Cover
Cover | 9 Months Ended |
Sep. 30, 2019 | |
Cover page. | |
Document Type | S-1/A |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2019 |
Entity Registrant Name | MYOMO INC |
Entity Central Index Key | 0001369290 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets: | |||
Cash and cash equivalents | $ 4,328,355 | $ 6,540,794 | $ 12,959,373 |
Accounts receivable, net | 134,006 | 382,258 | 297,039 |
Inventories, net | 454,379 | 256,149 | 201,155 |
Prepaid expenses and other current assets | 786,732 | 695,276 | 388,275 |
Total Current Assets | 5,703,472 | 7,874,477 | 13,845,842 |
Restricted cash | 75,000 | 75,000 | 52,000 |
Deferred offering costs | 133,976 | 144,582 | |
Equipment, net | 170,330 | 187,513 | 77,150 |
Total Assets | 6,082,778 | 8,281,572 | 13,974,992 |
Current Liabilities: | |||
Accounts payable and other accrued expenses | 1,552,307 | 1,743,427 | 1,277,236 |
Derivative liabilities | 43,942 | 3,661 | 39,930 |
Deferred revenue | 2,942 | 1,990 | 61,288 |
Customer advance payments | 63,567 | 106,609 | 106,718 |
Total Current Liabilities | 1,662,758 | 1,855,687 | 1,485,172 |
Deferred revenue, net of current portion | 44,042 | ||
Non-Current Liabilities | 1,495 | ||
Total Liabilities | 1,664,253 | 1,855,687 | 1,529,214 |
Commitments and Contingencies | |||
Stockholders' Equity: | |||
Common stock, value | 1,716 | 1,245 | 1,114 |
Undesignated preferred stock par value $0.0001 per share; 25,000,000 authorized at December 31, 2018 and 2017. No shares issued or outstanding | |||
Additional paid-in capital | 57,787,751 | 51,720,630 | 47,423,915 |
Accumulated deficit | (53,364,478) | (45,289,526) | (34,972,787) |
Treasury stock, 808 shares at cost | (6,464) | (6,464) | (6,464) |
Total Stockholders' Equity | 4,418,525 | 6,425,885 | 12,445,778 |
Total Liabilities and Stockholders' Equity | $ 6,082,778 | $ 8,281,572 | $ 13,974,992 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 17,189,737 | 12,450,187 | 11,139,667 |
Common stock, shares outstanding | 17,188,929 | 12,449,379 | 11,138,859 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized | 25,000,000 | 25,000,000 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Treasury shares at cost | 808 | 808 | 808 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||||||
Revenue | $ 606,619 | $ 608,981 | $ 2,317,034 | $ 1,554,529 | $ 2,444,104 | $ 1,558,866 |
Cost of revenue | 194,375 | 193,577 | 621,237 | 502,103 | 728,279 | 505,280 |
Gross margin | 412,244 | 415,404 | 1,695,797 | 1,052,426 | 1,715,825 | 1,053,586 |
Operating expenses: | ||||||
Research and development | 544,679 | 449,673 | 1,615,831 | 1,309,014 | 1,838,633 | 1,751,731 |
Selling, general and administrative | 2,692,613 | 2,674,160 | 8,294,153 | 7,536,802 | 10,405,609 | 5,849,969 |
Total operating expenses | 3,237,292 | 3,123,833 | 9,909,984 | 8,845,816 | 12,244,242 | 7,601,700 |
Loss from operations | (2,825,048) | (2,708,429) | (8,214,187) | (7,793,390) | (10,528,417) | (6,548,114) |
Other expense (income) | ||||||
Loss on early extinguishment of debt | 135,244 | |||||
Change in fair value of derivative liabilities | (14,536) | (13,310) | (155,955) | (31,278) | (36,269) | (116,795) |
Debt discount on convertible notes | 5,172,000 | |||||
Interest (income) and other expense, net | (22,394) | (45,297) | (106,727) | (137,327) | (175,409) | 358,916 |
Total other expense (income) | (36,930) | (58,607) | (262,682) | (168,605) | (211,678) | 5,549,365 |
Net loss | $ (2,788,118) | $ (2,649,822) | $ (7,951,505) | $ (7,624,785) | (10,316,739) | (12,097,479) |
Deemed dividend - accreted preferred stock | (274,011) | |||||
Cumulative dividend to Series B-1 preferred stockholders | (287,779) | |||||
Net loss available to common stockholders | $ (10,316,739) | $ (12,659,269) | ||||
Weighted average number of common shares outstanding: | ||||||
Basic and diluted | 17,158,731 | 12,415,494 | 16,412,754 | 12,244,075 | 12,292,402 | 4,317,864 |
Net loss per share | ||||||
Basic and diluted | $ (0.16) | $ (0.21) | $ (0.48) | $ (0.62) | $ (0.84) | $ (2.93) |
Condensed Statement of Changes
Condensed Statement of Changes in Stockholders' Equity - USD ($) | Total | Series B-1 Convertible Preferred Stock [Member] | Series A-1 Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] | IPO [Member] | IPO [Member]Common Stock [Member] | IPO [Member]Additional Paid-in Capital [Member] | Over-allotment Option [Member] | Over-allotment Option [Member]Common Stock [Member] | Over-allotment Option [Member]Additional Paid-in Capital [Member] |
Beginning balance at Dec. 31, 2016 | $ (17,530,456) | $ 8,174,693 | $ 4,497,548 | $ 112 | $ 5,351,204 | $ (22,875,308) | $ (6,464) | ||||||
Beginning balance, shares at Dec. 31, 2016 | 1,662,104 | 960,083 | 1,124,080 | 808 | |||||||||
Accretion of preferred stock | (274,011) | $ 31,493 | $ 242,518 | (274,011) | |||||||||
Proceeds from offering costs | $ 3,930,078 | $ 67 | $ 3,930,011 | $ 10,407,706 | $ 480 | $ 10,407,226 | |||||||
Proceeds from offering costs, shares | 665,498 | 4,801,250 | |||||||||||
Proceeds from private placement, net of offering costs of $2,500 | 2,922,885 | $ 56 | 2,922,829 | ||||||||||
Proceeds from private placement, net of offering costs of $2,500, shares | 557,216 | ||||||||||||
Conversion of Series A-1 and Series B-1 convertible preferred stock into common stock | 12,946,252 | $ (8,206,186) | $ (4,740,066) | $ 262 | 12,945,990 | ||||||||
Conversion of Series A-1 and Series B-1 convertible preferred stock into common stock, Shares | (1,662,104) | (960,083) | 2,622,187 | ||||||||||
Conversion of convertible promissory notes into common stock | 5,467,389 | $ 106 | 5,467,283 | ||||||||||
Conversion of convertible promissory notes into common stock, shares | 1,055,430 | ||||||||||||
Fair value of warrants issued with convertible promissory notes | 5,172,000 | 5,172,000 | |||||||||||
Warrants issued to IPO selling agent deemed to be derivative liability | (156,725) | (156,725) | |||||||||||
Exercise of stock options | $ 26,954 | $ 8 | 26,946 | ||||||||||
Exercise of stock options, shares | 80,085 | 80,085 | |||||||||||
Common stock issued for the exercise of warrants | $ 102,660 | $ 3 | 102,657 | ||||||||||
Common stock issued for the exercise of warrants, shares | 34,800 | ||||||||||||
Restricted stock vested, shares | 312 | ||||||||||||
Shares of common stock issued for services | 30,000 | 30,000 | |||||||||||
Shares of common stock issued for services, shares | 4,000 | ||||||||||||
Shares of common stock issued for repayment of promissory notes | 1,217,172 | $ 19 | 1,217,153 | ||||||||||
Shares of common stock issued for repayment of promissory notes, shares | 193,509 | ||||||||||||
Additional shares issued pursuant to software license agreement | 1,845 | $ 1 | 1,844 | ||||||||||
Additional shares issued pursuant to software license agreement, shares | 492 | ||||||||||||
Stock-based compensation | 279,508 | 279,508 | |||||||||||
Net loss | (12,097,479) | (12,097,479) | |||||||||||
Ending balance at Dec. 31, 2017 | 12,445,778 | $ 1,114 | 47,423,915 | (34,972,787) | $ (6,464) | ||||||||
Ending balance, shares at Dec. 31, 2017 | 11,138,859 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | (63,149) | $ 3 | (63,152) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 31,152 | ||||||||||||
Common stock issued for the exercise of warrants | $ 3,550,490 | $ 120 | 3,550,370 | ||||||||||
Common stock issued for the exercise of warrants, shares | 1,203,556 | ||||||||||||
Restricted stock vested | $ 3 | (3) | |||||||||||
Restricted stock vested, shares | 17,570 | 32,540 | |||||||||||
Stock-based compensation | $ 336,355 | 336,355 | |||||||||||
Net loss | (2,345,402) | (2,345,402) | |||||||||||
Ending balance at Mar. 31, 2018 | 13,924,072 | $ 1,240 | 51,247,485 | (37,318,189) | $ (6,464) | ||||||||
Ending balance, shares at Mar. 31, 2018 | 12,406,107 | 808 | |||||||||||
Beginning balance at Dec. 31, 2017 | 12,445,778 | $ 1,114 | 47,423,915 | (34,972,787) | $ (6,464) | ||||||||
Beginning balance, shares at Dec. 31, 2017 | 11,138,859 | 808 | |||||||||||
Net loss | (7,624,785) | ||||||||||||
Ending balance at Sep. 30, 2018 | 8,948,935 | $ 1,243 | 51,551,728 | (42,597,572) | $ (6,464) | ||||||||
Ending balance, shares at Sep. 30, 2018 | 12,435,223 | 808 | |||||||||||
Beginning balance at Dec. 31, 2017 | 12,445,778 | $ 1,114 | 47,423,915 | (34,972,787) | $ (6,464) | ||||||||
Beginning balance, shares at Dec. 31, 2017 | 11,138,859 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | (74,213) | $ 4 | (74,217) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 42,781 | ||||||||||||
Exercise of stock options | $ 2 | 2 | |||||||||||
Exercise of stock options, shares | 1,172 | 1,172 | |||||||||||
Common stock issued for the exercise of warrants | $ 3,556,391 | $ 121 | 3,556,270 | ||||||||||
Common stock issued for the exercise of warrants, shares | 1,205,556 | ||||||||||||
Restricted stock vested | $ 6 | (6) | |||||||||||
Restricted stock vested, shares | 22,819 | 61,011 | |||||||||||
Stock-based compensation | $ 814,666 | 814,666 | |||||||||||
Net loss | (10,316,739) | (10,316,739) | |||||||||||
Ending balance at Dec. 31, 2018 | 6,425,885 | $ 1,245 | 51,720,630 | (45,289,526) | $ (6,464) | ||||||||
Ending balance, shares at Dec. 31, 2018 | 12,449,379 | 808 | |||||||||||
Beginning balance at Mar. 31, 2018 | 13,924,072 | $ 1,240 | 51,247,485 | (37,318,189) | $ (6,464) | ||||||||
Beginning balance, shares at Mar. 31, 2018 | 12,406,107 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | (5,041) | $ (1) | (5,040) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 3,934 | ||||||||||||
Exercise of stock options | 2 | 2 | |||||||||||
Exercise of stock options, shares | 1,172 | ||||||||||||
Common stock issued for the exercise of warrants | $ 5,901 | $ 1 | 5,900 | ||||||||||
Common stock issued for the exercise of warrants, shares | 2,000 | ||||||||||||
Restricted stock vested | $ 1 | (1) | |||||||||||
Restricted stock vested, shares | 1,692 | 937 | |||||||||||
Stock-based compensation | $ 155,725 | 155,725 | |||||||||||
Net loss | (2,629,561) | (2,629,561) | |||||||||||
Ending balance at Jun. 30, 2018 | 11,451,098 | $ 1,241 | 51,404,071 | (39,947,750) | $ (6,464) | ||||||||
Ending balance, shares at Jun. 30, 2018 | 12,414,150 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | $ (3,222) | $ 1 | (3,223) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 3,971 | ||||||||||||
Restricted stock vested | $ 1 | (1) | |||||||||||
Restricted stock vested, shares | 1,653 | 17,102 | |||||||||||
Stock-based compensation | $ 150,881 | 150,881 | |||||||||||
Net loss | (2,649,822) | (2,649,822) | |||||||||||
Ending balance at Sep. 30, 2018 | 8,948,935 | $ 1,243 | 51,551,728 | (42,597,572) | $ (6,464) | ||||||||
Ending balance, shares at Sep. 30, 2018 | 12,435,223 | 808 | |||||||||||
Beginning balance at Dec. 31, 2018 | 6,425,885 | $ 1,245 | 51,720,630 | (45,289,526) | $ (6,464) | ||||||||
Beginning balance, shares at Dec. 31, 2018 | 12,449,379 | 808 | |||||||||||
Cumulative impact of ASC 606 | (123,447) | (123,447) | |||||||||||
Proceeds from offering costs | 5,603,829 | $ 454 | 5,603,375 | ||||||||||
Proceeds from offering costs, shares | 4,542,500 | ||||||||||||
Common stock issued upon vesting of restricted stock units | (72,115) | $ 10 | (72,125) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 95,001 | ||||||||||||
Restricted stock vested | $ 1 | $ 1 | |||||||||||
Restricted stock vested, shares | 45,459 | 10,436 | |||||||||||
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 | $ 1,710 | 57,451,969 | (48,011,033) | $ (6,464) | ||||||||
Ending balance, shares at Mar. 31, 2019 | 17,097,316 | 808 | |||||||||||
Beginning balance at Dec. 31, 2018 | $ 6,425,885 | $ 1,245 | 51,720,630 | (45,289,526) | $ (6,464) | ||||||||
Beginning balance, shares at Dec. 31, 2018 | 12,449,379 | 808 | |||||||||||
Exercise of stock options, shares | 9,928 | ||||||||||||
Net loss | $ (7,951,505) | ||||||||||||
Ending balance at Sep. 30, 2019 | 4,418,525 | $ 1,716 | 57,787,751 | (53,364,478) | $ (6,464) | ||||||||
Ending balance, shares at Sep. 30, 2019 | 17,188,929 | 808 | |||||||||||
Beginning balance at Mar. 31, 2019 | 9,436,182 | $ 1,710 | 57,451,969 | (48,011,033) | $ (6,464) | ||||||||
Beginning balance, shares at Mar. 31, 2019 | 17,097,316 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | (6,356) | $ 1 | (6,357) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 22,344 | ||||||||||||
Exercise of stock options | 15 | $ 1 | 14 | ||||||||||
Exercise of stock options, shares | 8,854 | ||||||||||||
Restricted stock vested | $ (72) | $ 1 | (73) | ||||||||||
Restricted stock vested, shares | 7,032 | 10,369 | |||||||||||
Stock-based compensation | $ 197,028 | 197,028 | |||||||||||
Net loss | (2,565,327) | (2,565,327) | |||||||||||
Ending balance at Jun. 30, 2019 | 7,061,470 | $ 1,713 | 57,642,581 | (50,576,360) | $ (6,464) | ||||||||
Ending balance, shares at Jun. 30, 2019 | 17,138,883 | 808 | |||||||||||
Common stock issued upon vesting of restricted stock units | (1,779) | $ 3 | (1,782) | ||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 41,837 | ||||||||||||
Exercise of stock options | $ 1 | 1 | |||||||||||
Exercise of stock options, shares | 1,074 | ||||||||||||
Restricted stock vested, shares | 3,015 | 7,135 | |||||||||||
Stock-based compensation | $ 146,951 | 146,951 | |||||||||||
Net loss | (2,788,118) | (2,788,118) | |||||||||||
Ending balance at Sep. 30, 2019 | $ 4,418,525 | $ 1,716 | $ 57,787,751 | $ (53,364,478) | $ (6,464) | ||||||||
Ending balance, shares at Sep. 30, 2019 | 17,188,929 | 808 |
Condensed Statement of Change_2
Condensed Statement of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2017 | |
Offering cost from sale of stock | $ 710,572 | |
Offering cost from private placement | $ 2,500 | |
Net withheld for employee taxes | 45,459 | |
IPO [Member] | ||
Offering cost from sale of stock | 1,061,157 | |
Over-allotment Option [Member] | ||
Offering cost from sale of stock | $ 1,115,294 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||
Net loss | $ (7,951,505) | $ (7,624,785) | $ (10,316,739) | $ (12,097,479) | ||
Adjustments to reconcile net loss to net cash used in operations: | ||||||
Depreciation | 70,678 | 48,833 | 69,682 | 11,415 | ||
Stock-based compensation | 740,304 | 642,961 | 814,666 | 279,508 | ||
Bad debt expense | 16,275 | |||||
Amortization of debt discount | 17,765 | |||||
Debt discount on convertible notes | 5,172,000 | |||||
Excess and obsolete inventory reserve | 26,645 | 32,645 | 42,355 | |||
Common stock issued for services and software license | 31,845 | |||||
Change in fair value of derivative liabilities | (155,955) | (31,278) | (36,269) | (116,795) | ||
Loss on disposal of asset | 2,481 | |||||
Other non-cash charges | 14,634 | (16,275) | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable | 248,252 | (39,510) | (101,494) | (182,533) | ||
Inventories | (302,608) | (151,332) | (140,817) | (161,075) | ||
Prepaid expenses and other | (130,268) | (332,591) | (307,001) | (235,938) | ||
Other assets | (2,000) | |||||
Accounts payable and other accrued expenses | (191,120) | 413,317 | 466,191 | 563,225 | ||
Accrued interest | 377,503 | |||||
Deferred revenue | 2,447 | (29,284) | (103,340) | 38,067 | ||
Customer advance payments | (43,042) | (109) | 106,718 | |||
Net cash used in operating activities | (7,697,702) | (7,093,299) | (9,606,310) | (6,153,419) | ||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||
Purchases of equipment | (38,261) | (117,370) | (126,867) | (67,002) | ||
Net cash used in investing activities | (38,261) | (117,370) | (126,867) | (67,002) | ||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||
Payments of issuance costs | (117,273) | (144,582) | ||||
Net settlement of vested restricted stock units to fund related employee statutory tax withholding | (80,321) | (71,412) | (74,213) | |||
Proceeds from exercise of stock options | 16 | 2 | 2 | 26,954 | ||
Proceeds from exercise of warrants | 3,556,391 | 3,556,391 | 102,660 | |||
Proceeds from public offering | 5,603,829 | 4,368,315 | [1] | |||
Proceeds from private placement, net of offering costs | 2,922,885 | |||||
Proceeds from FPO, net of offering costs | 10,407,706 | |||||
Proceeds from convertible promissory notes, net | 1,770,000 | |||||
Repayment of note payable, MLSC | (1,215,900) | |||||
Net cash provided by financing activities | 5,523,524 | 3,367,708 | 3,337,598 | 18,382,620 | ||
Net decrease in cash, cash equivalents and restricted cash | (2,212,439) | (3,842,961) | (6,395,579) | 12,162,199 | ||
Cash, cash equivalents and restricted cash, beginning of period | 6,615,794 | 13,011,373 | 13,011,373 | 849,174 | ||
Cash, cash equivalents and restricted cash, end of period | 4,403,355 | 9,168,412 | 6,615,794 | 13,011,373 | ||
SUPPLEMENTAL DISCLOSURE CASH FLOW INFORMATION | ||||||
Cash paid during the period for interest | 97,099 | |||||
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||
Inventory capitalized as sales demo equipment | 17,715 | $ 53,178 | $ 53,178 | |||
Conversion of accrued interest to principal | 21,916 | |||||
Issuance of warrants recorded as a derivative liability | $ 196,236 | |||||
Exchange of 2015 convertible promissory notes for 2016 convertible promissory notes | 430,000 | |||||
Accretion of convertible preferred stock to redemption value | 274,011 | |||||
Conversion of convertible preferred stock into common stock | 12,946,252 | |||||
Conversion of convertible promissory notes and accrued interest into common stock | 5,467,389 | |||||
Issuance of selling agent warrants in connection with IPO | 156,725 | |||||
Deferred offering costs to additional paid-in capital upon IPO closing | [1] | 438,237 | ||||
Common stock issued for repayment of promissory notes and related accrued interest | $ 1,217,172 | |||||
[1] | IPO gross proceeds of $4,991,236 are reduced by $622,921 of IPO offering costs that were incurred in 2017. Another $438,237 of IPO deferred offering costs were paid for in 2016. |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Cash Flows [Abstract] | ||
IPO gross proceeds | $ 4,991,236 | |
IPO offering costs | $ 622,921 | |
IPO deferred offering costs | $ 438,237 |
Description of Business
Description of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 ® | 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 ® Initial Public Offering under Regulation A and Private Placement under Regulation D On June 9, 2017, the Company completed its initial public offering (“IPO”) under Regulation A of the Securities Act of 1933, as amended, raising $4,991,235, before selling agent and other offering expenses of $1,061,157, through the sale of 665,498 shares of its common stock at a price to the public of $7.50 per share. On June 9, 2017, concurrent with the closing of the IPO, the Company also closed on a private placement under Regulation D Rule 506(b) pursuant to which it sold to accredited investors an aggregate of 557,216 units at $5.25 per unit, for aggregate proceeds of $2,925,385, before offering expenses of $2,500. Each unit consisted of one share of common stock and a three-year warrant to purchase one share of common stock exercisable for $7.50 per share. The combined aggregate gross proceeds raised were $7,916,620. In connection with the closing of the Company’s IPO on June 9, 2017, the Company filed an amended and restated certificate of incorporation and restated bylaws, both of which were approved by the Company’s board of directors and stockholders on October 23, 2016. Pursuant to the amended and restated certificate of incorporation, the Company is authorized to issue up to 125,000,000 shares of stock, consisting of 100,000,000 shares of common stock, par value $0.0001 and 25,000,000 shares of undesignated Preferred Stock, par value of $0.0001. Follow-on On December 4, 2017, the Company completed a follow-on |
Going Concern and Management's
Going Concern and Management's Plan | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Going Concern And Managements Plan [Abstract] | ||
Going Concern and Management's Plan | Note 2 — Going Concern and Management’s Plan The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company incurred a net loss of approximately $8.0 million and $7.6 million during the nine months ended September 30, 2019 and 2018, respectively; and had an accumulated deficit of approximately $53.4 million at September 30, 2019. Cash used in operating activities was approximately $7.7 million and $7.1 million for the nine months ended September 30, 2019 and 2018, respectively. In February 2019, the Company completed a follow-on The ability of the Company to continue as a going concern is dependent upon achieving a profitable level of operations and the ability of the Company to obtain necessary financing to fund ongoing operations. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance of these financial statements. On October 22, 2019, the Company entered into a Note Purchase Agreement, Senior Note and Security Agreement (collectively, the “Term Loan”) with Chicago Venture Partners (the “Lender”). 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 the Lender $3.3 million. .Management plans that are intended to mitigate the conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern are primarily focused on raising additional capital in order to meet its obligations, repay its debt and execute its business plan by pursuing its product development initiatives and penetrate markets for the sale of its products. Management believes that the Company has access to capital resources through possible public or private equity offerings, exercises of outstanding warrants, debt financings (if approved by the Lender), or other means; however, the Company cannot provide any assurance that it will be able to raise additional capital or obtain new financing on commercially acceptable terms. If the Company is unable to secure additional capital, it may be required to curtail its operations or delay the execution of its business plan. There can be no assurance the Company will be successful in implementing its plans to alleviate substantial doubt. | Note 2 — Going Concern and Management’s Plan The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company incurred a net loss of $10,316,739 and $12,097,479 during the years ended December 31, 2018 and 2017, respectively, and has an accumulated deficit of $45,289,526 and $34,972,787 at December 31, 2018 and 2017, respectively. Cash used in operating activities was $9,606,310 and $6,153,419 for the years ended December 31, 2018 and 2017, respectively. In February 2019, the Company completed a follow-on The ability of the Company to continue as a going concern is dependent upon achieving a profitable level of operations and the ability of the Company to obtain necessary financing to fund ongoing operations. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance of these financial statements. On July 2, 2018, the Company filed a Registration Statement on Form S-3 “at-the-market” Management plans that are intended to mitigate the conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern are primarily focused on raising additional capital in order to meet its obligations and execute its business plan by pursuing its product development initiatives and penetrate markets for the sale of its products. Management believes that the Company has access to capital resources through possible public or private equity offerings, including sales of common stock under the Sales Agreement, exercises of outstanding warrants, debt financings, or other means; however, the Company cannot provide any assurance that it will be able to raise additional capital or obtain new financing on commercially acceptable terms. If the Company is unable to secure additional capital, it may be required to curtail its operations or delay the execution of its business plan. There can be no assurance the Company will be successful in implementing its plans to alleviate substantial doubt. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | Note 3 — Summary of Significant Accounting Policies Interim Financial Statements The accompanying unaudited condensed 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. Reclassifications Certain prior year amounts have been reclassified 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 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, 2019 and December 31, 2018. 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 balance sheets that sum to the total of the same amounts shown in the condensed statements of cash flows. September 30, 2019 December 31, 2018 Cash and cash equivalents $ 4,328,355 $ 6,540,794 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 4,403,355 $ 6,615,794 Accounts Payable and Other Accrued Expenses: September 30, 2019 December 31, 2018 Trade payables $ 346,493 $ 426,727 Accrued compensation and benefits 813,655 1,027,757 Accrued directors fees 23,750 — Accrued warranty costs 65,230 92,000 Accrued professional fees 102,233 44,660 Other 200,946 152,283 $ 1,552,307 $ 1,743,427 Revenue Recognition Adoption of ASC Topic 606, “Revenue from Contracts with Customers” On January 1, 2019, the Company adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers” and all the related amendments (Topic 606) using the modified retrospective method for all contracts not completed as of the date of adoption. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with practical expedient ASC 606-10-65-1-(f)-4, Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement, and are evaluated using a five-step model. The adoption of Topic 606 did not have a material impact on the financial statements at initial implementation. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin on an ongoing basis. The Company recognizes revenue after applying the following five steps: 6) Identification of the contract, or contracts, with a customer, 7) Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract 8) Determination of the transaction price, including the constraint on variable consideration 9) Allocation of the transaction price to the performance obligations in the contract 10) 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. In certain cases, the Company ships the MyoPro device to O&P providers or directly to patients pending reimbursement from third party payors. As a result of these arrangements, elements of the revenue recognition criteria have not been met upon shipment of the MyoPro. During the three and nine months ended September 30, 2019, the Company recognized revenue of approximately $164,000 from O&P providers or third-party payors for which costs related to the completion of the Company’s performance obligations were recorded in a prior period. The Company periodically receives federally funded grants that requires us 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 required under Topic 606, grant proceeds are now booked as a reduction in R&D expenses. The Company adopted the accounting standard on a modified retrospective method, and the prior comparative 2018 grant revenue has not been restated for presentation purposes. Grant revenue was previously recognized when persuasive evidence of the arrangement existed, the service had been provided and adherence to specific parameters of the awarded grant were met, the amount was fixed and determinable and collection was reasonably assured. The Company recognized the revenue on a completion of performance basis where no ongoing obligation existed, or ratably over the term if the grant of no specific performance was required. Direct costs related to these grants were reported as a component of research and development costs in the statements of operations except for reimbursable costs which were reported as a component of cost of revenue in the statement of operations. The Company recognized approximately $10,100 and $19,100 of grant income in the three and nine months ended September 30, 2018. Direct costs related to these grants are reported as a component of research and development costs in the statements of operations except for reimbursable costs which are reported as a component of cost of revenue in the statements of operations. Shipping and handling activities are not considered a contract performance obligation. The Company records shipping and handling costs billed to customers as revenue with offsetting costs recorded as 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, 2019. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: For the Three Months For the Nine Months Clinical/Medical providers $ 405,914 $ 1,837,667 Direct to patient 200,705 479,367 Total revenue from contracts with customer $ 606,619 $ 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. 340-40-25, 340-40-25, The Company recorded a net decrease to opening retained earnings of approximately $123,000 as of January 1, 2019 due to the cumulative impact of adopting Topic 606. The cumulative effect of the changes made to the Company’s consolidated balance sheet for the adoption of Topic 606 were as follows: Selected Balance Sheet Accounts Balance at 12/31/18 Adjustments 2014-09 Balance at 1/1/19 Assets Inventories, net $ 256,149 $ (84,635 ) $ 171,514 Prepaid expenses and other 695,276 (38,812 ) 656,464 Stockholders’ Equity Accumulated deficit (45,289,526 ) (123,447 ) (45,412,973 ) Net Loss per Share Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss 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, 2019 and 2018, 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, 2019 2018 Stock options 668,785 626,619 Restricted stock units 385,337 43,751 Restricted stock 10,266 48,707 Stock warrants 5,435,287 5,071,887 Total 6,499,675 5,790,964 Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, 2016-02. 2016-02 2016-02 2016-02 2016-02 2016-02 In June 2018, the FASB issued ASU No. 2018-07, In August 2018, the FASB issued ASU No. 2018-13, 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. | Note 3 — Summary of Significant Accounting Policies 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 Cash and Cash Equivalents 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 December 31, 2018 and 2017. 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 balance sheets that sum to the total of the same amounts show in the statement of cash flows. 2018 2017 Cash and cash equivalents $ 6,540,794 $ 12,959,373 Restricted cash 75,000 52,000 Total cash, cash equivalents, and restricted cash in the balance sheet $ 6,615,794 $ 13,011,373 Accounts Receivable and Allowance for Doubtful Accounts The Company reports accounts receivable at invoiced amounts less an allowance for doubtful accounts. The Company evaluates its accounts receivable on a continuous basis, and if necessary, establishes an allowance for doubtful accounts based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At December 31, 2018, the Company recorded an allowance for doubtful account, which was immaterial to the financial statements. No allowance for doubtful accounts was necessary at December 31, 2017. Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is determined using a specific identification method. The Company reduces the carrying value of inventory for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technology developments or other economic factors. In addition, the carrying value of consigned inventories is reduced by the value of MyPro devices that will not be sold based on historical experience. Restricted Cash Restricted cash consisted of cash deposited with a financial institution as collateral for Company credit cards for sales personnel. Deferred Offering Costs Deferred offering costs are comprised of direct incremental legal, accounting and financial advisor fees related relating to capital raising efforts. Deferred offering costs are offset against proceeds of an offering. In the event a capital raising effort is terminated, deferred offering costs are expensed. Equipment Equipment is stated at historical cost, net of accumulated depreciation and is depreciated using the straight-line method over the estimated useful lives of the related assets, generally three years. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life, are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Demonstration units are sometimes provided to the Company’s indirect sales channel by the Company for marketing and patient evaluation purposes. These units are manufactured by the Company and are expensed in the statements of operations to selling, general, and administrative expense. During the years ended December 31, 2018 and 2017, respectively, the Company charged to operations approximately $256,700 and $26,900, respectively, of these units. Demonstrations units provided by the Company on its own sales force are capitalized as equipment on the Company’s balance sheet. Test units represent units provided to research and development staff to use in their development process and to end users who are given free units to act as testers so that research and development staff can evaluate and understand their use by patients. A primary objective of these units is to determine when and under what conditions they fail, at which time they are analyzed for cause of failure and then scrapped. These units are recorded at cost in the statements of operations as part of research and development expense. During the year ended December 31, 2018 and 2017 the Company charged to operations approximately $17,700 and $29,200, respectively, of these units. Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, including equipment when there are indications that the assets might be impaired. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. Based on its assessments, the Company did not record any impairment charges for the years ended December 31, 2018 and 2017. Accounts Payable and Other Accrued Expenses: 2018 2017 Trade payables $ 426,727 $ 264,890 Accrued compensation and benefits 1,027,757 642,425 Accrued directors fees — 100,000 Other 288,943 269,921 $ 1,743,427 $ 1,277,236 Derivative Liabilities The Company accounts for warrants determined to be derivative financial instruments by recording the warrants as a liability at fair value and marks-to-market Revenue Recognition The Company derives revenue primarily from the sale of its products to O&P providers, the VA, rehabilitation hospitals, and through distributors. Recently, the Company has begun providing devices directly to patients and billing their insurance companies directly, utilizing the clinical services of O&P providers for which they are paid a fee. The Company recognizes revenue upon shipment, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance, the sales price is fixed or determinable, and collectability is deemed probable. In certain cases, the Company ships the MyoPro device to O&P practices pending reimbursement from third party payors. As a result of this arrangement, elements of the revenue recognition criteria have not been met upon shipment of the MyoPro. The Company recognizes revenue when payment has been received, as all of the revenue recognition criteria has been met. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include an exemption from the adoption of certain new or revised financial accounting standards until they would apply to private companies. As such, we have delayed the adoption of Accounting Standards Codification (“ASC”) No. 606, Revenue from Contracts with Customers until January 1, 2019. The Company receives federally funded grants that require the Company 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. The Company’s grant revenue is recognized when persuasive evidence of the arrangement exists, the service has been provided and adherence to specific parameters of the awarded grant have been met, the amount is fixed and determinable and collection is reasonable assured. The Company recognized approximately $64,600 and $118,100, respectively, of grant income in 2018 and 2017, respectively. Direct costs related to these grants are reported as a component of research and development costs in the statements of operations except for reimbursable costs which are reported as a component of cost of revenue in the statements of operations. Cost of revenue includes reimbursable costs of approximately $31,600 and $11,600 in 2018 and 2017, respectively. Amounts received in advance are deferred. Shipping and Handling Costs Shipping and handling costs paid by customers are netted against the related shipping costs we incur. The net cost is recorded in cost of sales. Historically, such costs have not been material. Income Taxes The Company accounts for income taxes under Accounting Standards Codification ASC 740 Income Taxes (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the financial statement in the period in which the law is enacted. ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Tax benefits claimed or expected to be claimed on a tax return are recorded in the Company’s financial statements. A tax benefit from an uncertain tax position is only recognized if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution. Uncertain tax positions have had no impact on the Company’s financial condition, results of operations or cash flows. The Company files income tax returns in federal and state jurisdictions and is no longer subject to examinations by tax authorities for years prior to 2015. Currently, there are no income tax audits in process. Stock-Based Compensation The Company accounts for stock awards to employees by measuring the cost of services received in exchange for the award of equity instruments based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award. Options and warrants granted to consultants and other non-employees Stock-based compensation expense of approximately $814,700 and $279,500 was recorded in research and development, selling, general and administrative expense in 2018 and 2017, respectively. Net Loss per Share Basic loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Convertible debt, preferred 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 years ended December 31, 2018 and 2017, respectively, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potentially common shares issuable at December 31, 201 8 and 201 7 consist of: 2018 2017 Options 723,744 369,004 Warrants 5,071,887 6,277,443 Restricted stock units 38,125 — Restricted stock 38,269 — Total 5,872,025 6,646,447 Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $136,300 and $31,000 in 2018 and 2017, respectively. Research and Development Costs The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and benefits, facility and overhead costs, and outsourced research activities. Reclassification Certain prior period amounts included in the statement of cash flows for the year ended December 31, 2017 have been reclassified to conform to the current year’s presentation in accordance with ASU 2017-18. See Subsequent Events The Company evaluates events and/or transactions occurring after the balance sheet date and before the issue date of the financial statements to determine if any of those events and/or transactions require adjustment to or disclosure in the financial statements. Recent Accounting Pronouncements Revenue Related Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, 2014-09”). 2014-09 2014-09 In March 2016, the FASB issued ASU No. 2016-08, ASU No. 2014-09 — No. 2016-12, (“ASU 2016-12”). 2016-12 No. 2017-13, The Company qualifies as an “emerging growth company” as defined in the JOBS Act. An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include an exemption from the adoption of certain new or revised financial accounting standards until they would apply to private companies. As such, the Company delayed the adoption of Accounting Standards Codification (“ASC”) No. 606, Revenue from Contracts with Customers until January 1, 2019. The new revenue recognition guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (modified retrospective method). The Company is adopting ASU No 2016-08 Based on the results of the Company’s assessment to date, this standard did not have a material impact on the Company’s financial statements for 2018 and is not expected to have a material impact in future years. The Company will enhance its revenue recognition disclosures, as required by this standard, including significant judgments and practical expedients used by the Company in applying the five-step revenue model. The cumulative impact to the Company’s accumulated deficit as of December 31, 2018 is expected to be de minimums. Other Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 ASU 2016-02 ASU 2016-02 2016-02 2016-02 In March 2016, the FASB issued ASU No. 2016-09, In August 2016, the FASB issued ASU 2016-15, In November 2016, the FASB issued ASU 2016-18, In May 2017, the FASB issued ASU No. 2017-09, In July 2017, the FASB issued ASU No. 2017-11, No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11. 2017-11 In June 2018, the FASB issued ASU No. 2018-07, In August 2018, the FASB issued ASU No. 2018-13, Subsequent Events The Company evaluated subsequent events through the date the financial statements were issued, and determined that, except as disclosed 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | ||
Inventories | Note 4 — Inventories Inventories consist of the following at: September 30, 2019 December 31, 2018 Finished goods $ 35,165 $ 46,261 Consigned inventory — 135,635 Parts and components 419,214 149,253 454,379 331,149 Less: excess and obsolete inventory reserves — (24,000 ) Less: consigned inventory reserves — (51,000 ) Inventories, net $ 454,379 $ 256,149 Consigned inventory represents products that have been delivered for which the Company has not met the criteria to recognize revenue. At December 31, 2018, the Company recorded consigned inventory and associated reserves for units that will not be sold based on historical experience. Consigned inventory and the associated reserves were reversed upon adoption of ASC 606 on January 1, 2019. See Note 3 – Summary of Significant Accounting Policies – Cost of Revenue. | Note 4 — Inventories Inventories consist of the following at December 31: 2018 2017 Finished goods $ 146,640 $ 122,000 Consigned inventory 135,635 97,980 Parts and components 48,874 23,530 331,149 243,510 Less: excess and obsolete inventory reserves (24,000 ) (23,739 ) Less: consigned inventory reserves (51,000 ) (18,616 ) Inventories, net $ 256,149 $ 201,155 Consigned inventory represents products that have been delivered for which the Company does not have the right to bill. At December 31, 2018 and 2017, the Company has recorded reserves for excess and obsolete inventory and consigned inventory for units that will not sold based on historical experience. |
Equipment
Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Equipment | Note 5 — Equipment Equipment consists of the following at December 31: 2018 2017 Computer equipment $ 76,424 $ 32,257 Sales demonstration units 155,293 54,003 R&D tools and molds 52,644 22,650 Furniture and fixtures 3,270 — 287,631 108,910 Less: accumulated depreciation (100,118 ) (31,760 ) Equipment, net $ 187,513 $ 77,150 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Fair Value of Financial Instruments | Note 5 — Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: • Level 1 — Quoted prices available in active markets for identical assets or liabilities. • Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, 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, 2019 were as follows: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) September 30, 2019 Total Cash equivalents $ 3,828,167 $ — $ — $ 3,828,167 Derivative liabilities $ — $ — $ 43,942 $ 43,942 The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the nine months ended September 30, 2019: Common stock warrant liability Balance – January 1, 2019 $ 3,661 Issuance of warrants 196,236 Change in fair value of derivative liabilities (155,955 ) Balance – September 30, 2019 $ 43,942 The expected stock price volatility for the Company’s common stock warrant liabilities was determined by the historical volatilities for industry peers and used an average of those volatilities. 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. | Note 6 — Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: • Level 1 — Quoted prices available in active markets for identical assets or liabilities. • Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents are a money market fund that limits its investments to only short-term U.S. Treasury securities and repurchase agreements related to these securities. Cash equivalents and derivative liabilities (see Note 10) measured at fair value on a recurring basis at December 31, 2018 were as follows: In Active Significant Significant December 31, Cash equivalents $ 6,037,456 — — $ 6,037,456 Common stock warrant liabilities — — $ 3,661 $ 3,661 Cash equivalents and derivative liabilities (see Note 10) measured at fair value on a recurring basis at December 31, 2017 were as follows: In Active Significant Significant December 31, Cash equivalents $ 10,459,435 — — $ 10,459,435 Common stock warrant liabilities — — $ 39,930 $ 39,930 The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the year ended December 31, 2018 and 2017: Common stock warrant liability Balance – January 1, 2017 $ — Fair value of common stock warrant issued 156,725 Change in fair value of derivative liabilities (116,795 ) Balance – December 31, 2017 39,930 Change in fair value of derivative liabilities (36,269 ) Balance – December 31, 2018 $ 3,661 Assumptions utilized in the valuation of Level 3 liabilities at December 31, were as follows: 2018 2017 Risk-free interest rate 2.51 % 2.20 % Expected life 3.44 years 4.44 years Expected volatility of underlying stock 62 % 63 % Expected dividend yield — — The expected stock price volatility for the Company’s common stock warrant liabilities was determined by the historical volatilities for industry peers and used an average of those volatilities. 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. |
Common Stock
Common Stock | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Equity [Abstract] | ||
Common Stock | Note 6 — Common Stock During the nine months ended September 30, 2019, the Company completed an underwritten public offering in which it sold 4,542,500 shares of its common stock generating net proceeds of approximately $5,604,000. In conjunction with the offering, the Company issued to the underwriter a warrant to purchase 363,400 shares of common stock at an exercise price of $1.75 per share. The fair value of the grant was included in the net proceeds from the public offering. During the nine months ended September 30, 2019, 9,928 stock options were exercised. During the nine months ended September 30, 2019, 27,940 shares of restricted stock vested and 159,182 (net of 55,506 shares withheld for employee taxes) of restricted stock units vested. | Note 7 — Common Stock On July 2, 2018, the Company filed a Registration Statement on Form S-3 “at-the-market” On June 9, 2017, the Company completed its IPO raising $4,991,235, before selling agent commissions and other offering expenses of $1,061,157, through the sale of 665,498 shares of its common stock at a price of $7.50 per share. On June 9, 2017, the Company concurrently closed on a private placement pursuant to which it sold to accredited investors an aggregate of 557,216 units at $5.25 per unit, for aggregate proceeds of $2,925,385, before offering expenses of $2,500. Each unit consists of one share of common stock and a three-year warrant to purchase one share of common stock exercisable for $7.50 per share. Upon the closing of the Company’s IPO on June 9, 2017, in accordance with the terms of the 2016 convertible promissory notes, the principal balance of these notes, and all accrued but unpaid interest, totaling $5,467,389 were converted into 1,055,430 shares of common stock at weighted-average price of $5.18 per share. In connection with the closing of the Company’s IPO on June 9, 2017, the Company filed an amended and restated certificate of incorporation and restated bylaws, both of which were approved by the Company’s board of directors and stockholders on October 23, 2016. Pursuant to the amended and restated certificate of incorporation, the Company is authorized to issue up to 125,000,000 shares of stock, consisting of 100,000,000 shares of common stock, par value $0.0001 and 25,000,000 shares of undesignated Preferred Stock, par value of $0.0001. On December 4, 2017, the Company completed a follow-on On November 13, 2017, the Company repaid all outstanding principal and accrued but unpaid interest under certain notes payable, totaling approximately $1,081,135 in cash by issuing 107,505 shares of the Company’s common stock at a price per share equal to $5.03, 80% of the price per share of common stock on the repayment date, and issuing 86,004 shares of the Company’s common stock at a price per share equal to $6.29, the price per share of common stock on the repayment date. In June 2017, the Company issued 4,000 shares to an investor relations firm for services performed. The Company recorded a charge to operations for $30,000 for the fair value of the stock issued. During the year ended December 31, 2018 and 2017, the Company issued 1,172 and 80,085 shares of common stock through the exercise of stock options for proceeds of $2 and $26,954, respectively. During the year ended December 31, 2018, the Company issued 42,781 shares of common stock, net 22,819 shares withheld for employee taxes, upon the vesting of restricted stock units. During the year ended December 31, 2018 and 2017, the Company issued 61,011 and 312 shares of common stock upon the vesting of restricted stock awards, respectively. |
Treasury Stock
Treasury Stock | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Treasury Stock | Note 8 — Treasury Stock Treasury stock is reported at cost and consists of 808 shares of common stock as of December 31, 2018 and 2017. |
Stock Award Plans and Stock-bas
Stock Award Plans and Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [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 nine months ended September 30, 2019 and 2018. The assumptions underlying the calculation of grant date fair value per share are as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2019 2018 2019 2018 Number of options granted 4,500 41,000 181,000 278,000 Weighted-average expected volatility 63.45 % 60%-61 % 62.56 % 60%-62 % Weighted-average risk-free interest rate 1.90 % 2.73%-2.78 % 2.16 % 2.73%-3.04 % Weighted-average expected option term (in years) 6.25 6.25 6.46 6.25-9.92 Weighted-average dividend yield — % — % — % — % Weighted-average fair value per share of grants $ 0.46 $ 1.43 $ 0.64 $ 2.02 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. On June 19, 2018, the Company’s shareholders and the Board of Directors approved the Myomo, Inc. 2018 Stock Option and Incentive Plan (the “2018 Plan”). The number of shares of common stock available for awards under the 2018 Plan at inception was equal to 706,119 shares, which included the remaining 86,119 shares available for grant under the 2016 Plan on April 1, 2018. On January 1, 2019, the number of shares reserved and available for issuance under the 2018 Plan increased by 620,000 shares pursuant to a provision in the 2018 Plan that provides that the number of shares of common stock reserved and available for issuance under the 2018 Plan will be cumulatively increased each January 1, beginning on January 1, 2019, by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee. Awards of restricted stock units are often 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 Prior to the adoption of ASU 2018-07 Compensation – Stock Compensation Improvement to Non-Employee non-employees 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 to employees and non-employees, Three Months Ended Nine Months Ended 2019 2018 2019 2018 Research and development $ 29,100 $ 24,241 $ 94,550 $ 77,528 Selling, general and administrative 117,851 126,640 645,754 565,433 Total $ 146,951 $ 150,881 $ 740,304 $ 642,961 As of September 30, 2019, there was approximately $288,600 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 2.48 years. As of September 30, 2019, there was approximately $61,500 of unrecognized compensation cost related to unvested restricted stock awards that is expected to be recognized over a weighted-average period of 1.20 years. As of September 30, 2019, there was approximately $323,200 unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 1.63 years. | Note 9 — Stock Award Plans and Stock-based Compensation Equity Incentive Plan On June 19, 2018, the Company’s Shareholders and the Board of Directors approved the Myomo, Inc. 2018 Stock Options and Incentive Plan (the “2018 Plan”). The number of shares of common stock available for awards under the 2018 Plan was equal to 706,119 shares which carried over the remaining 86,119 shares available for grant under the 2016 Plan on April 1, 2018 and an increase of the share reserve by 620,000 shares. On January 1, 2019 and each January thereafter, the number of shares of common stock reserved and available for issuance under the 2018 Plan will cumulatively increase by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee. At December 31, 2018, there were 505,153 shares available for future grant under the 2018 Plan. On October 25, 2016, the Company’s shareholders approved the 2016 Equity Incentive Plan (2016 Plan) which became effective on June 9, 2017, the date that the Company completed its IPO. Upon effectiveness of the 2016 Plan, no additional awards have been granted under the Company’s prior equity incentive plans. The Company reserved 562,500 shares of its Common Stock for issuance under the 2016 Plan. Participation in the 2016 Plan will continue until all of the benefits to which the participants are entitled have been paid in full. Under the terms of the Stock Plans, incentive stock options (ISOs) may be granted to officers and employees and non-qualified Stock Option Awards Stock option activity under the Stock Option Plans during the years ended December 31, 2018 and 2017 is as follows: Shares Weighted Weighted Intrinsic Balance at January 1, 2017 246,344 $ 0.5133 7.10 $ 132,121 Granted 210,600 2.6568 Forfeited or cancelled (7,855 ) 0.9717 Exercised (80,085 ) 0.3366 Balance at December 31, 2017 369,004 1.7652 8.65 $ 732,399 Granted 375,186 3.0700 Forfeited or cancelled (13,632 ) 3.1100 Expired (5,642 ) 1.6900 Exercised (1,172 ) 3.8700 Balance at December 31, 2018 723,744 $ 2.4200 8.51 $ 157,260 Options exercisable at December 31, 2017 141,847 $ 0.6906 5.68 $ 99,879 Options exercisable at December 31, 2018 336,718 $ 1.9500 7.74 $ 141,506 The Company uses the Black-Scholes option pricing model to estimate the grant date fair value of its stock options. There was no income tax benefit recognized in the financial statements for share-based compensation arrangements for the years ended December 31, 2018 and 2017. The weighted-average grant date fair value per share was $1.77 and $1.62 for the years ended December 31, 2018 and 2017, respectively. The assumptions underlying the calculation of grant date fair value are as follows: 2018 2017 Volatility 60.00%-61.96% 62.71%-80.00% Risk-free interest rate 2.65%-3.17% 0.58%-2.29% Weighted-average expected option term (in years) 6.25-9.92 5.75-6.25 Dividend yield — % — % 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. Restricted Stock Awards Restricted stock activity for the years ended December 31, 2018 and 2017 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as January 1, 2017 — $ — — Awarded 46,500 6.75 Vested (312 ) 6.75 Canceled (2,000 ) 6.75 Outstanding as December 31, 2017 44,188 6.75 6.75 Awarded 55,092 3.27 Vested (61,011 ) 4.83 Canceled — — Outstanding as of December 31, 2018 38,269 $ 4.80 1.39 On August 15, 2017, the Company granted 46,500 restricted stock awards to certain executives and other managers at an aggregate fair market value on the date of grant of $313,900. The restricted stock awards vest over a period determined by the Company’s Board of Directors, ranging from five months to four years. The Company recorded $123,000 in compensation expense during the year ended December 31, 2017 in connection with the grant of these restricted stock awards. On January 3, 2018, the Company issued 15,228 shares of common stock to members of the Company’s board of directors. The shares of stock were fully vested on the date of issuance and the Company recorded a charge to operations for the fair value of shares in the amount of $60,000. On June 19, 2018, the Company issued 39,864 shares of common stock to members of the Company’s board of directors. The Company determined the fair value of the units based on the closing price of the Company’s common stock on the grant date. The compensation expense is being amortized over the respective vesting periods. The restricted stock units become fully vested on June 30, 2019. Restricted Stock Units Restricted stock unit activity for the year ended December 31, 2018 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as of January 1, 2018 — — — Awarded 103,723 3.56 Vested (65,598 ) 3.68 Canceled — 3.35 Outstanding as of December 31, 2018 38,125 3.35 1.49 On January 2, 2018, the Company granted 88,723 restricted stock units to key employees. They were issued with lapsing forfeiture rights extending up to 24 months. At December 31, 2018, 23,123 restricted stock units were subject to forfeiture. The Company determined the fair value of the units based on the closing price of the Company’s common stock on the grant date. The compensation expense is being amortized over the respective vesting periods. The Company recorded a charge in the amount of $242,551 for the year ended December 31, 2018. On July 9, 2018, the Company granted 5,000 restricted stock units to an officer of the Company which vest in full on the first anniversary date. The Company also issued 10,000 restricted stock units to the same officer which vest over four years. Awards of restricted stock units are generally 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 are presented in the statements of cash flows as a financing activity. Share-Based Compensation Expense The Company attributes the value of stock-based compensation, net of estimated forfeitures, 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 to employees and non-employees 2018 2017 Research and development $ 103,457 $ 12,382 Selling, general and administrative 711,209 267,126 Total $ 814,666 $ 279,508 As of December 31, 2018, there was approximately $586,600 of unrecognized compensation cost related to unvested stock options and is expected to recognized over a weighted-average period of 2.16 years. As of December 31, 2018, there was approximately $164,300 of total unrecognized compensation cost related to unvested restricted stock awards and is expected to recognized over a weighted-average period of 1.39 years. As of December 31, 2018, there was approximately $ 116,800 of unrecognized compensation cost related to unvested restricted stock unit awards and is expected to recognized over a weighted-average period of 1.49 years. |
Warrants
Warrants | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants | Note 7 — Warrants On June 9, 2017, the Company issued warrants for the purchase of 33,275 shares of common stock to its IPO selling agent (the “June 2017 Warrants”). The June 2017 Warrants became fully vested, exercisable on December 9, 2017 by the holder at an exercise price of $8.25 per share and have a life of five years. The June 2017 Warrants include a fundamental transaction clause which provide for the warrant holder to be paid in cash upon an event as defined in the warrant. The cash payment is to be computed using the Black-Scholes valuation model for the unexercised portion of the warrant. Accordingly, under ASC 815 Derivative and Hedging the June 2017 Warrants were deemed to be a derivative liability and are marked to market at each reporting period. On September 30, 2019 and December 31, 2018, the derivative liability was marked to its then fair value market value of approximately $300 and $3,700 respectively. Assumptions utilized in the valuation of the June 2017 Warrant, for the nine months ended September 30, 2019, were as follows: Risk-free interest rate 1.59 % Expected life 2.69 Expected volatility of underlying stock 66.20 % Expected dividend yield — On February 8, 2019, the Company issued warrants for the purchase of 363,400 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 $1.75 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. Accordingly, under ASC 815 Derivative and Hedging the warrants were deemed to be a derivative liability and marked to market at each reporting period The Company computed the fair value of the derivative liability using the Black-Scholes Option Valuation Model. The Company determined that the Binomial Lattice Model was not materially different to the Black Scholes Option Valuation Model. Accordingly, on the date of issuance the Company recorded as a derivative liability the fair value of the February 2019 Warrants of approximately $196,000 and on September 30, 2019 the derivative liability was marked to its then fair market value of approximately $43,600. Assumptions utilized in the valuation of the February 2019 Warrant for the nine months ended September 30, 2019, were as follows: Risk-free interest rate 1.56 % Expected life 3.36 Expected volatility of underlying stock 64.01 % Expected dividend yield — | Note 10 — Warrants On June 9, 2017, the Company issued warrants for the purchase of 557,216 shares of common stock to investors in connection with a private placement that closed concurrently with the Company’s IPO, as more fully described in Note 1. The warrants are exercisable for three years from the date of the IPO and are fully vested and exercisable at any time by the holder at a price of $7.50 per share. The warrants can only be settled in the Company’s own shares, and as such, under ASC 815 “Derivatives and Hedging” the warrants were deemed to be equity instruments and, therefore are included in stockholders’ equity and no fair value adjustments are required from period-to-period. On June 9, 2017, the Company issued warrants for the purchase of 33,275 shares of common stock to its IPO selling agent. The warrants are fully vested, exercisable at any time after December 9, 2017 by the holder at an exercise price of $8.25 per share and have a life of five years. The warrants include a fundamental transaction clause which provides for the warrant holder to be paid in cash upon an event as defined in the warrant. The cash payment is to be computed using the Black-Scholes valuation model for the unexercised portion of the warrant. Accordingly, under ASC 815 Derivatives and Hedging the warrants were deemed to be a derivative liability and are marked to market at each reporting period. Accordingly, on the date of issuance the Company recorded as a derivative liability the fair value of the warrants which was $156,725 and at December 31, 2017 the derivative liability was marked to its then fair market value of $39,930. On December 4, 2017, the Company issued 4,175,000 warrants to purchase shares of its common stock to investors in connection with its FPO, as more fully described in Note 1. The warrants, of which warrants to purchase 3,560,894 shares of common stock remain outstanding as of December 31, 2018, are exercisable at an exercise price of $2.95 per share of common stock, and they expire on December 4, 2022. The exercise price of these warrants has been subsequently reduced to $1.40 per share (see Note 14 – Subsequent Events). On December 6, 2017, the Company’s underwriters on its FPO exercised in full their option to purchase 626,250 shares of common stock and accompanying warrant. After giving effect to the full exercise of the over-allotment, the Company issued an aggregate 4,801,250 warrants to purchase an aggregate of 4,801,250 shares of common stock at an exercise price of $2.95 per share of common stock, which expire on December 4, 2022. The early adoption of ASU 2017-11 2017-11, period-to-period. On December 4, 2017, the Company issued warrants for the purchase of 83,500 shares of common stock to the underwriter of its FPO. The warrants are fully vested, exercisable at any time after June 2, 2018 by the holder at an exercise price of $2.40 per share and have a life of three years. The warrants can only be settled in the Company’s own shares, and as such, under ASC 815 Derivatives and Hedging, they were deemed to be equity instruments and, therefore are included in stockholders’ equity and no fair value adjustments are required from period-to-period. The following table presents the Company’s common stock warrant activity for the years ended December 31, 2018 and 2017: Warrants Weighted Average Exercise Price Outstanding Exercisable Outstanding Exercisable Balance, Jan 1, 2017 8,228 8,228 $ 6.47 $ 6.47 Issued 6,304,015 6,220,515 3.84 3.85 Exercised (34,800 ) (34,800 ) 2.95 2.95 Balance, Dec 31, 2017 6,277,443 6,193,943 3.85 3.86 Previously issued warrants which became exercisable — 83,500 2.40 2.40 Issued — — — — Exercised (1,205,556 ) (1,205,556 ) 2.95 2.95 Balance, Dec 31, 2018 5,071,887 5,071,887 $ 4.05 $ 4.05 The weighted average remaining contractual life of warrants outstanding and exercisable at December 31, 2018 was 3.23 years. |
Related Party Transactions
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 the nine months ended September 30, 2019 and 2018, revenue recognized on sales to this orthotics and prosthetics practice amounted to approximately $26,000 and $306,200, respectively. There were no amounts due from this related party at September 30, 2019 and December 31, 2018. 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 $338,200 and $397,300 during the nine months ended September 30, 2019 and 2018, respectively. Included in accounts payable and accrued expenses at September 30, 2019 and December 31, 2018 is approximately $49,200 and $54,000, respectively, due to the related party. | Note 11 — Related Party Transactions The Company sells its products to an orthotics and prosthetics practice whose ownership includes an individual who is both a minority shareholder and employee of the Company. Sales to this related party are sold at standard list prices. During the years ended December 31, 2018 and 2017 revenue recognized on sales to this orthotics and prosthetics practice amounted to approximately $306,200 and $53,500, respectively. There were no amounts due for this related party as of December 31, 2018. Included in accounts receivable at December 31, 2017 is approximately and $77,600, respectively, and due to the related party. The Company also obtains consulting and fabrication services from the same related party. Charges for these services amounted to approximately $530,300 and $356,400 during the years ended December 31, 2018 and 2017, respectively. Included in accounts payable and accrued expenses at December 31, 2018 and 2017 is approximately $54,300 and $65,800, respectively, due to the related party. An officer and director purchased 14,000 shares at $7.50 per share in the Company’s June 9, 2017 IPO. Certain directors and officers of the Company purchased 125,238 shares and 125,238 warrants to purchase shares of common stock, in the Company’s private placement under Regulation D Rule 506(b) that closed concurrently with its IPO on June 9, 2017, at the price of $5.25 per unit. The warrants are exercisable at an exercise price of $7.50 per share of common stock. Certain directors and officers of the Company purchased 285,000 shares and 285,000 warrants to purchase shares of its common stock in the Company’s FBO, that closed on December 4, 2017, at the price to the public of $2.40. The warrants are exercisable at an exercise price of $2.95 per share of common stock. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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. Major Customers For the nine months ended September 30, 2019, there were no individual customers who accounted for more than 10% of revenues. For the nine months ended September 30, 2018, one customer accounted for approximately 23% (related party) of revenues, excluding grant income. The Company sells its products to an orthotics and prosthetics practice whose ownership includes an individual who is both a minor shareholder and employee of the Company. At September 30, 2019, four customers accounted for approximately 24%, 19%, 19%, and 19% of accounts receivable. At December 31, 2018, two customers accounted for approximately 20% and 16% of accounts receivable. | Note 12 — 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. Operating Leases The Company has a month-to-month Licensing Agreement During 2006, the Company entered into an exclusive licensing agreement for access to certain patent rights that require the payment of royalties, which vary based on the level of the Company’s net sales. As part of the agreement, the Company must pay a nonrefundable annual license maintenance fee which may be credited to any royalty amounts due in that same year. The license agreement can be terminated if certain sales targets are not achieved. The royalty charge for each of the years ended December 31, 2018 and 2017 was $49,300 and $25,000, respectively, and is included as a component of cost of sales. The future minimum amounts due under this agreement for the next five years are as follows: 2019 $ 25,000 2020 25,000 2021 25,000 2022 25,000 2023 (year patents expire) 25,000 Under the licensing agreement, the Company has issued 6,172 shares of Common Stock to MIT, including 492 shares on December 29, 2017, pursuant to a licensing agreement share adjustment provision in the event that the Company has a dilutive financing, as defined. The licensing agreement also includes an anti-dilution provision such that the licensor’s ownership of the outstanding Common Stock shall not fall below 1% on a fully diluted basis. Such issuances of Common Stock continue until the date upon which the Company received a total of $3,000,000 for its capital stock. After the date the funding threshold was met in 2007, the licensor has the right to purchase additional shares of common stock to maintain its pro rata ownership. On November 15, 2016, the Company and MIT entered into a waiver agreement with regard to certain revenue and commercialization miles tones of the Company required under the License Agreement. Under the waiver agreement, MIT waived the compliance with any and all of such milestone obligations prior to the date of the waiver agreement. For the year ended December 31, 201 8 the Company met its minimum sales covenant of $750,000. Clinical Research Studies The Company had in-process Warranty Liability The Company accrues an estimate of their exposure to warranty claims based on both current and historical product sales data and warranty costs incurred. The majority of the Company’s current products carry a three-year warranty, but prior to 2017 most products carried a one-year Changes in warranty liability were as follows: 2018 2017 Accrued warranty liability, beginning of year $ 50,725 $ 63,147 Accrual provided for warranties issued during the period 23,452 14,867 Adjustments to prior accruals 38,382 570 Actual warranty expenditures (20,559 ) (27,859 ) Accrued warranty liability, end of year $ 92,000 $ 50,725 Credit Risk Financial instruments that potentially expose the Company to a concentration of credit risk consist primarily of cash, cash equivalents and restricted cash and accounts receivable. The Company maintains its cash, cash equivalents and restricted cash, with balances in excess of federally insured limits, with major financial institutions that management believes are financially sound and have minimum credit risk. The Company has not experienced any losses in such accounts and does not believe it is exposed to any significant credit risks related to cash. Major Customers For the year ended December 31, 2018 two customers accounted for approximately 25% of revenues, excluding grant income which includes 13% from a related party. The Company sells its product to an orthotics and prosthetics practice whose ownership includes an individual who is both a minor shareholder and employee of the company. For the year ended December 31, 2017 three customers accounted for approximately 23%, 17%, and 14%, of revenues, excluding grant income. As of December 31, 2018, two customers accounted for approximately 20% and 16% of accounts receivable. As of December 31, 2017, three customers accounted for approximately 55% of accounts receivable, 26% of which was due from the aforementioned related party, 18% and 11%. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 13 — Income Taxes The income tax provision (benefit) for the years ended December 31, 2018 and 2017 consist of the following: 12/31/18 12/31/17 U.S. federal Current $ — $ — Deferred (2,065,000 ) (534,000 ) State and local Current — — Deferred (571,000 ) (538,000 ) (2,636,000 ) (1,072,000 ) Deferred tax expense related to tax law change — 2,909,000 Change in valuation allowance 2,636,000 (1,837,000 ) Income tax provision $ — $ — The reconciliation between the U.S statutory federal income tax rate and the Company’s effective rate for the years ended December 31, 2018 and 2017 is as follows: 12/31/18 12/31/17 U.S. federal statutory rate 21.00 % 34.00 % State income taxes, net of federal benefit 5.57 % 4.67 % Federal rate change, deferred items — % (23.03 )% State rate change and other (0.03 )% 0.89 % Non-deductible — % (17.67 )% Federal NOLs to expire unutilized due to sec 382 limitation — % (14.02 )% Other permanent items (0.98 )% (0.03 )% Change in valuation allowance (25.56 )% 15.19 % Effective rate — % — % As of December 31, 2018, and 2017, the Company’s deferred tax assets consisted of the effects of temporary differences attributable to the following: 12/31/18 12/31/17 Net operating loss carryover $ 8,378,000 $ 5,925,000 Tax credits 178,000 190,000 Stock-based compensation 27,000 53,000 Other 440,000 219,000 Total deferred tax asset 9,023,000 6,387,000 Less: valuation allowance (9,023,000 ) (6,387,000 ) Deferred tax asset, net of valuation allowance $ — $ — There were no deferred tax liabilities at December 31, 2018 or 2017. As of December 31, 2018 and 2017, the Company had approximately $35,519,000 and $26,425,000 of Federal net operating loss (“NOL”), and $29,212,000 and $22,046,000 of state NOLs, respectively, available to offset future taxable income. The Federal NOLs incurred prior to 2018 of $26,425,000, if not utilized, begin expiring in the year 2028. The Federal NOLs incurred in 2018 of $9,094,000 have an indefinite carryforward period. The state NOLs, if not utilized begin to expire in 2019 through 2027. During 2017, the Company experienced an ownership change within the meaning of Section 382 of the Internal Revenue Code of 1986. The ownership change has and will continue to subject the Company’s pre-ownership tax-exempt Ownership changes were also determined to have occurred during the third quarter of 2014 and second quarter of 2015. As a result of these ownership changes, the Company is limited to an approximate $1,559,000 annual limitation on its ability to utilize pre-change pre-change On December 22, 2017, the Tax Cuts and Jobs Act (TCIA) was signed into law. The enacted law reduces the corporate tax rate from 35 percent to 21 percent for tax years beginning after December 31, 2017. ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the period in which the law is enacted. As a result of the enacted law, the Company is required to revalue deferred tax assets and liabilities at the enacted rate and reflect that change in its financial statements for the period that includes the date of enactment, since the deferred tax items would be expected to reverse at the reduced rate. As a result of the corporate tax rate decrease from the Tax Cuts and Jobs Act (TCIA), the deferred tax assets and valuation allowance have been reduced by approximately $2,909,000 at December 31, 2017. ASC 740, “Income Taxes” requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. A review of all available positive and negative evidence needs to be considered, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After consideration of all the information available, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of December 31, 2018 and 2017. For the years ended December 31, 2018 and December 31, 2017, the change in valuation allowance was a decrease of $2,636,000 and an increase of $1,837,000, respectively. The Company recognizes interest and penalties relating to unrecognized tax benefits on the income tax expense line in the statement of operations. There are no tax penalties and interest on the statement of operations as of December 31, 2018, 2017 and 2016. The Company operates in multiple tax jurisdictions and, in the normal course of business, its tax returns are subject to examination by various taxing authorities. Such examinations may result in future assessments by these taxing authorities. The Company is subject to examination by U.S. tax authorities beginning with the year ended December 31, 2015. No accrued interest and penalties are included on the related tax liability accrual on the balance sheet. There are no accrued interest and penalties at December 31, 2018 and December 31, 2017. |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Subsequent Events [Abstract] | ||
Subsequent Events | Note 11 — Subsequent Events On October 22, 2019, the Company entered into a Term Loan with Chicago Venture Partners. 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 the Lender $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 closing date, with the actual amount to be determined by the Lender. The Lender has granted the Company an option to defer up to three redemption payments. If the Company elects to defer any payments, the Company will pay the Lender a fee that is the greater of (i) $35,000, or (ii) 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, excluding intellectual property. The Company has agreed that it will 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 pay the Lender 50% of the gross proceeds that it receives from the sale of the Company’s common stock or other equity (excluding sales of common stock under the Company’s 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 note. 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 the Lender’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, the Lender 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 the Lender has the right to consent to any additional debt financing arrangements, including convertible debt financings. In connection with the Term Loan, the Company paid its placement agent a commission equal to 6% of the gross proceeds of the Term Loan. 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. | Note 14 — Subsequent Events Underwritten Public Offering On February 12, 2019, the Company completed an underwritten public offering in which the Company sold 4,542,500 shares of its common stock at a price to the public of $1.40. All of the shares of common stock sold were offered by the Company and were pursuant to a prospectus dated July 16, 2018, and a preliminary prospectus supplement dated February 7, 2019, in connection with a takedown from the Company’s shelf registration statement on Form S-3 No. 333-226045) On February 12, 2019, the Company issued to the underwriter a warrant (the “Underwriter Warrant”) to purchase 363,400 shares of common stock. The Underwriter Warrant has an exercise price $1.75 per share and may be exercised on a cashless basis in certain circumstances specified in the Underwriter Warrant. The Underwriter Warrant is exercisable six months from the date of issuance and will expire four years from the date of issuance. The Underwriter Warrant provides for adjustment in the number and price of such Underwriter Warrant (and the shares of common stock underlying such Underwriter Warrant) in the event of a recapitalization, merger or other fundamental transaction. The Company issued warrants (the “2017 Warrants”) in its December 2017 public offering. Pursuant to the terms of the warrants, the sale and issuance in this underwritten public offering of Common Stock at a public offering price of $1.40 per share triggered an adjustment to the exercise price of the outstanding 2017 Warrants. The exercise price of such warrants was reduced from $2.95 per share to $1.40 per share, pursuant to the terms of such warrants. Stock Awards Granted Subsequent to December 31, 2018, the Company issued: 156 shares of common stock issued upon vesting of restricted stock awards with an aggregate fair value of $1.63 at the time of vesting. 91,368 shares of common stock granted restricted stock units (RSUs) to key employees with an aggregate fair value of $1.60 at the grant date. On February 6, 2019, the Company announced the hiring of a Chief Financial Officer and pursuant to his employment agreement, the Company made the following grants for equity compensation to the Chief Financial Officer: • 50,000 Incentive Stock Options which vest 25% on the first anniversary of February 18, 2019 grant date and thereafter in 36 equal monthly installments, subject to continuous service with the Company; and • 20,000 Restricted Stock Units which vest 25% on the first anniversary of the February 18, 2019 grant date, and thereafter in 12 equal quarterly installments, subject to continuous service with the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
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 | 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 |
Cash and Cash Equivalents | Cash and Cash Equivalents 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 December 31, 2018 and 2017. 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 balance sheets that sum to the total of the same amounts show in the statement of cash flows. 2018 2017 Cash and cash equivalents $ 6,540,794 $ 12,959,373 Restricted cash 75,000 52,000 Total cash, cash equivalents, and restricted cash in the balance sheet $ 6,615,794 $ 13,011,373 | |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts The Company reports accounts receivable at invoiced amounts less an allowance for doubtful accounts. The Company evaluates its accounts receivable on a continuous basis, and if necessary, establishes an allowance for doubtful accounts based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At December 31, 2018, the Company recorded an allowance for doubtful account, which was immaterial to the financial statements. No allowance for doubtful accounts was necessary at December 31, 2017. | |
Inventories | Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is determined using a specific identification method. The Company reduces the carrying value of inventory for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technology developments or other economic factors. In addition, the carrying value of consigned inventories is reduced by the value of MyPro devices that will not be sold based on historical experience. | |
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, 2019 and December 31, 2018. 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 balance sheets that sum to the total of the same amounts shown in the condensed statements of cash flows. September 30, 2019 December 31, 2018 Cash and cash equivalents $ 4,328,355 $ 6,540,794 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 4,403,355 $ 6,615,794 | Restricted Cash Restricted cash consisted of cash deposited with a financial institution as collateral for Company credit cards for sales personnel. |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs are comprised of direct incremental legal, accounting and financial advisor fees related relating to capital raising efforts. Deferred offering costs are offset against proceeds of an offering. In the event a capital raising effort is terminated, deferred offering costs are expensed. | |
Equipment | Equipment Equipment is stated at historical cost, net of accumulated depreciation and is depreciated using the straight-line method over the estimated useful lives of the related assets, generally three years. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life, are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Demonstration units are sometimes provided to the Company’s indirect sales channel by the Company for marketing and patient evaluation purposes. These units are manufactured by the Company and are expensed in the statements of operations to selling, general, and administrative expense. During the years ended December 31, 2018 and 2017, respectively, the Company charged to operations approximately $256,700 and $26,900, respectively, of these units. Demonstrations units provided by the Company on its own sales force are capitalized as equipment on the Company’s balance sheet. Test units represent units provided to research and development staff to use in their development process and to end users who are given free units to act as testers so that research and development staff can evaluate and understand their use by patients. A primary objective of these units is to determine when and under what conditions they fail, at which time they are analyzed for cause of failure and then scrapped. These units are recorded at cost in the statements of operations as part of research and development expense. During the year ended December 31, 2018 and 2017 the Company charged to operations approximately $17,700 and $29,200, respectively, of these units. | |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company assesses the recoverability of its long-lived assets, including equipment when there are indications that the assets might be impaired. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated cash flows (undiscounted and with interest charges), the Company records an impairment charge for the difference. Based on its assessments, the Company did not record any impairment charges for the years ended December 31, 2018 and 2017. Accounts Payable and Other Accrued Expenses: 2018 2017 Trade payables $ 426,727 $ 264,890 Accrued compensation and benefits 1,027,757 642,425 Accrued directors fees — 100,000 Other 288,943 269,921 $ 1,743,427 $ 1,277,236 | |
Derivative Liabilities | Derivative Liabilities The Company accounts for warrants determined to be derivative financial instruments by recording the warrants as a liability at fair value and marks-to-market | |
Revenue Recognition | Revenue Recognition Adoption of ASC Topic 606, “Revenue from Contracts with Customers” On January 1, 2019, the Company adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers” and all the related amendments (Topic 606) using the modified retrospective method for all contracts not completed as of the date of adoption. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with practical expedient ASC 606-10-65-1-(f)-4, Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement, and are evaluated using a five-step model. The adoption of Topic 606 did not have a material impact on the financial statements at initial implementation. Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin on an ongoing basis. The Company recognizes revenue after applying the following five steps: 6) Identification of the contract, or contracts, with a customer, 7) Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract 8) Determination of the transaction price, including the constraint on variable consideration 9) Allocation of the transaction price to the performance obligations in the contract 10) 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. In certain cases, the Company ships the MyoPro device to O&P providers or directly to patients pending reimbursement from third party payors. As a result of these arrangements, elements of the revenue recognition criteria have not been met upon shipment of the MyoPro. During the three and nine months ended September 30, 2019, the Company recognized revenue of approximately $164,000 from O&P providers or third-party payors for which costs related to the completion of the Company’s performance obligations were recorded in a prior period. The Company periodically receives federally funded grants that requires us 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 required under Topic 606, grant proceeds are now booked as a reduction in R&D expenses. The Company adopted the accounting standard on a modified retrospective method, and the prior comparative 2018 grant revenue has not been restated for presentation purposes. Grant revenue was previously recognized when persuasive evidence of the arrangement existed, the service had been provided and adherence to specific parameters of the awarded grant were met, the amount was fixed and determinable and collection was reasonably assured. The Company recognized the revenue on a completion of performance basis where no ongoing obligation existed, or ratably over the term if the grant of no specific performance was required. Direct costs related to these grants were reported as a component of research and development costs in the statements of operations except for reimbursable costs which were reported as a component of cost of revenue in the statement of operations. The Company recognized approximately $10,100 and $19,100 of grant income in the three and nine months ended September 30, 2018. Direct costs related to these grants are reported as a component of research and development costs in the statements of operations except for reimbursable costs which are reported as a component of cost of revenue in the statements of operations. Shipping and handling activities are not considered a contract performance obligation. The Company records shipping and handling costs billed to customers as revenue with offsetting costs recorded as 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, 2019. Disaggregated Revenue from Contracts with Customers The following table presents revenue by major source: For the Three Months For the Nine Months Clinical/Medical providers $ 405,914 $ 1,837,667 Direct to patient 200,705 479,367 Total revenue from contracts with customer $ 606,619 $ 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. 340-40-25, 340-40-25, The Company recorded a net decrease to opening retained earnings of approximately $123,000 as of January 1, 2019 due to the cumulative impact of adopting Topic 606. The cumulative effect of the changes made to the Company’s consolidated balance sheet for the adoption of Topic 606 were as follows: Selected Balance Sheet Accounts Balance at 12/31/18 Adjustments 2014-09 Balance at 1/1/19 Assets Inventories, net $ 256,149 $ (84,635 ) $ 171,514 Prepaid expenses and other 695,276 (38,812 ) 656,464 Stockholders’ Equity Accumulated deficit (45,289,526 ) (123,447 ) (45,412,973 ) | Revenue Recognition The Company derives revenue primarily from the sale of its products to O&P providers, the VA, rehabilitation hospitals, and through distributors. Recently, the Company has begun providing devices directly to patients and billing their insurance companies directly, utilizing the clinical services of O&P providers for which they are paid a fee. The Company recognizes revenue upon shipment, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance, the sales price is fixed or determinable, and collectability is deemed probable. In certain cases, the Company ships the MyoPro device to O&P practices pending reimbursement from third party payors. As a result of this arrangement, elements of the revenue recognition criteria have not been met upon shipment of the MyoPro. The Company recognizes revenue when payment has been received, as all of the revenue recognition criteria has been met. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include an exemption from the adoption of certain new or revised financial accounting standards until they would apply to private companies. As such, we have delayed the adoption of Accounting Standards Codification (“ASC”) No. 606, Revenue from Contracts with Customers until January 1, 2019. The Company receives federally funded grants that require the Company 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. The Company’s grant revenue is recognized when persuasive evidence of the arrangement exists, the service has been provided and adherence to specific parameters of the awarded grant have been met, the amount is fixed and determinable and collection is reasonable assured. The Company recognized approximately $64,600 and $118,100, respectively, of grant income in 2018 and 2017, respectively. Direct costs related to these grants are reported as a component of research and development costs in the statements of operations except for reimbursable costs which are reported as a component of cost of revenue in the statements of operations. Cost of revenue includes reimbursable costs of approximately $31,600 and $11,600 in 2018 and 2017, respectively. Amounts received in advance are deferred. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs paid by customers are netted against the related shipping costs we incur. The net cost is recorded in cost of sales. Historically, such costs have not been material. | |
Income Taxes | Income Taxes The Company accounts for income taxes under Accounting Standards Codification ASC 740 Income Taxes (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the financial statement in the period in which the law is enacted. ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Tax benefits claimed or expected to be claimed on a tax return are recorded in the Company’s financial statements. A tax benefit from an uncertain tax position is only recognized if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution. Uncertain tax positions have had no impact on the Company’s financial condition, results of operations or cash flows. The Company files income tax returns in federal and state jurisdictions and is no longer subject to examinations by tax authorities for years prior to 2015. Currently, there are no income tax audits in process. | |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock awards to employees by measuring the cost of services received in exchange for the award of equity instruments based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award. Options and warrants granted to consultants and other non-employees Stock-based compensation expense of approximately $814,700 and $279,500 was recorded in research and development, selling, general and administrative expense in 2018 and 2017, respectively. | |
Net Loss per Share | Net Loss per Share Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss 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, 2019 and 2018, 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, 2019 2018 Stock options 668,785 626,619 Restricted stock units 385,337 43,751 Restricted stock 10,266 48,707 Stock warrants 5,435,287 5,071,887 Total 6,499,675 5,790,964 | Net Loss per Share Basic loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Convertible debt, preferred 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 years ended December 31, 2018 and 2017, respectively, and as a result, all potentially dilutive common shares are considered antidilutive for these periods. Potentially common shares issuable at December 31, 201 8 and 201 7 consist of: 2018 2017 Options 723,744 369,004 Warrants 5,071,887 6,277,443 Restricted stock units 38,125 — Restricted stock 38,269 — Total 5,872,025 6,646,447 |
Advertising | Advertising The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $136,300 and $31,000 in 2018 and 2017, respectively. | |
Research and Development Costs | Research and Development Costs The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and benefits, facility and overhead costs, and outsourced research activities. | |
Reclassification | Reclassifications Certain prior year amounts have been reclassified to conform with the current year presentation. | Reclassification Certain prior period amounts included in the statement of cash flows for the year ended December 31, 2017 have been reclassified to conform to the current year’s presentation in accordance with ASU 2017-18. See |
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. | Subsequent Events The Company evaluates events and/or transactions occurring after the balance sheet date and before the issue date of the financial statements to determine if any of those events and/or transactions require adjustment to or disclosure in the financial statements. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, 2016-02. 2016-02 2016-02 2016-02 2016-02 2016-02 In June 2018, the FASB issued ASU No. 2018-07, In August 2018, the FASB issued ASU No. 2018-13, | Recent Accounting Pronouncements Revenue Related Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, 2014-09”). 2014-09 2014-09 In March 2016, the FASB issued ASU No. 2016-08, ASU No. 2014-09 — No. 2016-12, (“ASU 2016-12”). 2016-12 No. 2017-13, The Company qualifies as an “emerging growth company” as defined in the JOBS Act. An emerging growth company may take advantage of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions include an exemption from the adoption of certain new or revised financial accounting standards until they would apply to private companies. As such, the Company delayed the adoption of Accounting Standards Codification (“ASC”) No. 606, Revenue from Contracts with Customers until January 1, 2019. The new revenue recognition guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (modified retrospective method). The Company is adopting ASU No 2016-08 Based on the results of the Company’s assessment to date, this standard did not have a material impact on the Company’s financial statements for 2018 and is not expected to have a material impact in future years. The Company will enhance its revenue recognition disclosures, as required by this standard, including significant judgments and practical expedients used by the Company in applying the five-step revenue model. The cumulative impact to the Company’s accumulated deficit as of December 31, 2018 is expected to be de minimums. Other Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 ASU 2016-02 ASU 2016-02 2016-02 2016-02 In March 2016, the FASB issued ASU No. 2016-09, In August 2016, the FASB issued ASU 2016-15, In November 2016, the FASB issued ASU 2016-18, In May 2017, the FASB issued ASU No. 2017-09, In July 2017, the FASB issued ASU No. 2017-11, No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11 No. 2017-11. 2017-11 In June 2018, the FASB issued ASU No. 2018-07, In August 2018, the FASB issued ASU No. 2018-13, Subsequent Events The Company evaluated subsequent events through the date the financial statements were issued, and determined that, except as disclosed herein, there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the financial statements. |
Interim Financial Statements | Interim Financial Statements The accompanying unaudited condensed 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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 balance sheets that sum to the total of the same amounts shown in the condensed statements of cash flows. September 30, 2019 December 31, 2018 Cash and cash equivalents $ 4,328,355 $ 6,540,794 Restricted cash 75,000 75,000 Total cash, cash equivalents, and restricted cash $ 4,403,355 $ 6,615,794 | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheets that sum to the total of the same amounts show in the statement of cash flows. 2018 2017 Cash and cash equivalents $ 6,540,794 $ 12,959,373 Restricted cash 75,000 52,000 Total cash, cash equivalents, and restricted cash in the balance sheet $ 6,615,794 $ 13,011,373 |
Summary of Accounts Payable and Other Accrued Expenses | Accounts Payable and Other Accrued Expenses: September 30, 2019 December 31, 2018 Trade payables $ 346,493 $ 426,727 Accrued compensation and benefits 813,655 1,027,757 Accrued directors fees 23,750 — Accrued warranty costs 65,230 92,000 Accrued professional fees 102,233 44,660 Other 200,946 152,283 $ 1,552,307 $ 1,743,427 | Accounts Payable and Other Accrued Expenses: 2018 2017 Trade payables $ 426,727 $ 264,890 Accrued compensation and benefits 1,027,757 642,425 Accrued directors fees — 100,000 Other 288,943 269,921 $ 1,743,427 $ 1,277,236 |
Summary of Potential Common Shares Issuable | Potential common shares issuable consist of the following at: September 30, 2019 2018 Stock options 668,785 626,619 Restricted stock units 385,337 43,751 Restricted stock 10,266 48,707 Stock warrants 5,435,287 5,071,887 Total 6,499,675 5,790,964 | Potentially common shares issuable at December 31, 201 8 and 201 7 consist of: 2018 2017 Options 723,744 369,004 Warrants 5,071,887 6,277,443 Restricted stock units 38,125 — Restricted stock 38,269 — Total 5,872,025 6,646,447 |
Summary of Revenue by Major Source | The following table presents revenue by major source: For the Three Months For the Nine Months Clinical/Medical providers $ 405,914 $ 1,837,667 Direct to patient 200,705 479,367 Total revenue from contracts with customer $ 606,619 $ 2,317,034 | |
Adoption of ASC 606 [Member] | ||
Cumulative Effect of Changes in Consolidated Balance Sheet for Adoption of Topic 606 | The cumulative effect of the changes made to the Company’s consolidated balance sheet for the adoption of Topic 606 were as follows: Selected Balance Sheet Accounts Balance at 12/31/18 Adjustments 2014-09 Balance at 1/1/19 Assets Inventories, net $ 256,149 $ (84,635 ) $ 171,514 Prepaid expenses and other 695,276 (38,812 ) 656,464 Stockholders’ Equity Accumulated deficit (45,289,526 ) (123,447 ) (45,412,973 ) |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | ||
Schedule of Inventories | Inventories consist of the following at: September 30, 2019 December 31, 2018 Finished goods $ 35,165 $ 46,261 Consigned inventory — 135,635 Parts and components 419,214 149,253 454,379 331,149 Less: excess and obsolete inventory reserves — (24,000 ) Less: consigned inventory reserves — (51,000 ) Inventories, net $ 454,379 $ 256,149 | Inventories consist of the following at December 31: 2018 2017 Finished goods $ 146,640 $ 122,000 Consigned inventory 135,635 97,980 Parts and components 48,874 23,530 331,149 243,510 Less: excess and obsolete inventory reserves (24,000 ) (23,739 ) Less: consigned inventory reserves (51,000 ) (18,616 ) Inventories, net $ 256,149 $ 201,155 |
Equipment (Tables)
Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Equipment | Equipment consists of the following at December 31: 2018 2017 Computer equipment $ 76,424 $ 32,257 Sales demonstration units 155,293 54,003 R&D tools and molds 52,644 22,650 Furniture and fixtures 3,270 — 287,631 108,910 Less: accumulated depreciation (100,118 ) (31,760 ) Equipment, net $ 187,513 $ 77,150 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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, 2019 were as follows: In Active Markets for Identical Assets or Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) September 30, 2019 Total Cash equivalents $ 3,828,167 $ — $ — $ 3,828,167 Derivative liabilities $ — $ — $ 43,942 $ 43,942 | Cash equivalents and derivative liabilities (see Note 10) measured at fair value on a recurring basis at December 31, 2018 were as follows: In Active Significant Significant December 31, Cash equivalents $ 6,037,456 — — $ 6,037,456 Common stock warrant liabilities — — $ 3,661 $ 3,661 Cash equivalents and derivative liabilities (see Note 10) measured at fair value on a recurring basis at December 31, 2017 were as follows: In Active Significant Significant December 31, Cash equivalents $ 10,459,435 — — $ 10,459,435 Common stock warrant liabilities — — $ 39,930 $ 39,930 |
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 nine months ended September 30, 2019: Common stock warrant liability Balance – January 1, 2019 $ 3,661 Issuance of warrants 196,236 Change in fair value of derivative liabilities (155,955 ) Balance – September 30, 2019 $ 43,942 | The following table presents the fair value reconciliation of Level 3 liabilities measured at fair value during the year ended December 31, 2018 and 2017: Common stock warrant liability Balance – January 1, 2017 $ — Fair value of common stock warrant issued 156,725 Change in fair value of derivative liabilities (116,795 ) Balance – December 31, 2017 39,930 Change in fair value of derivative liabilities (36,269 ) Balance – December 31, 2018 $ 3,661 |
Warrants [Member] | ||
Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured | Assumptions utilized in the valuation of the June 2017 Warrant, for the nine months ended September 30, 2019, were as follows: Risk-free interest rate 1.59 % Expected life 2.69 Expected volatility of underlying stock 66.20 % Expected dividend yield — Assumptions utilized in the valuation of the February 2019 Warrant for the nine months ended September 30, 2019, were as follows: Risk-free interest rate 1.56 % Expected life 3.36 Expected volatility of underlying stock 64.01 % Expected dividend yield — | |
Significant Unobservable Inputs (Level 3) [Member] | ||
Schedule of Fair Value Assumptions | Assumptions utilized in the valuation of Level 3 liabilities at December 31, were as follows: 2018 2017 Risk-free interest rate 2.51 % 2.20 % Expected life 3.44 years 4.44 years Expected volatility of underlying stock 62 % 63 % Expected dividend yield — — |
Stock Award Plans and Stock-b_2
Stock Award Plans and Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | ||
Summary of Stock Option Activity | Stock option activity under the Stock Option Plans during the years ended December 31, 2018 and 2017 is as follows: Shares Weighted Weighted Intrinsic Balance at January 1, 2017 246,344 $ 0.5133 7.10 $ 132,121 Granted 210,600 2.6568 Forfeited or cancelled (7,855 ) 0.9717 Exercised (80,085 ) 0.3366 Balance at December 31, 2017 369,004 1.7652 8.65 $ 732,399 Granted 375,186 3.0700 Forfeited or cancelled (13,632 ) 3.1100 Expired (5,642 ) 1.6900 Exercised (1,172 ) 3.8700 Balance at December 31, 2018 723,744 $ 2.4200 8.51 $ 157,260 Options exercisable at December 31, 2017 141,847 $ 0.6906 5.68 $ 99,879 Options exercisable at December 31, 2018 336,718 $ 1.9500 7.74 $ 141,506 | |
Schedule of Grant Date Fair Value | The assumptions underlying the calculation of grant date fair value per share are as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, 2019 2018 2019 2018 Number of options granted 4,500 41,000 181,000 278,000 Weighted-average expected volatility 63.45 % 60%-61 % 62.56 % 60%-62 % Weighted-average risk-free interest rate 1.90 % 2.73%-2.78 % 2.16 % 2.73%-3.04 % Weighted-average expected option term (in years) 6.25 6.25 6.46 6.25-9.92 Weighted-average dividend yield — % — % — % — % Weighted-average fair value per share of grants $ 0.46 $ 1.43 $ 0.64 $ 2.02 | The assumptions underlying the calculation of grant date fair value are as follows: 2018 2017 Volatility 60.00%-61.96% 62.71%-80.00% Risk-free interest rate 2.65%-3.17% 0.58%-2.29% Weighted-average expected option term (in years) 6.25-9.92 5.75-6.25 Dividend yield — % — % |
Summary of Restricted Stock Activity | Restricted stock activity for the years ended December 31, 2018 and 2017 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as January 1, 2017 — $ — — Awarded 46,500 6.75 Vested (312 ) 6.75 Canceled (2,000 ) 6.75 Outstanding as December 31, 2017 44,188 6.75 6.75 Awarded 55,092 3.27 Vested (61,011 ) 4.83 Canceled — — Outstanding as of December 31, 2018 38,269 $ 4.80 1.39 | |
Summary of Restricted Stock Unit Activity | Restricted stock unit activity for the year ended December 31, 2018 is summarized below: Number of Shares Weighted average grant date fair value Weighted average remaining contractual life (in years) Outstanding as of January 1, 2018 — — — Awarded 103,723 3.56 Vested (65,598 ) 3.68 Canceled — 3.35 Outstanding as of December 31, 2018 38,125 3.35 1.49 | |
Schedule of Stock-based Compensation Expense | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees, Three Months Ended Nine Months Ended 2019 2018 2019 2018 Research and development $ 29,100 $ 24,241 $ 94,550 $ 77,528 Selling, general and administrative 117,851 126,640 645,754 565,433 Total $ 146,951 $ 150,881 $ 740,304 $ 642,961 | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees 2018 2017 Research and development $ 103,457 $ 12,382 Selling, general and administrative 711,209 267,126 Total $ 814,666 $ 279,508 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Warrants and Rights Note Disclosure [Abstract] | |
Summary of Common Stock Warrants Activity | The following table presents the Company’s common stock warrant activity for the years ended December 31, 2018 and 2017: Warrants Weighted Average Exercise Price Outstanding Exercisable Outstanding Exercisable Balance, Jan 1, 2017 8,228 8,228 $ 6.47 $ 6.47 Issued 6,304,015 6,220,515 3.84 3.85 Exercised (34,800 ) (34,800 ) 2.95 2.95 Balance, Dec 31, 2017 6,277,443 6,193,943 3.85 3.86 Previously issued warrants which became exercisable — 83,500 2.40 2.40 Issued — — — — Exercised (1,205,556 ) (1,205,556 ) 2.95 2.95 Balance, Dec 31, 2018 5,071,887 5,071,887 $ 4.05 $ 4.05 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Amounts Due under Agreement | The future minimum amounts due under this agreement for the next five years are as follows: 2019 $ 25,000 2020 25,000 2021 25,000 2022 25,000 2023 (year patents expire) 25,000 |
Summary of Changes in Warranty Liability | Changes in warranty liability were as follows: 2018 2017 Accrued warranty liability, beginning of year $ 50,725 $ 63,147 Accrual provided for warranties issued during the period 23,452 14,867 Adjustments to prior accruals 38,382 570 Actual warranty expenditures (20,559 ) (27,859 ) Accrued warranty liability, end of year $ 92,000 $ 50,725 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Summary of Tax Provision (Benefit) | The income tax provision (benefit) for the years ended December 31, 2018 and 2017 consist of the following: 12/31/18 12/31/17 U.S. federal Current $ — $ — Deferred (2,065,000 ) (534,000 ) State and local Current — — Deferred (571,000 ) (538,000 ) (2,636,000 ) (1,072,000 ) Deferred tax expense related to tax law change — 2,909,000 Change in valuation allowance 2,636,000 (1,837,000 ) Income tax provision $ — $ — |
Summary of Reconciliation between U.S. Statutory Federal Income Tax Rate and Effective Rate | The reconciliation between the U.S statutory federal income tax rate and the Company’s effective rate for the years ended December 31, 2018 and 2017 is as follows: 12/31/18 12/31/17 U.S. federal statutory rate 21.00 % 34.00 % State income taxes, net of federal benefit 5.57 % 4.67 % Federal rate change, deferred items — % (23.03 )% State rate change and other (0.03 )% 0.89 % Non-deductible — % (17.67 )% Federal NOLs to expire unutilized due to sec 382 limitation — % (14.02 )% Other permanent items (0.98 )% (0.03 )% Change in valuation allowance (25.56 )% 15.19 % Effective rate — % — % |
Summary of Deferred Tax Assets | As of December 31, 2018, and 2017, the Company’s deferred tax assets consisted of the effects of temporary differences attributable to the following: 12/31/18 12/31/17 Net operating loss carryover $ 8,378,000 $ 5,925,000 Tax credits 178,000 190,000 Stock-based compensation 27,000 53,000 Other 440,000 219,000 Total deferred tax asset 9,023,000 6,387,000 Less: valuation allowance (9,023,000 ) (6,387,000 ) Deferred tax asset, net of valuation allowance $ — $ — |
Description of Business - Addit
Description of Business - Additional Information (Detail) - USD ($) | Dec. 06, 2017 | Dec. 04, 2017 | Jun. 09, 2017 | Mar. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Initial public offering raising amount | $ 5,603,829 | $ 4,368,315 | [1] | ||||||
Aggregate proceeds offering expenses | $ 2,922,885 | ||||||||
Authorized issue of shares | 125,000,000 | ||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | |||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||
Preferred stock, shares authorized | 25,000,000 | 25,000,000 | 25,000,000 | ||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
Warrants to purchase common stock outsatanding | 5,071,887 | 6,277,443 | 8,228 | ||||||
Common Stock [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Other offering expenses | $ 1,061,157 | ||||||||
Sale of stock | 665,498 | ||||||||
Stock issued during period | 4,542,500 | ||||||||
IPO [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Initial public offering raising amount | $ 4,991,235 | ||||||||
Other offering expenses | $ 1,061,157 | ||||||||
Sale of stock | 665,498 | ||||||||
Sale of common stock price per share | $ 7.50 | ||||||||
IPO [Member] | Common Stock [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Stock issued during period | 665,498 | ||||||||
Private Placement [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Other offering expenses | $ 2,500 | ||||||||
Sale of stock | 557,216 | ||||||||
Sale of common stock price per share | $ 5.25 | ||||||||
Share unit, description | Each unit consisted of one share of common stock and a three-year warrant to purchase one share of common stock exercisable for $7.50 per share. | ||||||||
Common stock warrants, exercise price per share | $ 7.50 | ||||||||
Warrant expiration period | 3 years | ||||||||
Aggregate proceeds offering expenses | $ 2,925,385 | ||||||||
FPO [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Warrants to purchase common stock | 4,175,000 | ||||||||
Warrants to purchase common stock outsatanding | 3,560,894 | ||||||||
Warrant expiration date | Dec. 4, 2022 | ||||||||
FPO [Member] | Common Stock [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Sale of common stock price per share | $ 2.40 | ||||||||
Common stock warrants, exercise price per share | $ 2.95 | ||||||||
Stock issued during period | 4,175,000 | ||||||||
FPO [Member] | Common Stock and Warrants [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Sale of common stock price per share | $ 2.40 | ||||||||
Stock issued during period | 626,250 | ||||||||
Over-allotment Option [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Other offering expenses | $ 1,115,000 | ||||||||
Warrants to purchase common stock | 4,801,250 | 4,801,250 | |||||||
Warrant expiration date | Dec. 4, 2022 | ||||||||
Stock issued during period | 4,801,250 | 4,801,250 | |||||||
Proceeds from sale of common stock | $ 11,523,000 | ||||||||
Over-allotment Option [Member] | Common Stock [Member] | |||||||||
Organization Consolidation and Presentation of Financial Statements [Line Items] | |||||||||
Common stock warrants, exercise price per share | $ 2.95 | ||||||||
Stock issued during period | 4,801,250 | ||||||||
[1] | IPO gross proceeds of $4,991,236 are reduced by $622,921 of IPO offering costs that were incurred in 2017. Another $438,237 of IPO deferred offering costs were paid for in 2016. |
Going Concern and Management'_2
Going Concern and Management's Plan - Additional Information (Detail) - USD ($) | Oct. 22, 2019 | Jul. 02, 2018 | Feb. 28, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 |
Going Concern and Managements Liquidity Plan [Line Items] | ||||||||||||||
Net loss | $ 2,788,118 | $ 2,565,327 | $ 2,598,060 | $ 2,649,822 | $ 2,629,561 | $ 2,345,402 | $ 7,951,505 | $ 7,624,785 | $ 10,316,739 | $ 12,097,479 | ||||
Accumulated deficit | $ 53,364,478 | 53,364,478 | 45,289,526 | 34,972,787 | $ 45,412,973 | |||||||||
Cash used in operating activities | $ 7,697,702 | $ 7,093,299 | $ 9,606,310 | 6,153,419 | ||||||||||
Proceeds from FPO, net of offering costs | $ 5,600,000 | $ 10,407,706 | ||||||||||||
Maximum [Member] | ||||||||||||||
Going Concern and Managements Liquidity Plan [Line Items] | ||||||||||||||
Aggregate public offering price | $ 75,000,000 | |||||||||||||
Maximum [Member] | Sales Agreement with B. Riley FBR, Inc. [Member] | ||||||||||||||
Going Concern and Managements Liquidity Plan [Line Items] | ||||||||||||||
At-the-market offering price | $ 15,000,000 | |||||||||||||
At-the-market offering, agent's commission as percent | 3.00% | |||||||||||||
Subsequent Event [Member] | ||||||||||||||
Going Concern and Managements Liquidity Plan [Line Items] | ||||||||||||||
Proceeds from FPO, net of offering costs | $ 5,600,000 | |||||||||||||
Subsequent Event [Member] | Chicago Venture Partners [Member] | Term Loan [Member] | ||||||||||||||
Going Concern and Managements Liquidity Plan [Line Items] | ||||||||||||||
Proceeds from term loan | $ 3,000,000 | |||||||||||||
Proposed repayment of term loan including original issue discount | $ 3,300,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents [Abstract] | |||||
Cash and cash equivalents | $ 4,328,355 | $ 6,540,794 | $ 12,959,373 | ||
Restricted cash | 75,000 | 75,000 | 52,000 | ||
Total cash, cash equivalents, and restricted cash | $ 4,403,355 | $ 6,615,794 | $ 9,168,412 | $ 13,011,373 | $ 849,174 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Allowance for doubtful accounts | $ 0 | |||||
Equipment estimated useful lives | 3 years | |||||
Impairment charges | $ 0 | 0 | ||||
Grant income recognized | $ 64,600 | 118,100 | ||||
Measurement of tax benefit, minimum likelihood of the largest amount being realized upon ultimate resolution | 50.00% | |||||
Stock-based compensation expense | $ 146,951 | $ 150,881 | $ 740,304 | $ 642,961 | $ 814,666 | 279,508 |
Advertising expense | 136,300 | 31,000 | ||||
Adoption of ASC 606 [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Cumulative adjustment to equity | 123,000 | 123,000 | ||||
Grant Income [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Grant income recognized | 10,100 | 19,100 | ||||
O&P Providers or Third Party Payors [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Revenue recognized | 164,000 | 164,000 | ||||
Grant Income [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Reimbursable costs | 31,600 | 11,600 | ||||
Selling, General and Administrative [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Demonstration units, expenses | 256,700 | 26,900 | ||||
Stock-based compensation expense | 117,851 | 126,640 | 645,754 | 565,433 | 711,209 | 267,126 |
Research and Development [Member] | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Test units, expenses | 17,700 | 29,200 | ||||
Stock-based compensation expense | $ 29,100 | $ 24,241 | $ 94,550 | $ 77,528 | $ 103,457 | $ 12,382 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Accounts Payable and Other Accrued Expenses (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Trade payables | $ 346,493 | $ 426,727 | $ 264,890 |
Accrued compensation and benefits | 813,655 | 1,027,757 | 642,425 |
Accrued directors fees | 23,750 | 100,000 | |
Accrued warranty costs | 65,230 | 92,000 | |
Accrued professional fees | 102,233 | 44,660 | |
Other | 200,946 | 152,283 | 269,921 |
Total | $ 1,552,307 | 1,743,427 | $ 1,277,236 |
Previously Reported [Member] | |||
Trade payables | 426,727 | ||
Accrued compensation and benefits | 1,027,757 | ||
Other | 288,943 | ||
Total | $ 1,743,427 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Potentially Common Shares Issuable (Detail) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 6,499,675 | 5,790,964 | 5,872,025 | 6,646,447 |
Stock Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 668,785 | 626,619 | 723,744 | 369,004 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 5,435,287 | 5,071,887 | 5,071,887 | 6,277,443 |
Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 385,337 | 43,751 | 38,125 | |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 10,266 | 48,707 | 38,269 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) | Sep. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Finished goods | $ 35,165 | $ 46,261 | $ 122,000 | |
Consigned inventory | 135,635 | 97,980 | ||
Parts and components | 419,214 | 149,253 | 23,530 | |
Total cost | 454,379 | 331,149 | 243,510 | |
Less: excess and obsolete inventory reserves | (24,000) | (23,739) | ||
Less: consigned inventory reserves | (51,000) | (18,616) | ||
Inventories, net | $ 454,379 | $ 171,514 | 256,149 | $ 201,155 |
Previously Reported [Member] | ||||
Finished goods | 146,640 | |||
Consigned inventory | 135,635 | |||
Parts and components | 48,874 | |||
Total cost | 331,149 | |||
Less: excess and obsolete inventory reserves | (24,000) | |||
Less: consigned inventory reserves | (51,000) | |||
Inventories, net | $ 256,149 |
Equipment - Schedule of Equipme
Equipment - Schedule of Equipment (Detail) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | |||
Equipment, gross | $ 287,631 | $ 108,910 | |
Less: accumulated depreciation | (100,118) | (31,760) | |
Equipment, net | $ 170,330 | 187,513 | 77,150 |
Computer Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Equipment, gross | 76,424 | 32,257 | |
Sales Demonstration Units [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Equipment, gross | 155,293 | 54,003 | |
R&D Tools and Molds [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Equipment, gross | 52,644 | $ 22,650 | |
Furniture and Fixtures [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Equipment, gross | $ 3,270 |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Cash equivalents | $ 3,828,167 | $ 6,037,456 | $ 10,459,435 |
Derivative liabilities | 43,942 | 3,661 | 39,930 |
In Active Markets for Identical Assets or Liabilities (Level 1) [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Cash equivalents | 3,828,167 | 6,037,456 | 10,459,435 |
Significant Unobservable Inputs (Level 3) [Member] | |||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Derivative liabilities | $ 43,942 | $ 3,661 | $ 39,930 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Fair Value Reconciliation of Level 3 Liabilities Measured (Detail) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |||
Beginning balance | $ 3,661 | $ 39,930 | |
Issuance of warrants | 196,236 | $ 156,725 | |
Change in fair value of derivative liabilities | (155,955) | (36,269) | (116,795) |
Ending balance | $ 43,942 | $ 3,661 | $ 39,930 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Schedule of Assumptions Utilized in Valuation of Level 3 Liabilities (Detail) | Dec. 31, 2018yr | Dec. 31, 2017yr |
Risk-free Interest Rate [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Fair value assumptions | 0.0251 | 0.0220 |
Expected Life [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Fair value assumptions | 3.44 | 4.44 |
Expected Volatility of Underlying Stock [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Fair value assumptions | 0.62 | 0.63 |
Expected Dividend Yield [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Fair value assumptions | 0 | 0 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | Jul. 02, 2018 | Dec. 06, 2017 | Dec. 04, 2017 | Nov. 13, 2017 | Jun. 09, 2017 | Feb. 28, 2019 | Jun. 30, 2017 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | ||||||||||||||||||
Aggregate proceeds offering expenses | $ 2,922,885 | |||||||||||||||||
Sale of stock on a private placement , description | The Company concurrently closed on a private placement pursuant to which it sold to accredited investors an aggregate of 557,216 units at $5.25 per unit, for aggregate proceeds of $2,925,385, before offering expenses of $2,500. Each unit consists of one share of common stock and a three-year warrant to purchase one share of common stock exercisable for $7.50 per share. | |||||||||||||||||
Authorized issue of shares | 125,000,000 | |||||||||||||||||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | |||||||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||
Preferred stock, shares authorized | 25,000,000 | 25,000,000 | 25,000,000 | |||||||||||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||
Warrants to purchase common stock outsatanding | 5,071,887 | 6,277,443 | 8,228 | |||||||||||||||
Common stock issued for the exercise of warrants | $ 5,901 | $ 3,550,490 | $ 3,556,391 | $ 102,660 | ||||||||||||||
Repayment of outstanding principal and accrued interest | $ 1,081,135 | $ 1,215,900 | ||||||||||||||||
Common stock shares issued | 17,189,737 | 17,189,737 | 12,450,187 | 11,139,667 | ||||||||||||||
Fair value of stock issued | $ 5,603,829 | |||||||||||||||||
Common stock issued for the exercise of common stock options, Shares | 9,928 | 1,172 | 80,085 | |||||||||||||||
Proceeds from exercise of stock options | $ 16 | $ 2 | $ 2 | $ 26,954 | ||||||||||||||
Net withheld for employee taxes | 3,015 | 7,032 | 45,459 | 1,653 | 1,692 | 17,570 | 22,819 | |||||||||||
Net proceeds from issuance of common stock | $ 5,600,000 | $ 10,407,706 | ||||||||||||||||
Underwriter Warrants [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock warrants, exercise price per share | $ 1.75 | $ 1.75 | ||||||||||||||||
Warrants to purchase common stock | 363,400 | 363,400 | ||||||||||||||||
80% of Share Price on Repayment Date [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common Stock Share price per share | $ 5.03 | |||||||||||||||||
Common stock shares issued | 107,505 | |||||||||||||||||
20% Share Price on Repayment Date [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common Stock Share price per share | $ 6.29 | |||||||||||||||||
Common stock shares issued | 86,004 | |||||||||||||||||
Common Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock raising | $ 4,991,235 | |||||||||||||||||
Other offering expenses | $ 1,061,157 | |||||||||||||||||
Sale of stock | 665,498 | |||||||||||||||||
Sale of stock price per share | $ 7.50 | |||||||||||||||||
Convertible common stock, shares | 1,055,430 | |||||||||||||||||
Stock issued during period | 4,542,500 | |||||||||||||||||
Common stock issued for the exercise of warrants, shares | 2,000 | 1,203,556 | 1,205,556 | 34,800 | ||||||||||||||
Common stock issued for the exercise of warrants | $ 1 | $ 120 | $ 121 | $ 3 | ||||||||||||||
Shares issued for services | 4,000 | |||||||||||||||||
Fair value of stock issued | $ 454 | |||||||||||||||||
Common stock issued for the exercise of common stock options, Shares | 1,074 | 8,854 | 1,172 | 1,172 | 80,085 | |||||||||||||
Proceeds from exercise of stock options | $ 2 | $ 26,954 | ||||||||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 41,837 | 22,344 | 95,001 | 3,971 | 3,934 | 31,152 | 42,781 | |||||||||||
Net withheld for employee taxes | 7,135 | 10,369 | 10,436 | 17,102 | 937 | 32,540 | 61,011 | 312 | ||||||||||
Restricted Stock Units [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Net withheld for employee taxes | 55,506 | |||||||||||||||||
Number of shares, Vested | 159,182 | 65,598 | ||||||||||||||||
Restricted Stock Units [Member] | Common Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 42,781 | |||||||||||||||||
Net withheld for employee taxes | 22,819 | |||||||||||||||||
Restricted Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock issued upon vesting of restricted stock units, Shares | 61,011 | 312 | ||||||||||||||||
Number of shares, Vested | 27,940 | 61,011 | 312 | |||||||||||||||
Investor [Member] | Common Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued for services | 4,000 | |||||||||||||||||
Fair value of stock issued | $ 30,000 | |||||||||||||||||
Convertible Debt [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Accrued but unpaid interest, total | $ 5,467,389 | |||||||||||||||||
Convertible common stock, shares | 1,055,430 | |||||||||||||||||
Weighted average price per share | $ 5.18 | |||||||||||||||||
Private Placement [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Other offering expenses | $ 2,500 | |||||||||||||||||
Sale of stock | 557,216 | |||||||||||||||||
Common Stock Share price per share | $ 5.25 | |||||||||||||||||
Aggregate proceeds offering expenses | $ 2,925,385 | |||||||||||||||||
Warrant expiration period | 3 years | |||||||||||||||||
Common stock warrants, exercise price per share | $ 7.50 | |||||||||||||||||
Share unit, description | Each unit consists of one share of common stock and a three-year warrant to purchase one share of common stock exercisable for $7.50 per share. | |||||||||||||||||
FPO [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants to purchase common stock | 4,175,000 | |||||||||||||||||
Warrants to purchase common stock outsatanding | 3,560,894 | |||||||||||||||||
Warrant expiration date | Dec. 4, 2022 | |||||||||||||||||
Common stock issued for the exercise of warrants, shares | 34,800 | |||||||||||||||||
Common stock issued for the exercise of warrants | $ 102,660 | |||||||||||||||||
FPO [Member] | Common Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common Stock Share price per share | $ 2.40 | |||||||||||||||||
Common stock warrants, exercise price per share | $ 2.95 | |||||||||||||||||
Stock issued during period | 4,175,000 | |||||||||||||||||
FPO [Member] | Common Stock and Warrants [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common Stock Share price per share | $ 2.40 | |||||||||||||||||
Stock issued during period | 626,250 | |||||||||||||||||
Over-allotment Option [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Other offering expenses | $ 1,115,000 | |||||||||||||||||
Stock issued during period | 4,801,250 | 4,801,250 | ||||||||||||||||
Warrants to purchase common stock | 4,801,250 | 4,801,250 | ||||||||||||||||
Warrant expiration date | Dec. 4, 2022 | |||||||||||||||||
Proceeds from sale of common stock | $ 11,523,000 | |||||||||||||||||
Fair value of stock issued | $ 10,407,706 | |||||||||||||||||
Over-allotment Option [Member] | Common Stock [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock warrants, exercise price per share | $ 2.95 | |||||||||||||||||
Stock issued during period | 4,801,250 | |||||||||||||||||
Fair value of stock issued | $ 480 | |||||||||||||||||
Underwritten Public Offering [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Stock issued during period | 4,542,500 | |||||||||||||||||
Net proceeds from issuance of common stock | $ 5,604,000 | |||||||||||||||||
Maximum [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Aggregate public offering price | $ 75,000,000 | |||||||||||||||||
Maximum [Member] | Sales Agreement with B. Riley FBR, Inc. [Member] | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
At-the-market offering price | $ 15,000,000 | |||||||||||||||||
At-the-market offering, agent's commission as percent | 3.00% |
Treasury Stock - Additional Inf
Treasury Stock - Additional Information (Detail) (Detail) - shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Treasury Stock, Shares [Abstract] | |||
Treasury stock, common, shares | 808 | 808 | 808 |
Stock Award Plans and Stock-b_3
Stock Award Plans and Stock-based Compensation - Additional Information (Detail) - USD ($) | Jul. 09, 2018 | Jun. 19, 2018 | Jan. 03, 2018 | Jan. 02, 2018 | Aug. 15, 2017 | Oct. 25, 2016 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 | Apr. 01, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Income tax benefit recognized | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||||
weighted-average grant date fair value per share | $ 0.46 | $ 1.43 | $ 0.64 | $ 2.02 | $ 1.77 | $ 1.62 | ||||||||
Number of shares, granted | 6,304,015 | |||||||||||||
Common Stock [Member] | Board Of Directors [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Number of shares, granted | 39,864 | 15,228 | ||||||||||||
Compensation expense | $ 60,000 | |||||||||||||
Minimum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 4 years | |||||||||||||
Maximum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 10 years | |||||||||||||
Restricted Stock [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Number of shares granted | 46,500 | |||||||||||||
Aggregate fair market value on the date of grant | $ 313,900 | |||||||||||||
Compensation expense | $ 123,000 | |||||||||||||
Number of shares, granted | 55,092 | 46,500 | ||||||||||||
Unrecognized compensation cost | $ 61,500 | $ 61,500 | $ 164,300 | |||||||||||
Weighted-average remaining contractual term | 1 year 2 months 12 days | 1 year 4 months 20 days | ||||||||||||
Restricted Stock [Member] | Minimum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 5 months | |||||||||||||
Restricted Stock [Member] | Maximum [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 4 years | |||||||||||||
Restricted Stock Units [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Compensation expense | $ 242,551 | |||||||||||||
Number of shares, granted | 88,723 | 103,723 | ||||||||||||
Provisions for lapsing forfeiture rights extended period | 24 months | |||||||||||||
Restricted Stock Units subject to forfeiture | 23,123 | |||||||||||||
Unrecognized compensation cost | 323,200 | $ 323,200 | $ 116,800 | |||||||||||
Weighted-average remaining contractual term | 1 year 7 months 17 days | 1 year 5 months 26 days | ||||||||||||
Restricted Stock Units [Member] | Officer [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Vesting period | 4 years | |||||||||||||
Restricted Stock Units [Member] | Officer [Member] | Vest in Full on the First Anniversary [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Number of shares, granted | 5,000 | |||||||||||||
Restricted Stock Units [Member] | Officer [Member] | Vest Over Four Years [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Number of shares, granted | 10,000 | |||||||||||||
Stock Option [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Unrecognized compensation cost | $ 288,600 | $ 288,600 | $ 586,600 | |||||||||||
Weighted-average remaining contractual term | 2 years 5 months 23 days | 2 years 1 month 28 days | ||||||||||||
2016 Equity Incentive Plan [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||
Number of shares available for future grant | 86,119 | |||||||||||||
Additional awards granted | 0 | |||||||||||||
Number of common shares reserved for issuance | 562,500 | |||||||||||||
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 | 706,119 | 505,153 | ||||||||||||
Number of common shares reserved for issuance | 620,000 | |||||||||||||
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 - Summary of Stock Option Activity (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Payment Arrangement [Abstract] | |||||||
Shares, Beginning balance | 723,744 | 369,004 | 369,004 | 246,344 | |||
Shares, Granted | 4,500 | 41,000 | 181,000 | 278,000 | 375,186 | 210,600 | |
Shares, Forfeited or cancelled | (13,632) | (7,855) | |||||
Shares, Expired | (5,642) | ||||||
Shares, Exercised | (9,928) | (1,172) | (80,085) | ||||
Shares, Ending balance | 723,744 | 369,004 | 246,344 | ||||
Weighted average exercise price, Beginning balance | $ 2.4200 | $ 1.7652 | $ 1.7652 | $ 0.5133 | |||
Shares, Options exercisable | 336,718 | 141,847 | |||||
Weighted average exercise price, Granted | $ 3.0700 | $ 2.6568 | |||||
Weighted average exercise price, Forfeited or cancelled | 3.1100 | 0.9717 | |||||
Weighted average exercise price, Expired | 1.6900 | ||||||
Weighted average exercise price, Exercised | 3.8700 | 0.3366 | |||||
Weighted average exercise price, Ending balance | 2.4200 | 1.7652 | $ 0.5133 | ||||
Weighted average exercise price, Options exercisable | $ 1.9500 | $ 0.6906 | |||||
Weighted average remaining life | 8 years 6 months 3 days | 8 years 7 months 24 days | 7 years 1 month 6 days | ||||
Weighted average remaining life, Options exercisable | 7 years 8 months 26 days | 5 years 8 months 4 days | |||||
Intrinsic value, Beginning balance | $ 157,260 | $ 732,399 | $ 132,121 | ||||
Intrinsic value, Options exercisable | $ 141,506 | $ 99,879 |
Stock Award Plans and Stock-b_5
Stock Award Plans and Stock-based Compensation - Schedule of Grant Date Fair Value (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Option Indexed to Issuer's Equity [Line Items] | ||||||
Dividend yield | 0.00% | 0.00% | ||||
Number of options granted | 4,500 | 41,000 | 181,000 | 278,000 | 375,186 | 210,600 |
Weighted-average expected volatility | 63.45% | 62.56% | ||||
Weighted-average fair value per share of grants | $ 0.46 | $ 1.43 | $ 0.64 | $ 2.02 | $ 1.77 | $ 1.62 |
Weighted-average risk-free interest rate | 1.90% | 2.16% | ||||
Weighted-average expected option term (in years) | 6 years 3 months | 6 years 3 months | 6 years 5 months 15 days | |||
Minimum [Member] | ||||||
Option Indexed to Issuer's Equity [Line Items] | ||||||
Weighted-average expected volatility | 60.00% | 60.00% | 60.00% | 62.71% | ||
Weighted-average risk-free interest rate | 2.73% | 2.73% | 2.65% | 0.58% | ||
Weighted-average expected option term (in years) | 6 years 3 months | 6 years 3 months | 5 years 9 months | |||
Maximum [Member] | ||||||
Option Indexed to Issuer's Equity [Line Items] | ||||||
Weighted-average expected volatility | 61.00% | 62.00% | 61.96% | 80.00% | ||
Weighted-average risk-free interest rate | 2.78% | 3.04% | 3.17% | 2.29% | ||
Weighted-average expected option term (in years) | 9 years 11 months 1 day | 9 years 11 months 1 day | 6 years 3 months |
Stock Award Plans and Stock-b_6
Stock Award Plans and Stock-based Compensation - Summary of Restricted Stock Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, Awarded | 6,304,015 | ||
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares outstanding, beginning balance | 38,269 | 44,188 | 0 |
Number of shares, Awarded | 55,092 | 46,500 | |
Number of shares, Vested | (27,940) | (61,011) | (312) |
Number of shares, Canceled | 2,000 | ||
Number of shares outstanding, ending balance | 38,269 | 44,188 | |
Weighted average grant date fair value outstanding, beginning balance | $ 4.80 | $ 6.75 | |
Weighted average grant date fair value, Awarded | 3.27 | $ 6.75 | |
Weighted average grant date fair value, Vested | 4.83 | 6.75 | |
Weighted average grant date fair value, Canceled | 6.75 | ||
Weighted average grant date fair value outstanding, ending balance | $ 4.80 | $ 6.75 | |
Weighted average remaining contractual life | 1 year 4 months 20 days | 6 years 9 months |
Stock Award Plans and Stock-b_7
Stock Award Plans and Stock-based Compensation - Summary of Restricted Stock Unit Activity (Detail) - $ / shares | Jan. 02, 2018 | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares, Awarded | 6,304,015 | |||
Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares outstanding, beginning balance | 38,125 | |||
Number of shares, Awarded | 88,723 | 103,723 | ||
Number of shares, Vested | (159,182) | (65,598) | ||
Number of shares, Canceled | 0 | |||
Number of shares outstanding, ending balance | 38,125 | |||
Weighted average grant date fair value outstanding, beginning balance | $ 3.35 | $ 0 | ||
Weighted average grant date fair value, Awarded | 3.56 | |||
Weighted average grant date fair value, Vested | 3.68 | |||
Weighted average grant date fair value, Canceled | 3.35 | |||
Weighted average grant date fair value outstanding, ending balance | $ 3.35 | $ 0 | ||
Weighted average remaining contractual life | 1 year 5 months 26 days |
Stock Award Plans and Stock-b_8
Stock Award Plans and Stock-based Compensation - Schedule of Stock-based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total share based compensation expense | $ 146,951 | $ 150,881 | $ 740,304 | $ 642,961 | $ 814,666 | $ 279,508 |
Research and Development [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total share based compensation expense | 29,100 | 24,241 | 94,550 | 77,528 | 103,457 | 12,382 |
Selling, General and Administrative [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total share based compensation expense | $ 117,851 | $ 126,640 | $ 645,754 | $ 565,433 | $ 711,209 | $ 267,126 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - USD ($) | Feb. 08, 2019 | Dec. 06, 2017 | Dec. 04, 2017 | Jun. 09, 2017 | Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding purchase of common stock, Shares | 557,216 | ||||||||
Warrants exercisable price per share | $ 7.50 | ||||||||
Warrants to purchase common stock outsatanding | 5,071,887 | 6,277,443 | 8,228 | ||||||
Exercise price of warrants | $ 1.40 | ||||||||
Weighted average remaining life, Options exercisable | 7 years 8 months 26 days | 5 years 8 months 4 days | |||||||
June 2017 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Fair value of the warrants derivative liability | $ 156,725 | $ 3,700 | $ 39,930 | $ 300 | |||||
Warrants are fully vested, exercise price | $ 8.25 | ||||||||
Common Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Stock issued during period | 4,542,500 | ||||||||
Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Weighted average remaining life, Options exercisable | 3 years 2 months 23 days | ||||||||
February 2019 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Fair value of the warrants derivative liability | $ 196,000 | $ 43,600 | |||||||
Warrants are fully vested, exercise price | $ 1.75 | ||||||||
IPO [Member] | June 2017 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants years of life | 5 years | ||||||||
IPO [Member] | February 2019 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants years of life | 4 years | ||||||||
IPO [Member] | 2016 Convertible Promissory Notes [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants years of life | 3 years | ||||||||
IPO Selling Agent [Member] | June 2017 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Purchase of warrants issued | 33,275 | ||||||||
IPO Selling Agent [Member] | February 2019 Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Purchase of warrants issued | 363,400 | ||||||||
FPO [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Purchase of warrants issued | 4,175,000 | ||||||||
Warrant expiration date | Dec. 4, 2022 | ||||||||
Warrants to purchase common stock | 4,175,000 | ||||||||
Warrants to purchase common stock outsatanding | 3,560,894 | ||||||||
FPO [Member] | Common Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Common stock warrants, exercise price per share | $ 2.95 | ||||||||
Stock issued during period | 4,175,000 | ||||||||
FPO [Member] | Common Stock and Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Stock issued during period | 626,250 | ||||||||
Over-allotment Option [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrant expiration date | Dec. 4, 2022 | ||||||||
Stock issued during period | 4,801,250 | 4,801,250 | |||||||
Warrants to purchase common stock | 4,801,250 | 4,801,250 | |||||||
Over-allotment Option [Member] | Common Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Common stock warrants, exercise price per share | $ 2.95 | ||||||||
Stock issued during period | 4,801,250 | ||||||||
Underwriters Follow on Public Offering [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants years of life | 3 years | ||||||||
Purchase of warrants issued | 83,500 | ||||||||
Warrants are fully vested, exercise price | $ 2.40 |
Warrants - Summary of Common St
Warrants - Summary of Common Stock Warrants Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Equity [Abstract] | ||
Warrants outstanding, beginning balance | 6,277,443 | 8,228 |
Warrants exercisable, previously issued warrants which became exerciseable | 83,500 | |
Weighted average exercise price outstanding, previously issued warrants which became exerciseable | $ 2.40 | |
Weighted average exercise price exercisable, previously issued warrants which became exerciseable | $ 2.40 | |
Warrants outstanding, issued | 6,304,015 | |
Warrants outstanding, exercised | (1,205,556) | (34,800) |
Warrants outstanding, ending balance | 5,071,887 | 6,277,443 |
Warrants exercisable, beginning balance | 6,193,943 | 8,228 |
Warrants exercisable, issued | 6,220,515 | |
Warrants exercisable, exercised | (1,205,556) | (34,800) |
Warrants exercisable, ending balance | 5,071,887 | 6,193,943 |
Weighted average exercise price outstanding, beginning balance | $ 3.85 | $ 6.47 |
Weighted average exercise price outstanding, issued | 3.84 | |
Weighted average exercise price outstanding, exercised | 2.95 | 2.95 |
Weighted average exercise price outstanding, ending balance | 4.05 | 3.85 |
Weighted average exercise price exercisable, beginning balance | 3.86 | 6.47 |
Weighted average exercise price exercisable, issued | 3.85 | |
Weighted average exercise price exercisable, exercised | 2.95 | 2.95 |
Weighted average exercise price exercisable, ending balance | $ 4.05 | $ 3.86 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | Dec. 04, 2017 | Jun. 09, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Related Party Transaction [Line Items] | ||||||
Revenue recognized from related party | $ 26,000 | $ 306,200 | $ 306,200 | $ 53,500 | ||
Due for related parties | 0 | |||||
Accounts receivable | 0 | 0 | 77,600 | |||
Charges for services | 338,200 | $ 397,300 | 530,300 | 356,400 | ||
Accounts payable and accrued expenses | $ 49,200 | 54,000 | $ 65,800 | |||
Private Placement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Common stock warrants, exercise price per share | $ 7.50 | |||||
Previously Reported [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Accounts payable and accrued expenses | $ 54,300 | |||||
Directors And Officers [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Stock issued during period | 285,000 | 14,000 | ||||
Share price | $ 2.40 | $ 7.50 | ||||
Warrants to purchase common stock | 285,000 | |||||
Common stock warrants, exercise price per share | $ 2.95 | |||||
Directors And Officers [Member] | Private Placement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Stock issued during period | 125,238 | |||||
Share price | $ 5.25 | |||||
Warrants to purchase common stock | 125,238 | |||||
Common stock warrants, exercise price per share | $ 7.50 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Dec. 29, 2017shares | Feb. 28, 2019USD ($) | Sep. 30, 2019Customer | Sep. 30, 2018Customer | Dec. 31, 2018USD ($)Customershares | Dec. 31, 2017USD ($)Customer | Dec. 31, 2016 |
Commitments And Contingencies [Line Items] | |||||||
Rent expense | $ 352,800 | $ 221,200 | |||||
Proceeds from issuance of common stock | $ 5,600,000 | $ 10,407,706 | |||||
Product warranty period | 3 years | 1 year | |||||
Sales Revenue, Net [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Number of customers | Customer | 0 | 1 | 2 | 3 | |||
Accounts Receivable [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Number of customers | Customer | 4 | 2 | 3 | ||||
Customer Concentration Risk [Member] | Sales Revenue, Net [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 25.00% | ||||||
Customer Concentration Risk [Member] | Sales Revenue, Net [Member] | One Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 23.00% | ||||||
Customer Concentration Risk [Member] | Sales Revenue, Net [Member] | Two Customers [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 17.00% | ||||||
Customer Concentration Risk [Member] | Sales Revenue, Net [Member] | Three Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 14.00% | ||||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 55.00% | ||||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | One Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 24.00% | 20.00% | |||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Two Customers [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 19.00% | 16.00% | |||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Three Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 19.00% | ||||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Four Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 19.00% | ||||||
Customer Concentration Risk [Member] | Due From Related Party [Member] | Sales Revenue, Net [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 23.00% | 13.00% | |||||
Customer Concentration Risk [Member] | Due From Related Party [Member] | Accounts Receivable [Member] | One Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 26.00% | ||||||
Customer Concentration Risk [Member] | Due From Related Party [Member] | Accounts Receivable [Member] | Two Customers [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 18.00% | ||||||
Customer Concentration Risk [Member] | Due From Related Party [Member] | Accounts Receivable [Member] | Three Customer [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Concentration risk, percentage | 11.00% | ||||||
Licensing Agreements [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Minimum sales covenant | $ 750,000 | ||||||
Licensing Agreements [Member] | MIT [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Stock issued during period | shares | 492 | 6,172 | |||||
Minimum percentage of outstanding common stock to be maintained | 1.00% | ||||||
Proceeds from issuance of common stock | $ 3,000,000 | ||||||
Licensing Agreements [Member] | Cost of Sales [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Royalty charge | $ 49,300 | $ 25,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Amounts Due under Agreement (Detail) (Detail) - Licensing Agreements [Member] | Dec. 31, 2018USD ($) |
Finite-Lived Intangible Assets [Line Items] | |
2019 | $ 25,000 |
2020 | 25,000 |
2021 | 25,000 |
2022 | 25,000 |
2023 (year patents expire) | $ 25,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Changes in Warranty Liability (Detail) (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Product Warranties Disclosures [Abstract] | ||
Accrual provided for warranties issued during the period Accrued warranty liability, beginning of year | $ 50,725 | $ 63,147 |
Accrual provided for warranties issued during the period | 23,452 | 14,867 |
Adjustments to prior accruals | 38,382 | 570 |
Actual warranty expenditures | (20,559) | (27,859) |
Accrued warranty liability, end of year | $ 92,000 | $ 50,725 |
Income Taxes - Summary of Tax P
Income Taxes - Summary of Tax Provision (Benefit) (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
U.S. federal | ||
Current | $ 0 | $ 0 |
Deferred | (2,065,000) | (534,000) |
State and local | ||
Current | 0 | 0 |
Deferred | (571,000) | (538,000) |
Total | (2,636,000) | (1,072,000) |
Deferred tax expense related to tax law change | 2,909,000 | |
Change in valuation allowance | 2,636,000 | (1,837,000) |
Income tax provision | $ 0 | $ 0 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation between U.S. Statutory Federal Income Tax Rate and Effective Rate (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | ||
U.S. federal statutory rate | 21.00% | 34.00% |
State income taxes, net of federal benefit | 5.57% | 4.67% |
Federal rate change, deferred items | (23.03%) | |
State rate change and other | (0.03%) | 0.89% |
Non-deductible interest | (17.67%) | |
Federal NOLs to expire unutilized due to sec 382 limitation | (14.02%) | |
Other permanent items | (0.98%) | (0.03%) |
Change in valuation allowance | (25.56%) | 15.19% |
Effective rate | 0.00% | 0.00% |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Components of Deferred Tax Assets [Abstract] | ||
Net operating loss carryover | $ 8,378,000 | $ 5,925,000 |
Tax credits | 178,000 | 190,000 |
Stock-based compensation | 27,000 | 53,000 |
Other | 440,000 | 219,000 |
Total deferred tax asset | 9,023,000 | 6,387,000 |
Less: valuation allowance | (9,023,000) | (6,387,000) |
Deferred tax asset, net of valuation allowance | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax [Line Items] | |||
Deferred tax liabilities | $ 0 | $ 0 | |
Net operating loss carryforwards limitations | 1,559,000 | ||
Operating loss carryforward unutilized | 5,000,000 | ||
Valuation allowance on net operating loss carryforwards | $ 1,700,000 | ||
U.S. federal statutory rate | 21.00% | 34.00% | |
Change in valuation allowance | $ (2,636,000) | $ 1,837,000 | |
Tax penalties and interest | 0 | 0 | $ 0 |
Accrued interest and penalties | 0 | $ 0 | |
Tax Liability [Member] | |||
Income Tax [Line Items] | |||
Accrued interest and penalties | $ 0 | ||
Tax Cuts and Jobs Act (TCIA) [Member] | |||
Income Tax [Line Items] | |||
U.S. federal statutory rate | 21.00% | 35.00% | |
Valuation of deferred tax assets due to change in enacted tax rate | $ 2,909,000 | ||
Federal [Member] | |||
Income Tax [Line Items] | |||
Net operating loss | $ 35,519,000 | 26,425,000 | |
Net operating loss beginning year | begin expiring in the year 2028 | ||
Federal [Member] | Tax Year 2018 [Member] | |||
Income Tax [Line Items] | |||
Net operating loss | $ 9,094,000 | ||
State [Member] | |||
Income Tax [Line Items] | |||
Net operating loss | $ 29,212,000 | $ 22,046,000 | |
Net operating loss beginning year | begin to expire in 2019 through 2027 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Oct. 22, 2019USD ($)Payment | Feb. 18, 2019Installmentshares | Feb. 12, 2019USD ($)$ / sharesshares | Jan. 01, 2019$ / sharesshares | Dec. 30, 2017$ / shares | Dec. 04, 2017$ / shares | Aug. 15, 2017shares | Feb. 28, 2019USD ($) | Dec. 31, 2017$ / shares | Sep. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2018$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares |
Subsequent Event [Line Items] | ||||||||||||
Proceeds from issuance of common stock | $ | $ 5,600,000 | $ 10,407,706 | ||||||||||
Exercise price of warrants | $ / shares | $ 1.40 | |||||||||||
Restricted Stock [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Shares of common stock granted of stock awards, aggregate fair value | shares | 46,500 | |||||||||||
Weighted average grant date fair value, Vested | $ / shares | $ 4.83 | $ 6.75 | ||||||||||
Weighted average grant date fair value, Awarded | $ / shares | $ 3.27 | $ 6.75 | ||||||||||
Restricted stock, vested | shares | 27,940 | 61,011 | 312 | |||||||||
Restricted Stock Units [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Weighted average grant date fair value, Vested | $ / shares | $ 3.68 | |||||||||||
Weighted average grant date fair value, Awarded | $ / shares | $ 3.56 | |||||||||||
Restricted stock, vested | shares | 159,182 | 65,598 | ||||||||||
2017 Warrants [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Exercise price of warrants | $ / shares | $ 2.95 | $ 1.40 | ||||||||||
Underwriter Warrants [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Warrants to purchase common stock | shares | 363,400 | |||||||||||
Common stock warrants, exercise price per share | $ / shares | $ 1.75 | |||||||||||
Subsequent Event [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Proceeds from issuance of common stock | $ | $ 5,600,000 | |||||||||||
Subsequent Event [Member] | Restricted Stock [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Shares of common stock granted of stock awards, aggregate fair value | shares | 156 | |||||||||||
Weighted average grant date fair value, Vested | $ / shares | $ 1.63 | |||||||||||
Subsequent Event [Member] | Restricted Stock Units [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Shares of common stock granted of stock awards, aggregate fair value | shares | 91,368 | |||||||||||
Weighted average grant date fair value, Awarded | $ / shares | $ 1.60 | |||||||||||
Vesting percentage | 25.00% | |||||||||||
Number of monthly installments for vesting | Installment | 12 | |||||||||||
Restricted stock, vested | shares | 20,000 | |||||||||||
Subsequent Event [Member] | Incentive Stock Option [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Number of shares vested | shares | 50,000 | |||||||||||
Vesting percentage | 25.00% | |||||||||||
Number of monthly installments for vesting | Installment | 36 | |||||||||||
Subsequent Event [Member] | Underwriter Warrants [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Warrants to purchase common stock | shares | 363,400 | |||||||||||
Common stock warrants, exercise price per share | $ / shares | $ 1.75 | |||||||||||
Warrant exercisable period | 6 months | |||||||||||
Warrant expiration period | 4 years | |||||||||||
Underwritten Public Offering [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Stock issued during period | shares | 4,542,500 | |||||||||||
Proceeds from issuance of common stock | $ | $ 5,604,000 | |||||||||||
Underwritten Public Offering [Member] | Subsequent Event [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Stock issued during period | shares | 4,542,500 | |||||||||||
Sale of common stock price per share | $ / shares | $ 1.40 | |||||||||||
Proceeds from issuance of common stock | $ | $ 6,400,000 | |||||||||||
Chicago Venture Partners [Member] | Term Loan [Member] | Subsequent Event [Member] | ||||||||||||
Subsequent Event [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 | |||||||||||
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 term loan payment on gross 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 placement agent commission | 6.00% | |||||||||||
Chicago Venture Partners [Member] | Term Loan [Member] | Maximum [Member] | Subsequent Event [Member] | ||||||||||||
Subsequent Event [Line Items] | ||||||||||||
Amount of monthly redemption of term loan | $ | $ 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% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Revenue by Major Source (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disaggregation of Revenue [Line Items] | ||||||
Total revenue from contracts with customer | $ 606,619 | $ 608,981 | $ 2,317,034 | $ 1,554,529 | $ 2,444,104 | $ 1,558,866 |
Clinical/Medical Providers [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Total revenue from contracts with customer | 405,914 | 1,837,667 | ||||
Direct To Patient [Member] | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Total revenue from contracts with customer | $ 200,705 | $ 479,367 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Cumulative Effect of Changes in Consolidated Balance Sheet for Adoption of Topic 606 (Detail) - USD ($) | Sep. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Assets | ||||
Inventories, net | $ 454,379 | $ 171,514 | $ 256,149 | $ 201,155 |
Prepaid expenses and other | 786,732 | 656,464 | 695,276 | 388,275 |
Stockholders' Equity | ||||
Accumulated deficit | $ (53,364,478) | (45,412,973) | (45,289,526) | $ (34,972,787) |
Adoption of ASC 606 [Member] | Balance [Member] | ||||
Assets | ||||
Inventories, net | 256,149 | |||
Prepaid expenses and other | 695,276 | |||
Stockholders' Equity | ||||
Accumulated deficit | $ (45,289,526) | |||
Adoption of ASC 606 [Member] | Adjustments due to ASC 2014-09 | ||||
Assets | ||||
Inventories, net | (84,635) | |||
Prepaid expenses and other | (38,812) | |||
Stockholders' Equity | ||||
Accumulated deficit | $ (123,447) |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Potential Common Shares Issuable (Detail) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 6,499,675 | 5,790,964 | 5,872,025 | 6,646,447 |
Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 385,337 | 43,751 | 38,125 | |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 10,266 | 48,707 | 38,269 | |
Stock Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 668,785 | 626,619 | 723,744 | 369,004 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 5,435,287 | 5,071,887 | 5,071,887 | 6,277,443 |
Warrants - Schedule of Assumpti
Warrants - Schedule of Assumptions Utilized in the Valuation of Warrant (Detail) | Sep. 30, 2019yr | Dec. 31, 2018yr | Dec. 31, 2017yr |
Risk-free Interest Rate [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0.0251 | 0.0220 | |
Risk-free Interest Rate [Member] | June 2017 Warrants [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0.0159 | ||
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 | ||
Expected Life [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 3.44 | 4.44 | |
Expected Life [Member] | June 2017 Warrants [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 2.69 | ||
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 Volatility of Underlying Stock [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0.62 | 0.63 | |
Expected Volatility of Underlying Stock [Member] | June 2017 Warrants [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0.6620 | ||
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 Dividend Yield [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0 | 0 | |
Expected Dividend Yield [Member] | June 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 Warrants [Member] | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Fair value assumptions | 0 |