Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 03, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | MYO | |
Entity Registrant Name | MYOMO, INC. | |
Entity Central Index Key | 0001369290 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 4,581,788 | |
Entity File Number | 001-38109 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Tax Identification Number | 47-0944526 | |
Entity Address, Address Line One | One Broadway | |
Entity Address, Address Line Two | 14th Floor | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 996-9058 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NYSEAMER | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 13,317,581 | $ 4,465,455 |
Accounts receivable, net | 308,523 | 424,287 |
Inventories, net | 759,803 | 439,533 |
Prepaid expenses and other | 790,290 | 820,206 |
Total Current Assets | 15,176,197 | 6,149,481 |
Restricted cash | 75,000 | 75,000 |
Deferred offering costs | 219,240 | |
Equipment, net | 105,589 | 154,972 |
Total Assets | 15,356,786 | 6,598,693 |
Current Liabilities: | ||
Convertible note payable, net of discount of $553 and $676,703 at September 30, 2020 and December 31, 2019, respectively | 78,045 | 1,763,887 |
Accounts payable and accrued expenses | 2,122,140 | 1,738,490 |
Derivative liabilities | 378,239 | |
Deferred revenue | 6,684 | 2,913 |
Total Current Liabilities | 2,206,869 | 3,883,529 |
Long-term debt, net of discount of $36,169 at December 31, 2019 | 888,961 | |
Other long-term liabilities | 165,889 | |
Deferred revenue | 1,495 | 1,495 |
Total Liabilities | 2,374,253 | 4,773,985 |
Commitments and Contingencies | ||
Stockholders’ Equity: | ||
Common stock par value $0.0001 per share, 100,000,000 shares authorized; 4,561,469 and 574,524 shares issued as of September 30, 2020 and December 31, 2019, respectively; and 4,561,442 and 574,497 shares outstanding at September 30, 2020 and December 31, 2019, respectively | 456 | 57 |
Additional paid-in capital | 78,980,021 | 57,957,097 |
Accumulated deficit | (65,991,480) | (56,125,982) |
Treasury stock, 27 shares at cost | (6,464) | (6,464) |
Total Stockholders’ Equity | 12,982,533 | 1,824,708 |
Total Liabilities and Stockholders’ Equity | $ 15,356,786 | $ 6,598,693 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Convertible note payable, discount | $ 553 | $ 676,703 |
Long-term debt, discount | $ 36,169 | |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 4,561,469 | 574,524 |
Common stock, shares outstanding | 4,561,442 | 574,497 |
Treasury shares at cost | 27 | 27 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenue | $ 1,926,660 | $ 606,619 | $ 3,793,395 | $ 2,317,034 |
Cost of revenue | 855,338 | 329,227 | 1,592,851 | 996,121 |
Gross margin | 1,071,322 | 277,392 | 2,200,544 | 1,320,913 |
Operating expenses: | ||||
Research and development | 345,666 | 433,065 | 1,250,430 | 1,306,986 |
Selling, general and administrative | 3,270,757 | 2,669,375 | 9,766,189 | 8,228,114 |
Total operating expenses | 3,616,423 | 3,102,440 | 11,016,619 | 9,535,100 |
Loss from operations | (2,545,101) | (2,825,048) | (8,816,075) | (8,214,187) |
Other expense (income) | ||||
Change in fair value of derivative liabilities | (888) | (14,536) | (122,706) | (155,955) |
Interest income and other expense, net | 29,915 | (22,394) | 254,039 | (106,727) |
Non-cash interest expense, debt discount | 12,135 | 218,803 | ||
Loss on extinguishment of debt | 189,155 | 696,436 | ||
Total other expense (income) | 230,317 | (36,930) | 1,046,572 | (262,682) |
Loss before income taxes | (2,775,418) | (2,788,118) | (9,862,647) | (7,951,505) |
Income tax expense | 1,153 | 2,851 | ||
Net loss | (2,776,571) | (2,788,118) | (9,865,498) | (7,951,505) |
Deemed dividend on repricing of warrants | (670,632) | (797,637) | ||
Net loss attributable to common stockholders | $ (2,776,571) | $ (2,788,118) | $ (10,536,130) | $ (8,749,142) |
Weighted average number of common shares outstanding: | ||||
Basic and diluted | 3,940,113 | 571,957 | 2,901,398 | 547,091 |
Net loss per share attributable to common stockholders | ||||
Basic and diluted | $ (0.70) | $ (4.87) | $ (3.63) | $ (15.99) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Total | Cumulative Effect Period of Adoption Adjustment [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Cumulative Effect Period of Adoption Adjustment [Member] | Treasury Stock [Member] |
Beginning balance at Dec. 31, 2018 | $ 6,425,885 | $ (123,447) | $ 41 | $ 51,721,834 | $ (45,289,526) | $ (123,447) | $ (6,464) |
Beginning balance, shares at Dec. 31, 2018 | 415,006 | 27 | |||||
Accounting Standards Update [Extensible List] | us-gaap:AccountingStandardsUpdate201409Member | us-gaap:AccountingStandardsUpdate201409Member | |||||
Proceeds of public offering, net offering costs | 5,603,829 | $ 15 | 5,603,814 | ||||
Proceeds of public offering, net offering costs, shares | 151,417 | ||||||
Common stock issued upon vesting of restricted stock units | (72,115) | (72,115) | |||||
Common stock issued upon vesting of restricted stock units, Shares | 3,166 | ||||||
Restricted stock vested | $ 1 | 1 | |||||
Restricted stock vested, shares | 1,515 | 347 | |||||
Warrants issued as offering costs and recorded as a derivative liability | $ (196,236) | (196,236) | |||||
Stock-based compensation | 396,325 | 396,325 | |||||
Net loss | (2,598,060) | (2,598,060) | |||||
Ending balance at Mar. 31, 2019 | 9,436,182 | $ 56 | 57,453,623 | (48,011,033) | $ (6,464) | ||
Ending balance, shares at Mar. 31, 2019 | 569,936 | 27 | |||||
Beginning balance at Dec. 31, 2018 | 6,425,885 | $ (123,447) | $ 41 | 51,721,834 | (45,289,526) | $ (123,447) | $ (6,464) |
Beginning balance, shares at Dec. 31, 2018 | 415,006 | 27 | |||||
Net loss | (7,951,505) | ||||||
Ending balance at Sep. 30, 2019 | 4,418,525 | $ 57 | 57,789,410 | (53,364,478) | $ (6,464) | ||
Ending balance, shares at Sep. 30, 2019 | 572,989 | 27 | |||||
Beginning balance at Mar. 31, 2019 | 9,436,182 | $ 56 | 57,453,623 | (48,011,033) | $ (6,464) | ||
Beginning balance, shares at Mar. 31, 2019 | 569,936 | 27 | |||||
Exercise of stock options | 15 | 15 | |||||
Exercise of common stock options, shares | 295 | ||||||
Common stock issued upon vesting of restricted stock units | (6,356) | $ 1 | (6,357) | ||||
Common stock issued upon vesting of restricted stock units, Shares | 744 | ||||||
Restricted stock vested | $ (72) | (72) | |||||
Restricted stock vested, shares | 234 | 345 | |||||
Stock-based compensation | $ 197,028 | 197,028 | |||||
Net loss | (2,565,327) | (2,565,327) | |||||
Ending balance at Jun. 30, 2019 | 7,061,470 | $ 57 | 57,644,237 | (50,576,360) | $ (6,464) | ||
Ending balance, shares at Jun. 30, 2019 | 571,320 | 27 | |||||
Exercise of stock options | 1 | 1 | |||||
Exercise of common stock options, shares | 36 | ||||||
Common stock issued upon vesting of restricted stock units | $ (1,779) | (1,779) | |||||
Common stock issued upon vesting of restricted stock units, Shares | 1,395 | ||||||
Restricted stock vested, shares | 100 | 238 | |||||
Stock-based compensation | $ 146,951 | 146,951 | |||||
Net loss | (2,788,118) | (2,788,118) | |||||
Ending balance at Sep. 30, 2019 | 4,418,525 | $ 57 | 57,789,410 | (53,364,478) | $ (6,464) | ||
Ending balance, shares at Sep. 30, 2019 | 572,989 | 27 | |||||
Beginning balance at Dec. 31, 2019 | 1,824,708 | $ 57 | 57,957,097 | (56,125,982) | $ (6,464) | ||
Beginning balance, shares at Dec. 31, 2019 | 574,524 | 27 | |||||
Proceeds of public offering, net offering costs | 13,475,535 | $ 166 | 13,475,369 | ||||
Proceeds of public offering, net 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 | ||||||
Exercise of warrants | 161,250 | $ 10 | 161,240 | ||||
Exercise of warrants, shares | 96,169 | ||||||
Exercise of common stock options, shares | 61 | ||||||
Common stock issued upon vesting of restricted stock units, Shares | 1,033 | ||||||
Restricted stock vested, shares | 16 | ||||||
Adjustment due to reverse stock split | (69) | ||||||
Stock-based compensation | 123,209 | 123,209 | |||||
Net loss | (3,801,993) | (3,801,993) | |||||
Ending balance at Mar. 31, 2020 | 11,782,757 | $ 281 | 71,716,915 | (59,927,975) | $ (6,464) | ||
Ending balance, shares at Mar. 31, 2020 | 2,814,734 | 27 | |||||
Beginning balance at Dec. 31, 2019 | $ 1,824,708 | $ 57 | 57,957,097 | (56,125,982) | $ (6,464) | ||
Beginning balance, shares at Dec. 31, 2019 | 574,524 | 27 | |||||
Proceeds of public offering, net offering costs, shares | 1,181,096 | ||||||
Net loss | $ (9,865,498) | ||||||
Ending balance at Sep. 30, 2020 | 12,982,533 | $ 456 | 78,980,021 | (65,991,480) | $ (6,464) | ||
Ending balance, shares at Sep. 30, 2020 | 4,561,469 | 27 | |||||
Beginning balance at Mar. 31, 2020 | 11,782,757 | $ 281 | 71,716,915 | (59,927,975) | $ (6,464) | ||
Beginning balance, shares at Mar. 31, 2020 | 2,814,734 | 27 | |||||
Proceeds from issuances under at-market sales facility, net of offering costs | 542,586 | $ 18 | 542,568 | ||||
Proceeds from issuances under at-market sales facility, net of offering costs, shares | 179,828 | ||||||
Issuances of common stock to repay debt | 910,420 | $ 23 | 910,397 | ||||
Issuances of common stock to repay debt, shares | 224,414 | ||||||
Exercise of warrants, shares | 500 | ||||||
Exercise of stock options | 3 | 3 | |||||
Exercise of common stock options, shares | 62 | ||||||
Common stock issued upon vesting of restricted stock units | $ (1,855) | (1,855) | |||||
Common stock issued upon vesting of restricted stock units, Shares | 4,237 | ||||||
Restricted stock vested, shares | 489 | 101 | |||||
Stock-based compensation | $ 106,281 | 106,281 | |||||
Net loss | (3,286,934) | (3,286,934) | |||||
Ending balance at Jun. 30, 2020 | 10,053,258 | $ 322 | 73,274,309 | (63,214,909) | $ (6,464) | ||
Ending balance, shares at Jun. 30, 2020 | 3,223,876 | 27 | |||||
Proceeds from issuances under at-market sales facility, net of offering costs | 4,374,989 | $ 102 | 4,374,887 | ||||
Proceeds from issuances under at-market sales facility, net of offering costs, shares | 1,001,268 | ||||||
Issuances of common stock to repay debt | 1,149,153 | $ 30 | 1,149,123 | ||||
Issuances of common stock to repay debt, shares | 300,105 | ||||||
Exercise of warrants | 1 | $ 1 | |||||
Exercise of warrants, shares | 22,166 | ||||||
Common stock issued upon vesting of restricted stock units | 1 | $ 1 | |||||
Common stock issued upon vesting of restricted stock units, Shares | 13,675 | ||||||
Restricted stock vested, shares | 379 | ||||||
Stock-based compensation | 181,702 | 181,702 | |||||
Net loss | (2,776,571) | (2,776,571) | |||||
Ending balance at Sep. 30, 2020 | $ 12,982,533 | $ 456 | $ 78,980,021 | $ (65,991,480) | $ (6,464) | ||
Ending balance, shares at Sep. 30, 2020 | 4,561,469 | 27 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Offering cost from sale of stock | $ 1,499,370 | $ 710,572 | $ 29,277 | |
Net withheld for employee taxes | 489 | 1,515 | ||
At-market Sales Facility [Member] | ||||
Offering cost from sale of stock | $ 131,976 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (9,865,498) | $ (7,951,505) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Depreciation | 79,729 | 70,678 |
Stock-based compensation | 411,192 | 740,304 |
Bad debt expense | 29,839 | |
Non-cash interest expense, debt discount | 218,803 | |
Amortization of original issue discount | 161,869 | |
Loss on extinguishment of debt | 696,436 | |
Change in fair value of derivative liabilities | (122,706) | (155,955) |
Loss on disposal of asset | 177 | 2,481 |
Other non-cash charges | (2,326) | 14,634 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 85,925 | 248,252 |
Inventories | (324,234) | (302,608) |
Prepaid expenses and other current assets | 30,020 | (130,268) |
Other assets | 57,987 | (2,000) |
Accounts payable and accrued expenses | 494,311 | (191,120) |
Deferred revenue | 3,771 | 2,447 |
Other liabilities | 165,889 | (43,042) |
Net cash used in operating activities | (7,878,816) | (7,697,702) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of equipment | (30,294) | (38,261) |
Net cash used in investing activities | (30,294) | (38,261) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Repayment of debt | (1,703,552) | |
Payment of prepayment penalty on debt | (255,533) | |
Net settlement of vested restricted stock units to fund related employee statutory tax withholding | (1,855) | (80,321) |
Proceeds from exercise of stock options | 3 | 16 |
Proceeds from exercise of warrants | 161,299 | |
Proceeds from issuance under at-market sales facility, net of offering costs | 5,049,551 | |
Proceeds from public offering, net of offering costs | 13,504,812 | 5,603,829 |
Proceeds from payment of grants | 6,928 | |
Net cash provided by financing activities | 16,761,653 | 5,523,524 |
Effect of foreign exchange rate changes on cash | (417) | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 8,852,126 | (2,212,439) |
Cash, cash equivalents and restricted cash, beginning of period | 4,540,455 | 6,615,794 |
Cash, cash equivalents and restricted cash, end of period | 13,392,581 | 4,403,355 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||
Inventory capitalized as sales demo equipment | 2,743 | 17,715 |
Sales demo equipment transferred to rental inventory | 2,514 | |
Issuance of warrants recorded as a derivative liability | $ 196,236 | |
Deferred issuance costs to additional paid-in capital paid in prior period | 161,253 | |
Issuance of common stock for debt | $ 2,059,573 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2020 | |
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 U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to orthotics and prosthetics (O&P) providers, the Veterans Health Administration, rehabilitation hospitals, and through distributors. Amended and Restated Certificate of Incorporation and Reverse Stock Split On January 30, 2020, the Company filed with the State of Delaware an amendment to its Eighth Amended and Restated Certificate of Incorporation for a one-for-thirty reverse stock split of the Company’s common stock. All share and per share information has been restated retroactively, giving effect to the reverse stock split for all periods presented. There was no change to reported net loss in any period presented. Liquidity The Company incurred net losses of approximately $9.9 million and $8.0 million during the nine months ended September 30, 2020 and 2019, respectively, and has an accumulated deficit of approximately $66.0 The outbreak of the novel coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (“COVID-19”), has evolved into a global pandemic. COVID-19 has spread to many regions of the world, including the United States and Europe. In response to the pandemic, the Company has implemented a work from home policy, with many employees continuing their work outside of the Company’s offices. While the Company was able to continue with certain parts of its business, such as lead generation and patient evaluations, public health and societal restrictions in place during the second quarter of 2020 adversely impacted other aspects of the Company’s business. For example, the Company provides a custom-fabricated device to each patient and in-person contact is required as part of the fabrication and delivery process. As a result of COVID-19-related public health restrictions on travel and personal interaction, fabrication and delivery processes were suspended during the majority of the second quarter of 2020. As a result of these restrictions, the Company’s ability to deliver its products to patients and to generate revenues was negatively affected. Similarly, the impairment in the ability for patient consultation and fittings is expected to delay the launch of MyoPal, its new product for pediatric patients, for an extended period of time. While the Company continued in-person interactions with, and deliveries to, patients during the third quarter of 2020, incidences of the virus are increasing in certain parts of the United States and the world. Public health restrictions may be reinstated in these and other areas in the future. While insurance reimbursement practices of government and third-party payers are so far largely unaffected by the pandemic, the Company can provide no assurance that will continue in the future. Similarly, it is unclear to what extent an extended period of significant unemployment will reduce the number of prospective candidates due to loss of health insurance. The Company has sufficient inventory of subassemblies available, and its contract manufacturing partners have either continued to operate or have resumed operations. While the Company has experienced some minor extensions of lead times in its supply chain, the Company believes it has sufficient inventories of all critical components. During the second quarter of 2020, the Company eliminated certain positions, furloughed other employees and reduced certain expenses in response to the adverse impact of the pandemic on its business. Almost all furloughed employees returned to work during the third quarter of 2020. The Company has a growing backlog of patients authorized by insurance companies to receive a MyoPro. In addition, the Company utilized its At-Market Sales Facility (“ATM facility”) during the third quarter to raise additional capital (see Note 6). The remaining capacity under the Company’s shelf registration statement on Form S-3 totals approximately $9.8 million. However, due to the Company’s public float, the amount of securities the Company may sell from time to time under such registration statement is subject to the limitations imposed by General Instruction I.B.6 of Form S-3. The Company’s operating plans are primarily focused on growing the number of MyoPro units provided to patients, increasing the proportion of patients carrying commercial health insurance with payers that have historically reimbursed for the Company’s products, executing on its plans to complete development of its pediatric product when public health conditions allow and continued work with the Centers for Medicare and Medicaid Services, or CMS, and their administrative contractors regarding reimbursement of its products. In addition, the Company believes that it has access to capital resources through possible public or private equity offerings, including usage of its ATM facility, exercises of outstanding warrants, additional debt financings, or other means. Additional debt financing may require the Company to pledge other assets not currently pledged and enter into covenants that could restrict certain business activities or its ability to incur further indebtedness; and may contain other terms that are not favorable to the Company or its stockholders. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 — Summary of Significant Accounting Policies Revised Financial Statements During the preparation of its Quarterly Report on Form 10-Q for the three months ended March 31, 2020, the Company determined that it had omitted to record a deemed dividend on the repricing of warrants it issued in 2017 (the “Roth 2017 Warrants”) as a result of the completion of an underwritten public offering in February 2019 (the February 2019 Offering”), which resulted in an understatement of net loss attributable to common stockholders and loss per share attributable to common stockholders for the three months ended March 31, 2019. The effect of this error also resulted in the net loss attributable to common stockholders and net loss per share attributable to common stockholders to be understated for the six months ended June 30, 2019, the nine months ended September 30, 2019 and the year ended December 31, 2019. The Company assessed the materiality of this misstatement in accordance with Staff Accounting Bulletin No. 108 – “Quantifying Misstatements” and concluded this error was not qualitatively material as there was no impact on net loss, stockholders’ equity, or any other balance sheet item and cash flows, among other considerations. As such, the correction of the error is revised in the March 31, 2019 statement of operations. Disclosure of the revised amounts is being reflected in future filings containing the applicable periods. The effect of this revision on the line items within the statement of operations for the three months ended March 31, 2019, the six months ended June 30, 2019, the nine months ended September 30, 2019 and the year ended December 31, 2019 was as follows: Three Months Ended March 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (2,598,060 ) $ (797,637 ) $ (3,395,697 ) Net loss per share attributable to common stockholders $ (5.22 ) $ (1.60 ) $ (6.82 ) Six Months Ended June 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (5,163,387 ) $ (797,637 ) $ (5,961,024 ) Net loss per share attributable to common stockholders $ (9.66 ) $ (1.49 ) $ (11.15 ) Nine Months Ended September 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (7,951,505 ) $ (797,637 ) $ (8,749,142 ) Net loss per share attributable to common stockholders $ (14.53 ) $ (1.46 ) $ (15.99 ) Year Ended December 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (10,713,009 ) $ (797,637 ) $ (11,510,646 ) Net loss per share attributable to common stockholders $ (19.35 ) $ (1.44 ) $ (20.79 ) The Company determined that this error was a material weakness in internal control over financial reporting. See Part I, Item 4 – “Controls and Procedures” elsewhere in this Quarterly Report on Form 10-Q for further discussion. Interim Financial Statements The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with GAAP for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of September 30, 2020 and for the three and nine months ended September 30, 2020. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2020, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2019 and 2018 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH, which was formed on January 30, 2020. All significant intercompany balances and transactions are eliminated. Reclassifications Certain prior year amounts in research and development and sales and marketing expenses have been reclassified to cost of goods sold to conform with the current year presentation. Certain current liabilities have been reclassified as Accounts payable and accrued expenses to conform with the current year presentation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from these estimates. The Company’s significant estimates include the allowance for doubtful accounts, deferred tax valuation allowances, warranty obligations and derivative liabilities. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at September 30, 2020 and December 31, 2019. Restricted cash consists of cash deposited with a financial institution as collateral for Company employee credit cards. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows. September 30, 2020 December 31, 2019 Cash and cash equivalents $ 13,317,581 $ 4,465,455 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 13,392,581 $ 4,540,455 Accounts Payable and Other Accrued Expenses: September 30, 2020 December 31, 2019 Trade payables $ 331,876 $ 450,101 Accrued compensation and benefits 1,251,351 889,583 Accrued professional services 119,058 142,804 Warranty reserve 154,722 81,981 Other 265,133 174,021 $ 2,122,140 $ 1,738,490 Revenue Recognition Revenues under ASC 606 and related amendments (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. 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 our 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 United States and internationally, the VA and rehabilitation hospitals. Under direct billing, the Company recognizes revenue when all of the following criteria are met: (i) The product has been delivered to the patient, including completion of initial instruction on its use. (ii) Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it notified that insurance intends to pay and a payment amount is provided. (iii) The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended September 30, 2020 and 2019, the Company recognized revenue of approximately $809,700 and $164,300, respectively, and during the nine months ended September 30, 2020 and 2019, the Company recognized revenue of approximately $89,500 and $25,900, 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 rehabilitation hospitals, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable. 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 the amount is estimable and the Company determines it is probable that payment will be received. In many cases, the Company is not able to recognize revenue in these situations until payment is received, as then all of the revenue recognition criteria have been met. The Company receives federally-funded grants that require it to perform research activities as specified in each respective grant. The Company is paid based on the fees stipulated in the respective grants which approximate the projected costs to be incurred by the Company to perform such activities. As a result of the adoption of ASC 606 on January 1, 2019, the Company’s grant proceeds are not deemed to be received from customers as defined under ASC 606 and are now reported as an offset to research and development expenses. Any amounts allowed for recovery of overhead are recorded as other income in the statements of operations. Such proceeds were immaterial to the financial statements during the three and nine months ended September 30, 2020 and 2019, respectively. 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 an immaterial amount of deferred revenue as of September 30, 2020. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2019 2020 2019 Clinical/Medical providers $ 612,207 $ 405,914 $ 1,433,276 $ 1,837,667 Direct to patient 1,314,453 200,705 2,360,119 479,367 Total revenue from contracts with customer $ 1,926,660 $ 606,619 $ 3,793,395 $ 2,317,034 Cost of Revenue In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from third-party payers. Under ASC 340-40-25, this inventory is expensed to cost of revenue as of the date of shipment. Under direct billing, fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25, as a cost of obtaining a contract. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to cast, fit and deliver the device to patients are expensed to cost of revenue upon delivery to the patient. Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the U.S. dollar. Net foreign currency gains and losses during the three and nine months ended September 30, 2020 were immaterial and included in interest (income) expense and other expense, net in the condensed consolidated statements of operations. Net Loss per Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Convertible debt, preferred stock, restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three and nine months ended September 30, 2020 and 2019, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potential common shares issuable consist of the following at: September 30, 2020 2019 Stock options 19,387 22,293 Restricted stock units 271,984 12,844 Restricted stock 122 342 Stock warrants 2,460,069 181,176 Total 2,751,562 216,655 Recent Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, “Leases (Topic 842)”, or ASU 2016-02. ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. As an emerging growth company, the Company adopted ASU 2016-02 on January 1, 2020. The Company’s only leases at that time were facilities leases for terms of less than one year. Consequently, the Company continues to account for these leases as operating leases and record rent expense in the Statements of Operations. The adoption of this standard did not have a material impact on the Company’s financial statements. In April 2019, The FASB issued ASU 2019-04 “ Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments” to clarify and improve guidance within the recently issued standards on credit losses, hedging, and recognition and measurement of financial instruments. Among other updates, this ASU amended provisions of ASU 2016-01, “ Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities” relating to fair value disclosures for held-to-maturity debt securities. The amendments related to ASU 2016-01 are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted in any interim period as long as the entity has adopted all of the amendments in ASU 2016-01. The amendments should be applied on a modified-retrospective basis through a cumulative-effect adjustment to opening retained earnings as of the date an entity adopted ASU 2016-01. The Company adopted ASU 2019-04 on January 1, 2020. The adoption of this standard did not have a material impact on the Company’s financial statements. In December 2019, the 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. Early adoption of the standard is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. In August 2020, the FASB issued ASU No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40).” This ASU simplifies the accounting for convertible debt instruments by removing certain accounting separation models as well as the accounting for debt instruments with embedded conversion features that are not required to be accounted for as derivative instruments. The ASU also updates and improves the consistency of earnings per share calculations for convertible instruments. The amendments in this ASU are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. We are currently assessing the potential impacts this ASU may have on our consolidated financial statements. Subsequent Events The Company evaluated subsequent events through the date the financial statements were issued, and determined that, except as disclosed in Note 11 herein, there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the financial statements. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 3 — Inventories Inventories consist of the following at: September 30, 2020 December 31, 2019 Finished goods $ 88,718 $ 46,854 Work in process 41,000 — Rental units 62,531 23,418 Parts and subassemblies 579,866 372,996 772,115 443,268 Less: reserve for rental units (12,312 ) (3,735 ) Inventories, net $ 759,803 $ 439,533 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Note 4 — 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, restricted cash, 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 and derivative liabilities measured at fair value on a recurring basis at September 30, 2020 were as follows: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Cash equivalents $ 12,818,930 $ — $ — $ 12,818,930 Derivative liabilities $ — $ — $ — $ — The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the three and nine months ended September 30, 2020 and 2019: Warrants Debt Derivative Total Balance – January 1, 2020 $ 7,268 $ 370,971 $ 378,239 Payment against derivative liability — (255,533 ) (255,533 ) Change in fair value of derivative liabilities (6,420 ) (75,681 ) (82,101 ) Balance – March 30, 2020 848 39,757 40,605 Change in fair value of derivative liabilities (848 ) (38,869 ) (39,717 ) Balance – June 30, 2020 — 888 888 Change in fair value of derivative liabilities — (888 ) (888 ) Balance – September 30, 2020 $ - $ - $ - The expected stock price volatility for the Company’s common stock warrant liabilities was determined by a blend of the historical volatilities for industry peers and using an average of those volatilities, combined with the historical volatility of the Company. Risk free interest rates were obtained from U.S. Treasury rates for the applicable periods. The expected term used is the contractual life of the instrument being valued. The expected dividend yield was not considered in the valuation of the common stock liabilities as the Company has never paid, nor has the intention to pay, cash dividends. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Note 5 - Debt On October 22, 2019, the Company entered into a term loan (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 will repay CVP $3.3 million. The Term Loan bears interest at a rate of 10% and matures 18 months from the issuance date. Monthly redemptions of up to $300,000 begin six months from the inception date, with the actual amount to be determined by CVP. CVP has granted the Company an option to defer up to three redemption payments. If the Company elects to defer any payments, it will pay CVP a fee that is the greater of $35,000, or 1%, 1.25% and 1.5% of the outstanding balance for each deferral, respectively, which shall be added to the outstanding balance. The Term Loan is secured by all of the Company’s assets, except for its intellectual property. The Company has agreed to not pledge its intellectual property assets to any other party for so long as the Term Loan is outstanding. Subject to the terms and conditions set forth in the Term Loan, the Company may prepay all or any portion of the outstanding balance of the Term Loan, which includes accrued but unpaid interest, as well as collections and enforcement costs, transfer, stamp, issuance and similar taxes and fees incurred under the Term Loan, at any time subject to a prepayment penalty of 15% of the amount of the outstanding balance to be repaid. For so long as the Term Loan remains outstanding, the Company has agreed to prepay CVP 50% of the outstanding balance of the Term Loan from the net proceeds it receives from the sale of its common stock or other equity (excluding sales of common stock under the at market sales agreement, dated as of July 2, 2018 with B. Riley FBR Inc.), which payments will be applied towards and reduce the outstanding balance of the Term Loan. The Term Loan also contains penalty provisions in an event of default. Events of default are categorized between minor events and major events, with penalties of 5% and 15% of the outstanding balance, respectively for each occurrence. Penalties can be incurred for up to three separate events of default, but are capped at 25% of the outstanding balance immediately prior to the first occurrence of an event of default. Events of default include (i) the failure to repay the Term Loan at maturity; (ii) the failure to make monthly redemption payments; (iii) the failure to make timely filings to the SEC; (iv) the failure to obtain CVP’s prior consent to enter into a fundamental transaction; and (v) conditions of insolvency, receivership and bankruptcy filings. After the occurrence of an event of default, interest on the Term Loan will accrue at a rate of 18% per annum, or such lesser rate as permitted under applicable law. As described in the Term Loan, upon the occurrence of certain events of default, the outstanding balance will become automatically due and payable, and upon the occurrence of other events of default, CVP may declare the outstanding balance immediately due and payable at such time or at any time thereafter. The Term Loan includes provisions for technical covenants, but no financial covenants, and CVP has the right to consent to any additional debt financing arrangements, including convertible debt financings. On February 14, 2020, the Company paid 50% of the then outstanding balance of the Term Loan from the proceeds from the Company’s underwritten public offering. In addition, the Company paid a prepayment penalty of approximately $256,000. In connection with the partial extinguishment of the debt, the Company recorded a loss on extinguishment of debt of approximately $159,200 during the three months ended March 31, 2020. On May 12, 2020, the Company amended the Term Loan (the “Amendment”) to provide for the conversion of outstanding amounts into shares of common stock in satisfaction of its repayment obligations at the Company’s option (as amended, the convertible instrument is referred to herein as the “Note”). The Company concluded that the Note should be accounted for as a modification as a result of not meeting the criteria in the two-step approach defined in ASC 470-20 and the determination that conversion option is non-substantive, as it is at the Company’s option. Pursuant to the terms of the Note, CVP has the right to redeem up to $400,000 of the Borrowings per calendar month for the first three redemptions after the inception date, and $300,000 per calendar month thereafter by submitting a notice to the Company (a “Redemption Notice”). Upon receipt of a Redemption Notice, the Company may, at its election, either (i) pay the amount set forth in the Redemption Notice in cash within seven trading days of Company’s receipt of such Redemption Notice, or (ii) convert the amount set forth in the Redemption Notice into shares of common stock within three trading days of Company’s receipt of such Redemption Notice. CVP’s per share conversion price is 91% of the lowest daily volume weighted average price per share of the common stock on the NYSE American for the ten trading days immediately preceding such conversion. The Company may not make redemptions in shares of common stock and must satisfy such redemption in cash within three trading days of receipt of the redemption notice if there is an Equity Conditions Failure (as defined in the Amendment). The Company retains the ability to defer up to three redemptions for up to thirty days as discussed above. In addition, the Company may not issue shares of common stock to CVP if such issuance would cause CVP to beneficially own in excess of 9.99% of the Company’s common stock outstanding on the date of such issuance. The Company is also prohibited from issuing shares of common stock to the extent that such issuance would exceed the amounts described in Section 713 of the NYSE American LLC Company Guide that would require stockholder approval of the Company. While the Company is under no obligation to seek such stockholder approval, if the Company does obtain such approval, this limit will be removed. The Company also agreed to pay to CVP a fee of $105,000 in consideration of the CVP’s agreement to make the Note convertible, which fee has been added onto the outstanding balance of the Note. During the three and nine months ended September 30, 2020, there were monthly redemptions which the Company elected to pay through the issuance of 300,105 and 544,519 shares of common stock, which extinguished $1,000,000 and $1,800,000 of the Note, respectively. As of September 30, 2020, the outstanding balance of the Note, including accrued interest, but excluding the unamortized debt discount was approximately $78,600. The entire amount is classified as a current liability as of September 30, 2020. The original issue discount and restructuring fees are amortized into interest expense, with a corresponding increase in the outstanding balance of the Note over its estimated remaining term. In addition, the Company incurred debt issuance costs, including a commission paid to its placement agent, of approximately $212,000. The original issue discount, the restructuring fee and the debt issuance costs have been recorded as a debt discount and are being amortized into interest expense over the estimated remaining term of the Note using the effective interest method. The provision in the Note that the Company must pay CVP 50% of the outstanding balance of the Note plus a 15% prepayment fee from the net proceeds it receives from an equity offering as discussed above, was determined by the Company to not be clearly and closely related to the host instrument. Therefore, the Company bifurcated the embedded component from the Note and accounted for it separately as a derivative liability with an offsetting increase in the debt discount. To determine the fair value of the entire Note, the debt component was separated from the equity payment derivative liability component. The cash flows of both components were then discounted using fair value assumptions. The Company recorded a derivative liability and corresponding debt discount of approximately $372,800 at the inception date of the Note. The Company is amortizing the debt discount associated with the derivative liability using the effective interest method over the estimated remaining term of the Note. In connection with the prepayment to CVP in February 2020 of 50% of the outstanding balance of the Note, half of the unamortized portion of the debt discounts was written off and charged to loss on extinguishment of debt. Redemptions under the Note are being accounted for as partial extinguishments. During the three and nine months ended September 30, 2020, the Company recorded loss on extinguishment of debt of approximately $189,200 and $696,400, respectively. Interest expense under the Note, including amortization of the debt discount was approximately $41,200 and $491,900 for the three and nine months ended September 30,2020, respectively, of which approximately $12,100 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Common Stock | Note 6 — Common Stock On February 13, 2020, the Company completed an underwritten public offering (the “ February 2020 Offering”) in which the Company sold 1,660,000 shares of its common stock at a price of $7.00 per share and 483,000 pre-funded warrants at a price of $6.9999 per share, generating net proceeds (including paid and unpaid offering expenses) of approximately $13,475,500. The pre-funded warrants had a nominal exercise price of $0.0001 per share. Investors also received 2,143,000 warrants (“Investor Warrants”), each entitling the holder to purchase one share of the Company’s common stock at an exercise price of $7.50 per share. The Investor Warrants expire on February 13, 2025. The underwriters in the February 2020 Offering were entitled to an over-allotment option to purchase to up to 321,450 shares of common stock at $6.99 per share, and 321,450 Investor Warrants at a price of $0.01 per share. The underwriters exercised their option to purchase the additional Investor Warrants concurrent with the closing of the transaction. All pre-funded warrants issued in the February 2020 Offering were exercised as of March 31, 2020. On February 13, 2020, the Company issued to the underwriters, warrants (the “Underwriter Warrants”) to purchase 214,300 shares of common stock. The Underwriter Warrants have an exercise price $7.00 per share. The Underwriter Warrants expire on February 13, 2025. The Investor Warrants and Underwriter Warrants are being accounted for as equity. None of the aforementioned warrants were exercised during the three months ended September 30, 2020. During the nine months ended September 30, 2020, 21,500 Investor Warrants were exercised, generating proceeds of approximately $161,200. During the three months ended September 30, 2020, the Company sold 1,001,268 shares to purchasers under its ATM facility at a weighted average sale price of approximately $4.50 per share, generating net proceeds after sales commissions of approximately $4,375,000. During the nine months ended September 30, 2020, the Company sold 1,181,096 shares at a weighted average price of approximately $4.41 per share, generating net proceeds after sales commissions of approximately $5,049,600 During the three and nine months ended September 30, 2020, 379 and 496 shares of restricted stock vested and 13,675 and 19,434 restricted stock units vested. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2020 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants | Note 7 — Warrants On February 8, 2019, the Company issued a warrant for the purchase of 12,113 shares of common stock to its February 2019 Offering selling agent (the “February 2019 Warrants”). The February 2019 Warrants are exercisable at any time after August 8, 2019 by the holder at an exercise price of $52.50 per share and have a life of four years. The warrants include a fundamental transaction clause that include transactions that may not require approval by the Company, such as a hostile tender offer. These transactions could require the Company to settle in cash upon exercise. Upon a fundamental transaction, the warrant holder would receive the equivalent securities or alternate considerations just prior to the triggering event by apportioning the exercise price among the equivalent securities. Assumptions utilized in the valuation of the February 2019 Warrant as of September 30, 2019 were as follows: Risk-free interest rate 1.56% Expected life 3.36 years Expected volatility of underlying stock 64.01% Expected dividend yield — The Company issued 160,041 warrants to purchase shares of its common stock in its December 2017 public offering (the “Roth 2017 Warrants”), of which 118,696 warrants were outstanding immediately prior to the closing of the Company’s 2020 Offering and 21,361 warrants remain outstanding as of September 30, 2020. These common stock warrants that were issued in the Company’s December 2017 public offering had an original exercise price of $88.50 per share with such exercise price adjustable if we effect a stock split or combination or similar transaction, depending on the relative trading prices before and after the transaction. The Roth 2017 Warrants also have anti-dilution protection in the event that the Company issues equity securities in the future below the then-exercise price of such warrants. Though the Roth 2017 Warrants contain a price reset provision in the event of a dilutive issuance of the Company’s securities, because the Roth 2017 Warrants can only be settled in shares of common stock, they were recorded as a component of stockholders’ equity at issuance. The price reset provision required the Company to compute a deemed dividend on the exercise price reduction of the Roth 2017 Warrants as a result of the February 2019 offering and the February 2020 Offering. The Company utilized the black-scholes valuation model to calculate the fair value of the Roth 2017 Warrants upon the pricings of both the February 2019 Offering and the February 2020 Offering at the previous and new exercise prices. The deemed dividends as a result of the February 2020 Offering and the February 2019 Offering are as follows: February 2020 Offering February 2019 Offering (Revised) Fair value per share of warrants at new exercise price $ 7.00 $ 25.19 Fair value per share of warrants at previous exercise price 1.35 18.47 Dividend per share $ 5.65 $ 6.72 Warrants outstanding prior to offering 118,696 118,696 Deemed dividend $ 670,632 $ 797,637 Because the Company has an accumulated deficit, the dividends were recorded as a component of additional paid-in capital and a deduction from net loss to determine net loss attributable to common stockholders in the statements of operations for the nine months ended September 30, 2020 and 2019, respectively. Assumptions utilized in the valuations of the Roth 2017 Warrant upon the pricing of the February 2020 Offering and the February 2019 Offering, were as follows: February 2019 February 2020 Offering Offering (Revised) Risk-free interest rate 1.39% 2.43% Expected life (in years) 2.81 3.82 Expected volatility of underlying stock 91.71% 82.62% Expected dividend yield — — |
Stock Award Plans and Stock-bas
Stock Award Plans and Stock-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Award Plans and Stock-based Compensation | Note 8 — Stock Award Plans and Stock-based Compensation Stock Option Awards 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 three and nine months ended September 30, 2020 and 2019. There were no stock options granted during the three and nine months ended September 30, 2020. The assumptions underlying the calculation of grant date fair value per share for the three and nine months ended September 30, 2019 are as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2019 2019 Number of options granted 150 6,033 Weighted-average expected volatility 63.45 % 62.56 % Weighted-average risk-free interest rate 1.90 % 2.16 % Weighted-average expected option term (in years) 6.25 6.46 Weighted-average dividend yield — % — % Weighted-average fair value per share of grants $ 13.80 $ 19.20 The stock price volatility for the Company’s options was determined using 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. As of September 30, 2020, there were 111,806 Awards of restricted stock units may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. These payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. Share-Based Compensation Expense The Company accounts for stock awards to employees and non-employees based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award. The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period. The Company recognized stock-based compensation expense related to the issuance of stock option awards, restricted stock awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Cost of goods sold $ 10,994 $ 4,449 $ 21,246 $ 13,058 Research and development 26,749 24,651 52,424 81,492 Selling, general and administrative 143,959 117,851 337,522 645,754 Total $ 181,702 $ 146,951 $ 411,192 $ 740,304 As of September 30, 2020, there was approximately $132,200 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 2.12 years. As of September 30, 2020, there was approximately $7,300 of unrecognized compensation cost related to unvested restricted stock awards that is expected to be recognized over a weighted-average period of 0.85 years. As of September 30, 2020, there was approximately $996,900 of unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 2.37 years. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 9 — Related Party Transactions The Company sells its products to an orthotics and prosthetics practice whose ownership includes an individual who is both a shareholder and executive officer of the Company. Sales to this related party are sold at standard list prices. During both the three and nine months ended September 30, 2020, approximately $109,300 and $176,200 of revenues were recognized from this related party, respectively. The Company also obtains consulting and fabrication services, reported in cost of goods sold, from the same related party. Charges for these services amounted to approximately $83,600 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10 — Commitments and Contingencies Litigation In the normal course of business, 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. Leases As of September 30, 2020, we have entered into a lease in Fort Worth, TX. that has not yet commenced with future lease payments of $0.3 million, that are not yet recorded on our Consolidated Balance Sheets. This lease will commence in Q4 2020 with a non-cancelable lease term of approximately five years. Major Customers At September 30, 2020, four customers accounted for approximately 17%, 11% 10% and 10% |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 11 — Subsequent Events On October 1, 2020, CVP issued to the Company a notice to redeem the remaining balance of $78.598 of the Note. The Company elected to pay for this redemption in common stock and issued 20,007 shares of common stock to CVP. The Company evaluated subsequent events through the date the financial statements were issued, and determined that, except as disclosed herein, there have been no other 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) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Revised Financial Statements | Revised Financial Statements During the preparation of its Quarterly Report on Form 10-Q for the three months ended March 31, 2020, the Company determined that it had omitted to record a deemed dividend on the repricing of warrants it issued in 2017 (the “Roth 2017 Warrants”) as a result of the completion of an underwritten public offering in February 2019 (the February 2019 Offering”), which resulted in an understatement of net loss attributable to common stockholders and loss per share attributable to common stockholders for the three months ended March 31, 2019. The effect of this error also resulted in the net loss attributable to common stockholders and net loss per share attributable to common stockholders to be understated for the six months ended June 30, 2019, the nine months ended September 30, 2019 and the year ended December 31, 2019. The Company assessed the materiality of this misstatement in accordance with Staff Accounting Bulletin No. 108 – “Quantifying Misstatements” and concluded this error was not qualitatively material as there was no impact on net loss, stockholders’ equity, or any other balance sheet item and cash flows, among other considerations. As such, the correction of the error is revised in the March 31, 2019 statement of operations. Disclosure of the revised amounts is being reflected in future filings containing the applicable periods. The effect of this revision on the line items within the statement of operations for the three months ended March 31, 2019, the six months ended June 30, 2019, the nine months ended September 30, 2019 and the year ended December 31, 2019 was as follows: Three Months Ended March 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (2,598,060 ) $ (797,637 ) $ (3,395,697 ) Net loss per share attributable to common stockholders $ (5.22 ) $ (1.60 ) $ (6.82 ) Six Months Ended June 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (5,163,387 ) $ (797,637 ) $ (5,961,024 ) Net loss per share attributable to common stockholders $ (9.66 ) $ (1.49 ) $ (11.15 ) Nine Months Ended September 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (7,951,505 ) $ (797,637 ) $ (8,749,142 ) Net loss per share attributable to common stockholders $ (14.53 ) $ (1.46 ) $ (15.99 ) Year Ended December 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (10,713,009 ) $ (797,637 ) $ (11,510,646 ) Net loss per share attributable to common stockholders $ (19.35 ) $ (1.44 ) $ (20.79 ) The Company determined that this error was a material weakness in internal control over financial reporting. See Part I, Item 4 – “Controls and Procedures” elsewhere in this Quarterly Report on Form 10-Q for further discussion. |
Interim Financial Statements | Interim Financial Statements The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with GAAP for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of September 30, 2020 and for the three and nine months ended September 30, 2020. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2020, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2019 and 2018 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. |
Basis of Consolidation | Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH, which was formed on January 30, 2020. All significant intercompany balances and transactions are eliminated. |
Reclassifications | Reclassifications Certain prior year amounts in research and development and sales and marketing expenses have been reclassified to cost of goods sold to conform with the current year presentation. Certain current liabilities have been reclassified as Accounts payable and accrued expenses to conform with the current year presentation. |
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 these estimates. The Company’s significant estimates include the allowance for doubtful accounts, deferred tax valuation allowances, warranty obligations and derivative liabilities. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at September 30, 2020 and December 31, 2019. Restricted cash consists of cash deposited with a financial institution as collateral for Company employee credit cards. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows. September 30, 2020 December 31, 2019 Cash and cash equivalents $ 13,317,581 $ 4,465,455 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 13,392,581 $ 4,540,455 |
Revenue Recognition | Revenue Recognition Revenues under ASC 606 and related amendments (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. 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 our 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 United States and internationally, the VA and rehabilitation hospitals. Under direct billing, the Company recognizes revenue when all of the following criteria are met: (i) The product has been delivered to the patient, including completion of initial instruction on its use. (ii) Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved. As an example, the Company will record revenue if it notified that insurance intends to pay and a payment amount is provided. (iii) The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin. During the three months ended September 30, 2020 and 2019, the Company recognized revenue of approximately $809,700 and $164,300, respectively, and during the nine months ended September 30, 2020 and 2019, the Company recognized revenue of approximately $89,500 and $25,900, 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 rehabilitation hospitals, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services. Revenues may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable. 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 the amount is estimable and the Company determines it is probable that payment will be received. In many cases, the Company is not able to recognize revenue in these situations until payment is received, as then all of the revenue recognition criteria have been met. The Company receives federally-funded grants that require it to perform research activities as specified in each respective grant. The Company is paid based on the fees stipulated in the respective grants which approximate the projected costs to be incurred by the Company to perform such activities. As a result of the adoption of ASC 606 on January 1, 2019, the Company’s grant proceeds are not deemed to be received from customers as defined under ASC 606 and are now reported as an offset to research and development expenses. Any amounts allowed for recovery of overhead are recorded as other income in the statements of operations. Such proceeds were immaterial to the financial statements during the three and nine months ended September 30, 2020 and 2019, respectively. 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 an immaterial amount of deferred revenue as of September 30, 2020. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2019 2020 2019 Clinical/Medical providers $ 612,207 $ 405,914 $ 1,433,276 $ 1,837,667 Direct to patient 1,314,453 200,705 2,360,119 479,367 Total revenue from contracts with customer $ 1,926,660 $ 606,619 $ 3,793,395 $ 2,317,034 Cost of Revenue In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25. In certain cases, the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from third-party payers. Under ASC 340-40-25, this inventory is expensed to cost of revenue as of the date of shipment. Under direct billing, fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25, as a cost of obtaining a contract. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to cast, fit and deliver the device to patients are expensed to cost of revenue upon delivery to the patient. |
Foreign Currency Transactions | Foreign Currency Translation The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the U.S. dollar. Net foreign currency gains and losses during the three and nine months ended September 30, 2020 were immaterial and included in interest (income) expense and other expense, net in the condensed consolidated statements of operations. |
Net Loss per Share | Net Loss per Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Convertible debt, preferred stock, restricted stock, restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the three and nine months ended September 30, 2020 and 2019, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potential common shares issuable consist of the following at: September 30, 2020 2019 Stock options 19,387 22,293 Restricted stock units 271,984 12,844 Restricted stock 122 342 Stock warrants 2,460,069 181,176 Total 2,751,562 216,655 |
Recent Accounting Pronouncements | Recent Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, “Leases (Topic 842)”, or ASU 2016-02. ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. As an emerging growth company, the Company adopted ASU 2016-02 on January 1, 2020. The Company’s only leases at that time were facilities leases for terms of less than one year. Consequently, the Company continues to account for these leases as operating leases and record rent expense in the Statements of Operations. The adoption of this standard did not have a material impact on the Company’s financial statements. In April 2019, The FASB issued ASU 2019-04 “ Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments” to clarify and improve guidance within the recently issued standards on credit losses, hedging, and recognition and measurement of financial instruments. Among other updates, this ASU amended provisions of ASU 2016-01, “ Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities” relating to fair value disclosures for held-to-maturity debt securities. The amendments related to ASU 2016-01 are effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted in any interim period as long as the entity has adopted all of the amendments in ASU 2016-01. The amendments should be applied on a modified-retrospective basis through a cumulative-effect adjustment to opening retained earnings as of the date an entity adopted ASU 2016-01. The Company adopted ASU 2019-04 on January 1, 2020. The adoption of this standard did not have a material impact on the Company’s financial statements. In December 2019, the 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. Early adoption of the standard is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. In August 2020, the FASB issued ASU No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40).” This ASU simplifies the accounting for convertible debt instruments by removing certain accounting separation models as well as the accounting for debt instruments with embedded conversion features that are not required to be accounted for as derivative instruments. The ASU also updates and improves the consistency of earnings per share calculations for convertible instruments. The amendments in this ASU are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. We are currently assessing the potential impacts this ASU may have on our consolidated financial statements. |
Subsequent Events | Subsequent Events The Company evaluated subsequent events through the date the financial statements were issued, and determined that, except as disclosed in Note 11 herein, 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_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Effect of Revision on Line Items Within Statement of Operations | The effect of this revision on the line items within the statement of operations for the three months ended March 31, 2019, the six months ended June 30, 2019, the nine months ended September 30, 2019 and the year ended December 31, 2019 was as follows: Three Months Ended March 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (2,598,060 ) $ (797,637 ) $ (3,395,697 ) Net loss per share attributable to common stockholders $ (5.22 ) $ (1.60 ) $ (6.82 ) Six Months Ended June 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (5,163,387 ) $ (797,637 ) $ (5,961,024 ) Net loss per share attributable to common stockholders $ (9.66 ) $ (1.49 ) $ (11.15 ) Nine Months Ended September 30, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (7,951,505 ) $ (797,637 ) $ (8,749,142 ) Net loss per share attributable to common stockholders $ (14.53 ) $ (1.46 ) $ (15.99 ) Year Ended December 31, 2019 Previously reported Adjustments As revised Net loss attributable to common stockholders $ (10,713,009 ) $ (797,637 ) $ (11,510,646 ) Net loss per share attributable to common stockholders $ (19.35 ) $ (1.44 ) $ (20.79 ) |
Summary of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows. September 30, 2020 December 31, 2019 Cash and cash equivalents $ 13,317,581 $ 4,465,455 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 13,392,581 $ 4,540,455 |
Summary of Accounts Payable and Other Accrued Expenses | Accounts Payable and Other Accrued Expenses: September 30, 2020 December 31, 2019 Trade payables $ 331,876 $ 450,101 Accrued compensation and benefits 1,251,351 889,583 Accrued professional services 119,058 142,804 Warranty reserve 154,722 81,981 Other 265,133 174,021 $ 2,122,140 $ 1,738,490 |
Summary of Revenue by Major Source | The following table presents revenue by major source: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2020 2019 2020 2019 Clinical/Medical providers $ 612,207 $ 405,914 $ 1,433,276 $ 1,837,667 Direct to patient 1,314,453 200,705 2,360,119 479,367 Total revenue from contracts with customer $ 1,926,660 $ 606,619 $ 3,793,395 $ 2,317,034 |
Summary of Potential Common Shares Issuable | Potential common shares issuable consist of the following at: September 30, 2020 2019 Stock options 19,387 22,293 Restricted stock units 271,984 12,844 Restricted stock 122 342 Stock warrants 2,460,069 181,176 Total 2,751,562 216,655 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following at: September 30, 2020 December 31, 2019 Finished goods $ 88,718 $ 46,854 Work in process 41,000 — Rental units 62,531 23,418 Parts and subassemblies 579,866 372,996 772,115 443,268 Less: reserve for rental units (12,312 ) (3,735 ) Inventories, net $ 759,803 $ 439,533 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Cash Equivalents and Derivative Liabilities Measured at Fair Value on Recurring Basis | Cash equivalents and derivative liabilities measured at fair value on a recurring basis at September 30, 2020 were as follows: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Cash equivalents $ 12,818,930 $ — $ — $ 12,818,930 Derivative liabilities $ — $ — $ — $ — |
Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured | The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the three and nine months ended September 30, 2020 and 2019: Warrants Debt Derivative Total Balance – January 1, 2020 $ 7,268 $ 370,971 $ 378,239 Payment against derivative liability — (255,533 ) (255,533 ) Change in fair value of derivative liabilities (6,420 ) (75,681 ) (82,101 ) Balance – March 30, 2020 848 39,757 40,605 Change in fair value of derivative liabilities (848 ) (38,869 ) (39,717 ) Balance – June 30, 2020 — 888 888 Change in fair value of derivative liabilities — (888 ) (888 ) Balance – September 30, 2020 $ - $ - $ - |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Class Of Warrant Or Right [Line Items] | |
Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured | The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the three and nine months ended September 30, 2020 and 2019: Warrants Debt Derivative Total Balance – January 1, 2020 $ 7,268 $ 370,971 $ 378,239 Payment against derivative liability — (255,533 ) (255,533 ) Change in fair value of derivative liabilities (6,420 ) (75,681 ) (82,101 ) Balance – March 30, 2020 848 39,757 40,605 Change in fair value of derivative liabilities (848 ) (38,869 ) (39,717 ) Balance – June 30, 2020 — 888 888 Change in fair value of derivative liabilities — (888 ) (888 ) Balance – September 30, 2020 $ - $ - $ - |
Roth 2017 Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured | Assumptions utilized in the valuations of the Roth 2017 Warrant upon the pricing of the February 2020 Offering and the February 2019 Offering, were as follows: February 2019 February 2020 Offering Offering (Revised) Risk-free interest rate 1.39% 2.43% Expected life (in years) 2.81 3.82 Expected volatility of underlying stock 91.71% 82.62% Expected dividend yield — — |
Summary of Deemed Dividends | The deemed dividends as a result of the February 2020 Offering and the February 2019 Offering are as follows: February 2020 Offering February 2019 Offering (Revised) Fair value per share of warrants at new exercise price $ 7.00 $ 25.19 Fair value per share of warrants at previous exercise price 1.35 18.47 Dividend per share $ 5.65 $ 6.72 Warrants outstanding prior to offering 118,696 118,696 Deemed dividend $ 670,632 $ 797,637 |
Warrant [Member] | |
Class Of Warrant Or Right [Line Items] | |
Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured | Assumptions utilized in the valuation of the February 2019 Warrant as of September 30, 2019 were as follows: Risk-free interest rate 1.56% Expected life 3.36 years Expected volatility of underlying stock 64.01% Expected dividend yield — |
Stock Award Plans and Stock-b_2
Stock Award Plans and Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Grant Date Fair Value | There were no stock options granted during the three and nine months ended September 30, 2020. The assumptions underlying the calculation of grant date fair value per share for the three and nine months ended September 30, 2019 are as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2019 2019 Number of options granted 150 6,033 Weighted-average expected volatility 63.45 % 62.56 % Weighted-average risk-free interest rate 1.90 % 2.16 % Weighted-average expected option term (in years) 6.25 6.46 Weighted-average dividend yield — % — % Weighted-average fair value per share of grants $ 13.80 $ 19.20 |
Schedule of Stock-based Compensation Expense | The Company recognized stock-based compensation expense related to the issuance of stock option awards, restricted stock awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows: Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Cost of goods sold $ 10,994 $ 4,449 $ 21,246 $ 13,058 Research and development 26,749 24,651 52,424 81,492 Selling, general and administrative 143,959 117,851 337,522 645,754 Total $ 181,702 $ 146,951 $ 411,192 $ 740,304 |
Description of Business - Addit
Description of Business - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||||||||
Net loss | $ 2,776,571 | $ 3,286,934 | $ 3,801,993 | $ 2,788,118 | $ 2,565,327 | $ 2,598,060 | $ 9,865,498 | $ 7,951,505 | |
Accumulated deficit | 65,991,480 | 65,991,480 | $ 56,125,982 | ||||||
Cash used in operating activities | 7,878,816 | $ 7,697,702 | |||||||
Remaining capital amount under shelf registration | $ 9,800,000 | $ 9,800,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Effect of Revision on Line Items Within Statement of Operations (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Summary Of Significant Accounting Policies [Line Items] | |||||||
Net loss attributable to common stockholders | $ (3,395,697) | $ (5,961,024) | $ (8,749,142) | $ (11,510,646) | |||
Basic and diluted | $ (0.70) | $ (4.87) | $ (6.82) | $ (11.15) | $ (3.63) | $ (15.99) | $ (20.79) |
Previously Reported [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Net loss attributable to common stockholders | $ (2,598,060) | $ (5,163,387) | $ (7,951,505) | $ (10,713,009) | |||
Basic and diluted | $ (5.22) | $ (9.66) | $ (14.53) | $ (19.35) | |||
Adjustments [Member] | |||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||
Net loss attributable to common stockholders | $ (797,637) | $ (797,637) | $ (797,637) | $ (797,637) | |||
Basic and diluted | $ (1.60) | $ (1.49) | $ (1.46) | $ (1.44) |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 13,317,581 | $ 4,465,455 | ||
Restricted cash | 75,000 | 75,000 | ||
Total cash, cash equivalents, and restricted cash | $ 13,392,581 | $ 4,540,455 | $ 4,403,355 | $ 6,615,794 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Accounts Payable and Other Accrued Expenses (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Trade payables | $ 331,876 | $ 450,101 |
Accrued compensation and benefits | 1,251,351 | 889,583 |
Accrued professional services | 119,058 | 142,804 |
Warranty reserve | 154,722 | 81,981 |
Other | 265,133 | 174,021 |
Total | $ 2,122,140 | $ 1,738,490 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
O&P Providers or Third Party Payors [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Revenue recognized | $ 809,700 | $ 164,300 | $ 89,500 | $ 25,900 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Revenue by Major Source (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue from contracts with customer | $ 1,926,660 | $ 606,619 | $ 3,793,395 | $ 2,317,034 |
Clinical/Medical Providers [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue from contracts with customer | 612,207 | 405,914 | 1,433,276 | 1,837,667 |
Direct to Patient [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue from contracts with customer | $ 1,314,453 | $ 200,705 | $ 2,360,119 | $ 479,367 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Potential Common Shares Issuable (Detail) - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,751,562 | 216,655 |
Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 19,387 | 22,293 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 271,984 | 12,844 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 122 | 342 |
Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,460,069 | 181,176 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 88,718 | $ 46,854 |
Work in process | 41,000 | |
Rental units | 62,531 | 23,418 |
Parts and subassemblies | 579,866 | 372,996 |
Total cost | 772,115 | 443,268 |
Less: reserve for rental units | (12,312) | (3,735) |
Inventories, net | $ 759,803 | $ 439,533 |
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 ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash equivalents | $ 12,818,930 | |
Derivative liabilities | $ 378,239 | |
In Active Markets for Identical Assets or Liabilities (Level 1) [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash equivalents | $ 12,818,930 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured (Detail) - USD ($) | 3 Months Ended | ||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Beginning balance | $ 888 | $ 40,605 | $ 378,239 |
Payment against derivative liability | (255,533) | ||
Change in fair value of derivative liabilities | (888) | (39,717) | (82,101) |
Ending balance | 888 | 40,605 | |
Warrants [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Beginning balance | 848 | 7,268 | |
Change in fair value of derivative liabilities | (848) | (6,420) | |
Ending balance | 848 | ||
Debt Derivative [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Beginning balance | 888 | 39,757 | 370,971 |
Payment against derivative liability | (255,533) | ||
Change in fair value of derivative liabilities | $ (888) | (38,869) | (75,681) |
Ending balance | $ 888 | $ 39,757 |
Debt - Additional Information (
Debt - Additional Information (Detail) | May 12, 2020USD ($) | Feb. 14, 2020USD ($) | Oct. 22, 2019USD ($)Payment | Sep. 30, 2020USD ($)shares | Mar. 31, 2020USD ($) | Sep. 30, 2020USD ($)shares | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | ||||||||
Prepayment penalty fees | $ 255,533 | |||||||
Loss on extinguishment of debt | $ 189,155 | 696,436 | ||||||
Derivative liability | $ 40,605 | $ 888 | $ 378,239 | |||||
Amortization of Debt Issuance Costs and Discounts | 161,869 | |||||||
Chicago Venture Partners [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of options granted for deferred redemption payments | 7 days | |||||||
Redemption payment in cash term | 3 days | |||||||
Redemption payment in common stock term | 3 days | |||||||
Redemption amount divided by the product. percentage | 91.00% | |||||||
Number of preceding trading days with lowest daily volume weighted average price | 10 days | |||||||
Percentage of restriction on owning common stock | 9.99% | |||||||
Debt instrument maximum defer period of redemption | 30 days | |||||||
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% | |||||||
Term loan, maturity period | 18 months | |||||||
Amount of monthly redemption of term loan | $ 300,000 | |||||||
Debt instrument first defer redemption payment, fee percentage | 1.00% | |||||||
Debt instrument second defer redemption payment, fee percentage | 1.25% | |||||||
Debt instrument third defer redemption payment, fee percentage | 1.50% | |||||||
Rate of penalty prepayment of outstanding balance of term loan | 15.00% | |||||||
Percentage of outstanding balance of term loan on proceeds from sale of common stock or other equity | 50.00% | |||||||
Debt instrument, Minor event of default penalty rate | 5.00% | |||||||
Debt instrument, Major event of default penalty rate | 15.00% | |||||||
Debt instrument, default penalty capped rate | 25.00% | |||||||
Percentage of payment of outstanding term loan from the proceeds of underwritten public offering | 50.00% | |||||||
Prepayment penalty fees | $ 256,000 | |||||||
Loss on extinguishment of debt | $ 159,200 | |||||||
Chicago Venture Partners [Member] | Term Loan [Member] | Maximum [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount of monthly redemption of term loan | 400,000 | $ 300,000 | ||||||
Number of options granted for deferred redemption payments | Payment | 3 | |||||||
Debt instrument, defer redemption payments fee | $ 35,000 | |||||||
Interest on term loan accrued,after default | 18.00% | |||||||
Chicago Venture Partners [Member] | Convertible Note [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Loss on extinguishment of debt | $ 189,200 | $ 696,400 | ||||||
Restructuring fee | $ 105,000 | |||||||
Shares issued for the redemption of Note | shares | 300,105 | 544,519 | ||||||
Extinguishment of debt, amount | $ 1,000,000 | $ 1,800,000 | ||||||
Unamortized debt discount | 78,600 | 78,600 | ||||||
Debt issuance costs, commission paid | $ 212,000 | |||||||
Percentage of provision in term loan | 50.00% | |||||||
Percentage of prepayment fee from equity offering | 15.00% | |||||||
Derivative liability | $ 372,800 | |||||||
Debt discount | $ 372,800 | 41,200 | $ 491,900 | |||||
Prepayment percentage of outstanding balance term loan | 50.00% | |||||||
Amortization of Debt Issuance Costs and Discounts | $ 12,100 | $ 218,800 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | Feb. 13, 2020 | Sep. 30, 2020 | Sep. 30, 2020 |
Class of Stock [Line Items] | |||
Stock issued during period | 1,181,096 | ||
Proceeds from exercise of warrants | $ 161,299 | ||
Weighted average sale price of shares sold | $ 4.41 | $ 4.41 | |
Net proceeds from shares sold | $ 5,049,600 | ||
Restricted Stock [Member] | |||
Class of Stock [Line Items] | |||
Number of shares, Vested | 379 | 496 | |
Restricted Stock Units [Member] | |||
Class of Stock [Line Items] | |||
Number of shares, Vested | 13,675 | 19,434 | |
Investor Warrants [Member] | |||
Class of Stock [Line Items] | |||
Warrants exercised | 0 | 21,500 | |
Proceeds from exercise of warrants | $ 161,200 | ||
Underwriter Warrants [Member] | |||
Class of Stock [Line Items] | |||
Warrants to purchase common stock | 214,300 | ||
Common stock warrants, exercise price per share | $ 7 | ||
Warrants maturity date | Feb. 13, 2025 | ||
ATM Facility [Member] | |||
Class of Stock [Line Items] | |||
Stock issued during period | 1,001,268 | ||
Weighted average sale price of shares sold | $ 4.50 | $ 4.50 | |
Net proceeds from shares sold | $ 4,375,000 | ||
February 2020 Offering [Member] | |||
Class of Stock [Line Items] | |||
Number of shares entitled to warrant holder | 1 | ||
February 2020 Offering [Member] | Pre-funded Warrants [Member] | |||
Class of Stock [Line Items] | |||
Warrants to purchase common stock | 483,000 | ||
Common stock warrants, sale price per share | $ 6.9999 | ||
Net proceeds (including paid and unpaid offering expenses) of warrants | $ 13,475,500 | ||
Common stock warrants, exercise price per share | $ 0.0001 | ||
Warrants exercised date | Mar. 31, 2020 | ||
February 2020 Offering [Member] | Investor Warrants [Member] | |||
Class of Stock [Line Items] | |||
Warrants to purchase common stock | 2,143,000 | ||
Common stock warrants, exercise price per share | $ 7.50 | ||
Warrants maturity date | Feb. 13, 2025 | ||
February 2020 Offering [Member] | Underwritten Public Offering [Member] | |||
Class of Stock [Line Items] | |||
Stock issued during period | 1,660,000 | ||
Sale of common stock price per share | $ 7 | ||
February 2020 Offering [Member] | Underwriters [Member] | |||
Class of Stock [Line Items] | |||
Stock issued during period | 321,450 | ||
Sale of common stock price per share | $ 6.99 | ||
Warrants to purchase common stock | 321,450 | ||
February 2020 Offering [Member] | Underwriters [Member] | Investor Warrants [Member] | |||
Class of Stock [Line Items] | |||
Common stock warrants, exercise price per share | $ 0.01 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - $ / shares | Feb. 08, 2019 | Sep. 30, 2020 | Jan. 31, 2020 | Dec. 31, 2017 |
Roth 2017 Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrants to purchase common stock | 160,041 | |||
Warrants outstanding | 21,361 | 118,696 | ||
Common stock warrants, exercise price per share | $ 88.50 | |||
February 2019 Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrants are fully vested, exercise price | $ 52.50 | |||
February 2019 Warrants [Member] | IPO Selling Agent [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Purchase of warrant issued | 12,113 | |||
February 2019 Warrants [Member] | IPO [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrants years of life | 4 years | |||
February 2019 Offering [Member] | Roth 2017 Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrants outstanding | 118,696 | |||
Exercise price of warrants | $ 42 | |||
February 2020 Offering [Member] | Roth 2017 Warrants [Member] | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrants outstanding | 118,696 | |||
Exercise price of warrants | $ 0.0001 |
Warrants - Schedule of Assumpti
Warrants - Schedule of Assumptions Utilized in the Valuation of Warrant (Detail) | Sep. 30, 2020yr |
Risk-free Interest Rate [Member] | February 2019 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.0156 |
Risk-free Interest Rate [Member] | February 2020 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.0139 |
Risk-free Interest Rate [Member] | February 2019 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.0243 |
Expected Life [Member] | February 2019 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 3.36 |
Expected Life [Member] | February 2020 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 2.81 |
Expected Life [Member] | February 2019 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 3.82 |
Expected Volatility of Underlying Stock [Member] | February 2019 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.6401 |
Expected Volatility of Underlying Stock [Member] | February 2020 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.9171 |
Expected Volatility of Underlying Stock [Member] | February 2019 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0.8262 |
Expected Dividend Yield [Member] | February 2019 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0 |
Expected Dividend Yield [Member] | February 2020 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0 |
Expected Dividend Yield [Member] | February 2019 Offering [Member] | Roth 2017 Warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Fair value assumptions | 0 |
Warrants - Summary of Deemed Di
Warrants - Summary of Deemed Dividends (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Jan. 31, 2020 | |
Class Of Warrant Or Right [Line Items] | |||
Deemed dividend | $ (670,632) | $ (797,637) | |
Roth 2017 Warrants [Member] | |||
Class Of Warrant Or Right [Line Items] | |||
Warrants outstanding | 21,361 | 118,696 | |
Roth 2017 Warrants [Member] | February 2020 Offering [Member] | |||
Class Of Warrant Or Right [Line Items] | |||
Fair value per share of warrants at new exercise price | $ 7 | ||
Fair value per share of warrants at previous exercise price | 1.35 | ||
Dividend per share | $ 5.65 | ||
Warrants outstanding | 118,696 | ||
Deemed dividend | $ 670,632 | ||
Roth 2017 Warrants [Member] | February 2019 Offering (Revised) [Member] | |||
Class Of Warrant Or Right [Line Items] | |||
Fair value per share of warrants at new exercise price | $ 25.19 | ||
Fair value per share of warrants at previous exercise price | 18.47 | ||
Dividend per share | $ 6.72 | ||
Warrants outstanding | 118,696 | ||
Deemed dividend | $ 797,637 |
Stock Award Plans and Stock-b_3
Stock Award Plans and Stock-based Compensation - Additional Information (Detail) - USD ($) | Jan. 01, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Income tax benefit recognized | $ 0 | $ 0 | $ 0 | $ 0 | |
Number of stock options granted | 0 | 150 | 0 | 6,033 | |
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost | $ 132,200 | $ 132,200 | |||
Weighted-average remaining contractual term | 2 years 1 month 13 days | ||||
Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost | 7,300 | $ 7,300 | |||
Weighted-average remaining contractual term | 10 months 6 days | ||||
Restricted Stock Units [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost | $ 996,900 | $ 996,900 | |||
Weighted-average remaining contractual term | 2 years 4 months 13 days | ||||
2018 Stock Option and Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for future grant | 111,806 | 111,806 | |||
Number of common shares reserved for issuance | 22,980 | ||||
Percentage increase in number of shares of common stock reserved and available for issuance | 4.00% |
Stock Award Plans and Stock-b_4
Stock Award Plans and Stock-based Compensation - Schedule of Grant Date Fair Value (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Number of options granted | 0 | 150 | 0 | 6,033 |
Weighted-average expected volatility | 63.45% | 62.56% | ||
Weighted-average risk-free interest rate | 1.90% | 2.16% | ||
Weighted-average expected option term (in years) | 6 years 3 months | 6 years 5 months 15 days | ||
Weighted-average fair value per share of grants | $ 13.80 | $ 19.20 |
Stock Award Plans and Stock-b_5
Stock Award Plans and Stock-based Compensation - Schedule of Stock-based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share based compensation expense | $ 181,702 | $ 146,951 | $ 411,192 | $ 740,304 |
Cost of Goods Sold [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share based compensation expense | 10,994 | 4,449 | 21,246 | 13,058 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share based compensation expense | 26,749 | 24,651 | 52,424 | 81,492 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share based compensation expense | $ 143,959 | $ 117,851 | $ 337,522 | $ 645,754 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |||||
Revenue recognized from related party | $ 109,300 | $ 176,200 | $ 26,000 | ||
Due from related party | 19,000 | 19,000 | $ 25,900 | ||
Charges for services | 83,600 | $ 95,000 | 355,200 | $ 338,200 | |
Accounts payable and accrued expenses | $ 38,400 | $ 38,400 | $ 47,800 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($)Customer | |
Accounts Receivable [Member] | |
Commitments And Contingencies [Line Items] | |
Number of customers | Customer | 4 |
Customer Concentration Risk | Accounts Receivable [Member] | One Customer [Member] | |
Commitments And Contingencies [Line Items] | |
Concentration risk, percentage | 17.00% |
Customer Concentration Risk | Accounts Receivable [Member] | Two Customers [Member] | |
Commitments And Contingencies [Line Items] | |
Concentration risk, percentage | 11.00% |
Customer Concentration Risk | Accounts Receivable [Member] | Three Customer [Member] | |
Commitments And Contingencies [Line Items] | |
Concentration risk, percentage | 10.00% |
Customer Concentration Risk | Accounts Receivable [Member] | Four Customer [Member] | |
Commitments And Contingencies [Line Items] | |
Concentration risk, percentage | 10.00% |
Fort Worth, TX [Member] | |
Commitments And Contingencies [Line Items] | |
Future lease payments not yet commenced | $ | $ 0.3 |
Non-cancelable lease term not yet commenced | 5 years |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - Chicago Venture Partners [Member] | Oct. 01, 2020USD ($)shares |
Subsequent Event [Line Items] | |
Remaining balance of Note to be redeemed | $ | $ 78.598 |
Shares issued for the redemption of Note | shares | 20,007 |