Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Document Transition Report | false | ||
Entity File Number | 001-35312 | ||
Entity Registrant Name | NUWELLIS, INC. | ||
Entity Central Index Key | 0001506492 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 68-0533453 | ||
Entity Address, Address Line One | 12988 Valley View Road | ||
Entity Address, City or Town | Eden Prairie | ||
Entity Address, State or Province | MN | ||
Entity Address, Postal Zip Code | 55344 | ||
City Area Code | 952 | ||
Local Phone Number | 345-4200 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | NUWE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 27.4 | ||
Entity Common Stock, Shares Outstanding | 10,537,606 | ||
Auditor Firm ID | 23 | ||
Auditor Name | Baker Tilly US, LLP | ||
Auditor Location | Minneapolis, Minnesota |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 24,205 | $ 14,437 |
Accounts receivable | 750 | 905 |
Inventories | 2,843 | 2,957 |
Other current assets | 328 | 237 |
Total current assets | 28,126 | 18,536 |
Property, plant and equipment, net | 1,188 | 1,200 |
Operating lease right-of-use asset | 1,082 | 255 |
Other assets | 21 | 21 |
TOTAL ASSETS | 30,417 | 20,012 |
Current liabilities | ||
Accounts payable | 1,414 | 1,097 |
Accrued compensation | 1,664 | 2,192 |
Current portion of operating lease liability | 167 | 206 |
Current portion of finance lease liability | 26 | 24 |
Other current liabilities | 36 | 66 |
Total current liabilities | 3,307 | 3,585 |
Operating lease liability | 956 | 55 |
Finance lease liability | 28 | 54 |
Other long-term liability | 179 | 0 |
Total liabilities | 4,470 | 3,694 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2021 and December 31, 2020, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 10,537,606 and 2,736,060, respectively | 1 | 0 |
Additional paid-in capital | 278,873 | 249,663 |
Accumulated other comprehensive loss: | ||
Foreign currency translation adjustment | (11) | (7) |
Accumulated deficit | (252,916) | (233,338) |
Total stockholders' equity | 25,947 | 16,318 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 30,417 | 20,012 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,873 | 39,969,873 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 10,537,606 | 2,736,060 |
Common stock, shares outstanding (in shares) | 10,537,606 | 2,736,060 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 127 | 127 |
Preferred stock, shares issued (in shares) | 127 | 127 |
Preferred stock, shares outstanding (in shares) | 127 | 127 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 7,921 | $ 7,441 |
Cost of goods sold | 3,430 | 3,384 |
Gross profit | 4,491 | 4,057 |
Operating expenses: | ||
Selling, general and administrative | 19,039 | 17,417 |
Research and development | 4,978 | 3,668 |
Total operating expenses | 24,017 | 21,085 |
Loss from operations | (19,526) | (17,028) |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | 1,202 |
Other income (expense), net | (43) | (1) |
Loss before income taxes | (19,569) | (15,827) |
Income tax expense | (9) | (9) |
Net loss | $ (19,578) | $ (15,836) |
Basic loss per share (in dollars per share) | $ (2.87) | $ (10.67) |
Diluted loss per share (in dollars per share) | $ (2.87) | $ (10.67) |
Weighted average shares outstanding - basic (in shares) | 6,852 | 1,649 |
Weighted average shares outstanding - diluted (in shares) | 6,852 | 1,649 |
Other comprehensive loss: | ||
Realized foreign currency translation gain from dissolution of subsidiary | $ 0 | $ (1,202) |
Unrealized foreign currency translation adjustment | (4) | (19) |
Total comprehensive loss | $ (19,582) | $ (17,057) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2019 | $ 0 | $ 218,278 | $ 1,214 | $ (217,502) | $ 1,990 |
Balance (in shares) at Dec. 31, 2019 | 155,802 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (15,836) | (15,836) |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | 0 | (1,202) | 0 | (1,202) |
Unrealized foreign currency translation adjustment | 0 | 0 | (19) | 0 | (19) |
Stock-based compensation, net | $ 0 | 1,349 | 0 | 0 | 1,349 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 25,921 | 0 | 0 | 25,921 |
Issuance of common stock, net (in shares) | 1,695,877 | ||||
Exercise of warrants | $ 0 | 4,115 | 0 | 0 | 4,115 |
Exercise of warrants (in shares) | 455,139 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 429,242 | ||||
Balance at Dec. 31, 2020 | $ 0 | 249,663 | (7) | (233,338) | 16,318 |
Balance (in shares) at Dec. 31, 2020 | 2,736,060 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (19,578) | (19,578) |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | ||||
Unrealized foreign currency translation adjustment | 0 | 0 | (4) | 0 | (4) |
Stock-based compensation, net | $ 0 | 1,314 | 0 | 0 | 1,314 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 1 | 27,895 | 0 | 0 | 27,896 |
Issuance of common stock, net (in shares) | 7,801,404 | ||||
Exercise of warrants | $ 0 | 1 | 0 | 0 | 1 |
Exercise of warrants (in shares) | 142 | ||||
Balance at Dec. 31, 2021 | $ 1 | $ 278,873 | $ (11) | $ (252,916) | $ 25,947 |
Balance (in shares) at Dec. 31, 2021 | 10,537,606 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Activities: | ||
Net loss | $ (19,578,000) | $ (15,836,000) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 488,000 | 376,000 |
Stock-based compensation expense, net | 1,314,000 | 1,349,000 |
Loss on disposal of property and equipment | 0 | 40,000 |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | (1,202,000) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 155,000 | (106,000) |
Inventory | (143,000) | (1,420,000) |
Other current assets | (91,000) | (76,000) |
Other assets and liabilities | 186,000 | 112,000 |
Accounts payable and accrued expenses | (211,000) | 191,000 |
Net cash used in operating activities | (17,880,000) | (16,572,000) |
Investing Activities: | ||
Purchases of property and equipment | (219,000) | (298,000) |
Proceeds from sale of property and equipment | 0 | 31,000 |
Net cash used in investing activities | (219,000) | (267,000) |
Financing Activities: | ||
Proceeds from public stock offerings, net | 27,896,000 | 25,921,000 |
Proceeds from warrant exercises | 1,300 | 4,115,000 |
Payments on finance lease liability | (26,000) | (20,000) |
Net cash provided by financing activities | 27,871,000 | 30,016,000 |
Effect of exchange rate changes on cash | (4,000) | (19,000) |
Net increase in cash and cash equivalents | 9,768,000 | 13,158,000 |
Cash and cash equivalents - beginning of year | 14,437,000 | 1,279,000 |
Cash and cash equivalents - end of year | 24,205,000 | 14,437,000 |
Supplemental schedule of non-cash activities | ||
Inventory transferred to property, plant and equipment | 257,000 | 260,000 |
Equipment acquired through finance lease liability | 0 | 98,000 |
Operating right-of-use asset recorded as an operating lease liability | 901,000 | 0 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 11,000 | $ 10,000 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Nature of Business and Significant Accounting Policies | Note 1—Nature of Business and Significant Accounting Policies Nature of Business Nuwellis, Inc. (the “Company”) is a medical device company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex SmartFlow® system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20kg or more whose fluid overload is unresponsive to medical management, including diuretics In August 2016, the Company acquired the business associated with the Aquadex System (the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. On April 27, 2021, the Company announced that it was changing its name from CHF Solutions, Inc. to Nuwellis, Inc. to reflect the expansion of its customer base from treating fluid imbalance resulting from congestive heart failure to also include critical care and pediatrics applications Liquidity The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2021 and 2020, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of December 31, 2021, the Company had an accumulated deficit of $252.9 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2020 and through December 31, 2021, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $52.2 million after deducting the underwriting discounts and commissions and other costs associated with the offerings . In addition, during 2021 and 2020 we received approximately $1,300 and $4.1 million, respectively, in proceeds from the exercise of investor warrants. See Note 4—Stockholders’ Equity for additional related disclosure The Company believes that its existing capital resources will be sufficient to support its operating plan through June 30, 2023. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly-owned subsidiaries, Nuwellis, LLC, Sunshine Heart Company Pty Ltd (through November 2020) and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. During the year ended December 31, 2020, the Company closed its Australian subsidiary and recognized a gain of $1.2 million on the dissolution of the entity, due to the recognition of previously unrealized foreign currency translation gains. This subsidiary represented an immaterial portion of our operations, and the dissolution did not represent a strategic shift and therefore, is not presented as a discontinued operation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2021 or December 31, 2020. As of December 31, 2021, two customers represented 12% and 11% of the accounts receivable balance. As of December 31, 2020, no customer represented over 10% of the accounts receivable balance. Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following as of December 31: 2021 2020 Finished Goods $ 1,409 $ 1,343 Work in Process 276 342 Raw Materials 1,158 1,272 Total $ 2,843 $ 2,957 Other Current Assets Other current assets represent prepayments and deposits made by the Company. Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful life of the respective asset. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance cost is expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of is removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years Depreciation expense was $488,000 and $376,000 for the years ended December 31, 2021 and 2020, respectively. Property, plant and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed, and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using expected cash flows associated with its loaner units by considering sales prices for similar assets and by estimating future discounted cash flows expected from the units. For recently acquired assets within the asset group, primarily equipment, the Company determined the fair value based on the replacement cost. For the operating lease right-of-use asset the Company compared its carrying value to an estimated fair market value calculated as its occupancy percentage based off of the most recent property tax statement. Because the Company consists of one asset group, consideration is also given to the relationship between the Company’s market capitalization and its carrying value to further support the Company’s determination of fair value. There have been no impairment losses recognized for the years ended December 31, 2021 or 2020. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers For the years ended December 31, 2021, two customers represented 12.3% and 10.7% of net sales. Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net Stock-Based Compensation The Company recognizes all share-based payments to employees, directors and consultants, including grants of stock options and common stock awards in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model and market-based warrants using a Monte Carlo valuation model. Market price at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures except for market-based warrants which are expensed based on the grant date fair value regardless of whether the award vests. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates . See Note 5—Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of stock-based compensation Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 offerings. The net loss allocable to common stockholders for the year ended December 31, 2020, reflects a $1.8 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. This net deemed dividend includes $0.2 million that resulted from the subsequent reduction in the exercise of price of the warrants as a result of the March 2020 offering (see Note 4—Stockholders’ Equity) Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2021 2020 Stock options 754,525 16,889 Warrants to purchase common stock 1,631,798 1,631,948 Series F convertible preferred stock 50,800 14,224 Total 2,437,123 1,663,061 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2021 2020 Net loss $ (19,578 ) $ (15,836 ) Deemed dividend to preferred stockholders (see Note 4) (75 ) (1,757 ) Net loss after deemed dividend (19,653 ) (17,593 ) Weighted average shares outstanding 6,852 1,649 Basic and diluted loss per share $ (2.87 ) $ (10.67 ) Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex System and potential related products. Research and development costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. Research and development expenses are expensed as incurred. Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses. The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses and entities will need to measure expected credit losses on assets that have a low risk of loss. As a smaller reporting company pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management is currently evaluating the potential impact of these changes on the condensed consolidated financial statements of the Company. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2021 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. Revenue from product sales is recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point unless the customer requests that control and title to the inventory transfer upon delivery. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers which are recognized over time. This revenue represents less than 1% of net sales for each of the years ended December 31, 2021 and 2020. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue, which is included in other current liabilities on the consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Note 3—Property, Plant and Equipment Property, plant and equipment were as follows: (in thousands) December 31, 2021 December 31, 2020 Production Equipment $ 1,321 $ 1,201 Loaners and Demo Equipment 1,364 1,073 Computer Software and Equipment 714 691 Office Furniture & Fixtures 364 364 Leasehold Improvements 245 242 Total 4,008 3,571 Accumulated Depreciation (2,820 ) (2,371 ) $ 1,188 $ 1,200 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 4—Stockholders’ Equity Series F Convertible Preferred Stock The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at an initial conversion price of $1,890.00 per share. Each share of Series F convertible preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $1,890.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $1,890.00 per share. The Series F convertible preferred stock has full ratchet price based anti-dilution protection, subject to customary carve outs, in the event of a down-round financing at a price per share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F convertible preferred stock initially convertible into 9,557 shares of common stock and warrants to purchase 19,122 shares of common stock were issued in the offering. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced from $890.40 to $157.50, the per share price to the public of the Series G convertible preferred stock issued in the March 2019 Offering. Effective October 25, 2019, the conversion price of the Series F convertible preferred stock was reduced from $157.50 to $42.30, and on November 6, 2019, from $42.30 to $29.83, the per share price to the public in the October and November 2019 transactions, respectively. Effective January 28, 2020, the conversion price of the Series F convertible preferred stock was reduced from $29.83 to $16.50, the per share price to the public of the Series H convertible preferred stock which closed in an underwritten public offering on January 28, 2020, described below. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $16.50 to $9.00, the per share price to the public in the March 2020 transaction, described below. In connection with the September 2021 offering, the conversion price of the Series F convertible preferred stock was reduced from $5.50 to $2.50, the per share price to the public in the September 2021 offering, described below. As of December 31, 2021, and December 31, 2020, 127 shares of the Series F convertible preferred stock remained outstanding. Series H Convertible Preferred Stock and January 2020 Offering: The January 2020 Offering was comprised of 201,546 shares of common stock priced at $16.50 per share and 11,517,269 shares of Series H convertible preferred stock, convertible into common stock at $16.50 per share, . Each share of Series H convertible preferred stock and each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 585,460 shares of common stock. As of December 31, 2020, all 11,517,269 shares of the Series H convertible preferred stock had been converted into common stock and none remained outstanding. As of December 31, 2020, warrants to purchase 455,162 shares of common stock had been exercised for total cash proceeds of $4.1 million. March 2020 Offering: five and a half years April 2020 Offering five and a half years May 2020 Offering five and a half years August 2020 Offering 1,064,678 shares of common stock priced at $13.50 per share. Each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 1,064,678 shares of common stock. March 2021 Offering In connection with the March 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 Offering. September 2021 Offering In connection with the September 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $5.50 to $2.50, the per share price to the public in the September 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $5.50 to $2.50, the per share price to the public in the September 2021 Offering. Placement Agent Fees Market-Based Warrants Reverse Stock Split 1-for-5 1-for-30 1-for-30 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 5— Stock-Based Compensation Stock Options and Restricted Stock Awards The Company has various share-based compensation plans, including the Third Amended and Restated 2017 Equity Incentive Plan, the 2013 Non-Employee Directors’ Equity Incentive Plan and the 2021 Inducement Plan (collectively, the “Plans” The Company recognized stock-based compensation expense related to grants of stock options and common stock awards to employees, directors and consultants of $1.3 million, and $1.3 million during the years ended December 31, 2021 and 2020, respectively. The following table summarizes the stock-based compensation expense which was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2021 2020 Selling, general and administrative $ 1,171 $ 1,252 Research and development 143 97 Total $ 1,314 $ 1,349 The majority of the RSUs and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one Stock Options The following is a summary of the Plans’ stock option activity during the years ended December 31: 2021 2020 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 16,889 $ 405.34 13,471 $ 515.33 Granted 912,999 4.46 5,542 10.03 Exercised — — — — Forfeited/expired (175,363 ) 27.76 (2,124 ) 71.51 Outstanding at December 31 754,525 $ 8.00 16,889 $ 405.34 Vested at December 31 43,691 $ 64.16 7,254 $ 697.37 For options outstanding and vested at December 31, 2021, the weighted average remaining contractual life was 9.38 years and 9.09 years, respectively. There were no option exercises in 2021 or 2020. The total fair value of options that vested in 2021 and 2020 was $0.7 million, and $1.7 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions The Company has not historically paid cash dividends to its stockholders, and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2021 2020 Expected dividend yield 0 % 0 % Risk-free interest rate 1.19 % 0.65 % Expected volatility 131.03 % 127.87 % Expected life (in years) 6.21 5.91 The weighted-average fair value of stock options granted in 2021 and 2020 was $3.98 and $8.79, respectively. As of December 31, 2021, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $2.4 million and is expected to be recognized over the remaining weighted-average period of 3.19 years. Warrants |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 6—Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents and warrants. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” ● Level 1 ● Level 2 ● Level 3 The fair value of the market-based warrants described in Note 4 was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. These warrants were classified as permanent equity and as a result, were measured at the grant date and are not required to be remeasured to fair value at each reporting period end. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or Level 3 and there were no movements between these categories as of December 31, 2021 and December 31, 2020. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes [Abstract] | |
Income Taxes | Note 7—Income Taxes Domestic and foreign income (loss) before income taxes, consists of the following for the years ended December 31: (in thousands) 2021 2020 Domestic $ (19,606 ) $ (15,865 ) Foreign 37 38 Loss before income taxes $ (19,569 ) $ (15,827 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2021 2020 Current: United States and state $ — $ — Foreign, net (9 ) (9 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (9 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2021 2020 Statutory federal income tax benefit $ 4,109 $ 3,324 State tax benefit, net of federal taxes 560 94 Foreign tax (1 ) (1 ) Foreign deferred exchange rate adjustments — 1,027 Dissolution of foreign subsidiary — (11,401 ) Nondeductible/nontaxable items (220 ) 34 Other 406 (255 ) Valuation allowance (increase) decrease (4,863 ) 7,169 Total income tax expense $ (9 ) $ (9 ) Deferred taxes consist of the following as of December 31: (in thousands) 2021 2020 Deferred tax assets: Noncurrent: Accrued leave $ 59 $ 61 Stock based compensation 368 293 Net operating loss carryforward 42,363 37,665 Other 131 11 Intangibles 723 751 R&D credit carryforward 531 531 Total deferred tax assets 44,175 39,312 Less: valuation allowance (44,175 ) (39,312 ) Total $ — $ — As of December 31, 2021, the Company had federal net operating loss (“NOL”) 2025 2038 The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying consolidated financial statements. For the years ended December 31, 2021, and 2020, the valuation allowance increased by $4.9 million and decreased by $7.2 million, respectively. The current year increase was primarily due to the Federal and state net operating losses generated. During 2018, 2019, 2020 and 2021, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carry-forwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2021 or 2020. The Company recognizes interest and penalties on unrecognized tax benefits as well as interest received from favorable tax settlements within income tax expense. At December 31, 2021 and 2020, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2018 through December 31, 2021 remain open to examination by the Internal Revenue Service and for the various states where the Company is subject to taxation. Additionally, the returns of the Company’s Australian (through November 2020) and Irish subsidiaries are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2016 and December 31, 2016, respectively. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2021 | |
Operating Leases [Abstract] | |
Operating Leases | Note 8—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for The cost components of the Company’s operating lease were as follows for the year ended December 31: (in thousands) 2021 2020 Operating lease cost $ 219 $ 213 Variable lease cost 123 114 Total $ 342 $ 327 Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space. Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2021 2022 $ 213 2023 249 2024 257 2025 264 2026 272 2027 69 Total lease payments 1,324 Less: Interest (201 ) Present value of lease liability $ 1,123 As of December 31, 2021, and 2020, the remaining lease terms were 5.25 and 1.25 years, respectively, and discount rates were 7.5% for each year. For the years ended December 31, 2021, and 2020, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $219,000 and $213,000, respectively. |
Finance Lease Liability
Finance Lease Liability | 12 Months Ended |
Dec. 31, 2021 | |
Finance Lease Liability [Abstract] | |
Finance Lease Liability | Note 9—Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 10—Commitments and Contingencies Employee Retirement Plan The Company has a 401(k)-profit sharing plan that provides a retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employee’s contributions at the discretion of the Company. Matching contributions totaled $293,000 and $234,000 for the years ended December 31, 2021 and 2020, respectively. Non-refundable Technology License Fee On June 24, 2021, the Company entered into a research and development collaboration agreement with Koronis Biomedical Corporation (KBT) to design and develop an integrated continuous renal replacement therapy device. This agreement became effective on August 5, 2021, when KBT received approval of a $1.7 million grant from the National Institutes of Health (NIH) to support this project. As part of this agreement, the Company will pay KBT a non-refundable technology license fee of $428,160, payable in twelve equal monthly installments commencing on June 1, 2022. The Company has recorded a liability for the non-refundable technology license fee with $249,760 included in Current Accounts Payable and $178,400 included in Other Long-term Liabilities. The full amount of $428,160 was expensed and included in the Research and Development Expense line for the year ended December 31, 2021. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11—Related Party Transactions There were no related party transactions requiring disclosure during the year ended December 31, 2021 and 2020. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2021 | |
Segment and Geographic Information [Abstract] | |
Segment and Geographic Information | Note 12—Segment and Geographic Information The Company has one reportable segment, fluid management. At December 31, 2021 and 2020, long-lived assets were located primarily in the United States. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2021 and 2020, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of December 31, 2021, the Company had an accumulated deficit of $252.9 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2020 and through December 31, 2021, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $52.2 million after deducting the underwriting discounts and commissions and other costs associated with the offerings . In addition, during 2021 and 2020 we received approximately $1,300 and $4.1 million, respectively, in proceeds from the exercise of investor warrants. See Note 4—Stockholders’ Equity for additional related disclosure The Company believes that its existing capital resources will be sufficient to support its operating plan through June 30, 2023. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly-owned subsidiaries, Nuwellis, LLC, Sunshine Heart Company Pty Ltd (through November 2020) and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. During the year ended December 31, 2020, the Company closed its Australian subsidiary and recognized a gain of $1.2 million on the dissolution of the entity, due to the recognition of previously unrealized foreign currency translation gains. This subsidiary represented an immaterial portion of our operations, and the dissolution did not represent a strategic shift and therefore, is not presented as a discontinued operation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. |
Accounts Receivable | Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2021 or December 31, 2020. As of December 31, 2021, two customers represented 12% and 11% of the accounts receivable balance. As of December 31, 2020, no customer represented over 10% of the accounts receivable balance. |
Inventories | Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following as of December 31: 2021 2020 Finished Goods $ 1,409 $ 1,343 Work in Process 276 342 Raw Materials 1,158 1,272 Total $ 2,843 $ 2,957 |
Other Current Assets | Other Current Assets Other current assets represent prepayments and deposits made by the Company. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful life of the respective asset. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance cost is expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of is removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years Depreciation expense was $488,000 and $376,000 for the years ended December 31, 2021 and 2020, respectively. Property, plant and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed, and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using expected cash flows associated with its loaner units by considering sales prices for similar assets and by estimating future discounted cash flows expected from the units. For recently acquired assets within the asset group, primarily equipment, the Company determined the fair value based on the replacement cost. For the operating lease right-of-use asset the Company compared its carrying value to an estimated fair market value calculated as its occupancy percentage based off of the most recent property tax statement. Because the Company consists of one asset group, consideration is also given to the relationship between the Company’s market capitalization and its carrying value to further support the Company’s determination of fair value. There have been no impairment losses recognized for the years ended December 31, 2021 or 2020. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers For the years ended December 31, 2021, two customers represented 12.3% and 10.7% of net sales. |
Foreign Currency Translation | Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes all share-based payments to employees, directors and consultants, including grants of stock options and common stock awards in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model and market-based warrants using a Monte Carlo valuation model. Market price at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures except for market-based warrants which are expensed based on the grant date fair value regardless of whether the award vests. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates . See Note 5—Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of stock-based compensation |
Income Taxes | Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. |
Loss per Share | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 offerings. The net loss allocable to common stockholders for the year ended December 31, 2020, reflects a $1.8 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. This net deemed dividend includes $0.2 million that resulted from the subsequent reduction in the exercise of price of the warrants as a result of the March 2020 offering (see Note 4—Stockholders’ Equity) Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2021 2020 Stock options 754,525 16,889 Warrants to purchase common stock 1,631,798 1,631,948 Series F convertible preferred stock 50,800 14,224 Total 2,437,123 1,663,061 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2021 2020 Net loss $ (19,578 ) $ (15,836 ) Deemed dividend to preferred stockholders (see Note 4) (75 ) (1,757 ) Net loss after deemed dividend (19,653 ) (17,593 ) Weighted average shares outstanding 6,852 1,649 Basic and diluted loss per share $ (2.87 ) $ (10.67 ) |
Research and Development | Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex System and potential related products. Research and development costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. Research and development expenses are expensed as incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses. The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses and entities will need to measure expected credit losses on assets that have a low risk of loss. As a smaller reporting company pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management is currently evaluating the potential impact of these changes on the condensed consolidated financial statements of the Company. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Inventories | Inventories consisted of the following as of December 31: 2021 2020 Finished Goods $ 1,409 $ 1,343 Work in Process 276 342 Raw Materials 1,158 1,272 Total $ 2,843 $ 2,957 |
Estimated Useful Lives | Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years |
Potential Shares of Common Stock not Included in Diluted Net Loss Per Share | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2021 2020 Stock options 754,525 16,889 Warrants to purchase common stock 1,631,798 1,631,948 Series F convertible preferred stock 50,800 14,224 Total 2,437,123 1,663,061 |
Reconciles Reported Net Loss with Reported Net Loss Per Share | The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2021 2020 Net loss $ (19,578 ) $ (15,836 ) Deemed dividend to preferred stockholders (see Note 4) (75 ) (1,757 ) Net loss after deemed dividend (19,653 ) (17,593 ) Weighted average shares outstanding 6,852 1,649 Basic and diluted loss per share $ (2.87 ) $ (10.67 ) |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2021 December 31, 2020 Production Equipment $ 1,321 $ 1,201 Loaners and Demo Equipment 1,364 1,073 Computer Software and Equipment 714 691 Office Furniture & Fixtures 364 364 Leasehold Improvements 245 242 Total 4,008 3,571 Accumulated Depreciation (2,820 ) (2,371 ) $ 1,188 $ 1,200 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation [Abstract] | |
Summary of Stock-Based Compensation Expense | The following table summarizes the stock-based compensation expense which was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2021 2020 Selling, general and administrative $ 1,171 $ 1,252 Research and development 143 97 Total $ 1,314 $ 1,349 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2021 2020 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 16,889 $ 405.34 13,471 $ 515.33 Granted 912,999 4.46 5,542 10.03 Exercised — — — — Forfeited/expired (175,363 ) 27.76 (2,124 ) 71.51 Outstanding at December 31 754,525 $ 8.00 16,889 $ 405.34 Vested at December 31 43,691 $ 64.16 7,254 $ 697.37 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2021 2020 Expected dividend yield 0 % 0 % Risk-free interest rate 1.19 % 0.65 % Expected volatility 131.03 % 127.87 % Expected life (in years) 6.21 5.91 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes [Abstract] | |
Domestic and Foreign Income (Loss) Before Income Taxes | Domestic and foreign income (loss) before income taxes, consists of the following for the years ended December 31: (in thousands) 2021 2020 Domestic $ (19,606 ) $ (15,865 ) Foreign 37 38 Loss before income taxes $ (19,569 ) $ (15,827 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2021 2020 Current: United States and state $ — $ — Foreign, net (9 ) (9 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (9 ) |
Actual Income Tax Expense Differs from Statutory Federal Income Tax Expense | Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2021 2020 Statutory federal income tax benefit $ 4,109 $ 3,324 State tax benefit, net of federal taxes 560 94 Foreign tax (1 ) (1 ) Foreign deferred exchange rate adjustments — 1,027 Dissolution of foreign subsidiary — (11,401 ) Nondeductible/nontaxable items (220 ) 34 Other 406 (255 ) Valuation allowance (increase) decrease (4,863 ) 7,169 Total income tax expense $ (9 ) $ (9 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2021 2020 Deferred tax assets: Noncurrent: Accrued leave $ 59 $ 61 Stock based compensation 368 293 Net operating loss carryforward 42,363 37,665 Other 131 11 Intangibles 723 751 R&D credit carryforward 531 531 Total deferred tax assets 44,175 39,312 Less: valuation allowance (44,175 ) (39,312 ) Total $ — $ — |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Operating Leases [Abstract] | |
Cost Components of Operating Leases | The cost components of the Company’s operating lease were as follows for the year ended December 31: (in thousands) 2021 2020 Operating lease cost $ 219 $ 213 Variable lease cost 123 114 Total $ 342 $ 327 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2021 2022 $ 213 2023 249 2024 257 2025 264 2026 272 2027 69 Total lease payments 1,324 Less: Interest (201 ) Present value of lease liability $ 1,123 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Nature of Business, Going Concern, Basis of Presentation, Accounts Receivable and Inventories (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)Customer | Dec. 31, 2020USD ($)Customer | |
Going Concern [Abstract] | ||
Accumulated deficit | $ (252,916,000) | $ (233,338,000) |
Net proceeds from issuance of public offering | 52,200,000 | |
Proceeds from exercise of investor warrants | 1,300 | 4,115,000 |
Basis of Presentation [Abstract] | ||
Gain on dissolution of foreign subsidiary | $ 1,200,000 | |
Accounts Receivable [Abstract] | ||
Accounts receivables maximum credit period from invoice date | 30 days | |
Allowance for doubtful accounts | $ 0 | 0 |
Inventories [Abstract] | ||
Finished Goods | 1,409,000 | 1,343,000 |
Work in Process | 276,000 | 342,000 |
Raw Materials | 1,158,000 | 1,272,000 |
Total | $ 2,843,000 | $ 2,957,000 |
Accounts Receivable [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Number of major customers | Customer | 2 | 0 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 12.00% | |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 11.00% |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment and Revenue Recognition (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)Customer | Dec. 31, 2020USD ($)Customer | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 488,000 | $ 376,000 |
Impairment losses recognized | $ 0 | $ 0 |
Production Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Production Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 7 years | |
Office Furniture & Fixtures [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Office Furniture & Fixtures [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years | |
Computer Software and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Computer Software and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 4 years | |
Loaners and Demo Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 1 year | |
Loaners and Demo Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years | |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years | |
ASC 606 [Member] | Net Sales [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Number of major customers | Customer | 2 | 1 |
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 12.30% | 10.50% |
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 10.70% |
Nature of Business and Signif_6
Nature of Business and Significant Accounting Policies, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Loss per share [Abstract] | ||
Net deemed dividends resulting from subsequent reduction in exercise price of warrants | $ 75,000 | $ 200 |
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 2,437,123 | 1,663,061 |
Reconciliation of reported net loss with reported net loss per share [Abstract] | ||
Net loss | $ (19,578) | $ (15,836) |
Deemed dividend to preferred shareholders (see Note 4) | (75) | (1,757) |
Net loss after deemed dividend | $ (19,653) | $ (17,593) |
Weighted average shares outstanding - basic (in shares) | 6,852,000 | 1,649,000 |
Weighted average shares outstanding - diluted (in shares) | 6,852,000 | 1,649,000 |
Basic loss per share (in dollars per share) | $ (2.87) | $ (10.67) |
Diluted loss per share (in dollars per share) | $ (2.87) | $ (10.67) |
Stock Options [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 754,525 | 16,889 |
Warrants to Purchase Common Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 1,631,798 | 1,631,948 |
Series F Convertible Preferred Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 50,800 | 14,224 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2021-01-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 1 year | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-01-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 1 year | |
Sales Revenue [Member] | Customer Concentration Risk [Member] | ASC 606 [Member] | Maximum [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Percentage of net sales | 1.00% | 1.00% |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 4,008 | $ 3,571 |
Accumulated Depreciation | (2,820) | (2,371) |
Property, Plant and Equipment, Net | 1,188 | 1,200 |
Production Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,321 | 1,201 |
Loaners and Demo Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,364 | 1,073 |
Computer Software and Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 714 | 691 |
Office Furniture & Fixtures [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 364 | 364 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 245 | $ 242 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | Sep. 17, 2021USD ($)$ / sharesshares | Mar. 19, 2021USD ($)$ / sharesshares | Oct. 09, 2020 | Oct. 06, 2020 | Aug. 21, 2020USD ($)$ / sharesshares | May 05, 2020USD ($)$ / sharesshares | Apr. 01, 2020USD ($)shares | Mar. 23, 2020USD ($)$ / sharesshares | Jan. 28, 2020USD ($)$ / sharesshares | Mar. 12, 2019$ / shares | Nov. 27, 2017USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)shares | Apr. 02, 2020$ / sharesshares | Nov. 06, 2019$ / shares | Oct. 25, 2019$ / shares | May 30, 2019$ / sharesshares | Jul. 03, 2018$ / shares |
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants exercised to purchase common stock (in shares) | shares | 455,162 | |||||||||||||||||
Proceeds from warrant exercises | $ | $ 1,300 | $ 4,115,000 | ||||||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 0 | 0 | ||||||||||||||||
Reverse stock split | 0.03 | |||||||||||||||||
Minimum [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Reverse stock split | 0.2 | |||||||||||||||||
Maximum [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Reverse stock split | 0.03 | |||||||||||||||||
Expected Stock Price Volatility [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants measurement input | 1.3621 | |||||||||||||||||
January 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 585,460 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 9 | $ 16.50 | ||||||||||||||||
Issuance of common stock, net (in shares) | shares | 201,546 | |||||||||||||||||
Public offering price (in dollars per share) | $ 16.50 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 9,700,000 | |||||||||||||||||
Net proceeds from public stock offering | $ | 8,600,000 | |||||||||||||||||
Down-round protection in connection with re-pricing of warrants | $ | 200,000 | |||||||||||||||||
Beneficial conversion amount | $ | $ 1,600,000 | |||||||||||||||||
March 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 138,715 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 11.18 | |||||||||||||||||
Issuance of common stock, net (in shares) | shares | 138,715 | |||||||||||||||||
Public offering price (in dollars per share) | $ 9 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 1,200,000 | |||||||||||||||||
Net proceeds from public stock offering | $ | $ 1,000,000 | |||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||
Warrants exercisable period | 6 months | |||||||||||||||||
April 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 85,506 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 11.15 | |||||||||||||||||
Issuance of common stock, net (in shares) | shares | 171,008 | |||||||||||||||||
Public offering price (in dollars per share) | $ 13.02 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,200,000 | |||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||
May 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 59,966 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 12.30 | |||||||||||||||||
Issuance of common stock, net (in shares) | shares | 119,930 | |||||||||||||||||
Public offering price (in dollars per share) | $ 14.18 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 1,700,000 | |||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||
August 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 1,064,678 | |||||||||||||||||
Public offering price (in dollars per share) | $ 13.50 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 14,400,000 | |||||||||||||||||
Net proceeds from public stock offering | $ | $ 13,000,000 | |||||||||||||||||
Number of shares issuable on the exercise of warrants (in shares) | shares | 1,064,678 | |||||||||||||||||
Warrant expiry period | 5 years | |||||||||||||||||
March 2021 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 3,795,816 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 20,900,000 | |||||||||||||||||
Net proceeds from public stock offering | $ | $ 18,900,000 | |||||||||||||||||
September 2021 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 4,005,588 | |||||||||||||||||
Gross proceeds from public stock offering | $ | $ 10,000,000 | |||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,000,000 | |||||||||||||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Number of warrants vested (in shares) | shares | 0 | |||||||||||||||||
Warrants to Purchase Common Stock [Member] | Minimum [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.50 | |||||||||||||||||
Warrants to Purchase Common Stock [Member] | Maximum [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Exercise price of warrants (in dollars per share) | 41,916 | |||||||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 3,334 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 57.90 | $ 95.40 | ||||||||||||||||
Series F Convertible Preferred Stock [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000,000 | |||||||||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200,000 | |||||||||||||||||
Conversion price (in dollars per share) | $ 1,890 | $ 890.40 | ||||||||||||||||
Number of consecutive trading days considered for expiration | 20 days | |||||||||||||||||
Number of consecutive trading days | 30 days | |||||||||||||||||
Preferred stock issued (in shares) | shares | 18,000 | 127 | 127 | |||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | shares | 9,557 | |||||||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 127 | 127 | ||||||||||||||||
Aggregate cash placement fee | 8.00% | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Percentage of volume weighted average price of common stock | 300.00% | |||||||||||||||||
Trading volume for each trading day | $ | $ 200,000 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2019 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 157.50 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 42.30 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 29.83 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 16.50 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | 9 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 9 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 5.50 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 5.50 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 2.50 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.50 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrants to Purchase Common Stock [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 19,122 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 16 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 1,890 | |||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 16 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 1,890 | |||||||||||||||||
Series H Preferred Stock [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Conversion price (in dollars per share) | $ 16.50 | |||||||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 0 | |||||||||||||||||
Maximum percentage of the applicable Unit offering price, by which exercise price can be lower than adjustment | 10.00% | |||||||||||||||||
Conversion of preferred stock into common stock (in shares) | shares | 11,517,269 | |||||||||||||||||
Series H Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 11,517,269 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1,314 | $ 1,349 |
Minimum [Member] | ||
Additional Disclosures [Abstract] | ||
Award vesting period | 1 year | |
Maximum [Member] | ||
Additional Disclosures [Abstract] | ||
Award vesting period | 4 years | |
Selling, General and Administrative [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1,171 | 1,252 |
Research and Development [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 143 | $ 97 |
Stock Options [Member] | ||
Stock Options Activity [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 16,889 | 13,471 |
Granted (in shares) | 912,999 | 5,542 |
Exercised (in shares) | 0 | 0 |
Forfeited/expired (in shares) | (175,363) | (2,124) |
Outstanding, ending balance (in shares) | 754,525 | 16,889 |
Vested at the end of the year (in shares) | 43,691 | 7,254 |
Weighted Average Exercise Price [Abstract] | ||
Outstanding, beginning balance (in dollars per share) | $ 405.34 | $ 515.33 |
Granted (in dollars per share) | 4.46 | 10.03 |
Exercised (in dollars per share) | 0 | 0 |
Forfeited/expired (in dollars per share) | 27.76 | 71.51 |
Outstanding, ending balance (in dollars per share) | 8 | 405.34 |
Vested at the end of the year (in dollars per share) | $ 64.16 | $ 697.37 |
Weighted Average Remaining Contractual Term [Abstract] | ||
Options outstanding, weighted average remaining contractual life | 9 years 4 months 17 days | |
Options vested, weighted average remaining contractual life | 9 years 1 month 2 days | |
Aggregate Intrinsic Value [Abstract] | ||
Fair value of options, vested | $ 700 | $ 1,700 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||
Expected dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 1.19% | 0.65% |
Expected volatility | 131.03% | 127.87% |
Expected life | 6 years 2 months 15 days | 5 years 10 months 28 days |
Additional Disclosures [Abstract] | ||
Weighted-average fair value of options granted (in dollars per share) | $ 3.98 | $ 8.79 |
Total unrecognized compensation costs related to non-vested stock option awards | $ 2,400 | |
Unrecognized compensation costs related to non-vested stock option awards, recognition period | 3 years 2 months 8 days |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Warrant or Right [Abstract] | ||
Warrants outstanding (in shares) | 1,631,798 | 1,631,948 |
Minimum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 2.50 | |
Warrants exercisable period | 3 months | |
Maximum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 41,916 | |
Warrants exercisable period | 3 years 10 months 6 days |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value Transfers between levels [Abstract] | ||
Level 1 to Level 2 asset transfers | $ 0 | $ 0 |
Level 2 to Level 1 asset transfers | 0 | 0 |
Level 1 to Level 2 liability transfers | 0 | 0 |
Level 2 to Level 1 liability transfers | 0 | 0 |
Asset transfers into Level 3 | 0 | 0 |
Asset transfers out of Level 3 | 0 | 0 |
Liability transfers into Level 3 | 0 | 0 |
Liability transfers out of Level 3 | $ 0 | $ 0 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Domestic and foreign income (loss) before income taxes [Abstract] | ||
Domestic | $ (19,606) | $ (15,865) |
Foreign | 37 | 38 |
Loss before income taxes | $ (19,569) | $ (15,827) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current [Abstract] | ||
United States and state | $ 0 | $ 0 |
Foreign, net | (9) | (9) |
Deferred [Abstract] | ||
United States and state | 0 | 0 |
Foreign | 0 | 0 |
Total income tax expense | $ (9) | $ (9) |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Effective income tax rate reconciliation [Abstract] | ||
Statutory federal income tax benefit | $ 4,109 | $ 3,324 |
State tax benefit, net of federal taxes | 560 | 94 |
Foreign tax | (1) | (1) |
Foreign deferred exchange rate adjustments | 0 | 1,027 |
Dissolution of foreign subsidiary | 0 | (11,401) |
Nondeductible/nontaxable items | (220) | 34 |
Other | 406 | (255) |
Valuation allowance (increase) decrease | (4,863) | 7,169 |
Total income tax expense | $ (9) | $ (9) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020AUD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 59 | $ 61 | |
Stock based compensation | 368 | 293 | |
Net operating loss carryforward | 42,363 | 37,665 | |
Other | 131 | 11 | |
Intangibles | 723 | 751 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 44,175 | 39,312 | |
Less: valuation allowance | (44,175) | (39,312) | |
Total | 0 | 0 | |
Operating Loss Carryforwards [Abstract] | |||
Increase (decrease) in valuation allowance | 4,900 | (7,200) | |
Unrecognized Tax Benefits [Abstract] | |||
Uncertain tax positions | 0 | 0 | |
Penalties and Interest Accrued [Abstract] | |||
Interest and penalties accrued on uncertain tax positions | $ 0 | $ 0 | |
Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2025 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2038 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 186,400 | ||
Net operating loss (NOL) carryforwards with expiration date | 120,100 | ||
Net operating loss (NOL) carryforwards with no expiration date | 66,300 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 44,400 | ||
Australian [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 0 |
Operating Leases (Details)
Operating Leases (Details) | 12 Months Ended | |
Dec. 31, 2021USD ($)$ / ft²ft² | Dec. 31, 2020USD ($) | |
Operating Lease s [Abstract] | ||
Area of property leased under operating lease | ft² | 23,000 | |
Monthly rent and common area maintenance charges | $ 29,000 | |
Annual base rent (per square foot) | $ / ft² | 10.50 | |
Cost Components of Operating Leases [Abstract] | ||
Operating lease cost | $ 219,000 | $ 213,000 |
Variable lease cost | 123,000 | 114,000 |
Total | 342,000 | $ 327,000 |
Maturities of Lease Liability [Abstract] | ||
2022 | 213,000 | |
2023 | 249,000 | |
2024 | 257,000 | |
2025 | 264,000 | |
2026 | 272,000 | |
2027 | 69,000 | |
Total lease payments | 1,324,000 | |
Less: Interest | (201,000) | |
Present value of lease liability | $ 1,123,000 | |
Remaining lease term | 5 years 3 months | 1 year 3 months |
Discount rate | 7.50% | 7.50% |
Operating cash outflows from operating lease | $ 219,000 | $ 213,000 |
Minimum [Member] | ||
Operating Lease s [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.32 | |
Maximum [Member] | ||
Operating Lease s [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.34 |
Finance Lease Liability (Detail
Finance Lease Liability (Details) | Dec. 31, 2020USD ($) |
Finance Lease Liability [Abstract] | |
Value of finance lease equipment | $ 98,000 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net |
Principal amount under lease agreement | $ 93,000 |
Implied interest rate | 7.50% |
Finance lease term | 39 months |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Aug. 05, 2021USD ($)Installment | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Employee Retirement Plan [Abstract] | |||
Employer's matching contribution | $ 293,000 | $ 234,000 | |
Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Amount of grant approval received | $ 1,700,000 | ||
Non-refundable technology license fee | $ 428,160 | ||
Number of equal monthly installments | Installment | 12 | ||
Research and Development Expense [Member] | Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee expenses | 428,160 | ||
Current Accounts Payable [Member] | Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee | 249,760 | ||
Other Long-term Liabilities [Member] | Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee | $ 178,400 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transactions [Abstract] | ||
Amount of related party transactions | $ 0 | $ 0 |
Segment and Geographic Inform_2
Segment and Geographic Information (Details) | 12 Months Ended |
Dec. 31, 2021Segment | |
Segment and Geographic Information [Abstract] | |
Number of reportable segments | 1 |