related to operating leases: As of December 31 2021 2020 Weighted-average remaining lease term 2.5 3.1 Weighted-average discount rate 20 % 20 % If the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rate as the discount rate. The Company uses its best judgment when determining the incremental borrowing rate, which is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term to the lease payments in a similar currency. Licensing Agreement During 2006, the Company entered into an exclusive licensing agreement (the “MIT License”) with Massachusetts Institute of Technology (“MIT”)for access to certain patent rights that require the payment of royalties, which vary based on the level of the Company’s net sales and whether the customer is located in the U.S., or in an international location. As part of the agreement, the Company must pay to MIT a nonrefundable annual license maintenance fee which may be credited to any royalty amounts due in that same year. The license agreement can be terminated if certain sales targets are not achieved. The royalty charge for each of the years ended December 31, 2021 and 2020 was $262,200 and $147,500, respectively, and is included as a component of cost of revenue. The future minimum amounts due under this agreement for the next two years are as follows: 2022 25,000 2023 (year patents expire) 25,000 Under the MIT License, the Company has issued 205 shares of Common Stock to MIT. On November 15, 2016, the Company and MIT entered into a waiver agreement with regard to certain revenue and commercialization milestones of the Company required under the License Agreement. Under the waiver agreement, MIT waived the compliance with any and all of such milestone obligations prior to the date of the waiver agreement. For the year ended December 31, 2021 the Company met its minimum sales covenant of $750,000. Warranty Liability The Company accrues an estimate of their exposure to warranty claims based on historical warranty costs incurred and a projection of future warranty costs to be incurred. Most of the Company’s current product sales include a three-year one-year Changes in warranty liability were as follows: 2021 2020 Accrued warranty liability, beginning of year $ 119,713 $ 81,981 Accrual provided for warranties issued during the period 79,142 61,752 Adjustments to prior accruals 26,735 — Actual warranty expenditures (49,309 ) (24,020 ) Accrued warranty liability, end of year $ 176,281 $ 119,713 Credit Risk Financial instruments that potentially expose the Company to a concentration of credit risk consist primarily of cash, cash equivalents and restricted cash and accounts receivable. The Company maintains its cash, cash equivalents and restricted cash, with balances in excess of federally insured limits, with major financial institutions that management believes are financially sound and have minimum credit risk. The Company has not experienced any losses in such accounts and believes credit risks related to its cash, cash equivalents and restricted cash are limited based upon the creditworthiness of the financial institutions holding these funds. Major Customers For the year ended December 31, 2021 and 2020, there were no customers which accounted for more than 10% of revenues. For the year ended December 31, 2021, a U.S. insurance payer represented 30% and another represented 11% of revenues, respectively. For the year ended December 31, 2020 one U.S. insurance payer represented 28% of revenue. For the year ended December 31, 2021 and 2020, one insurer and its affiliates accounted for approximately 43% and 45% of accounts receivable, respectively. For the year ended December 31, 2021 and 2020, approximately 59% and 50% of our revenues were derived from patients with Medicare Advantage insurance plans, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 13 — Income Taxes Income (loss) before provision for incomes taxes was as follows: 2021 2020 United States $ (10,494,693 ) $ (11,552,483 ) Foreign $ 211,292 $ (11,428 ) Loss before income taxes $ (10,283,401 ) $ (11,563,911 ) The income tax provision (benefit) for the years ended December 31, 2021 and 2020 consist of the following: 2021 2020 U.S. federal Current $ — $ — Deferred (2,038,000 ) (2,065,000 ) State and local Current — — Deferred (510,000 ) (515,000 ) Foreign Current 88,928 — Deferred — — (2,459,072 ) (2,580,000 ) Change in valuation allowance 2,548,000 2,580,000 Income tax provision $ 88,928 $ — The income tax provision for the year ended December 31, 2021 differs from the amount computed by applying the statutory federal income tax rate to consolidated loss before provision for income taxes due to the higher foreign tax rate. The reconciliation between the U.S statutory federal income tax rate and the Company’s effective rate for the years ended December 31, 2021 and 2020 is as follows: 2021 2020 U.S. federal statutory rate 21.00 % 21.00 % State income taxes, net of federal benefit 5.21 % 5.57 % State rate change and other 1.36 % (0.48 )% Federal NOLs' to expire unutilized due to 382 limitation — % (0.79 )% Foreign tax rate differential (0.86 )% — % Other permanent items (2.79 )% (2.99 )% Change in valuation allowance (24.78 )% (22.31 )% Effective rate (0.86 )% —% As of December 31, 2021, and 2020, the Company’s deferred tax assets consisted of the effects of temporary differences attributable to the following: 2021 2020 Net operating loss carryover $ 16,067,000 $ 13,761,000 Tax credits 311,000 158,000 Stock-based compensation 27,000 28,000 Other 648,000 558,000 Total deferred tax asset 17,053,000 14,505,000 Less: valuation allowance (17,053,000 ) (14,505,000 ) Deferred tax asset, net of valuation allowance $ — $ — There were no deferred tax liabilities at December 31, 2021 or 2020. As of December 31, 2021 and 2020, the Company had approximately $64,620,000 and $55,798,000 of Federal net operating loss (“NOL”), and $55,976,000 and $48,863,000 of state NOLs, respectively, available to offset future taxable income. The Federal NOLs incurred prior to 2018 of $26,425,000, if not utilized, begins expiring in the year 2028. The Federal NOLs incurred after 2017 of $38,759,000 have an indefinite carryforward period. The state NOLs, if not utilized will expire in 2022 through 2042. Additionally, the Company had U.S. federal and state research and development tax credits, or tax credits, of $236,000 and $74,000, respectively, which begin to expire in the year 2027 and 2023, respectively. We also had a MA Investment Tax Credit of approximately $32,000. NOL carryforwards may face limitations caused by changes in ownership under Section 382 of the Internal Revenue Code. During 2020, the Company experienced an ownership change within the meaning of Section 382 of the Internal Revenue Code of 1986. In 2021, the Company did not perform a section 382 study, which may identify a potential ownership change. The ownership change has and will continue to subject the Company’s pre-ownership change net operating loss carryforwards to an annual limitation, which will significantly restrict its ability to use them to offset taxable income in periods following the ownership change. The annual use limitation equals the aggregate value of the Company’s stock at the time of the ownership change multiplied by a specified tax-exempt interest rate. As a result of these ownership changes, the Company is limited to an approximate $281,000 annual limitation on its ability to utilize pre-change NOLs during the carryforward period and has determined that approximately $437,000 of the Company’s pre-change NOLs will expire unutilized. Accordingly, the deferred tax asset and valuation allowance have been adjusted by approximately $92,000 to reflect the Federal NOL's that will expire unutilized. ASC 740, “Income Taxes” requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. A review of all available positive and negative evidence needs to be considered, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After consideration of all the information available, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of December 31, 2021 and 2020. For the years ended December 31, 2021 and December 31, 2020, the change in valuation allowance was an increase of $2,548,000 and $2,580,000, respectively. Under current federal law, federal and certain state NOL’s incurred in 2018-2020 to be carried back five years or carried forward indefinitely, and to be fully utilized without being subjected to the 80% taxable income limitation. However, NOL’s incurred after December 31, 2020 and NOL’s incurred in 2018-2020 (if they are carried forward to a taxable year beginning after December 31, 2020) will be subjected to the 80% taxable income limitation. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion, or all, of the deferred tax asset will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during periods in which those temporary differences become deductible. The Company does not believe that the CARES Act will have a significant impact on the Company’s financial position or statement of operations. The Company recognizes interest and penalties relating to unrecognized tax benefits on the income tax expense line in the statement of operations. There are no tax penalties and interest on the statement of operations as of December 31, 2021 and 2020. The Company operates in multiple tax jurisdictions and, in the normal course of business, its tax returns are subject to examination by various taxing authorities. Such examinations may result in future assessments by these taxing authorities. The Company is subject to examination by U.S. tax authorities beginning with the year ended December 31, 201 8 . No accrued interest and penalties are included on the related tax liability accrual on the balance sheet. There are no accrued interest and penalties at December 31, 2021 and December 31, 2020. The Company believes there are no uncertain tax positions that could have a material impact on its financial condition, results or operations or cash flows. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14 — Subsequent Events The Company evaluated subsequent events through the issuance date of the financial statements and determined that there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Consolidation | Basis of Consolidation The 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 Loss | Comprehensive 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. There were no reclassifications out of accumulated other comprehensive loss in the years ended December 31, 2021 and 2020. |
Use of 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. The Company’s estimates include the allowance for doubtful accounts, deferred tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for slow-moving inventory. |
Cash and Cash Equivalents | Cash and Cash Equivalents 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 December 31, 2021 and 2020. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts The Company reports accounts receivable at invoiced amounts less an allowance for doubtful accounts. The Company evaluates its accounts receivable on a continuous basis, and if necessary, establishes an allowance for |
Inventories | Inventories Inventories are recorded at the lower of average cost or net realizable value. Average cost approximates valuation on a first-in, first-out basis. The Company reduces the carrying value of inventory for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technology developments or other economic factors. In addition, the carrying value of consigned inventories is reduced by the value of MyoPro devices that will not be sold based on historical experience. |
Equipment | Equipment Equipment is stated at historical cost, net of accumulated depreciation and is depreciated using the straight-line method over the estimated useful lives of the related assets, generally three years. Leasehold improvements are depreciated using the straight-line method over the shorter of the lease term or the estimated useful life. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life, are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Demonstration units are sometimes provided by the Company’s to its indirect sales channel for marketing and patient evaluation purposes. These units are manufactured by the Company and are expensed in the statements of operations to selling, general, and administrative expense. During the years ended December 31, 2021 and 2020, the Company charged to operations approximately $22,200 and $61,700, respectively, for these units. Demonstrations units provided to its own sales force are capitalized as equipment on the Company’s balance sheet. Test units are provided to research and development staff to use in their development process and to end users who are given free units to act as testers so that research and development staff can evaluate and understand their use by patients. A primary objective of these units is to determine when and under what conditions they fail, at which time they are analyzed for cause of failure and then scrapped. These units are expensed in the statements of operations as part of research and development expense. During the year ended December 31, 2021 and 2020 the Company charged to operations approximately $17,400 and $15,400, respectively, of these units. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, including equipment when there are indications that the assets might be impaired. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated undiscounted cash flows, the Company records an impairment charge for the difference. Based on its assessments, the Company did not record any impairment charges for the years ended December 31, 2021 and 2020. |
Leases | Leases The Company accounts for leases under Accounting Standards Topic 842 (“ASC 842”). The Company assesses whether a contract is or contains a lease at inception of the contract and recognizes right-of-use assets and corresponding lease liabilities at the lease commencement date, except for short-term leases, which are under one year, and leases of low value. For these leases, the Company recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease. |
Revenue Recognition | Revenue Recognition The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all 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: 1) Identification of the contract, or contracts, with a customer, 2) Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract 3) Determination of the transaction price, including the constraint on variable consideration 4) Allocation of the transaction price to the performance obligations in the contract 5) Recognition of revenue when, or as, performance obligations are satisfied Revenue is recognized when control of these services is transferred to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. 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 U.S. and internationally, the Veterans Administration (“VA”), and distributors in Europe and Australia. 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. (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 expect to receive in exchange for the device. During the fourth quarter of 2020, the Company made such a determination for certain insurers. These insurers represented approximately 39% and 40% of direct billing channel revenue in 2021 and 2020, respectively. 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 on an ongoing basis. During the year ended December 31, 2021 and 2020, the Company recognized revenue of approximately $2,050,345 and $490,800, respectively, from O&P providers or third-party payers for which costs related to the completion of the Company’s performance obligations were recorded in a prior period. For revenues derived from O&P providers, the VA, and distributors, 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, which 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. In certain cases, the Company ships its products to O&P providers pending reimbursement from non-government, third party payers. As a result of this arrangement, elements of the revenue recognition criteria have not been met upon shipment. In this instance, the Company recognizes revenue when payment has been received, as then all of the revenue recognition criteria has been met. 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. 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 approximately $1,500 and $4,000 of deferred revenue as of December 31, 2021 and 2020, respectively. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: 2021 2020 Clinical/medical providers $ 3,186,248 $ 2,255,263 Direct-to-patient 10,670,126 5,328,108 Total revenue from contracts with customers $ 13,856,374 $ 7,583,371 Geographic Data The Company generated 89% of its revenue from the United States, 10% from Germany, and 1% from other international locations for the year ended December 31, 2021. The Company generated 92% of its revenue from the United States and 8% from international locations for the year ended December 31, 2020. 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, such as when the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from certain third party payers, which triggers revenue recognition. For the years ended December 31, 2021 and December 31, 2020, the Company recorded cost of goods sold of approximately $21,400 and $216,100, respectively without corresponding revenue. The cost of clinical services by O&P providers for which they are paid a fee in conjunction with devices being sold directly to patients and billing their insurance companies directly 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, with the remaining costs associated with the patient being expensed to cost of revenue. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs paid by customers are netted against the related shipping costs we incur. The net cost is recorded in cost of revenues. Historically, such costs have not been material. |
Income Taxes | Income Taxes The Company accounts for income taxes under Accounting Standards Codification ASC 740 Income Taxes (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the financial statement in the period in which the law is enacted. ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Tax benefits claimed or expected to be claimed on a tax return are recorded in the Company’s financial statements. A tax benefit from an uncertain tax position is only recognized if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution. The Company files income tax returns in federal and state jurisdictions and is no longer subject to examinations by tax authorities for years prior to 2018. Currently, there are no income tax audits in process. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock awards to employees by measuring the cost of services received in exchange for the award of equity instruments 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. |
Foreign Currency Transaction | Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Net foreign currency gains and losses during the year ended December 31, 2021 were immaterial and included in accumulated other comprehensive loss in the consolidated balance sheets. Transaction foreign exchange gains and losses are included in net loss. Foreign exchange translation gains and losses from the functional currency of Myomo Europe GmbH, which is the euro, to USD are captured in other comprehensive loss. The balance sheet is translated using the spot date on the day of reporting and the income statement is translated monthly using the average rate for the month. |
Net Loss per Share | Net Loss per Share Basic 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 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 years ended December 31, 2021 and 2020, respectively, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potentially common shares issuable at December 31, 2020 and 2019 consist of: 2021 2020 Options 31,725 24,088 Warrants 693,643 2,709,159 Restricted stock units 292,473 276,568 Restricted stock — 30 Total 1,017,841 3,009,845 |
Advertising | Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $3,587,300 and $841,300 in 2021 and 2020, respectively. |
Research and Development Costs | Research and Development Costs The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and benefits, facility and overhead costs, and outsourced research activities. |
Recent Accounting Standards | Recent Accounting Standards In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU 2019-12 “Income Taxes (Topic 740) -- Simplifying the Accounting for Income Taxes. This ASU modifies certain provisions of ASC 740 to simplify the accounting for income taxes. The amendments in ASU 2019-12 are effective for public business entities for fiscal years beginning after December 15, 2020, including interim periods therein. The Company adopted ASU 2019-12 in the first quarter of 2021. The guidance did not have a material impact on our consolidated financial statements. In May 2021, the FASB issued ASU 2021-04 Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early application is permitted, including in an interim period as of the beginning of the fiscal year that includes that interim period. The Company adopted the provisions of ASU 2021-04 in the fourth quarter of 2021. The implementation resulted in a deemed dividend of approximately $640,000 on the discounting of certain warrants. |
Subsequent Events | Subsequent Events The Company evaluates whether there have been subsequent events through the date the financial statements were issued and determines whether subsequent events exist that would require recognition in the financial statements or disclosure in the notes of the financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Revenue by Major Source | The following table presents revenue by major source: 2021 2020 Clinical/medical providers $ 3,186,248 $ 2,255,263 Direct-to-patient 10,670,126 5,328,108 Total revenue from contracts with customers $ 13,856,374 $ 7,583,371 |
Summary of Potentially Common Shares Issuable | Potentially common shares issuable at December 31, 2020 and 2019 consist of: 2021 2020 Options 31,725 24,088 Warrants 693,643 2,709,159 Restricted stock units 292,473 276,568 Restricted stock — 30 Total 1,017,841 3,009,845 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following at December 31: 2021 2020 Finished goods $ 176,082 $ 40,682 Work in Process 23,161 18,000 Rental units 62,531 62,531 Parts and subassemblies 584,996 603,443 846,770 724,656 Less: Reserve for rental units (38,462 ) (17,542 ) Inventories, net $ 808,308 $ 707,114 |
Equipment, net (Tables)
Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Equipment | Equipment consists of the following at December 31: 2021 2020 Computer equipment $ 180,979 $ 119,780 Sales demonstration units 186,951 187,179 R&D tools and molds 52,644 52,644 Leasehold improvements 246,268 4,900 Furniture and fixtures 40,341 17,965 707,183 382,468 Less: accumulated depreciation (431,894 ) (287,445 ) Equipment, net $ 275,289 $ 95,023 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Cash Equivalents and Derivative Liabilities Measured at Fair Value on Recurring Basis | Cash equivalents, which are measured at fair value, were as follows At December 31, 2021: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2021 Total Cash equivalents $ 14,803,456 — — $ 14,803,456 Cash equivalents, which are measured at fair value, were as follows at December 31, 2020: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) December 31, 2020 Total Cash equivalents $ 11,718,319 — — $ 11,718,319 |
Accounts Payable and other Ac_2
Accounts Payable and other Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables And Accruals [Abstract] | |
Summary of Accounts Payable and Other Accrued Expenses | Accounts Payable and Other Accrued Expenses consists of the following at December 31: 2021 2020 Trade payables $ 723,352 $ 180,499 Accrued compensation and benefits 2,188,869 1,843,402 Accrued professional services 108,417 92,399 Deferred payroll taxes under CARES Act 113,423 118,060 Warranty reserve 176,281 119,713 Customer Deposits 192,501 300 Other 446,941 494,531 $ 3,949,784 $ 2,848,904 |
Stock Award Plans and Stock-B_2
Stock Award Plans and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | Stock option activity under the Stock Option Plans during the years ended December 31, 2021 and 2020 is as follows: Shares Weighted Average Exercise Price Weighted Average Remaining Life (years) Intrinsic Value Balance at January 1, 2020 21,805 $ 63.0000 7.83 $ 17,581 Granted 5,000 4.4700 Adjustment due to reverse stock split 28 63.0000 Forfeited or cancelled (123 ) 0.0500 Expired (2,201 ) 58.6600 Exercised (421 ) 80.5500 Balance at December 31, 2020 24,088 51.2900 7.51 $ 23,194 Granted 9,250 17.0700 Forfeited or cancelled (1,174 ) 50.9600 Expired - - Exercised (439 ) 0.0500 Balance at December 31, 2021 31,725 $ 40.5800 Options exercisable at December 31, 2020 14,998 $ 68.0300 6.58 $ 11,894 Options exercisable at December 31, 2021 17,390 $ 63.2600 5.97 $ 12,392 |
Schedule of Grant Date Fair Value | The following weighted average assumptions underlying the calculation of grant date fair value are as follows: 2021 2020 Volatility 111.90% 110.14% Risk-free interest rate 1.15% 0.54% Weighted-average expected option term (in years) 6.25 6.25 Dividend yield 0% 0% |
Summary of Restricted Stock Activity | Restricted stock activity for the years ended December 31, 2021 and 2020 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as January 1, 2020 659 $ 109.91 0.97 Awarded - - Vested (609 ) 102.41 Canceled (20 ) 202.50 Outstanding as December 31, 2020 30 202.50 0.62 Awarded - - Vested (30 ) 202.50 Canceled - Outstanding as of December 31, 2021 - $ - - |
Summary of Restricted Stock Unit Activity | Restricted stock unit “RSU” activity for the years ended December 31, 2021 and 2020 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as of January 1, 2020 18,395 $ 25.00 1.65 Awarded 294,530 3.70 Vested (31,050 ) 9.65 Canceled (5,307 ) 15.57 Outstanding as of December 31, 2020 276,568 4.22 2.36 Awarded 194,095 13.29 Vested (153,357 ) 5.18 Canceled (22,833 ) 5.10 Outstanding as of December 31, 2021 294,473 $ 9.56 2.27 |
Schedule of Stock-based Compensation Expense | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and time-based and performance-based restricted stock units to employees and directors, and restricted stock units to employees in the statements of operations as follows: 2021 2020 Cost of goods sold $ 53,130 $ 32,367 Research and development 132,610 81,033 Selling, general and administrative 910,668 500,902 Total $ 1,096,408 $ 614,302 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Summary of Common Stock Warrants Activity | The following table presents the Company’s common stock warrant activity for the years ended December 31, 2021 and 2020: Warrants Weighted Average Exercise Price Outstanding Exercisable Outstanding Exercisable Balance, Jan 1, 2020 181,176 181,176 $ 86.40 $ 86.40 Issued 2,694,823 2,694,823 7.46 7.46 Expired (48,005 ) (48,005 ) 198.98 198.98 Exercised (118,835 ) (118,835 ) 1.36 1.36 Balance, Dec 31, 2020 2,709,159 2,709,159 7.77 7.77 Issued — — — — Expired (273 ) (273 ) 194.10 194.10 Exercised (2,015,243 ) (2,015,243 ) 7.40 7.40 Balance, Dec 31, 2021 693,643 693,643 $ 8.76 $ 8.76 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Maturity of Operating Lease Liabilities | The maturity of the Company’s operating lease liabilities as of December 31, 2020, are as follows: As of December 31, 2021 2022 454,774 2023 312,014 2024 57,852 2025 59,459 Thereafter — Total future minimum lease payments 884,099 Less imputed interest 149,097 Total operating lease liabilities $ 735,002 Included in the consolidated balance sheet: Current operating lease liabilities $ 333,380 Non-current operating lease liabilities 401,622 Total operating lease liabilities $ 735,002 |
Summary of Operating Lease Cost | For the twelve months ended December 31, 2020, the total lease cost is comprised of the following amounts: Years ended December 31, 2021 2020 Operating lease expense 372,114 9,072 Short-term lease expense 29,759 631,433 Total lease expense $ 401,873 $ 640,505 |
Summary of Additional Information Related to Operating Leases | The following summarizes additional information related to operating leases: As of December 31 2021 2020 Weighted-average remaining lease term 2.5 3.1 Weighted-average discount rate 20 % 20 % |
Future Minimum Amounts Due under Agreement | The future minimum amounts due under this agreement for the next two years are as follows: 2022 25,000 2023 (year patents expire) 25,000 |
Summary of Changes in Warranty Liability | Changes in warranty liability were as follows: 2021 2020 Accrued warranty liability, beginning of year $ 119,713 $ 81,981 Accrual provided for warranties issued during the period 79,142 61,752 Adjustments to prior accruals 26,735 — Actual warranty expenditures (49,309 ) (24,020 ) Accrued warranty liability, end of year $ 176,281 $ 119,713 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (Loss) Before Provision for Incomes Taxes | Income (loss) before provision for incomes taxes was as follows: 2021 2020 United States $ (10,494,693 ) $ (11,552,483 ) Foreign $ 211,292 $ (11,428 ) Loss before income taxes $ (10,283,401 ) $ (11,563,911 ) |
Summary of Tax Provision (Benefit) | The income tax provision (benefit) for the years ended December 31, 2021 and 2020 consist of the following: 2021 2020 U.S. federal Current $ — $ — Deferred (2,038,000 ) (2,065,000 ) State and local Current — — Deferred (510,000 ) (515,000 ) Foreign Current 88,928 — Deferred — — (2,459,072 ) (2,580,000 ) Change in valuation allowance 2,548,000 2,580,000 Income tax provision $ 88,928 $ — |
Summary of Reconciliation between U.S. Statutory Federal Income Tax Rate and Effective Rate | The reconciliation between the U.S statutory federal income tax rate and the Company’s effective rate for the years ended December 31, 2021 and 2020 is as follows: 2021 2020 U.S. federal statutory rate 21.00 % 21.00 % State income taxes, net of federal benefit 5.21 % 5.57 % State rate change and other 1.36 % (0.48 )% Federal NOLs' to expire unutilized due to 382 limitation — % (0.79 )% Foreign tax rate differential (0.86 )% — % Other permanent items (2.79 )% (2.99 )% Change in valuation allowance (24.78 )% (22.31 )% Effective rate (0.86 )% —% |
Summary of Deferred Tax Assets | As of December 31, 2021, and 2020, the Company’s deferred tax assets consisted of the effects of temporary differences attributable to the following: 2021 2020 Net operating loss carryover $ 16,067,000 $ 13,761,000 Tax credits 311,000 158,000 Stock-based compensation 27,000 28,000 Other 648,000 558,000 Total deferred tax asset 17,053,000 14,505,000 Less: valuation allowance (17,053,000 ) (14,505,000 ) Deferred tax asset, net of valuation allowance $ — $ — |
Description of Business - Addit
Description of Business - Additional Information (Detail) | Oct. 31, 2021USD ($)$ / shares | Jun. 25, 2021USD ($) | May 14, 2021USD ($) | Jul. 02, 2018 | Jun. 30, 2021USD ($) | Feb. 29, 2020USD ($)shares$ / shares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares |
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Authorized issue of shares | shares | 75,000,000 | |||||||
Common stock, shares authorized | shares | 65,000,000 | 65,000,000 | ||||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares authorized | shares | 10,000,000 | 10,000,000 | ||||||
Preferred stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Proceeds from FPO, net of offering costs | $ | $ 1,100,000 | |||||||
Net loss | $ | 10,372,329 | $ 11,563,911 | ||||||
Accumulated deficit | $ | 78,062,222 | 67,689,893 | ||||||
Cash used in operating activities | $ | 9,547,695 | $ 9,032,896 | ||||||
Remaining availability under offerings | $ | $ 13,700,000 | |||||||
Exercise price of warrants | $ / shares | $ 5 | |||||||
Proceeds from exercise of warrants | $ | $ 4,800,000 | |||||||
Maximum [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Aggregate public offering price | $ | $ 100,000,000 | |||||||
Common Stock [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Stock issued during period | shares | 1,660,000 | |||||||
FPO [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Warrants to purchase common stock | shares | 1,660,000 | |||||||
Proceeds from FPO, net of offering costs | $ | $ 13,500,000 | |||||||
FPO [Member] | Common Stock [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Stock issued during period | shares | 1,660,000 | |||||||
FPO [Member] | Common Stock and Investor Warrants [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Sale of common stock price per share | $ / shares | $ 7 | |||||||
Number of shares entitled to warrant holder | shares | 1 | |||||||
FPO [Member] | Pre-funded Warrants [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Warrants to purchase common stock | shares | 483,000 | |||||||
FPO [Member] | Investor Warrants [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Warrants to purchase common stock | shares | 483,000 | |||||||
FPO [Member] | Pre Funded and Investor Warrants [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Common stock warrants, sale price per share | $ / shares | $ 6.999 | |||||||
Number of shares entitled to warrant holder | shares | 1 | |||||||
ATM Facility [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Stock issued during period | shares | 107,500 | 1,181,096 | ||||||
Proceeds from FPO, net of offering costs | $ | $ 1,252,700 | $ 5,049,600 | ||||||
Number of shares offer and sell | $ | $ 15,000,000 | |||||||
Percentage of gross proceeds from sales of common stock | 0.030 | |||||||
ATM Facility [Member] | Maximum [Member] | ||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | ||||||||
Number of shares offer and sell | $ | $ 15,000,000 | |||||||
Percentage of gross proceeds from sales of common stock | 0.030 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Reclassifications out of accumulated other comprehensive loss | $ 0 | $ 0 | |
Equipment estimated useful lives | 3 years | ||
Impairment charges | $ 0 | $ 0 | |
Percentage of direct billing channel revenue insures represent | 39.00% | 40.00% | |
Deferred revenue | $ 1,500 | $ 1,500 | $ 4,000 |
Cost of goods sold | $ 112,900 | 457,200 | |
Measurement of tax benefit, minimum likelihood of the largest amount being realized upon ultimate resolution | 50.00% | ||
Advertising expense | $ 3,587,300 | 841,300 | |
Deemed dividend on discounting of warrants | $ 640,000 | 639,953 | 670,632 |
Adoption of ASC 606 [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cost of goods sold | $ 21,400 | $ 216,100 | |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | United States [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Percentage of revenue | 89.00% | 92.00% | |
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | Germany [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Percentage of revenue | 10.00% | ||
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | Other International Locations [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Percentage of revenue | 1.00% | ||
Sales Revenue, Net [Member] | Geographic Concentration Risk [Member] | International Locations [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Percentage of revenue | 8.00% | ||
O&P Providers or Third Party Payors [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Revenue recognized | $ 2,050,345 | $ 490,800 | |
Selling, General and Administrative [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Demonstration units, expenses | 22,200 | 61,700 | |
Research and Development [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Test units, expenses | $ 17,400 | $ 15,400 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Revenue by Major Source (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue from contracts with customers | $ 13,856,374 | $ 7,583,371 |
Clinical/Medical Providers [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue from contracts with customers | 3,186,248 | 2,255,263 |
Direct to Patient [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue from contracts with customers | $ 10,670,126 | $ 5,328,108 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Potentially Common Shares Issuable (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,017,841 | 3,009,845 |
Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 31,725 | 24,088 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 693,643 | 2,709,159 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 292,473 | 276,568 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 30 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 176,082 | $ 40,682 |
Work in Process | 23,161 | 18,000 |
Rental units | 62,531 | 62,531 |
Parts and subassemblies | 584,996 | 603,443 |
Total cost | 846,770 | 724,656 |
Less: Reserve for rental units | (38,462) | (17,542) |
Inventories, net | $ 808,308 | $ 707,114 |
Equipment, net - Schedule of Eq
Equipment, net - Schedule of Equipment (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | $ 707,183 | $ 382,468 |
Less: accumulated depreciation | (431,894) | (287,445) |
Equipment, net | 275,289 | 95,023 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 180,979 | 119,780 |
Sales Demonstration Units [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 186,951 | 187,179 |
R&D Tools and Molds [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 52,644 | 52,644 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 246,268 | 4,900 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | $ 40,341 | $ 17,965 |
Equipment, net - Additional Inf
Equipment, net - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expenses | $ 146,000 | $ 105,400 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Cash Equivalents and Derivative Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash equivalents | $ 14,803,456 | $ 11,718,319 |
In Active Markets for Identical Assets or Liabilities (Level 1) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash equivalents | $ 14,803,456 | $ 11,718,319 |
Accounts Payable and other Ac_3
Accounts Payable and other Accrued Expenses - Summary of Accounts Payable and Other Accrued Expenses (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Trade payables | $ 723,352 | $ 180,499 |
Accrued compensation and benefits | 2,188,869 | 1,843,402 |
Accrued professional services | 108,417 | 92,399 |
Deferred payroll taxes under CARES Act | 113,423 | 118,060 |
Warranty reserve | 176,281 | 119,713 |
Customer Deposits | 192,501 | 300 |
Other | 446,941 | 494,531 |
Total | $ 3,949,784 | $ 2,848,904 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | May 12, 2020 | Oct. 22, 2019 | Dec. 31, 2020 | Feb. 29, 2020 |
Debt Instrument [Line Items] | ||||
Amortization of Debt Issuance Costs and Discounts | $ 161,869 | |||
Loss on extinguishment of loan | $ 709,222 | |||
Chicago Venture Partners [Member] | ||||
Debt Instrument [Line Items] | ||||
Redemption amount divided by the product. percentage | 91.00% | |||
Number of preceding trading days with lowest daily volume weighted average price | 10 days | |||
Aggregate shares of common stock issued percentage | 19.99% | |||
Percentage of restriction on owning common stock | 9.99% | |||
Restructuring fee | $ 105,000 | |||
Proceeds from public offering, net of offering costs, shares | 544,526 | |||
Chicago Venture Partners [Member] | Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Proceeds from term loan | $ 3,000,000 | |||
Proposed repayment of term loan including original issue discount | $ 3,300,000 | |||
Term loan, interest rate | 10.00% | |||
Percentage of outstanding balance of term loan on proceeds from sale of common stock or other equity | 50.00% | |||
Debt instrument outstanding amount | $ 1,703,600 | |||
Debt discount | $ 492,600 | |||
Amortization of Debt Issuance Costs and Discounts | 218,800 | |||
Loss on extinguishment of loan | $ 709,000 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) | Jun. 25, 2021USD ($) | Jul. 02, 2018 | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares |
Class of Stock [Line Items] | |||||
Proceeds from sale of common stock | $ | $ 1,100,000 | ||||
Common stock issued for the exercise of common stock options, Shares | 439 | 421 | |||
Net withheld for employee taxes | 489 | ||||
Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Stock issued during period | 1,660,000 | ||||
Common stock issued for the exercise of common stock options, Shares | 439 | 123 | |||
Common stock issued upon vesting of restricted stock units, Shares | 153,357 | 30,561 | |||
Net withheld for employee taxes | 30 | 588 | |||
Restricted Stock Units [Member] | Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Common stock issued upon vesting of restricted stock units, Shares | 153,357 | 30,561 | |||
Net withheld for employee taxes | 489 | ||||
Restricted Stock [Member] | Common Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Common stock issued upon vesting of restricted stock units, Shares | 30 | 588 | |||
ATM Facility [Member] | |||||
Class of Stock [Line Items] | |||||
Offering, issuance and sale | $ | $ 5,200,000 | ||||
Number of shares offer and sell | $ | $ 15,000,000 | ||||
Percentage of gross proceeds from sales of common stock | 0.030 | ||||
Stock issued during period | 107,500 | 1,181,096 | |||
Average selling price | $ / shares | $ 12.02 | $ 4.41 | |||
Proceeds from sale of common stock | $ | $ 1,252,700 | $ 5,049,600 | |||
Maximum [Member] | ATM Facility [Member] | |||||
Class of Stock [Line Items] | |||||
At-the-market offering price | $ | $ 15,000,000 | ||||
Number of shares offer and sell | $ | $ 15,000,000 | ||||
Percentage of gross proceeds from sales of common stock | 0.030 |
Stock Award Plans and Stock-B_3
Stock Award Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jun. 19, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 01, 2021 | Jan. 01, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Income tax benefit recognized | $ 0 | $ 0 | |||
weighted-average grant date fair value per share | $ 8.32 | $ 3.73 | |||
Number of shares, granted | 2,694,823 | ||||
Restricted Stock Units [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 194,095 | 294,530 | |||
Unrecognized compensation cost | $ 1,996,300 | ||||
Weighted-average remaining contractual term | 2 years 3 months 18 days | ||||
Restricted Stock Units [Member] | Executive Officer [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 79,600 | 160,500 | |||
Restricted Stock Units [Member] | Board of Directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 11,780 | 45,330 | |||
Restricted Stock Units [Member] | Certain Executives [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 52,900 | ||||
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost | $ 125,100 | ||||
Weighted-average remaining contractual term | 2 years 7 months 6 days | ||||
Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Minimum [Member] | Restricted Stock Units [Member] | Certain Executives [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 0 | ||||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 10 years | ||||
Maximum [Member] | Restricted Stock Units [Member] | Executive Officer [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | 3 years | |||
Maximum [Member] | Restricted Stock Units [Member] | Certain Executives [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares, granted | 105,800 | ||||
2018 Stock Options and Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage increase in number of shares of common stock reserved and available for issuance | 4.00% | ||||
Number of shares available for future grant | 96,868 | ||||
Number of common shares reserved for issuance | 183,726 | 22,980 |
Stock Award Plans and Stock-B_4
Stock Award Plans and Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Shares, Beginning balance | 24,088 | 21,805 | |
Shares, Granted | 9,250 | 5,000 | |
Shares, Adjustment due to reverse stock split | 28 | ||
Shares, Forfeited or cancelled | (1,174) | (123) | |
Shares, Expired | (2,201) | ||
Shares, Exercised | (439) | (421) | |
Shares, Ending balance | 31,725 | 24,088 | 21,805 |
Shares, Options exercisable | 17,390 | 14,998 | |
Weighted average exercise price, Beginning balance | $ 51.2900 | $ 63 | |
Weighted average exercise price, Granted | 4.4700 | ||
Weighted average exercise price, Adjustment due to reverse stock split | 17.0700 | 63 | |
Weighted average exercise price, Forfeited or cancelled | 50.9600 | 0.0500 | |
Weighted average exercise price, Expired | 58.6600 | ||
Weighted average exercise price, Exercised | 0.0500 | 80.5500 | |
Weighted average exercise price, Ending balance | 40.5800 | 51.2900 | $ 63 |
Weighted average exercise price, Options exercisable | $ 63.2600 | $ 68.0300 | |
Weighted average remaining life | 7 years 6 months 3 days | 7 years 9 months 29 days | |
Weighted average remaining life, Options exercisable | 5 years 11 months 19 days | 6 years 6 months 29 days | |
Intrinsic value, Beginning balance | $ 23,194 | $ 17,581 | |
Intrinsic value, Ending balance | 23,194 | $ 17,581 | |
Intrinsic value, Options exercisable | $ 12,392 | $ 11,894 |
Stock Award Plans and Stock-B_5
Stock Award Plans and Stock-Based Compensation - Schedule of Grant Date Fair Value (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Volatility | 111.90% | 110.14% |
Risk-free interest rate | 1.15% | 0.54% |
Weighted-average expected option term (in years) | 6 years 3 months | 6 years 3 months |
Dividend yield | 0.00% | 0.00% |
Stock Award Plans and Stock-B_6
Stock Award Plans and Stock-Based Compensation - Summary of Restricted Stock Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, Awarded | 2,694,823 | ||
Number of shares, Canceled | (273) | (48,005) | |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares outstanding, beginning balance | 30 | 659 | |
Number of shares, Vested | (30) | (609) | |
Number of shares, Canceled | (20) | ||
Number of shares outstanding, ending balance | 30 | 659 | |
Weighted average grant date fair value outstanding, beginning balance | $ 202.50 | $ 109.91 | |
Weighted average grant date fair value, Vested | $ 202.50 | 102.41 | |
Weighted average grant date fair value, Canceled | 202.50 | ||
Weighted average grant date fair value outstanding, ending balance | $ 202.50 | $ 109.91 | |
Weighted average remaining contractual life | 7 months 13 days | 11 months 19 days |
Stock Award Plans and Stock-B_7
Stock Award Plans and Stock-Based Compensation - Summary of Restricted Stock Unit Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, Awarded | 2,694,823 | ||
Number of shares, Canceled | (273) | (48,005) | |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares outstanding, beginning balance | 276,568 | 18,395 | |
Number of shares, Awarded | 194,095 | 294,530 | |
Number of shares, Vested | (153,357) | (31,050) | |
Number of shares, Canceled | (22,833) | (5,307) | |
Number of shares outstanding, ending balance | 294,473 | 276,568 | 18,395 |
Weighted average grant date fair value outstanding, beginning balance | $ 4.22 | $ 25 | |
Weighted average grant date fair value, Awarded | 13.29 | 3.70 | |
Weighted average grant date fair value, Vested | 5.18 | 9.65 | |
Weighted average grant date fair value, Canceled | 5.10 | 15.57 | |
Weighted average grant date fair value outstanding, ending balance | $ 9.56 | $ 4.22 | $ 25 |
Weighted average remaining contractual life | 2 years 3 months 7 days | 2 years 4 months 9 days | 1 year 7 months 24 days |
Stock Award Plans and Stock-B_8
Stock Award Plans and Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share based compensation expense | $ 1,096,408 | $ 614,302 |
Cost of Goods Sold [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share based compensation expense | 53,130 | 32,367 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share based compensation expense | 132,610 | 81,033 |
Selling, General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share based compensation expense | $ 910,668 | $ 500,902 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - USD ($) | Feb. 12, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 31, 2021 |
Class Of Warrant Or Right [Line Items] | ||||
Exercise price of warrants | $ 5 | |||
Weighted average remaining contractual life of warrants outstanding and exercisable | 5 years 11 months 19 days | 6 years 6 months 29 days | ||
Underwriter Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Change in fair value of derivative liabilities | $ 122,700 | |||
Warrants to purchase common stock | 12,113 | |||
Exercise price of warrants | $ 52.50 | |||
Warrant exercisable period | 6 months | |||
Warrant expiration date | Feb. 12, 2023 | |||
Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Weighted average remaining contractual life of warrants outstanding and exercisable | 3 years |
Warrants - Summary of Common St
Warrants - Summary of Common Stock Warrants Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Warrants outstanding, beginning balance | 2,709,159 | 181,176 |
Warrants outstanding, issued | 2,694,823 | |
Warrants outstanding, expired | (273) | (48,005) |
Warrants outstanding, exercised | (2,015,243) | (118,835) |
Warrants outstanding, ending balance | 693,643 | 2,709,159 |
Warrants exercisable, beginning balance | 2,709,159 | 181,176 |
Warrants exercisable, issued | 2,694,823 | |
Warrants exercisable, expired | (273) | (48,005) |
Warrants exercisable, exercised | (2,015,243) | (118,835) |
Warrants exercisable, ending balance | 693,643 | 2,709,159 |
Weighted average exercise price outstanding, beginning balance | $ 7.77 | $ 86.40 |
Weighted average exercise price outstanding, issued | 7.46 | |
Weighted average exercise price outstanding, expired | 194.10 | 198.98 |
Weighted average exercise price outstanding, exercised | 7.40 | 1.36 |
Weighted average exercise price outstanding, ending balance | 8.76 | 7.77 |
Weighted average exercise price exercisable, beginning balance | 7.77 | 86.40 |
Weighted average exercise price exercisable, issued | 7.46 | |
Weighted average exercise price exercisable, expired | 194.10 | 198.98 |
Weighted average exercise price exercisable, exercised | 7.40 | 1.36 |
Weighted average exercise price exercisable, ending balance | $ 8.76 | $ 7.77 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transactions [Abstract] | ||
Revenue recognized from related party | $ 25,900 | $ 175,900 |
Accounts receivable | 44,900 | |
Charges for services | $ 112,900 | 457,200 |
Accounts payable and accrued expenses | $ 29,600 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2021USD ($)CustomerInsurancepayerInsurershares | Dec. 31, 2020USD ($)CustomerInsurancepayerInsurer | Dec. 31, 2016 | |
Commitments And Contingencies [Line Items] | |||
Description of operating lease agreement for office space | The Company has a non-cancelable lease agreement for its corporate headquarters in Boston, MA expiring in 2023, and it has a non-cancelable lease agreement for its office space in Fort Worth, TX expiring in 2025 with early termination available at the company’s discretion in 2023. Termination options were not included in the lease term for the Company's existing operating lease. Certain of the 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 consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term. | ||
Operating lease assets with right-of-use | $ 632,906 | $ 168,784 | |
Operating lease liabilities | $ 735,002 | ||
Product warranty period | 3 years | 1 year | |
Number of customers | Insurancepayer | 1 | ||
One U.S. Insurance Payer [Member] | |||
Commitments And Contingencies [Line Items] | |||
Number of customers | Insurancepayer | 1 | ||
Other US Insurance Payer [Member] | |||
Commitments And Contingencies [Line Items] | |||
Number of customers | Insurancepayer | 1 | ||
Sales Revenue, Net [Member] | |||
Commitments And Contingencies [Line Items] | |||
Number of customers | Customer | 0 | 0 | |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | One U.S. Insurance Payer [Member] | |||
Commitments And Contingencies [Line Items] | |||
Concentration risk, percentage | 30.00% | 28.00% | |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Other US Insurance Payer [Member] | |||
Commitments And Contingencies [Line Items] | |||
Concentration risk, percentage | 11.00% | ||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Patients with Medicare Advantage Insurance Plans [Member] | |||
Commitments And Contingencies [Line Items] | |||
Concentration risk, percentage | 59.00% | 50.00% | |
Accounts Receivable [Member] | |||
Commitments And Contingencies [Line Items] | |||
Number of customers | Insurer | 1 | 1 | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | One Insurer [Member] | |||
Commitments And Contingencies [Line Items] | |||
Concentration risk, percentage | 43.00% | 45.00% | |
MIT License [Member] | |||
Commitments And Contingencies [Line Items] | |||
Minimum sales covenant | $ 750,000 | ||
MIT License [Member] | MIT [Member] | |||
Commitments And Contingencies [Line Items] | |||
Stock issued during period | shares | 205 | ||
Minimum percentage of outstanding common stock to be maintained | 1.00% | ||
MIT License [Member] | Cost of Goods Sold [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalty charge | $ 262,200 | $ 147,500 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Maturity of Operating Lease Liabilities (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Lease Liabilities Payments Due [Abstract] | ||
2022 | $ 454,774 | |
2023 | 312,014 | |
2024 | 57,852 | |
2025 | 59,459 | |
Total future minimum lease payments | 884,099 | |
Less imputed interest | 149,097 | |
Operating lease liabilities | 735,002 | |
Included in the consolidated balance sheet: | ||
Current operating lease liability | 333,380 | $ 18,289 |
Non-current operating lease liability | 401,622 | $ 155,148 |
Total operating lease liabilities | $ 735,002 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Operating Lease Cost (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lease Cost [Abstract] | ||
Operating lease expense | $ 372,114 | $ 9,072 |
Short-term lease expense | 29,759 | 631,433 |
Total lease expense | $ 401,873 | $ 640,505 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Additional Information Related to Operating Leases (Detail) | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Weighted-average remaining lease term | 2 years 6 months | 3 years 1 month 6 days |
Weighted-average discount rate | 20.00% | 20.00% |
Commitments and Contingencies_5
Commitments and Contingencies - Future Minimum Amounts Due under Agreement (Detail) - MIT License [Member] | Dec. 31, 2021USD ($) |
Finite Lived Intangible Assets [Line Items] | |
2022 | $ 25,000 |
2023 (year patents expire) | $ 25,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Summary of Changes in Warranty Liability (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Product Warranties Disclosures [Abstract] | ||
Accrual provided for warranties issued during the period Accrued warranty liability, beginning of year | $ 119,713 | $ 81,981 |
Accrual provided for warranties issued during the period | 79,142 | 61,752 |
Adjustments to prior accruals | 26,735 | |
Actual warranty expenditures | (49,309) | (24,020) |
Accrued warranty liability, end of year | $ 176,281 | $ 119,713 |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income (Loss) Before Provision for Incomes Taxes (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (10,494,693) | $ (11,552,483) |
Foreign | 211,292 | (11,428) |
Loss before income taxes | $ (10,283,401) | $ (11,563,911) |
Income Taxes - Summary of Tax P
Income Taxes - Summary of Tax Provision (Benefit) (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
U.S. federal | ||
Deferred | $ (2,038,000) | $ (2,065,000) |
State and local | ||
Deferred | (510,000) | (515,000) |
Foreign | ||
Current | 88,928 | |
Total | (2,459,072) | (2,580,000) |
Change in valuation allowance | 2,548,000 | $ 2,580,000 |
Income tax provision | $ 88,928 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation between U.S. Statutory Federal Income Tax Rate and Effective Rate (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | ||
U.S. federal statutory rate | 21.00% | 21.00% |
State income taxes, net of federal benefit | 5.21% | 5.57% |
State rate change and other | 1.36% | (0.48%) |
Federal NOLs' to expire unutilized due to 382 limitation | (0.79%) | |
Foreign tax rate differential | (0.86%) | |
Other permanent items | (2.79%) | (2.99%) |
Change in valuation allowance | (24.78%) | (22.31%) |
Effective rate | (0.86%) |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Components Of Deferred Tax Assets [Abstract] | ||
Net operating loss carryover | $ 16,067,000 | $ 13,761,000 |
Tax credits | 311,000 | 158,000 |
Stock-based compensation | 27,000 | 28,000 |
Other | 648,000 | 558,000 |
Total deferred tax asset | 17,053,000 | 14,505,000 |
Less: valuation allowance | $ (17,053,000) | $ (14,505,000) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 13, 2017 | |
Income Tax [Line Items] | ||||
Deferred tax liabilities | $ 0 | $ 0 | ||
Net operating loss carryforwards annual limitations | 281,000 | |||
Net operating loss carryforward unutilized | 437,000 | |||
Deferred tax asset and valuation allowance adjusted to reflect federal NOL unutilized | 92,000 | |||
Change in valuation allowance | 2,548,000 | 2,580,000 | ||
Tax penalties and interest | 0 | 0 | ||
Accrued interest and penalties | 0 | 0 | ||
Tax Liability | ||||
Income Tax [Line Items] | ||||
Accrued interest and penalties | $ 0 | |||
Current Federal Law [Member] | ||||
Income Tax [Line Items] | ||||
Net operating loss carryforwards, limitations on use | Under current federal law, federal and certain state NOL’s incurred in 2018-2020 to be carried back five years or carried forward indefinitely, and to be fully utilized without being subjected to the 80% taxable income limitation. However, NOL’s incurred after December 31, 2020 and NOL’s incurred in 2018-2020 (if they are carried forward to a taxable year beginning after December 31, 2020) will be subjected to the 80% taxable income limitation | |||
Net operating loss, adjustment description | NOL’s incurred in 2018-2020 to be carried back five years or carried forward indefinitely | |||
Operating loss carryforwards, subject to taxable income limitation, percentage | 80.00% | |||
MA Investment Tax Credit [Member] | ||||
Income Tax [Line Items] | ||||
Tax credits | $ 32,000 | |||
Federal [Member] | ||||
Income Tax [Line Items] | ||||
Net operating loss | $ 64,620,000 | 55,798,000 | $ 26,425,000 | |
Net operating loss beginning year | begins expiring in the year 2028 | |||
Federal [Member] | Research and Development Tax Credits [Member] | ||||
Income Tax [Line Items] | ||||
Tax credits | $ 236,000 | |||
Tax credit carryforward, beginning of expiration year | 2027 | |||
Federal [Member] | Tax Year 2018 [Member] | ||||
Income Tax [Line Items] | ||||
Net operating loss | $ 38,759,000 | |||
State [Member] | ||||
Income Tax [Line Items] | ||||
Net operating loss | $ 55,976,000 | $ 48,863,000 | ||
Net operating loss beginning year | will expire in 2022 through 2042 | |||
State [Member] | Research and Development Tax Credits [Member] | ||||
Income Tax [Line Items] | ||||
Tax credits | $ 74,000 | |||
Tax credit carryforward, beginning of expiration year | 2023 |