Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Jan. 27, 2021 | Jun. 30, 2020 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Document Transition Report | false | ||
Entity Registrant Name | NEUROMETRIX, INC. | ||
Entity File Number | 001-33351 | ||
Entity Tax Identification Number | 04-3308180 | ||
Entity Address, Address Line One | 4B Gill Street | ||
Entity Address, City or Town | Woburn | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 01801 | ||
City Area Code | 781 | ||
Local Phone Number | 890-9989 | ||
Entity Central Index Key | 0001289850 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 7,690,938 | ||
Trading Symbol | NURO | ||
Entity Common Stock, Shares Outstanding | 3,796,147 | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Entity Interactive Data Current | Yes | ||
Title of 12(g) Security | Common Stock, $0.0001 par value per share | ||
Security Exchange Name | NASDAQ |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 5,226,213 | $ 3,126,206 |
Accounts receivable, net of allowances of $25,000 and $70,000 at December 31, 2020 and 2019, respectively | 334,297 | 298,967 |
Inventories | 1,051,282 | 1,163,714 |
Collaborator Payments Receivable | 0 | 189,008 |
Prepaid expenses and other current assets | 478,074 | 652,919 |
Total current assets | 7,089,866 | 5,430,814 |
Fixed assets, net | 183,494 | 273,448 |
Operating Lease, Right-of-Use Asset | 692,692 | 1,159,774 |
Other long-term assets | 28,523 | 29,650 |
Total assets | 7,994,575 | 6,893,686 |
Current liabilities: | ||
Accounts payable | 142,316 | 725,658 |
Accrued product returns | 998,442 | 1,443,574 |
Accrued Sales Return provisions | 545,000 | 689,000 |
Operating Lease, Liability, Current | 599,632 | 588,546 |
Total current liabilities | 2,285,390 | 3,446,778 |
Operating Lease, Liability, Noncurrent | 461,410 | 916,674 |
Total liabilities | 2,746,800 | 4,363,452 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity | ||
Common stock, $0.0001 par value; 25,000,000 authorized at December 31, 2020 and 2019; 3,793,739 and 1,400,674 shares issued and outstanding at December 31, 2020 and 2019, respectively | 379 | 140 |
Additional paid-in capital | 202,129,195 | 197,319,698 |
Accumulated deficit | (196,881,800) | (194,789,605) |
Total stockholders’ equity | 5,247,775 | 2,530,234 |
Total liabilities and stockholders’ equity | $ 7,994,575 | $ 6,893,686 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Common stock, shares outstanding (in shares) | 3,793,739 | 1,400,674 |
Convertible preferred stock | ||
Stockholders’ equity | ||
Preferred stock | $ 1 | $ 1 |
Total stockholders’ equity | 1 | 1 |
Preferred Non-Convertible Stock | ||
Stockholders’ equity | ||
Preferred stock | $ 0 | $ 0 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Assets, Current [Abstract] | ||
Accounts Receivable, Allowance for Credit Loss, Current | $ 25,000 | $ 70,000 |
Stockholders' Equity Attributable to Parent [Abstract] | ||
Common stock, shares issued (in shares) | 3,793,739 | 1,400,674 |
Common stock, shares outstanding (in shares) | 3,793,739 | 1,400,674 |
Common stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 7,377,975 | $ 9,272,522 |
Cost of revenues | 2,128,417 | 7,026,899 |
Gross profit | 5,249,558 | 2,245,623 |
Operating expenses: | ||
Research and development | 2,391,316 | 3,101,976 |
Sales and marketing | 1,436,806 | 4,755,168 |
General and administrative | 3,516,340 | 5,923,190 |
Total operating expenses | 7,344,462 | 13,780,334 |
Loss from operations | (2,094,904) | (11,534,711) |
Collaboration Income | 0 | 7,716,667 |
Other Nonoperating Income | 2,709 | 45,030 |
Nonoperating Income (Expense) | 2,709 | 7,761,697 |
Net loss applicable to common stockholders: | $ (2,092,195) | $ (3,773,014) |
Earnings Per Share, Basic and Diluted | $ (0.69) | $ (3.90) |
Net income (loss) applicable to common stockholders: | ||
Net income (loss) applicable to common stockholders | $ (2,092,195) | $ (3,773,014) |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) | Total | Additional Paid-In Capital | Accumulated Deficit | Convertible Preferred Stock [Member] | Common Stock |
Beginning Balance at Dec. 31, 2018 | $ 6,097,811 | $ 197,114,310 | $ (191,016,591) | $ 18 | $ 74 |
Beginning Balance (in shares) at Dec. 31, 2018 | 17,513.63 | 738,029 | |||
Stock-based compensation expense | 190,331 | 190,331 | |||
Conversion of Stock, Shares Converted | 17,313.63 | ||||
Conversion of Stock, Amount Converted | (48) | $ (17) | |||
Issuance of common stock upon conversion of preferred stock | $ 65 | ||||
Issuance of common stock upon conversion of preferred stock (in shares) | (658,314) | ||||
Issuance of common stock under employees stock purchase plan | 15,106 | 15,105 | |||
Net income (loss) | (3,773,014) | (3,773,014) | |||
Ending Balance at Dec. 31, 2019 | 2,530,234 | 197,319,698 | (194,789,605) | $ 1 | $ 140 |
Ending Balance (in shares) at Dec. 31, 2019 | 200 | 1,400,674 | |||
Stock-based compensation expense | 599,117 | 599,117 | |||
Stock Issued During Period, Value, New Issues | 4,143,431 | 4,143,197 | $ 234 | ||
Shares Issued, Value, Share-based Payment Arrangement, after Forfeiture | 43,751 | 43,748 | $ 3 | ||
Shares Issued, Shares, Share-based Payment Arrangement, after Forfeiture | 31,000 | ||||
Issuance of common stock under employees stock purchase plan | 23,437 | 23,435 | $ 23,437 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 13,446 | ||||
Net income (loss) | (2,092,195) | (2,092,195) | |||
Ending Balance at Dec. 31, 2020 | $ 5,247,775 | $ 202,129,195 | $ (196,881,800) | $ 1 | $ 379 |
Ending Balance (in shares) at Dec. 31, 2020 | 200 | 3,793,739 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Cash Flows [Abstract] | ||
Net Cash Provided by (Used in) Financing Activities | $ 4,166,868 | $ 15,106 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect | 2,100,007 | (3,654,223) |
Net Income (Loss), Including Portion Attributable to Noncontrolling Interest | (2,092,195) | (3,773,014) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 89,954 | 124,012 |
Stock-based compensation | 599,117 | 190,331 |
Compensation Obligation Settlement | 43,751 | 0 |
Accounts Receivable, Credit Loss Expense (Reversal) | 0 | 49,361 |
IdleFacilityImpairmentCharge | 350,000 | 400,000 |
Inventory Write-down | 0 | 2,595,884 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (35,330) | 734,629 |
Inventories | 112,432 | (897,734) |
Increase (Decrease) In Collaboration Receivable | 189,008 | (189,008) |
Prepaid expenses and other current and long-term assets | (151,124) | 243,536 |
Accounts payable | (583,342) | (572,426) |
Accrued expenses and compensation | (445,132) | (157,644) |
Increase (Decrease) in Accrued Product Returns | (144,000) | (412,658) |
Increase (Decrease) in Deferred Collaboration Income | 0 | (1,956,522) |
Net Cash Provided by (Used in) Operating Activities | (2,066,861) | (3,621,253) |
Cash flows for investing activities: | ||
Purchases of fixed assets | 0 | (48,076) |
Net Cash Provided by (Used in) Investing Activities | 0 | (48,076) |
Proceeds from Issuance or Sale of Equity | 4,166,868 | 15,106 |
Proceeds from Issuance of Debt | 773,200 | 0 |
Repayments of Debt | (773,200) | 0 |
Cash flows from financing activities: | ||
Cash and cash equivalents, end of year | 5,226,213 | 3,126,206 |
Supplemental Cash Flow Elements [Abstract] | ||
Stock Issuance Settle Incentive Compensation Obligation | 43,751 | 0 |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | $ 5,226,213 | $ 3,126,206 |
Management Retention and Incent
Management Retention and Incentive Plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
Management Retention and Incentive Plan | Management Retention and Incentive PlanUnder the Company’s Management Retention and Incentive Plan (the “Plan”), a portion of the consideration payable upon a change in control transaction, as defined in the Plan and its amendments, would be paid in cash to certain executive officers and key employees and recorded as compensation expense within the Statement of Operations during the period in which the change of control transaction occurs. |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | Description of Business and Basis of Presentation NeuroMetrix, Inc (the Company) develops and commercializes health care products that utilize non-invasive neurostimulation. Revenues are derived from the sale of medical devices and after-market consumable products and accessories. The Company’s products are sold in the United States and select overseas markets. They are cleared by the U.S. Food and Drug Administration (FDA) and regulators in foreign jurisdictions where appropriate. The Company has two primary products. DPNCheck® is a point-of-care test for diabetic peripheral neuropathy which is the most common long-term complication of Type 2 diabetes. Quell is an app-enabled, over-the-counter wearable device for chronic pain. The Company entered a collaboration with GlaxoSmithKline ("GSK") to enhance the development of Quell for promotion by GSK outside the United States and by the Company within the United States. GSK made development milestone payments to the Company of approximately $20.5 million through 2019 and co-funded specific development projects through 2020. If GSK commercializes Quell in pre-defined countries, GSK would be obligated to pay approximately $4.5 million in commercialization milestones which the Company has assigned to the Federal Trade Commission (see Note 8 Commitments and Contingencies). The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered recurring losses from operations and negative cash flows from operating activities. At December 31, 2020, the Company had an accumulated deficit of $196.9 million. These factors raise substantial doubt about the Company’s ability to continue as a going concern for the one-year period from the date of issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. At December 31, 2020, the Company held cash and cash equivalents of $5.2 million. The Company believes that these resources and the cash to be generated from future product sales will be sufficient to meet its projected operating requirements through 2021. Accordingly, the Company will need to raise additional funds to support its operating and capital needs in the first quarter of 2022 and beyond. The Company continues to face significant challenges and uncertainties and, as a result, the Company’s available capital resources may be consumed more rapidly than currently expected due to (a) decreases in sales of the Company’s products related to the COVID-19 pandemic and other factors, and the uncertainty of future revenues from new products; (b) the effect of the COVID-19 pandemic on the Company's ability to obtain parts and materials from suppliers while continuing to staff critical production and fulfillment functions; (c) changes the Company may make to the business that affect ongoing operating expenses; (d) changes the Company may make in its business strategy; (e) regulatory developments affecting the Company’s existing products; (f) changes the Company may make in its research and development spending plans; and (g) other items affecting the Company’s forecasted level of expenditures and use of cash resources. The Company may attempt to obtain additional funding from a public or private financing, collaborative arrangements with strategic partners, divestiture of assets or through additional credit lines or other debt financing sources to increase the funds available to fund operations. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity or debt securities to raise additional funds, its existing stockholders may experience dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders. If the Company raises additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to its potential products or to proprietary technologies, or grant licenses on terms that are not favorable to the Company. Without additional funds, the Company may be forced to delay, scale back or eliminate some of its sales and marketing efforts, research and development activities, or other operations and potentially delay product development in an effort to provide sufficient funds to continue its operations. If any of these events occurs, the Company’s ability to achieve its development and commercialization goals would be adversely affected. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates and Assumptions The preparation of financial statements in conformity with United States generally accepted accounting principles requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances and regularly assesses these estimates, but actual results could differ materially from these estimates. Effects of changes in estimates are recorded in the period in which they occur. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of ninety days or less to be cash equivalents. Cash equivalents are recorded at cost which approximates fair value. The Company invests cash primarily in a money market account and other investments. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash equivalents and trade receivables. The Company invests its cash equivalents in highly rated institutions and limits its investment in any individual account to not exceed FDIC limits. At December 31, 2020 and 2019, two customers accounted for 50% and 42% of accounts receivable, respectively. Two customers accounted for 35% of revenues for the year ended December 31, 2020 and one customer accounted for 19% of revenues, for the year ended December 31, 2019. Inventories Inventories, consisting primarily of finished goods and purchased components, are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The net realizable value of inventories is based upon the types and levels of inventories held, forecasted demand, pricing, competition, and changes in technology. Deterioration in market and economic conditions could adversely affect the recovery of inventory value. Leases The Company presents the lease obligations on the balance sheet, by recording a right- of-use asset and a lease liability for all leases other than those that, at lease commencement, have a lease term of 12 months or less. On the lease commencement date, the Company is required to measure and record a lease liability equal to the present value of the remaining lease payments, discounted using the rate implicit in the lease or if that cannot be readily determined, the Company's incremental borrowing rate. Fair Value The carrying amounts of the Company’s cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their fair value at December 31, 2020 and 2019 due to their short-term nature. Revenue Recognition Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. In most cases, the Company has a single product delivery performance obligation. Accrued product returns are estimated based on historical data and evaluation of current information. Accounts Receivable Accounts receivable are recorded at the amount the Company expects to collect, net of the allowance for doubtful accounts receivable. The allowance for doubtful accounts is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for doubtful accounts was $25,000 as of December 31, 2020 and $70,000 as of December 31, 2019. Income Taxes The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company’s financial statements contain certain deferred tax assets, which have arisen primarily as a result of operating losses, as well as other temporary differences between financial and tax accounting. In accordance with the provisions of the Income Taxes topic of the Codification, the Company is required to establish a valuation allowance if the likelihood of realization of the deferred tax assets is reduced based on an evaluation of objective verifiable evidence. Significant management judgment is required in determining the Company’s provision for income taxes, the Company’s deferred tax assets and liabilities and any valuation allowance recorded against those net deferred tax assets. The Company evaluates the weight of all available evidence to determine whether it is more likely than not that some portion or all of the net deferred income tax assets will not be realized. Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future, as provided by Section 382 of the Internal Revenue Code of 1986, as well as similar state provisions. Ownership changes may limit the amount of NOL and tax credit carryforwards that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. If the Company has experienced a change of control, utilization of its NOL or tax credits carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the NOL or research and development credit carryforwards before utilization. Subsequent ownership changes could further impact the limitation in future years. Further, until a study is completed and any limitation known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s NOL carryforwards and research and development credit carryforwards and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheet or statement of operations if an adjustment were required. A two-step evaluation of all tax positions was performed, ensuring that these tax return positions meet the “more likely than not” recognition threshold and can be measured with sufficient precision to determine the benefit recognized in the financial statements. These evaluations provide the Company with a comprehensive model for how it should recognize, measure, present, and disclose in its financial statements certain tax positions that it has taken or expects to take on income tax returns. Research and Development Costs incurred in research and development are expensed as incurred. Included in research and development costs are wages, benefits, product design consulting, and other operating costs such as facilities, supplies, and overhead directly related to research and development efforts. Collaboration income Collaboration income is recognized within Other Income when contractual performance obligations, outside the ordinary activities of the Company, have been satisfied and control has been transferred to a collaboration partner. Collaboration income for each performance obligation is based on relative fair value of the overall transaction price. A deferred collaboration income liability is recorded when payments are received prior to satisfaction of performance obligations. Product Warranty Costs Product warranty costs are estimated based on historical experience, product failure rates, repair volume and labor costs. Warranty costs are accrued at the time of sale within cost of revenue and periodically reviewed in the aggregate. The liabilities for product warranty costs of $49,600 and $75,300 at December 31, 2020 and 2019, respectively, are included in accrued expenses and compensation in the accompanying balance sheets. Fixed Assets and Long-Lived Assets Fixed assets are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset. Expenditures for repairs and maintenance are charged to expense as incurred. On disposal, the related assets and accumulated depreciation are eliminated from the accounts and any resulting gain or loss is included in the Company’s statement of operations. Leasehold improvements are amortized over the shorter of the estimated useful life of the improvement or the remaining term of the lease. The Company periodically evaluates the recoverability of its fixed assets and other long-lived assets which may result in an adjustment of estimated depreciable lives or asset impairment. When indicators of impairment are present, the carrying values of the asset are evaluated in relation to the assets operating performance and future undiscounted cash flows of the underlying assets. If an impairment is indicated, the asset carrying value is reduced to fair value based on market value estimates and assumptions concerning the amount and timing of future cash flows and discount rates. Accounting for Stock-Based Compensation Stock-based compensation cost is recognized ratably over the service period. The Company uses the Black-Scholes option pricing model for determining the fair value of stock options and amortizes stock-based compensation expense using the straight-line method. The Black-Scholes model requires assumptions regarding expected share price volatility, expected life of options, expected annual dividend yield, and risk-free interest rate (See Note 3 — Stock-Based Compensation). Net Loss per Common Share Basic and dilutive net loss per common share were as follows: Years Ended December 31, 2020 2019 Net loss applicable to common stockholders $ (2,092,195) $ (3,773,014) Weighted average number of common shares outstanding, basic and dilutive 3,014,497 968,116 Net loss per common share applicable to common stockholders, basic and diluted $ (0.69) $ (3.90) The following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented: Years Ended December 31, 2020 2019 Options 198,484 38,936 Warrants 17,248 44,534 Convertible preferred stock 62 478,184 Total 215,794 561,654 Advertising and Promotional Costs Advertising and promotional costs are expensed as incurred. Advertising and promotion expense were $210,548 and $1,652,171, in 2020 and 2019, respectively. Accumulated Other Comprehensive Items For 2020 and 2019, the Company had no components of other comprehensive income or loss other than net loss. Segments The Company operates in a single segment covering the sale of medical equipment and consumables. The majority of the Company’s assets, revenues, and expenses for 2020 and 2019 were located in or derived from operations in the United States. Revenues from sales outside the United States accounted for approximately 15% and 13% of total revenues in 2020 and 2019, respectively. Risks and Uncertainties The Company is subject to risks common to companies in the medical device industry, including, but not limited to, environmental risk such as the COVID-19 pandemic, development by the Company or its competitors of new technological innovations, dependence on key personnel, customers’ reimbursement from third-party payers, protection of proprietary technology, and compliance with regulations of the FDA, FTC and other governmental agencies. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company's 2004 Stock Option and Incentive Plan (the "Stock Plan") amended and restated in 2019 provides for granting of incentive and nonqualified stock option and stock bonus awards to officers, employees and outside consultants. Outstanding options under the Stock Plan generally vest over four years and terminate 10 years after the grant date, or earlier if the option holder is no longer an executive officer, employee, consultant, advisor or director of the Company. As of December 31, 2020, 439,890 shares of common stock were authorized for issuance under the 2004 Stock Plan, of which 24,578 shares had been issued, 361,956 shares were subject to outstanding options at a weighted average exercise price of $3.68 per share and 53,356 shares were available for future grant. The Company's 2009 Non-Qualified Inducement Stock Plan (the “Inducement Plan”) is intended to encourage employees, including prospective employees, upon whose efforts the Company depends for the successful conduct of its business, to acquire an equity interest in the Company. The Inducement Plan provides for the granting of awards, including non-qualified stock options, restricted stock, and unrestricted stock. As of December 31, 2020, 1,250 shares of common stock were authorized for issuance and were available for future grant under the Inducement Plan. The exercise price of stock options awarded under the Stock Plan and the Inducement Plan may not be less than the fair value of the common stock on the date of the option grant. For holders of more than 10% of the Company’s total combined voting power of all classes of stock, incentive stock options may not be granted at less than 110% of the fair value of the Company’s common stock and for a term not to exceed five years. The Company's 2010 Employee Stock Purchase Plan (the "ESPP"), amended and restated in 2018 authorizes an annual increase on the first day of each of the Company’s fiscal years equal to the lesser of (i) 2,500 shares, (ii) 1 percent of the shares of common stock outstanding on the last day of the immediately preceding fiscal year, or (iii) such lesser number of shares as is determined by the Board. All full-time employees and certain part-time employees are eligible to participate in the ESPP. For part-time employees to be eligible, they must have customary employment of more than five months in any calendar year and more than 20 hours per week. Employees who, after exercising their rights to purchase shares under the ESPP, would own shares representing 5% or more of the voting power of the Company’s common stock, are ineligible to participate. Under the ESPP, participating employees can authorize the Company to withhold up to 10% of their earnings during consecutive six-month payment periods for the purchase of the shares. At the conclusion of each period, participating employees can purchase shares at 85% of the lower of their fair value at the beginning or end of the period. The ESPP is regarded as a compensatory plan. For the years ended December 31, 2020 and 2019, the Company issued 13,446 and 4,331 shares of its common stock, respectively, under the ESPP. As of December 31, 2020, there were no remaining shares to be issued under the ESPP. The Company uses the Black-Scholes option pricing model for determining the fair value of shares of common stock issued or to be issued under the ESPP. The following assumptions were used in determining fair value: The risk-free interest rate assumption is based on the United States Treasury’s constant maturity rate for a three or five year term (corresponding to the expected option term) on the date the option was granted. The expected dividend yield is zero as the Company does not currently pay dividends nor expects to do so during the expected option term. The expected option term of three The weighted average grant-date fair value of stock options used in the calculation of stock-based compensation expense for the years ended December 31, 2020 and 2019 was calculated using the following assumptions: Years Ended December 31, 2020 2019 Risk-free interest rate 0.8% 1.9% Expected dividend yield — — Expected option term 10 years 10 years Volatility 70.0 % 72.4 % A summary of option activity for the year ended December 31, 2020 is presented below: Number of Weighted Weighted Aggregate Outstanding at December 31, 2019 164,980 $ 7.16 Granted 200,000 1.57 Exercised — — Forfeited (2,996) 31.57 Expired (28) 5,875.19 Outstanding at December 31, 2020 361,956 $ 3.68 9.2 $ — Vested or expected to vest at December 31, 2020 161,158 $ 6.25 8.5 $ — Exercisable at December 31, 2020 161,158 $ 6.25 8.5 $ — Expected to vest options are determined by applying the pre-vesting forfeiture rate to the total outstanding options. Aggregate intrinsic value represents the total pre-tax intrinsic value (the aggregate difference between the closing stock price of the Company’s common stock as of December 31, 2020, as applicable, and the exercise price for the in-the-money options) that would have been received by the option holders if all the in-the-money options had been exercised on December 31, 2020. The weighted average per share grant-date fair values of options granted during 2020 and 2019 was $1.57 and $4.58, respectively. The aggregate intrinsic value of options issued or exercised during 2020 and 2019 was $0. Total unrecognized stock-based compensation costs related to non-vested stock options was $197,162, which related to 361,956 shares with a per share weighted fair value of $3.68 as of December 31, 2020. This unrecognized cost is expected to be recognized over a weighted average period of approximately 0.8 years. Cash received from option exercises and purchases under the Stock Plan and ESPP for 2020 and 2019, was $23,436 and $15,106, respectively. The Company issues new shares upon option exercises and purchases under the Company’s ESPP. The Company recorded stock-based compensation expense of $599,117 and $190,331 for 2020 and 2019, respectively. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories consist of the following: December 31, 2020 2019 Purchased components $ 716,848 $ 720,209 Finished goods 334,434 443,505 $ 1,051,282 $ 1,163,714 |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets | Fixed Assets Fixed assets consist of the following: Estimated December 31, 2020 2019 Computer and laboratory equipment 3 $ 905,966 $ 905,966 Furniture and equipment 3 241,413 241,413 Production equipment 7 216,000 216,000 Leasehold improvements * 141,485 141,485 1,504,864 1,504,864 Less – accumulated depreciation (1,321,370) (1,231,416) $ 183,494 $ 273,448 * Lesser of life of lease or estimated useful life. Depreciation expense was $89,954 and $124,012 for 2020 and 2019, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses and Compensation Accrued expenses and compensation consist of the following for the years ended December 31, 2020 and 2019: December 31, 2020 2019 Technology fees $ 450,000 $ 450,000 Professional services 343,000 454,000 Compensation 49,837 62,322 Advertising and promotion 31,000 68,000 Warranty 49,600 75,300 Other 75,005 333,952 $ 998,442 $ 1,443,574 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Current income tax expense (benefit) attributable to continuing operations was zero for the years ended December 31, 2020 and 2019. The Company’s effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2020 and 2019. Years Ended December 31, 2020 2019 Federal tax provision (benefit) rate (21.0) % (21.0) % State tax provision, net of federal provision (4.6) 19.9 Permanent items 5.9 1.1 Federal research and development credits — — 382 Limitation - NOL and tax credits (1.9) 861.5 Other (0.3) — Change in statutory tax rate — — Valuation allowance 21.9 (861.5) Effective income tax rate — — The Company’s deferred tax assets consist of the following: December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 2,211,161 $ 1,592,993 Research and development credit carryforwards 43,667 — Accrued expenses 112,995 96,030 Inventory reserve 311,639 306,855 Stock-based compensation 245,988 222,420 Right of use asset 290,268 — Other — (9,455) Total gross deferred tax assets 3,215,718 2,208,843 Valuation allowance (3,012,513) (2,208,843) Deferred tax liabilities: Lease liability $ (189,498) $ — Other $ (13,707) $ — Net deferred tax assets $ — $ — At December 31, 2020, the Company has federal net operating loss carryforwards (“NOL”) of approximately $143.7 million, of which $138.4 million begin to expire in 2021 and $5.3 million have an indefinite carryforward. At December 31, 2020, the Company has state NOLs of $53.1 million, some of which have an indefinite carryforward, and others that begin to expire in 2025. At December 31, 2020, the Company has federal and state tax credits of approximately $1.8 million and $1.1 million, respectively, which may be available to reduce future taxable income and related taxes thereon. These amounts include tax benefits of approximately $2.5 million and $75,000 attributable to NOL and tax credit carryforwards, respectively, that result from the exercise of employee stock options. The Company experienced an ownership change in 2019 as defined under Internal Revenue Service Regulations, which significantly reduced the tax benefits associated with these carryforwards under Internal Revenue Code Sections 382 and 383. The federal NOLs, the state NOLs, and the federal and state research and development credits each began to expire in 2020. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company's lease on its Woburn, Massachusetts corporate office and manufacturing facilities (the “Woburn Lease”) extends through September 2025 at a monthly base rent of $13,846 and with a 5-year extension option. The Company's lease on its former corporate office in Waltham, Massachusetts (the "Waltham lease") extends through February 2022 at a current monthly rent of $41,074, subject to annual increase, and with a 5-year extension option. The Company is actively seeking to sublet the Waltham lease. At December 31, 2020, the Company carried an impairment reserve of $400,000 that reduced the right of use asset for idle facility costs. The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of December 31, 2020: 2021 $ 653,164 2022 247,347 2023 165,785 2024 165,785 2025 117,431 Total minimum lease payments $ 1,349,512 Weighted-average discount rate, 14.7% $ 288,470 Lease obligation, current portion 599,632 Lease obligation, net of current portion 461,410 $ 1,349,512 Total recorded rent expense was $667,618 and $664,098, for 2020 and 2019, respectively. The Company records rent expense on its facility leases on a straight-line basis over the lease term. Weighted average remaining operating lease term was 3.0 years as of December 31, 2020. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables present information about the Company’s assets and liabilities that are measured at fair value for the periods presented and indicates the fair value hierarchy of the valuation techniques it utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates, and yield curves. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. December 31, 2020 Fair Value Measurements at December 31, 2020 Using Quoted Prices in Significant Significant Assets: Cash equivalents $ 2,374,216 $ 2,374,216 $ — $ — Total $ 2,374,216 $ 2,374,216 $ — $ — December 31, 2019 Fair Value Measurements at December 31, 2019 Using Quoted Prices in Significant Significant Assets: Cash equivalents $ 698,807 $ 698,807 $ — $ — Total $ 698,807 $ 698,807 $ — $ — |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement PlanThe Company maintains a 401(k) defined contribution savings plan for its employees who meet certain service period and age requirements. Contributions are permitted up to the maximum allowed under the Internal Revenue Code of each covered employee’s salary. The savings plan permits the Company to contribute at its discretion. In 2020 and 2019 the Company made no contributions to the plan. |
Credit Facility
Credit Facility | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Credit Facility | Credit Facility and DebtThe Company terminated a Loan and Security Agreement (the “Credit Facility”) with a bank in 2020. The Credit Facility had previously supported letters of credit in the amount of $226,731 issued in favor of the Company's landlords. These letters of credit are now secured by the Company's cash balances.In April 2020 the Company received a loan of $773,200 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act and fully repaid the loan in May 2020. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred stock and convertible preferred stock consist of the following: December 31, 2020 2019 Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2020 and 2019; no shares issued and outstanding at December 31, 2020 and 2019 $ — $ — Series B convertible preferred stock, $0.001 par value, 147,000 shares designated at December 31, 2020 and 2019, and 200 shares issued and outstanding at December 31, 2020 and 2019, respectively 1 1 Series D convertible preferred stock, $0.001 par value, 21,300 shares designated at December 31, 2020 and 2019, and no shares issued and outstanding at December 31, 2020 and 2019, respectively — — Series F convertible preferred stock, $0.001 par value, 10,621 shares designated at December 31, 2020 and 2019, and no shares issued and outstanding at December 31, 2020 and 2019, respectively — — Preferred stock activity As of December 31, 2020, 200.00 shares of Series B Preferred Stock remained outstanding. There were no preferred stock conversions in 2020. In 2019, 14,052.93 shares of Series D Preferred Stock were converted into a total of 534,333 shares of common stock and 3,260.70 shares of the Series F Preferred Stock were converted into a total of 123,981 shares of common stock. Other equity activity In February 2020, the Company entered into an At Market Issuance Sales Agreement (the "Agreement") with respect to an at-the-market equity offering program ("ATM program"), under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $4,482,000 (the "Placement Shares"). The issuance and sale of the Placement Shares by the Company under the Agreement will be made pursuant to the Company's effective "shelf" registration statement on Form S-3. During the year ended December 31, 2020, 2,348,619 shares of common stock were issued pursuant to the Agreement for net proceeds of $4,143,431. In March 2020, the Company issued 31,000 shares of fully vested common stock with a value of $43,751 pursuant to a Separation Agreement between the Company and an employee. The shares issued reflected the $1.41 closing price of the Company's common stock as reported on the Nasdaq Capital Market on March 11, 2020. In June and December 2020, the Company issued 13,446 shares of fully vested common stock with a value of $23,437 pursuant to the Company's 2010 Employee Stock Purchase Plan. As of December 31, 2020, the Company had 25,000,000 shares of common stock authorized and 3,793,739 shares issued and outstanding. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends unless declared by the Board of Directors. At December 31, 2020, the Company has reserved authorized shares of common stock for future issuance as follows: Outstanding stock options 361,956 Possible future issuance under inducement plan 1,250 Possible future issuance under stock option plans 53,356 Possible future issuance under employee stock purchase plan — Total 416,562 |
Business Restructuring (Notes)
Business Restructuring (Notes) | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Activities Disclosure | 13. Business Restructuring The Company restructured its business activities in the second quarter of 2019 to reduce operating costs and improve efficiency. Operations were consolidated in a single location, headcount was reduced, and excess inventory was written down to net realizable value. The impairment reserve was further adjusted in the third quarter of 2019 to bring the total recorded restructuring charge to $2.6 million in 2019. This charge was increased by $350,000 in 2020 to reflect estimates of idle facility costs. The impairment reserve against the right to use asset was $400,000 at December 31, 2020. The reserve for business restructuring as of December 31, 2020 is presented below. Description Balance at Beginning of Period Provision Amounts Paid Out Balance at End of Period December 31, 2020 Severance obligations: $ — $ — $ — $ — Relocation costs: — — — — Impairment charge for idle facility 400,000 350,000 (350,000) 400,000 December 31, 2019 Severance obligations: $ — $ 224,773 $ (224,773) $ — Relocation costs: — 100,000 (100,000) — Impairment charge for idle facility — 400,000 — 400,000 Within the Company's Statements of Operations for the year ended December 31, 2020, $350,000 of impairment costs were recorded as follows: $154,000 within research and development, $87,500 within sales and marketing, and $108,500 within general and administrative. Within the Company's Statement of Operations for the year ended December 31, 2019, $1,895,884 of inventory-related write downs were recorded within cost of revenues, and severance and relocation costs were recorded as follows: $311,514 within research and development, $221,387 within sales and marketing, and $191,872 within general and administrative. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule of Valuation and Qualifying Accounts Disclosure | Schedule II — Valuation and Qualifying Accounts Description Balance at Charged to Charged to Recoveries/ Balance at December 31, 2020 Allowance for Doubtful Accounts $ 70,000 $ — $ — $ (45,000) $ 25,000 Deferred Tax Asset Valuation Allowance 2,208,843 3,427,540 — (2,623,870) (1) 3,012,513 Accrued Product Returns 689,000 — (144,000) 545,000 Warranty Reserve 75,300 — — (25,700) 49,600 December 31, 2019 Allowance for Doubtful Accounts $ 25,000 $ 49,361 $ — $ (4,361) $ 70,000 Deferred Tax Asset Valuation Allowance 35,041,300 1,535,093 — (34,367,550) (1) 2,208,843 Accrued Product Returns 1,101,658 — — (412,658) 689,000 Warranty Reserve 129,837 — — (54,537) 75,300 (1) Expiration of Federal and State Net Operating Loss Carryforwards and other reductions. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of financial statements in conformity with United States generally accepted accounting principles requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances and regularly assesses these estimates, but actual results could differ materially from these estimates. Effects of changes in estimates are recorded in the period in which they occur. | |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company considers all highly liquid investments with an original maturity of ninety days or less to be cash equivalents. Cash equivalents are recorded at cost which approximates fair value. The Company invests cash primarily in a money market account and other investments. | |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash equivalents and trade receivables. The Company invests its cash equivalents in highly rated institutions and limits its investment in any individual account to not exceed FDIC limits. | |
Inventories | Inventories Inventories, consisting primarily of finished goods and purchased components, are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The net realizable value of inventories is based upon the types and levels of inventories held, forecasted demand, pricing, competition, and changes in technology. Deterioration in market and economic conditions could adversely affect the recovery of inventory value. | |
Fair Value | Fair ValueThe carrying amounts of the Company’s cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their fair value at December 31, 2020 and 2019 due to their short-term nature. | |
Revenue Recognition | Revenue Recognition Revenues include product sales, net of estimated returns. Revenue is measured as the amount of consideration the Company expects to receive in exchange for product transferred. Revenue is recognized when contractual performance obligations have been satisfied and control of the product has been transferred to the customer. In most cases, the Company has a single product delivery performance obligation. Accrued product returns are estimated based on historical data and evaluation of current information. | |
Accounts Receivable | Accounts ReceivableAccounts receivable are recorded at the amount the Company expects to collect, net of the allowance for doubtful accounts receivable. The allowance for doubtful accounts is the Company’s best estimate of the amount of probable credit losses based on customer past payment history, product usage activity, and recent communications with the customer. Individual customer balances which are over 90 days past due are reviewed individually for collectability and written-off when recovery is not probable. The Company does not have any off-balance sheet credit exposure related to its customers. Allowance for doubtful accounts was $25,000 as of December 31, 2020 and $70,000 as of December 31, 2019. | |
Income Taxes | Income Taxes The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company’s financial statements contain certain deferred tax assets, which have arisen primarily as a result of operating losses, as well as other temporary differences between financial and tax accounting. In accordance with the provisions of the Income Taxes topic of the Codification, the Company is required to establish a valuation allowance if the likelihood of realization of the deferred tax assets is reduced based on an evaluation of objective verifiable evidence. Significant management judgment is required in determining the Company’s provision for income taxes, the Company’s deferred tax assets and liabilities and any valuation allowance recorded against those net deferred tax assets. The Company evaluates the weight of all available evidence to determine whether it is more likely than not that some portion or all of the net deferred income tax assets will not be realized. Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future, as provided by Section 382 of the Internal Revenue Code of 1986, as well as similar state provisions. Ownership changes may limit the amount of NOL and tax credit carryforwards that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. If the Company has experienced a change of control, utilization of its NOL or tax credits carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the NOL or research and development credit carryforwards before utilization. Subsequent ownership changes could further impact the limitation in future years. Further, until a study is completed and any limitation known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s NOL carryforwards and research and development credit carryforwards and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheet or statement of operations if an adjustment were required. A two-step evaluation of all tax positions was performed, ensuring that these tax return positions meet the “more likely than not” recognition threshold and can be measured with sufficient precision to determine the benefit recognized in the financial statements. These evaluations provide the Company with a comprehensive model for how it should recognize, measure, present, and disclose in its financial statements certain tax positions that it has taken or expects to take on income tax returns. | |
Research and Development | Research and Development Costs incurred in research and development are expensed as incurred. Included in research and development costs are wages, benefits, product design consulting, and other operating costs such as facilities, supplies, and overhead directly related to research and development efforts. | |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaboration incomeCollaboration income is recognized within Other Income when contractual performance obligations, outside the ordinary activities of the Company, have been satisfied and control has been transferred to a collaboration partner. Collaboration income for each performance obligation is based on relative fair value of the overall transaction price. A deferred collaboration income liability is recorded when payments are received prior to satisfaction of performance obligations. | |
Product Warranty Costs | Product Warranty Costs Product warranty costs are estimated based on historical experience, product failure rates, repair volume and labor costs. Warranty costs are accrued at the time of sale within cost of revenue and periodically reviewed in the aggregate. The liabilities for product warranty costs of $49,600 and $75,300 at December 31, 2020 and 2019, respectively, are included in accrued expenses and compensation in the accompanying balance sheets. | |
Fixed Assets and Long-Lived Assets | Fixed Assets and Long-Lived Assets Fixed assets are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset. Expenditures for repairs and maintenance are charged to expense as incurred. On disposal, the related assets and accumulated depreciation are eliminated from the accounts and any resulting gain or loss is included in the Company’s statement of operations. Leasehold improvements are amortized over the shorter of the estimated useful life of the improvement or the remaining term of the lease. The Company periodically evaluates the recoverability of its fixed assets and other long-lived assets which may result in an adjustment of estimated depreciable lives or asset impairment. When indicators of impairment are present, the carrying values of the asset are evaluated in relation to the assets operating performance and future undiscounted cash flows of the underlying assets. If an impairment is indicated, the asset carrying value is reduced to fair value based on market value estimates and assumptions concerning the amount and timing of future cash flows and discount rates. | |
Accounting for Stock-Based Compensation | Accounting for Stock-Based Compensation Stock-based compensation cost is recognized ratably over the service period. The Company uses the Black-Scholes option pricing model for determining the fair value of stock options and amortizes stock-based compensation expense using the straight-line method. The Black-Scholes model requires assumptions regarding expected share price volatility, expected life of options, expected annual dividend yield, and risk-free interest rate (See Note 3 — Stock-Based Compensation). | |
Net Loss per Common Share | Net Loss per Common Share Basic and dilutive net loss per common share were as follows: Years Ended December 31, 2020 2019 Net loss applicable to common stockholders $ (2,092,195) $ (3,773,014) Weighted average number of common shares outstanding, basic and dilutive 3,014,497 968,116 Net loss per common share applicable to common stockholders, basic and diluted $ (0.69) $ (3.90) The following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented: Years Ended December 31, 2020 2019 Options 198,484 38,936 Warrants 17,248 44,534 Convertible preferred stock 62 478,184 Total 215,794 561,654 | |
Advertising and Promotional Costs | Advertising and Promotional Costs Advertising and promotional costs are expensed as incurred. Advertising and promotion expense were $210,548 and $1,652,171, in 2020 and 2019, respectively. | |
Accumulated Other Comprehensive Items | Accumulated Other Comprehensive Items For 2020 and 2019, the Company had no components of other comprehensive income or loss other than net loss. | |
Segments | Segments The Company operates in a single segment covering the sale of medical equipment and consumables. The majority of the Company’s assets, revenues, and expenses for 2020 and 2019 were located in or derived from operations in the United States. Revenues from sales outside the United States accounted for approximately 15% and 13% of total revenues in 2020 and 2019, respectively. | |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks common to companies in the medical device industry, including, but not limited to, environmental risk such as the COVID-19 pandemic, development by the Company or its competitors of new technological innovations, dependence on key personnel, customers’ reimbursement from third-party payers, protection of proprietary technology, and compliance with regulations of the FDA, FTC and other governmental agencies. | |
Recently Issued or Adopted Accounting Pronouncements | ||
Lessee, Leases | LeasesThe Company presents the lease obligations on the balance sheet, by recording a right- of-use asset and a lease liability for all leases other than those that, at lease commencement, have a lease term of 12 months or less. On the lease commencement date, the Company is required to measure and record a lease liability equal to the present value of the remaining lease payments, discounted using the rate implicit in the lease or if that cannot be readily determined, the Company's incremental borrowing rate. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Basic and dilutive net loss per common share were as follows: Years Ended December 31, 2020 2019 Net loss applicable to common stockholders $ (2,092,195) $ (3,773,014) Weighted average number of common shares outstanding, basic and dilutive 3,014,497 968,116 Net loss per common share applicable to common stockholders, basic and diluted $ (0.69) $ (3.90) |
Schedule of Anti-Dilutive Securities | e following potentially dilutive weighted average number of common stock equivalents were excluded from the calculation of diluted net loss per common share because their effect was anti-dilutive for each of the periods presented: Years Ended December 31, 2020 2019 Options 198,484 38,936 Warrants 17,248 44,534 Convertible preferred stock 62 478,184 Total 215,794 561,654 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Schedule of Weighted Average Grant-Date Fair Value of Stock Options | The weighted average grant-date fair value of stock options used in the calculation of stock-based compensation expense for the years ended December 31, 2020 and 2019 was calculated using the following assumptions: Years Ended December 31, 2020 2019 Risk-free interest rate 0.8% 1.9% Expected dividend yield — — Expected option term 10 years 10 years Volatility 70.0 % 72.4 % |
Summary of Option Activity | A summary of option activity for the year ended December 31, 2020 is presented below: Number of Weighted Weighted Aggregate Outstanding at December 31, 2019 164,980 $ 7.16 Granted 200,000 1.57 Exercised — — Forfeited (2,996) 31.57 Expired (28) 5,875.19 Outstanding at December 31, 2020 361,956 $ 3.68 9.2 $ — Vested or expected to vest at December 31, 2020 161,158 $ 6.25 8.5 $ — Exercisable at December 31, 2020 161,158 $ 6.25 8.5 $ — |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories consist of the following: December 31, 2020 2019 Purchased components $ 716,848 $ 720,209 Finished goods 334,434 443,505 $ 1,051,282 $ 1,163,714 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets | Fixed assets consist of the following: Estimated December 31, 2020 2019 Computer and laboratory equipment 3 $ 905,966 $ 905,966 Furniture and equipment 3 241,413 241,413 Production equipment 7 216,000 216,000 Leasehold improvements * 141,485 141,485 1,504,864 1,504,864 Less – accumulated depreciation (1,321,370) (1,231,416) $ 183,494 $ 273,448 * Lesser of life of lease or estimated useful life. |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Compensation and Expenses | Accrued expenses and compensation consist of the following for the years ended December 31, 2020 and 2019: December 31, 2020 2019 Technology fees $ 450,000 $ 450,000 Professional services 343,000 454,000 Compensation 49,837 62,322 Advertising and promotion 31,000 68,000 Warranty 49,600 75,300 Other 75,005 333,952 $ 998,442 $ 1,443,574 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Effective Income Tax Rate to Statutory Federal Rate | The Company’s effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2020 and 2019. Years Ended December 31, 2020 2019 Federal tax provision (benefit) rate (21.0) % (21.0) % State tax provision, net of federal provision (4.6) 19.9 Permanent items 5.9 1.1 Federal research and development credits — — 382 Limitation - NOL and tax credits (1.9) 861.5 Other (0.3) — Change in statutory tax rate — — Valuation allowance 21.9 (861.5) Effective income tax rate — — |
Schedule of Deferred Tax Assets | The Company’s deferred tax assets consist of the following: December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 2,211,161 $ 1,592,993 Research and development credit carryforwards 43,667 — Accrued expenses 112,995 96,030 Inventory reserve 311,639 306,855 Stock-based compensation 245,988 222,420 Right of use asset 290,268 — Other — (9,455) Total gross deferred tax assets 3,215,718 2,208,843 Valuation allowance (3,012,513) (2,208,843) Deferred tax liabilities: Lease liability $ (189,498) $ — Other $ (13,707) $ — Net deferred tax assets $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments Under Noncancelable Operating Leases | December 31, 2020: 2021 $ 653,164 2022 247,347 2023 165,785 2024 165,785 2025 117,431 Total minimum lease payments $ 1,349,512 Weighted-average discount rate, 14.7% $ 288,470 Lease obligation, current portion 599,632 Lease obligation, net of current portion 461,410 $ 1,349,512 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | December 31, 2020 Fair Value Measurements at December 31, 2020 Using Quoted Prices in Significant Significant Assets: Cash equivalents $ 2,374,216 $ 2,374,216 $ — $ — Total $ 2,374,216 $ 2,374,216 $ — $ — December 31, 2019 Fair Value Measurements at December 31, 2019 Using Quoted Prices in Significant Significant Assets: Cash equivalents $ 698,807 $ 698,807 $ — $ — Total $ 698,807 $ 698,807 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Preferred stock and convertible preferred stock | Preferred stock and convertible preferred stock consist of the following: December 31, 2020 2019 Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2020 and 2019; no shares issued and outstanding at December 31, 2020 and 2019 $ — $ — Series B convertible preferred stock, $0.001 par value, 147,000 shares designated at December 31, 2020 and 2019, and 200 shares issued and outstanding at December 31, 2020 and 2019, respectively 1 1 Series D convertible preferred stock, $0.001 par value, 21,300 shares designated at December 31, 2020 and 2019, and no shares issued and outstanding at December 31, 2020 and 2019, respectively — — Series F convertible preferred stock, $0.001 par value, 10,621 shares designated at December 31, 2020 and 2019, and no shares issued and outstanding at December 31, 2020 and 2019, respectively — — |
Reserved Authorized Shares of Common Stock for Future Issuance | At December 31, 2020, the Company has reserved authorized shares of common stock for future issuance as follows: Outstanding stock options 361,956 Possible future issuance under inducement plan 1,250 Possible future issuance under stock option plans 53,356 Possible future issuance under employee stock purchase plan — Total 416,562 |
Business Restructuring Business
Business Restructuring Business Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring and Related Costs [Table Text Block] | The reserve for business restructuring as of December 31, 2020 is presented below. Description Balance at Beginning of Period Provision Amounts Paid Out Balance at End of Period December 31, 2020 Severance obligations: $ — $ — $ — $ — Relocation costs: — — — — Impairment charge for idle facility 400,000 350,000 (350,000) 400,000 December 31, 2019 Severance obligations: $ — $ 224,773 $ (224,773) $ — Relocation costs: — 100,000 (100,000) — Impairment charge for idle facility — 400,000 — 400,000 |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) | 12 Months Ended | 24 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2019 | |
Organization And Basis Of Presentation [Line Items] | |||
Substantial Doubt about Going Concern, within One Year [true false] | true | ||
Proceeds from Issuance or Sale of Equity | $ 4,166,868 | $ 15,106 | |
Accumulated deficit | 196,881,800 | 194,789,605 | $ 194,789,605 |
Cash and cash equivalents | 5,226,213 | $ 3,126,206 | 3,126,206 |
Attainment Of Development Milestone [Member] | |||
Organization And Basis Of Presentation [Line Items] | |||
Proceeds from Collaborators | $ 20,500,000 | ||
Attainment of Commercialization Milestone [Member] | |||
Organization And Basis Of Presentation [Line Items] | |||
Potential Proceeds From Collaborators | $ 4,500,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Concentration Risk [Line Items] | ||
Accounts Receivable, Allowance for Credit Loss, Current | $ 25,000 | $ 70,000 |
Collaboration Income | 0 | 7,716,667 |
Accumulated deficit | (196,881,800) | (194,789,605) |
Liabilities for product warranty costs | 49,600 | 75,300 |
Marketing and Advertising Expense [Abstract] | ||
Advertising and promotion expense | $ 210,548 | $ 1,652,171 |
Segment Reporting [Abstract] | ||
Revenues from sales outside the United States, percentage | 15.00% | 13.00% |
Product Warranties Disclosures [Abstract] | ||
Liabilities for product warranty costs | $ 49,600 | $ 75,300 |
Accounts Receivable [Member] | Two Customers [Member] | ||
Concentration Risk [Line Items] | ||
Concentration Risk, Percentage | 50.00% | 42.00% |
Revenue Benchmark [Member] | Two Customers [Member] | ||
Concentration Risk [Line Items] | ||
Concentration Risk, Percentage | 35.00% | |
Revenue Benchmark [Member] | One Customer [Member] | ||
Concentration Risk [Line Items] | ||
Concentration Risk, Percentage | 19.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Net Loss per Common Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Stock [Line Items] | ||
Potentially dilutive common stock equivalents excluded from calculation of diluted net income per common share | 215,794 | 561,654 |
Convertible preferred stock | ||
Class of Stock [Line Items] | ||
Potentially dilutive common stock equivalents excluded from calculation of diluted net income per common share | 62 | 478,184 |
Options | ||
Class of Stock [Line Items] | ||
Potentially dilutive common stock equivalents excluded from calculation of diluted net income per common share | 198,484 | 38,936 |
Warrants | ||
Class of Stock [Line Items] | ||
Potentially dilutive common stock equivalents excluded from calculation of diluted net income per common share | 17,248 | 44,534 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies Earnings Per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Net Income (Loss) Available to Common Stockholders, Diluted | $ (2,092,195) | $ (3,773,014) |
Weighted Average Number of Shares Outstanding, Basic and Diluted | 3,014,497 | 968,116 |
Earnings Per Share, Basic and Diluted | $ (0.69) | $ (3.90) |
Net Income (Loss) Available to Common Stockholders, Basic | $ (2,092,195) | $ (3,773,014) |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares outstanding (in shares) | 361,956 | 164,980 |
Weighted average exercise price (in usd per share) | $ 3.68 | $ 7.16 |
Weighted average grant-date fair value of options granted (in usd per share) | $ 1.57 | $ 4.58 |
Aggregate instrinsic value of options issued or exercised | $ 0 | $ 0 |
Unrecognized stock-based compensation costs related to non-vested stock options | $ 197,162 | |
Non-vested stock options (in shares) | 361,956 | |
Weighted average fair value of non-vested stock options (in usd per share) | $ 3.68 | |
Weighted average period of recognition | 9 months 18 days | |
Stock-based compensation expense | $ 599,117 | $ 190,331 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 10 years | 10 years |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% |
2004 Stock Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expiration period | 10 years | |
Shares authorized (in shares) | 439,890 | |
Shares issued in period (in shares) | 24,578 | |
Shares outstanding (in shares) | 361,956 | |
Weighted average exercise price (in usd per share) | $ 3.68 | |
Shares available for future grant (in shares) | 53,356 | |
2004 Stock Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award vesting period | 4 years | |
2009 Inducement Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares authorized (in shares) | 1,250 | |
2004 Stock Plan and 2009 Inducement Plan | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Percentage of combined voting power of all classes of stock | 10.00% | |
Percentage of fair value of common stock at date of grant | 110.00% | |
2004 Stock Plan and 2009 Inducement Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award vesting period | 5 years | |
2010 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares issued in period (in shares) | 13,446 | 4,331 |
Shares outstanding (in shares) | 0 | |
Percentage of fair value of common stock at date of grant | 85.00% | |
Maximum percentage of earnings employee can authorize to withhold, percentage | 10.00% | |
Award vesting rights | All full-time employees and certain part-time employees are eligible to participate in the ESPP. For part-time employees to be eligible, they must have customary employment of more than five months in any calendar year and more than 20 hours per week. Employees who, after exercising their rights to purchase shares under the ESPP, would own shares representing 5% or more of the voting power of the Company’s common stock, are ineligible to participate. | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |
2010 ESPP | Annual Fiscal First Day [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 1.00% | |
2010 ESPP | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 3 years | |
2010 ESPP | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | |
2010 ESPP | Maximum | Annual Fiscal First Day [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional shares authorized (in shares) | 2,500 | |
2004 and 2010 ESPPs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Cash received from option exercises and purchases | $ 23,436 | $ 15,106 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted Average Grant-Date Fair Value Used in the Calculation of Stock-Based Compensation Expense (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 0.80% | 1.90% |
Expected dividend yield | 0.00% | 0.00% |
Expected option term | 10 years | 10 years |
Volatility | 70.00% | 72.40% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Option Activity (Details) | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Number of Options | |
Number of options outstanding, beginning balance (in shares) | shares | 164,980 |
Number of options granted (in shares) | shares | 200,000 |
Number of options exercised (in shares) | shares | 0 |
Number of options forfeited (in shares) | shares | (2,996) |
Number of options expired (in shares) | shares | (28) |
Number of options outstanding, ending balance (in shares) | shares | 361,956 |
Number of options vested or expected to vest (in shares) | shares | 161,158 |
Number of options exercisable (in shares) | shares | 161,158 |
Weighted Average Exercise Price | |
Weighted average exercise price of options outstanding, beginning of period (in usd per share) | $ / shares | $ 7.16 |
Weighted average exercise price of options granted (in usd per share) | $ / shares | 1.57 |
Weighted average exercise price of options exercised (in usd per share) | $ / shares | 0 |
Weighted average exercise price of options forfeited (in usd per share) | $ / shares | 31.57 |
Weighted average exercise price of options expired (in usd per share) | $ / shares | 5,875.19 |
Weighted average exercise price of options outstanding, end of period (in usd per share) | $ / shares | 3.68 |
Weighted average exercise price of options vested or expected to vest (in usd per share) | $ / shares | 6.25 |
Weighted average exercise price of options exercisable (in usd per share) | $ / shares | $ 6.25 |
Weighted Average Remaining Contractual Life (in years) and Aggregate Intrinsic Value | |
Weighted average remaining contractual life of options outstanding (in years) | 9 years 2 months 12 days |
Weighted average remaining contractual life of options vested or expected to vest (in years) | 8 years 6 months |
Weighted average remaining contractual life of options exercisable (in years) | 8 years 6 months |
Aggregate intrinsic value of options outstanding | $ | $ 0 |
Aggregate intrinsic value of options vested and expected to vest | $ | 0 |
Aggregate intrinsic value of options exercisable | $ | $ 0 |
Inventories (Detail)
Inventories (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | ||
Inventory Write-down | $ 0 | $ 2,595,884 |
Purchased components | 716,848 | 720,209 |
Finished goods | 334,434 | 443,505 |
Inventories | $ 1,051,282 | $ 1,163,714 |
Fixed Assets (Details)
Fixed Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 1,504,864 | $ 1,504,864 |
Less – accumulated depreciation | (1,321,370) | (1,231,416) |
Fixed assets, net | $ 183,494 | 273,448 |
Computer and laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, estimated useful life | 3 years | |
Fixed assets, gross | $ 905,966 | 905,966 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, estimated useful life | 3 years | |
Fixed assets, gross | $ 241,413 | 241,413 |
Production equipment | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, estimated useful life | 7 years | |
Fixed assets, gross | $ 216,000 | 216,000 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Estimated Useful Lives | Lesser of life of lease or estimated useful life. | |
Fixed assets, gross | $ 141,485 | $ 141,485 |
Fixed Assets - Additional Infor
Fixed Assets - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 89,954 | $ 124,012 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Technology Fees | $ 450,000 | $ 450,000 |
Professional services | 343,000 | 454,000 |
Accrued Salaries, Current | 49,837 | 62,322 |
Advertising and promotion | 31,000 | 68,000 |
Warranty | 49,600 | 75,300 |
Other | 75,005 | 333,952 |
Accrued expenses | $ 998,442 | $ 1,443,574 |
Income Taxes Income Taxes - Eff
Income Taxes Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal tax provision (benefit) rate | (21.00%) | (21.00%) |
State tax provision, net of federal provision | (4.60%) | 19.90% |
EffectiveIncomeTaxRateReconciliationImpactOfPermanentDifferences | 5.90% | 1.10% |
Federal research and development credits | 0.00% | 0.00% |
Effective Income Tax Rate Reconciliation 382 Limitation | (1.90%) | 861.50% |
Effective Income Tax Rate Reconciliation, Other Adjustments, Percent | 0.30% | 0.00% |
Change in statutory tax rate | 0.00% | 0.00% |
Valuation allowance | 21.90% | (861.50%) |
Effective income tax rate | 0.00% | 0.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Tax Credit Carryforward [Line Items] | ||
Current Federal, State and Local, Tax Expense (Benefit) | $ 0 | $ 0 |
Federal tax provision (benefit) rate | 21.00% | 21.00% |
Deferred tax assets, valuation allowance | $ 3,012,513 | $ 2,208,843 |
Tax benefits attributable to tax credit caryforwards | 75,000 | |
Tax benefits attributable to NOL | $ 2,500,000 | |
Minimum | ||
Tax Credit Carryforward [Line Items] | ||
Open Tax Year | 2017 | |
Federal Tax Authority | ||
Tax Credit Carryforward [Line Items] | ||
TaxCreditCarryforwardBeforeValuationAllowance | $ 0 | |
NOLCarryforwardBeforeValuationAllowance | 7,300,000 | |
NOLAndTaxCreditCarryforwardsEliminated | $ 143,300,000 | |
TaxCreditCarryforwardsExpirationBeginningYear | 2020 | |
Tax credit carryforwards | $ 1,800,000 | |
Net operating loss carryforwards | $ 143,700,000 | |
Operating Loss Carryforwards, Expiration Date | 2020 | |
Federal Tax Authority | Indefinite [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Net operating loss carryforwards | $ 5,300,000 | |
Federal Tax Authority | Expiration Begins 2021 [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Net operating loss carryforwards | 138,400,000 | |
State Tax Authority | ||
Tax Credit Carryforward [Line Items] | ||
TaxCreditCarryforwardBeforeValuationAllowance | $ 0 | |
TaxCreditCarryforwardsExpirationBeginningYear | 2020 | |
Tax credit carryforwards | $ 1,100,000 | |
Net operating loss carryforwards | $ 53,100,000 | |
Operating Loss Carryforwards, Expiration Date | 2020 | |
State Tax Authority | Portion of Current [Member] | ||
Tax Credit Carryforward [Line Items] | ||
Operating Loss Carryforwards, Expiration Date | 2025 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 2,211,161 | $ 1,592,993 |
Research and development credit carryforwards | 43,667 | 0 |
Accrued expenses | 112,995 | 96,030 |
Deferred Tax Assets, Inventory | 311,639 | 306,855 |
Stock-based compensation | 245,988 | 222,420 |
Deferred Tax Assets Right Of Use Assets | 290,268 | 0 |
Other | 0 | (9,455) |
Total gross deferred tax assets | 3,215,718 | 2,208,843 |
Valuation allowance | (3,012,513) | (2,208,843) |
Deferred Tax Liabilities Lease Liability | (189,498) | 0 |
Deferred Tax Liabilities, Other | (13,707) | 0 |
Net deferred tax assets | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Leased Assets [Line Items] | ||
Operating Lease, Weighted Average Discount Rate, Percent | 14.70% | |
Operating Leases, Rent Expense | $ 667,618 | $ 664,098 |
Restructuring Reserve | $ 400,000 | |
Operating Lease, Weighted Average Remaining Lease Term | 3 years | |
Waltham Lease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating lease, renewal term | 5 years | |
Woburn Lease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating lease, renewal term | 5 years | |
Month Rent [Member] | Waltham Lease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating Lease, Payments | $ 41,074 | |
Month Rent [Member] | Woburn Lease [Member] | ||
Operating Leased Assets [Line Items] | ||
Operating Lease, Payments | $ 13,846 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Commitments and Contingencies Disclosure [Abstract] | ||
2018 | $ 653,164 | |
2019 | 247,347 | |
2020 | 165,785 | |
2021 | 165,785 | |
2022 | 117,431 | |
Total minimum lease payments | 1,349,512 | |
Operating Lease Discount | 288,470 | |
Operating Lease, Liability, Current | 599,632 | $ 588,546 |
Operating Lease, Liability, Noncurrent | $ 461,410 | $ 916,674 |
Operating Lease, Weighted Average Discount Rate, Percent | 14.70% |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Cash equivalents | $ 2,374,216 | $ 698,807 |
Assets, Fair Value Disclosure | 2,374,216 | 698,807 |
Level 1 | ||
Assets | ||
Cash equivalents | 2,374,216 | 698,807 |
Assets, Fair Value Disclosure | 2,374,216 | 698,807 |
Level 2 | ||
Assets | ||
Cash equivalents | 0 | 0 |
Assets, Fair Value Disclosure | 0 | 0 |
Level 3 | ||
Assets | ||
Cash equivalents | 0 | 0 |
Assets, Fair Value Disclosure | $ 0 | $ 0 |
Retirement Plan Retirement Plan
Retirement Plan Retirement Plan - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | ||
Contributions to the plan | $ 0 | $ 0 |
Credit Facility - Additional In
Credit Facility - Additional Information (Detail) - USD ($) | May 06, 2020 | Apr. 28, 2020 | Dec. 31, 2020 |
Line of Credit Facility [Line Items] | |||
Credit facility limit restricted to support letter of credit | $ 226,731 | ||
Paycheck Protection Program [Member] | |||
Line of Credit Facility [Line Items] | |||
Repayments of Bank Debt | $ 773,200 | ||
Proceeds from Bank Debt | $ 773,200 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock and Convertible Preferred Stock (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Series B Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Preferred stock, outstanding (in shares) | 200 | 200 |
Preferred stock, shares issued (in shares) | 200 | 200 |
Preferred stock, shares designated (in shares) | 147,000 | 147,000 |
Preferred stock | $ 1 | $ 1 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Series D Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Preferred stock, outstanding (in shares) | 0 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares designated (in shares) | 21,300 | 21,300 |
Preferred stock | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Series F Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Preferred stock, outstanding (in shares) | 0 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares designated (in shares) | 10,621 | 10,621 |
Preferred stock | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Non-Convertible Stock | ||
Class of Stock [Line Items] | ||
Preferred stock, outstanding (in shares) | 0 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 11, 2020 | Feb. 29, 2020 | |
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, Employee Stock Purchase Plan | $ 23,437 | $ 15,106 | |||
Common stock, shares outstanding (in shares) | 3,793,739 | 1,400,674 | |||
Common Stock, Voting Rights | Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. | ||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||
Common stock, shares authorized (in shares) | 25,000,000 | 25,000,000 | |||
Proceeds from Issuance or Sale of Equity | $ 4,166,868 | $ 15,106 | |||
Common Stock | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, Employee Stock Purchase Plan | $ 2 | $ 1 | |||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 13,446 | 4,331 | |||
Stock Issued During Period, Shares, New Issues | 2,348,619 | ||||
Common Stock From Series D Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Convertible preferred stock, shares issued upon conversion (in shares) | 534,333 | ||||
Common Stock From Series F Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Convertible preferred stock, shares issued upon conversion (in shares) | 123,981 | ||||
At The Market Offering Program [Member] | |||||
Class of Stock [Line Items] | |||||
Proceeds from Issuance of Common Stock | $ 4,143,431 | ||||
Stock Issued During Period, Shares, New Issues | 2,348,619 | ||||
Maximum Aggregate Offering Price | $ 4,482,000 | ||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||
Series F Convertible Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||
Preferred stock, shares designated (in shares) | 10,621 | 10,621 | |||
Conversion of Stock, Shares Converted | 3,260.70 | ||||
Series D Convertible Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||
Preferred stock, shares designated (in shares) | 21,300 | 21,300 | |||
Conversion of Stock, Shares Converted | 14,052.93 | ||||
Series B Convertible Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Preferred Stock, Shares Outstanding | 200 | 200 | |||
Preferred stock, shares designated (in shares) | 147,000 | 147,000 | |||
Common Stock | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Value, Employee Stock Purchase Plan | $ 23,437 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 13,446 | ||||
Separation Agreement [Member] | Common Stock | |||||
Class of Stock [Line Items] | |||||
Shares issued during period (in shares) | 31,000 | ||||
Stock Issued During Period, Value, Other | $ 43,751 | ||||
Share price (in dollars per share) | $ 1.41 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Reserved for Future Issuance (Details) | Dec. 31, 2020shares |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance | 416,562 |
Inducement Plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance | 1,250 |
Stock Option Plans | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance | 53,356 |
Employee Stock Purchase Plan | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance | 0 |
Options | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance | 361,956 |
Business Restructuring Busine_2
Business Restructuring Business Restructuring - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Restructuring Cost and Reserve [Line Items] | |||
Inventory Write-down | $ 0 | $ 2,595,884 | |
Restructuring Reserve | 400,000 | ||
IdleFacilityImpairmentCharge | 350,000 | 400,000 | |
Research and Development Expense [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Severance And Relocation Costs | 311,514 | ||
IdleFacilityImpairmentCharge | 154,000 | ||
Selling and Marketing Expense [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Severance And Relocation Costs | 221,387 | ||
IdleFacilityImpairmentCharge | 87,500 | ||
General and Administrative Expense [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Severance And Relocation Costs | 191,872 | ||
IdleFacilityImpairmentCharge | 108,500 | ||
Cost of Sales [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Inventory Write-down | 1,895,884 | ||
Facility Relocation [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring Charges | 100,000 | ||
Restructuring Reserve | 0 | 0 | $ 0 |
Payments for Restructuring | (100,000) | ||
Employee Severance [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring Charges | 224,773 | ||
Restructuring Reserve | 0 | 0 | 0 |
Payments for Restructuring | (224,773) | ||
IdleFacilityImpairment [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring Charges | 350,000 | 400,000 | |
Restructuring Reserve | 400,000 | $ 400,000 | $ 0 |
Payments for Restructuring | $ (350,000) |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Allowance for Doubtful Accounts | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | $ 70,000 | $ 25,000 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Additions, Charge to Cost and Expense | 49,361 | |
Balance at End of Period | 25,000 | 70,000 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Deduction | (45,000) | (4,361) |
Deferred Tax Asset Valuation Allowance | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 2,208,843 | 35,041,300 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Additions, Charge to Cost and Expense | 3,427,540 | 1,535,093 |
Balance at End of Period | 3,012,513 | 2,208,843 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Deduction | (2,623,870) | (34,367,550) |
SalesReturnsReservesMember [Member] | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 689,000 | 1,101,658 |
Balance at End of Period | 545,000 | 689,000 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Deduction | (144,000) | (412,658) |
SEC Schedule, 12-09, Reserve, Warranty [Member] | ||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Balance at Beginning of Period | 75,300 | 129,837 |
Balance at End of Period | 49,600 | 75,300 |
SEC Schedule, 12-09, Valuation Allowances and Reserves, Deduction | $ (25,700) | $ (54,537) |
Uncategorized Items - nuro-2020
Label | Element | Value |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents | us-gaap_CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents | $ 6,780,429 |