Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 01, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
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 | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 5 | ||
Entity Common Stock, Shares Outstanding | 6,801,443 | ||
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, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 3,800 | $ 17,737 |
Marketable securities | 0 | 569 |
Accounts receivable | 1,951 | 1,406 |
Inventories, net | 1,997 | 2,661 |
Other current assets | 461 | 396 |
Total current assets | 8,209 | 22,769 |
Property, plant and equipment, net | 728 | 980 |
Operating lease right-of-use asset | 713 | 903 |
Other assets | 120 | 21 |
TOTAL ASSETS | 9,770 | 24,673 |
Current liabilities | ||
Accounts payable and accrued liabilities | 2,380 | 2,245 |
Accrued compensation | 525 | 2,161 |
Current portion of operating lease liability | 216 | 196 |
Current portion of finance lease liability | 0 | 28 |
Other current liabilities | 51 | 58 |
Total current liabilities | 3,172 | 4,688 |
Common stock warrant liability | 2,843 | 6,868 |
Operating lease liability | 544 | 760 |
Total liabilities | 6,559 | 12,316 |
Commitments and contingencies | ||
Mezzanine Equity | ||
Series J Convertible Preferred Stock as of December 31, 2023 and December 31, 2022, par value $0.0001 per share; authorized 600,000 and none, issued and outstanding 11,950 and none, respectively | 221 | 0 |
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2023 and December 31, 2022, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 5,682,461 and 536,394, respectively | 1 | 0 |
Additional paid-in capital | 290,646 | 279,736 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (31) | (18) |
Unrealized gain (loss) on marketable securities | 0 | 56 |
Accumulated deficit | (287,626) | (267,417) |
Total stockholders' equity | 2,990 | 12,357 |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | 9,770 | 24,673 |
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 |
Series I Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,802,000 | 39,802,000 |
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) | 5,682,461 | 536,394 |
Common stock, shares outstanding (in shares) | 5,682,461 | 536,394 |
Series J Convertible Preferred Stock [Member] | ||
Mezzanine Equity | ||
Mezzanine equity, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Mezzanine equity, shares authorized (in shares) | 600,000 | 0 |
Mezzanine equity, shares issued (in shares) | 11,950 | 0 |
Mezzanine equity, shares outstanding (in shares) | 11,950 | 0 |
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) | 18,000 | 18,000 |
Preferred stock, shares issued (in shares) | 127 | 127 |
Preferred stock, shares outstanding (in shares) | 127 | 127 |
Series I Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 1,049,280 | 1,049,280 |
Preferred stock, shares issued (in shares) | 0 | 1,049,280 |
Preferred stock, shares outstanding (in shares) | 0 | 1,049,280 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 8,864 | $ 8,543 |
Cost of goods sold | 3,881 | 3,788 |
Gross profit | 4,983 | 4,755 |
Operating expenses: | ||
Selling, general and administrative | 17,191 | 17,584 |
Research and development | 5,422 | 4,342 |
Total operating expenses | 22,613 | 21,926 |
Loss from operations | (17,630) | (17,171) |
Other income (expense), net | ||
Other income | 154 | 75 |
Financing expense | (3,483) | (9,247) |
Change in fair value of warrant liability | 758 | 11,827 |
Loss before income taxes | (20,201) | (14,516) |
Income tax expense | (8) | (9) |
Net loss | (20,209) | (14,525) |
Deemed dividend attributable to Series J Convertible Preferred Stock | (2,297) | 0 |
Dividend on Series J Convertible Preferred Stock | (121) | 0 |
Net loss attributable to common stockholders | $ (22,627) | $ (14,525) |
Basic loss per share (in dollars per share) | $ (11.52) | $ (83.55) |
Diluted loss per share (in dollars per share) | $ (11.52) | $ (83.55) |
Weighted average shares outstanding - basic (in shares) | 1,964,406 | 173,846 |
Weighted average shares outstanding - diluted (in shares) | 1,964,406 | 173,846 |
Other comprehensive loss: | ||
Net loss | $ (20,209) | $ (14,525) |
Unrealized (loss) gain on marketable securities | (56) | 80 |
Unrealized foreign currency translation adjustment | (13) | (7) |
Total comprehensive loss | $ (20,278) | $ (14,452) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Common Stock [Member] Series I Convertible Preferred Stock [Member] | Common Stock [Member] Series J Convertible Preferred Stock [Member] | Additional Paid in Capital [Member] | Additional Paid in Capital [Member] Series I Convertible Preferred Stock [Member] | Additional Paid in Capital [Member] Series J Convertible Preferred Stock [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Other Comprehensive Income [Member] Series I Convertible Preferred Stock [Member] | Accumulated Other Comprehensive Income [Member] Series J Convertible Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] Series I Convertible Preferred Stock [Member] | Accumulated Deficit [Member] Series J Convertible Preferred Stock [Member] | Total | Series I Convertible Preferred Stock [Member] | Series J Convertible Preferred Stock [Member] |
Balance at Dec. 31, 2021 | $ 0 | $ 278,874 | $ (35) | $ (252,892) | $ 25,947 | ||||||||||
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (14,525) | (14,525) | ||||||||||
Unrealized foreign currency translation adjustment | 0 | 0 | (7) | 0 | (7) | ||||||||||
Unrealized gain on marketable securities | 0 | 0 | 80 | 0 | 80 | ||||||||||
Stock-based compensation | $ 0 | 862 | 0 | 0 | 862 | ||||||||||
Stock-based compensation (in shares) | 0 | ||||||||||||||
Issuance of common stock from ATM offering, net | $ 0 | 0 | 0 | 0 | 0 | ||||||||||
Issuance of common stock from ATM offering, net (in shares) | 209,940 | ||||||||||||||
Issuance of common stock from conversion of convertible preferred stock | $ 0 | 0 | 0 | 0 | 0 | ||||||||||
Issuance of common stock from conversion of convertible preferred stock (in shares) | 221,078 | ||||||||||||||
Balance at Dec. 31, 2022 | $ 0 | 279,736 | 38 | (267,417) | 12,357 | ||||||||||
Balance (in shares) at Dec. 31, 2022 | 536,394 | ||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (20,209) | (20,209) | ||||||||||
Unrealized foreign currency translation adjustment | 0 | 0 | (13) | 0 | (13) | ||||||||||
Unrealized gain on marketable securities | 0 | 0 | (56) | 0 | (56) | ||||||||||
Stock-based compensation | $ 0 | 670 | 0 | 0 | 670 | ||||||||||
Stock-based compensation (in shares) | 0 | ||||||||||||||
Issuance of common stock from ATM offering, net | $ 0 | 2,119 | 0 | 0 | 2,119 | ||||||||||
Issuance of common stock from ATM offering, net (in shares) | 657,333 | ||||||||||||||
Issuance of common stock from conversion of convertible preferred stock | $ 0 | $ 1 | $ 0 | $ 2,620 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 2,621 | |||||
Issuance of common stock from conversion of convertible preferred stock (in shares) | 10,493 | 3,417,079 | |||||||||||||
Issuance costs related to 2022 common stock offering | $ 0 | (11) | 0 | 0 | (11) | ||||||||||
Issuance of common stock from exercise of warrants | $ 0 | $ 307 | $ 0 | $ 0 | $ 307 | ||||||||||
Issuance of common stock from warrant conversions (in shares) | 1,061,162 | ||||||||||||||
Reclassification of warrants to equity | 0 | 7,623 | 0 | 0 | 7,623 | ||||||||||
Series J Convertible Preferred Stock deemed dividend | 0 | (2,297) | 0 | 0 | (2,297) | ||||||||||
Series J Convertible Preferred Stock PIK dividend | 0 | (121) | 0 | 0 | (121) | ||||||||||
Balance at Dec. 31, 2023 | $ 1 | $ 290,646 | $ (31) | $ (287,626) | $ 2,990 | ||||||||||
Balance (in shares) at Dec. 31, 2023 | 5,682,461 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Activities | ||
Net loss | $ (20,209) | $ (14,525) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 362 | 372 |
Stock-based compensation expense | 670 | 862 |
Change in fair value of warrant liability | (758) | (11,827) |
Financing expense | 3,483 | 9,247 |
Net realized and unrealized gains on marketable securities | (65) | 124 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (545) | (656) |
Inventory | 697 | 140 |
Other current assets | (65) | (68) |
Other assets and liabilities | (7) | (96) |
Accounts payable and accrued expenses | (1,500) | 1,278 |
Net cash used in operating activities | (17,937) | (15,149) |
Investing Activities: | ||
Additions to intangible assets | (99) | 0 |
Proceeds from sales of marketable securities | 578 | 14,850 |
Purchase of property and equipment | (149) | (122) |
Net cash provided by investing activities | 330 | 14,728 |
Financing Activities: | ||
Proceeds from public stock offerings, net | 2,109 | 9,449 |
Proceeds from Series J Preferred Stock and Warrants | 1,482 | 0 |
Proceeds from the exercise of warrants | 120 | 0 |
Payments on finance lease liability | (28) | (26) |
Net cash provided by financing activities | 3,683 | 9,423 |
Effect of exchange rate changes on cash | (13) | (7) |
Net decrease in cash and cash equivalents | (13,937) | 8,995 |
Cash and cash equivalents - beginning of year | 17,737 | 8,742 |
Cash and cash equivalents - end of year | 3,800 | 17,737 |
Supplemental schedule of non-cash activities | ||
Inventory transferred to property, plant and equipment | 41 | 42 |
Issuance of Common Stock for exercise of Series I Warrants | 7,623 | 0 |
Issuance of Series J Preferred Stock for exercise of Warrants | 2,927 | 0 |
Deemed dividend on Series J Preferred Stock | 2,297 | 0 |
Series J Preferred Stock issued for payment in kind dividend | 121 | 0 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 12 | $ 9 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
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 technology 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 20 kg. 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 Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s chief executive officer, views the Company’s operations and manages its business as a single operating segment. At December 31, 2023 and 2022, long-lived assets were located primarily in the United States. Going Concern 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, 2023 and 2022, 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, 2023, the Company had an accumulated deficit of $287.6 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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, investing in clinical research and new product development, 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 2021 and through December 31, 2023, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $40.9 million after deducting the underwriting discounts and commissions and other costs associated with the offerings . 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 May 31, 2024. However, the Company will 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 subsidiary, Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. 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 approximates fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Marketable securities The Company’s marketable securities typically consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, which are classified as available-for-sale and included in current assets. Most marketable securities mature within twelve months from their date of purchase and generally are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive income (loss). Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis and impairment is indicated, it must be determined whether the impairment is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive gain (loss). 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 in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2023, or December 31, 2022. As of December 31, 2023, two 14% 15% two 15% 10% 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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (in thousands) 2023 2022 Finished Goods $ 393 $ 993 Work in Process 207 204 Raw Materials 1,472 1,609 Inventory Reserve (75 ) (145 ) Total $ 1,997 $ 2,661 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 and amortization expense was $362,000 and $372,000 for the years ended December 31, 2023, and 2022, 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 its market capitalization determined with level 1 fair value inputs. For the operating lease right-of-use asset the Company believes that the remaining lease payments represent a fair value of the right of use asset. There have been no impairment losses recognized for the years ended December 31, 2023, or 2022. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers two 13.9% 12.6% one 12.5% 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 recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. 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 using the Black-Scholes option pricing model. Market price at the date of grant is used to calculate the fair value of common stock awards. Stock-based compensation expense is recorded based on awards ultimately expected to vest and is reduced for forfeitures. 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 of 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, 2023, includes a deemed dividend (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, 2023 2022 Stock options 110,916 10,485 Warrants to purchase common stock 2,963,192 679,244 Series F convertible preferred stock 125,857 5,080 Series I convertible preferred stock — 10,493 Series J convertible preferred stock 295,792 — Total 3,495,757 705,302 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) 2023 2022 Net loss to common stockholders $ (20,209 ) $ (14,525 ) Deemed dividend attributable to Series J Convertible Preferred Stock (2,297 ) — Dividend on Series J Convertible Preferred Stock (121 ) — Net loss after deemed dividend (22,627 ) (14,525 ) Weighted average shares outstanding 1,964 174 Basic and diluted loss per share $ (11.52 ) $ (83.55 ) Research and Development Research and development (R&D) costs include activities related to development, design, and testing improvements of the Aquadex System and potential related new products. These R&D costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. R&D costs are expensed as incurred. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (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. The Company has adopted the new standard effective January 1, 2023, which didn’t have a material impact on the consolidated financial statements. The Company evaluates subsequent 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, 2023 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct salesforce. 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, Belarus, Brazil, Colombia, Czech Republic, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Panama, Romania, Singapore, Slovak Republic, Spain, Switzerland, Thailand, United Arab Emirates and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. Product Returns: |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 December 31, 2022 Production Equipment $ 1,360 $ 1,360 Loaners and Demo Equipment 1,534 1,444 Computer Software and Equipment 688 719 Office Furniture & Fixtures 375 375 Leasehold Improvements 253 253 Total 4,210 4,151 Accumulated Depreciation (3,482 ) (3,171 ) $ 728 $ 980 Depreciation and amortization expense was $362,000 and $372,000 for the years ended December 31, 2023, and 2022, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
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 a conversion price of $189,000 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 $189,000 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 4 shares of the Company’s common stock at an exercise price of $189,000 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 convertible into 96 shares of common stock and warrants to purchase 191 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 $89,040 to $15,750, 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 $15,750 to $4,230, and on November 6, 2019, from $4,230 to $2,983, 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 $2,983 to $1,650, 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 $1,650 to $900, 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 $550 to $250, the per share price to the public in the September 2021 offering, described below. In connection with the October 2022 offering, the conversion price of the Series F convertible preferred stock was reduced from $250 to $25, the per share price to the public in the October 2020 offering, described below . In connection with the October 2023 offering, the conversion price of the Series F convertible preferred stock was reduced from $25 to $1.01, the per share price to the public in the October 2023 offering, described below. As of December 31, 2023 and December 31, 2022, 127 shares of the Series F convertible preferred stock remained outstanding. Market-Based Warrants Series H Convertible Preferred Stock and January 2020 Offering: The January 2020 Offering was comprised of 2,015 shares of common stock priced at $1,650 per share and 115,173 shares of Series H convertible preferred stock, convertible into common stock at $1,650 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 5,855 shares of common stock. As of December 31, 2023 and 2022, there were 6,532 warrants outstanding. 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 10,647 shares of common stock priced at $1,350 per share. Each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 10,647 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 $900 to $550, 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 $900 to $550, 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 $550 to $250, 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 $550 to $250, the per share price to the public in the September 2021 Offering. October 2022 Offering The offering was comprised of (1) 209,940 Class A Units, priced at a public offering price of per Class A Unit, with each Class A Unit consisting of one share of common stock and 1.5 warrants to purchase one share of common stock at an exercise price of per share, and (2) 23,157,124 Class , priced at a public offering price of per Class , with each Class consisting of one share of Series I convertible preferred stock, convertible into one share of common stock and 1.5 warrants to purchase one share of common stock a .00 exercise price. The warrants became exercisable beginning on the effective date of a reverse stock split in an amount sufficient to permit the exercise in full of the warrants, contingent upon stockholder approval of such reverse stock split and of the exercisability of the warrants under Nasdaq rules and will expire on the sixth anniversary of the initial exercise date. The warrants were reflected as a liability and were valued on day 1. The valuation exceeded the gross proceeds of the offering, which resulted in a day 1 financing expense of $7.7 million. The warrants were re-measured at fair value as of December 31, 2022, with the fair value change being recorded as non-operating income. On December 8, 2022, following a special meeting of stockholders, the Company’s board of directors approved a one-for-one hundred The conversion price of the preferred stock issued in the transaction was fixed and does not contain any variable pricing feature or any price-based anti-dilutive feature. The preferred stock issued in this transaction includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock) or liquidation preference and, subject to limited exceptions, has no voting rights. The securities comprising the units are immediately separable and were issued separately. In connection with the October 2022 Offering, the conversion price of the Series F convertible preferred stock was reduced from $250 to $25, the per share price to the public in the October 2022 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $250 to $25, the per share price to the public in the October 2022 Offering. In connection with the October 2023 offering, the conversion price of the Series F convertible preferred stock was reduced from $25 to $1.01, the per share price to the public in the October 2023 offering, described below. Reverse Stock Split 1-for-50 1-for-100 1-for-100 2023 At-the-Market Program Supply Agreement Warrants October 2023 Offering The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1, as amended (File No. 333-274610), which was initially filed with the Securities Exchange Commission on September 21, 2023, as amended on September 29, 2023, and declared effective by the SEC on September 29, 2023 with an additional registration statement on Form S-1 filed on October 6, 2023 pursuant to Rule 462(c). A final prospectus relating to the Offering was filed with the SEC on October 13, 2023. The closing of the Offering contemplated by the Placement Agency Agreement occurred on October 17, 2023. On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who will act as warrant agent for the Company, setting forth the terms and conditions of the Warrants sold in this Offering. Each Warrant has an exercise price of $7.50 per one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance. There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not intend to list the Series J Convertible Preferred Stock or the Warrants on The Nasdaq Capital Market or any other national securities exchange or any other nationally recognized trading system. The gross proceeds to the Company from the October 17, 2023, Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and Offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes. The Series J Convertible Preferred Stock is classified as mezzanine equity and accreted to reflect its redemption value as of each reporting date. The accretion will be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations. The warrants are recorded as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The warrants were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million. Underwriter and Placement Agent Fees In conjunction with the Supply Agreement, the Company issued DaVita a warrant to purchase up to an aggregate of 1,289,081 shares of common stock of the Company, par value $0.0001 per share, at an exercise price of $3.2996 per share, provided that at no time can the DaVita Warrant be exercised for an amount of shares that would represent greater than 19.9% ownership in the Company subject to certain vesting milestones. The DaVita Warrant is expected to vest in four tranches as follows: (i) 25% upon receipt of notice to extend the Supply Agreement past the initial pilot-term; (ii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twelve months of Ultrafiltration Services Approval; (iii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twenty-four months of Ultrafiltration Services Approval; and (iv) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within thirty-six months of Ultrafiltration Services Approval. This warrant had not vested as of December 31, 2023. The Company evaluated the accounting treatment for the DaVita Warrant pursuant to ASC 718, “Stock Compensation,” and ASC 480, “Distinguishing Liabilities from Equity,” and concluded that the DaVita Warrant should be classified as an equity instrument on the balance sheet as of December 31, 2023. In accordance with this treatment, the Company’s management concluded none of the performance-based vesting conditions of the DaVita Warrant were probable of vesting as of December 31, 2023, and therefore, no expense associated with the DaVita Warrant was recognized in the Company’s financial statements as of that date. The Company will continue to evaluate the probability of achieving the performance milestones associated with the DaVita Supply Agreement and will record the related equity-based expense in its financial statements based on the grant date fair value of the DaVita Warrant when management deems it is probable that the performance-based vesting conditions will be achieved. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
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 $670,000 and $862,000 during the years ended December 31, 2023 and 2022, respectively. The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (in thousands) 2023 2022 Selling, general and administrative $ 630 $ 784 Research and development 40 78 Total $ 670 $ 862 The majority of the common stock awards 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: 2023 2022 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 10,485 $ 404.08 7,481 $ 656.05 Granted 127,353 6.38 5,833 83.96 Exercised — — — — Forfeited/expired (26,922 ) 39.68 (2,829 ) 410.34 Outstanding at December 31 110,916 $ 35.90 10,485 $ 404.08 Vested at December 31 8,882 $ 293.89 3,531 $ 727.26 For options outstanding and vested at December 31, 2023 and 2022, the weighted average remaining contractual life was 9.18 years and 8.79 years, respectively. There were no option exercises in 2023 or 2022. The total fair value of options that vested in 2023 and 2022 was $614,100, and $1.1 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 common 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: 2023 2022 Expected dividend yield 0 % 0 % Risk-free interest rate 4.16 % 2.13 % Expected volatility 152.28 % 132.48 % Expected life (in years) 6.19 6.15 The weighted-average fair value of stock options granted in 2023 and 2022 was $6.09 and $76.05, respectively. As of December 31, 2023, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $1.1 million and is expected to be recognized over the remaining weighted-average life of 3.01 years. Warrants |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
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, marketable securities, and warrants. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” ● Level 1 ● Level 2 ● Level 3 All cash equivalents and marketable securities are considered Level 1 measurements for all periods presented. The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2023 2022 (in thousand s) Fair Value Level 1 Fair Value Level 1 Marketable securities — — $ 569 $ 569 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2023 and October 2022 public offerings, were calculated using a Monte Carlo valuation model and were classified as Level 3 in the fair value hierarchy. The following is a roll-forward of the fair value of Level 3 warrants: (in thousands) 2023 Balance at December 31, 2021 $ — October 18, 2022, issuance of Series I warrants 18,695 Change in fair value (11,827 ) Balance at December 31, 2022 6,868 Change in fair value 755 Issuance of Common Stock for exercise of Series I warrants (7,623 ) October 17, 2023, issuance of Series J warrants 4,965 Exercise of Series J warrants (536 ) Change in fair value (1,586 ) Balance at December 31, 2023 $ 2,483 Fair values were calculated using the following assumptions: 2023 2022 Risk-free interest rates, adjusted for continuous compounding 3.84%-4.92 % 3.97 % Term (years) 2.78-3.0 6.11 Expected volatility 141.1%-146.4 % 145.3 % Dates and probability of future equity raises various various A significant change in the inputs used for the Monte Carlo valuation models, such as the expected volatility, risk-free interest rate, or probability of future equity financings, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
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) 2023 2022 Domestic $ (20,233 ) $ (14,551 ) Foreign 32 35 Loss before income taxes $ (20,201 ) $ (14,516 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2023 2022 Current: United States and state $ — $ — Foreign, net (8 ) (9 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (8 ) $ (9 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2023 2022 Statutory federal income tax benefit $ 4,242 $ 3,048 State tax benefit, net of federal taxes 531 783 Foreign tax (1 ) (1 ) Nondeductible/nontaxable items (694 ) 548 Other (295 ) (41 ) Valuation allowance (increase) decrease (3,791 ) (4,346 ) Total income tax expense $ (8 ) $ (9 ) Deferred taxes consist of the following as of December 31: (in thousands) 2023 2022 Deferred tax assets: Noncurrent: Accrued leave $ 25 $ 397 Stock based compensation 285 360 Net operating loss carryforward 48,818 45,405 Other 26 42 Intangibles 2,627 1,786 R&D credit carryforward 531 531 Total deferred tax assets 52,312 48,521 Less: valuation allowance (52,312 ) (48,521 ) Total $ — $ — As of December 31, 2023, the Company had federal net operating loss (“NOL”) 2024 2037 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, 2023 and 2022, the valuation allowance increased by $3.8 million and $4.3 million, respectively. The current year increase was primarily due to the federal and state net operating losses generated. During 2023 and 2022, 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 carryforwards 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, 2023 or 2022. 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, 2023 and 2022, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2020 through December 31, 2023 remain open to examination by the Internal Revenue Service and by the various states where the Company is subject to taxation. Additionally, the returns of the Company’s Irish subsidiary are subject to examination by tax authorities for the tax years ended December 31, 2020 and subsequent years. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2023 | |
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) 2023 2022 Operating lease cost $ 249 $ 238 Variable lease cost 142 127 Total $ 391 $ 365 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) 2023 2024 $ 257 2025 264 2026 272 2027 69 Total lease payments 862 Less: Interest (102 ) Present value of lease liability $ 760 As of December 31, 2023 and 2022, the remaining lease terms were 3.25 and 4.25 years, respectively, and discount rates were 6.25% and 6.25% respectively. For the years ended December 31, 2023, and 2022, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $249,000 and $238,000, respectively. |
Finance Lease Liability
Finance Lease Liability | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 10—Commitments and Contingencies Employee Retirement Plan The Company has a 401(k) 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 employees’ contributions at the discretion of the Company. Matching contributions totaled $268,000 and $185,000 for the years ended December 31, 2023, and 2022, respectively. Milestone Payment On December 27, 2022, the Company entered into a license and distribution agreement with SeaStar Medical Holding Corporation, (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs (“SeaStar”), appointing the Company as the exclusive U.S. distributor to promote, advertise, market, distribute and sell certain products. As a part of this agreement, the Company agreed to pay SeaStar, a milestone payment of $450,000, upon its receipt of a Human Device Exemption (HDE) approval from the U.S. Food and Drug Administration’s (FDA). This payment is due on the later to occur of 30 days after achievement of the milestone event or April 1, 2024. As of December 31, 2023, the Company concluded it was probable HDE approval would be obtained and recorded a liability of $450,000 on the consolidated balance sheet. On February 22, 2024, SeaStar obtained HDE approval. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023, and 2022. |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Going Concern | Going Concern 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, 2023 and 2022, 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, 2023, the Company had an accumulated deficit of $287.6 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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, investing in clinical research and new product development, 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 2021 and through December 31, 2023, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $40.9 million after deducting the underwriting discounts and commissions and other costs associated with the offerings . 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 May 31, 2024. However, the Company will 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. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s chief executive officer, views the Company’s operations and manages its business as a single operating segment. At December 31, 2023 and 2022, long-lived assets were located primarily in the United States. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly owned subsidiary, Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. |
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 approximates fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. |
Marketable securities | Marketable securities The Company’s marketable securities typically consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, which are classified as available-for-sale and included in current assets. Most marketable securities mature within twelve months from their date of purchase and generally are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive income (loss). Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis and impairment is indicated, it must be determined whether the impairment is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive gain (loss). |
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 in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2023, or December 31, 2022. As of December 31, 2023, two 14% 15% two 15% 10% |
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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (in thousands) 2023 2022 Finished Goods $ 393 $ 993 Work in Process 207 204 Raw Materials 1,472 1,609 Inventory Reserve (75 ) (145 ) Total $ 1,997 $ 2,661 |
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 and amortization expense was $362,000 and $372,000 for the years ended December 31, 2023, and 2022, 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 its market capitalization determined with level 1 fair value inputs. For the operating lease right-of-use asset the Company believes that the remaining lease payments represent a fair value of the right of use asset. There have been no impairment losses recognized for the years ended December 31, 2023, or 2022. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers two 13.9% 12.6% one 12.5% |
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 recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. |
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 using the Black-Scholes option pricing model. Market price at the date of grant is used to calculate the fair value of common stock awards. Stock-based compensation expense is recorded based on awards ultimately expected to vest and is reduced for forfeitures. 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 of 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, 2023, includes a deemed dividend (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, 2023 2022 Stock options 110,916 10,485 Warrants to purchase common stock 2,963,192 679,244 Series F convertible preferred stock 125,857 5,080 Series I convertible preferred stock — 10,493 Series J convertible preferred stock 295,792 — Total 3,495,757 705,302 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) 2023 2022 Net loss to common stockholders $ (20,209 ) $ (14,525 ) Deemed dividend attributable to Series J Convertible Preferred Stock (2,297 ) — Dividend on Series J Convertible Preferred Stock (121 ) — Net loss after deemed dividend (22,627 ) (14,525 ) Weighted average shares outstanding 1,964 174 Basic and diluted loss per share $ (11.52 ) $ (83.55 ) |
Research and Development | Research and Development Research and development (R&D) costs include activities related to development, design, and testing improvements of the Aquadex System and potential related new products. These R&D costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. R&D costs are expensed as incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (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. The Company has adopted the new standard effective January 1, 2023, which didn’t have a material impact on the consolidated financial statements. The Company evaluates subsequent 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, 2023 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Inventories | Inventories consisted of the following as of December 31: (in thousands) 2023 2022 Finished Goods $ 393 $ 993 Work in Process 207 204 Raw Materials 1,472 1,609 Inventory Reserve (75 ) (145 ) Total $ 1,997 $ 2,661 |
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, 2023 2022 Stock options 110,916 10,485 Warrants to purchase common stock 2,963,192 679,244 Series F convertible preferred stock 125,857 5,080 Series I convertible preferred stock — 10,493 Series J convertible preferred stock 295,792 — Total 3,495,757 705,302 |
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) 2023 2022 Net loss to common stockholders $ (20,209 ) $ (14,525 ) Deemed dividend attributable to Series J Convertible Preferred Stock (2,297 ) — Dividend on Series J Convertible Preferred Stock (121 ) — Net loss after deemed dividend (22,627 ) (14,525 ) Weighted average shares outstanding 1,964 174 Basic and diluted loss per share $ (11.52 ) $ (83.55 ) |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2023 December 31, 2022 Production Equipment $ 1,360 $ 1,360 Loaners and Demo Equipment 1,534 1,444 Computer Software and Equipment 688 719 Office Furniture & Fixtures 375 375 Leasehold Improvements 253 253 Total 4,210 4,151 Accumulated Depreciation (3,482 ) (3,171 ) $ 728 $ 980 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stock-Based Compensation [Abstract] | |
Summary of Stock-Based Compensation Expense | The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (in thousands) 2023 2022 Selling, general and administrative $ 630 $ 784 Research and development 40 78 Total $ 670 $ 862 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2023 2022 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 10,485 $ 404.08 7,481 $ 656.05 Granted 127,353 6.38 5,833 83.96 Exercised — — — — Forfeited/expired (26,922 ) 39.68 (2,829 ) 410.34 Outstanding at December 31 110,916 $ 35.90 10,485 $ 404.08 Vested at December 31 8,882 $ 293.89 3,531 $ 727.26 |
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: 2023 2022 Expected dividend yield 0 % 0 % Risk-free interest rate 4.16 % 2.13 % Expected volatility 152.28 % 132.48 % Expected life (in years) 6.19 6.15 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value of Financial Instruments [Abstract] | |
Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis | The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2023 2022 (in thousand s) Fair Value Level 1 Fair Value Level 1 Marketable securities — — $ 569 $ 569 |
Roll-Forward of Fair Value of Level 3 Warrants | The following is a roll-forward of the fair value of Level 3 warrants: (in thousands) 2023 Balance at December 31, 2021 $ — October 18, 2022, issuance of Series I warrants 18,695 Change in fair value (11,827 ) Balance at December 31, 2022 6,868 Change in fair value 755 Issuance of Common Stock for exercise of Series I warrants (7,623 ) October 17, 2023, issuance of Series J warrants 4,965 Exercise of Series J warrants (536 ) Change in fair value (1,586 ) Balance at December 31, 2023 $ 2,483 |
Fair Value Assumptions | Fair values were calculated using the following assumptions: 2023 2022 Risk-free interest rates, adjusted for continuous compounding 3.84%-4.92 % 3.97 % Term (years) 2.78-3.0 6.11 Expected volatility 141.1%-146.4 % 145.3 % Dates and probability of future equity raises various various |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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) 2023 2022 Domestic $ (20,233 ) $ (14,551 ) Foreign 32 35 Loss before income taxes $ (20,201 ) $ (14,516 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2023 2022 Current: United States and state $ — $ — Foreign, net (8 ) (9 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (8 ) $ (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) 2023 2022 Statutory federal income tax benefit $ 4,242 $ 3,048 State tax benefit, net of federal taxes 531 783 Foreign tax (1 ) (1 ) Nondeductible/nontaxable items (694 ) 548 Other (295 ) (41 ) Valuation allowance (increase) decrease (3,791 ) (4,346 ) Total income tax expense $ (8 ) $ (9 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2023 2022 Deferred tax assets: Noncurrent: Accrued leave $ 25 $ 397 Stock based compensation 285 360 Net operating loss carryforward 48,818 45,405 Other 26 42 Intangibles 2,627 1,786 R&D credit carryforward 531 531 Total deferred tax assets 52,312 48,521 Less: valuation allowance (52,312 ) (48,521 ) Total $ — $ — |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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) 2023 2022 Operating lease cost $ 249 $ 238 Variable lease cost 142 127 Total $ 391 $ 365 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2023 2024 $ 257 2025 264 2026 272 2027 69 Total lease payments 862 Less: Interest (102 ) Present value of lease liability $ 760 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Going Concern, Accounts Receivable and Inventories (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) Customer | Dec. 31, 2022 USD ($) Customer | |
Going Concern [Abstract] | ||
Accumulated deficit | $ (287,626) | $ (267,417) |
Net proceeds from issuance of public offering | $ 40,900 | |
Accounts Receivable [Abstract] | ||
Accounts receivables maximum credit period from invoice date | 30 days | |
Allowance for doubtful accounts | $ 0 | 0 |
Inventories [Abstract] | ||
Finished Goods | 393 | 993 |
Work in Process | 207 | 204 |
Raw Materials | 1,472 | 1,609 |
Inventory Reserve | (75) | (145) |
Total | $ 1,997 | $ 2,661 |
Accounts Receivable [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Number of major customers | Customer | 2 | 2 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 14% | 15% |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 15% | 10% |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment, Intangible Assets and Revenue Recognition (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) Customer | Dec. 31, 2022 USD ($) Customer | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 362 | $ 372 |
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 and Fixtures [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Office Furniture and 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 Recognition [Abstract] | ||
Number of major customers | Customer | 2 | 1 |
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Concentration risk percentage | 13.90% | 12.50% |
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||
Revenue Recognition [Abstract] | ||
Concentration risk percentage | 12.60% |
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, 2023 | Dec. 31, 2022 | |
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) | 3,495,757 | 705,302 |
Reconciliation of reported net loss with reported net loss per share [Abstract] | ||
Net loss to common stockholders | $ (20,209) | $ (14,525) |
Deemed dividend attributable to Series J Convertible Preferred Stock | (2,297) | 0 |
Dividend on Series J Convertible Preferred Stock | (121) | 0 |
Net loss attributable to common stockholders | $ (22,627) | $ (14,525) |
Weighted average shares outstanding - basic (in shares) | 1,964,406 | 173,846 |
Weighted average shares outstanding - diluted (in shares) | 1,964,406 | 173,846 |
Basic loss per share (in dollars per share) | $ (11.52) | $ (83.55) |
Diluted loss per share (in dollars per share) | $ (11.52) | $ (83.55) |
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) | 110,916 | 10,485 |
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) | 2,963,192 | 679,244 |
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) | 125,857 | 5,080 |
Series I 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) | 0 | 10,493 |
Series J 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) | 295,792 | 0 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-01-01 | ||
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]: 2024-01-01 | ||
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] | ||
Concentration risk percentage | 1% | 1% |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 4,210 | $ 4,151 |
Accumulated Depreciation | (3,482) | (3,171) |
Property, Plant and Equipment, Net | 728 | 980 |
Depreciation and amortization expense | 362 | 372 |
Production Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,360 | 1,360 |
Loaners and Demo Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,534 | 1,444 |
Computer Software and Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 688 | 719 |
Office Furniture & Fixtures [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 375 | 375 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 253 | $ 253 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Millions | 12 Months Ended | |||||||||||||||||||||||
Oct. 17, 2023 USD ($) $ / shares shares | Oct. 17, 2023 AUD ($) | Oct. 12, 2023 shares $ / shares | Jun. 19, 2023 Tranche $ / shares shares | Dec. 08, 2022 | Dec. 05, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Aug. 21, 2020 USD ($) $ / shares shares | May 05, 2020 USD ($) $ / shares shares | Apr. 01, 2020 USD ($) shares | Mar. 23, 2020 USD ($) $ / shares shares | Jan. 28, 2020 USD ($) $ / shares shares | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | Sep. 30, 2022 $ / shares | Apr. 02, 2020 $ / shares shares | Nov. 06, 2019 $ / shares | Oct. 25, 2019 $ / shares | May 30, 2019 $ / shares shares | Jul. 03, 2018 $ / shares | |
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Reverse stock split | 0.02 | |||||||||||||||||||||||
Period of warrants expected to vest | 1 year | |||||||||||||||||||||||
Maximum [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||||
Period of warrants expected to vest | 4 years | |||||||||||||||||||||||
Maximum [Member] | Supply Agreement [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Period for ultrafiltration services | 10 years | |||||||||||||||||||||||
January 2020 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 5,855 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 25 | $ 900 | $ 1,650 | $ 250 | ||||||||||||||||||||
Issuance of common stock, net (in shares) | 2,015 | |||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||
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) | 1,387 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,118 | |||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,387 | |||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||||
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) | 855 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,115 | |||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,710 | |||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,302 | |||||||||||||||||||||||
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) | 600 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,230 | |||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,199 | |||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,418 | |||||||||||||||||||||||
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) | 10,647 | |||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,350 | |||||||||||||||||||||||
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) | 10,647 | |||||||||||||||||||||||
Warrant expiry period | 5 years | |||||||||||||||||||||||
March 2021 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 37,958 | |||||||||||||||||||||||
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) | 40,056 | |||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 10,000,000 | |||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,000,000 | |||||||||||||||||||||||
October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 11,000,000 | |||||||||||||||||||||||
Net proceeds from public stock offering | $ | 9,400,000 | |||||||||||||||||||||||
Financing expense | $ | $ 7,700,000 | |||||||||||||||||||||||
At-the-Market Program [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 657,333 | |||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,300,000 | |||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 2,100,000 | |||||||||||||||||||||||
Aggregate cash fee paid to underwriter or placement agent | 3% | |||||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Number of warrants vested (in shares) | 0 | |||||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 33 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9,540 | |||||||||||||||||||||||
DaVita Warrant [Member] | Supply Agreement [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 1,289,081 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.2996 | |||||||||||||||||||||||
Number of warrants vested (in shares) | 0 | |||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||||
Number of tranches | Tranche | 4 | |||||||||||||||||||||||
DaVita Warrant [Member] | Supply Agreement [Member] | Tranche One [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Percentage of warrants expected to vest | 25% | |||||||||||||||||||||||
DaVita Warrant [Member] | Supply Agreement [Member] | Tranche Two [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Percentage of warrants expected to vest | 25% | |||||||||||||||||||||||
Period of warrants expected to vest | 12 months | |||||||||||||||||||||||
DaVita Warrant [Member] | Supply Agreement [Member] | Tranche Three [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Percentage of warrants expected to vest | 25% | |||||||||||||||||||||||
Period of warrants expected to vest | 24 months | |||||||||||||||||||||||
DaVita Warrant [Member] | Supply Agreement [Member] | Tranche Four [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Percentage of warrants expected to vest | 25% | |||||||||||||||||||||||
Period of warrants expected to vest | 36 months | |||||||||||||||||||||||
DaVita Warrant [Member] | Maximum [Member] | Supply Agreement [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to be exercised for amount of shares ownership percentage in entity | 19.90% | |||||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 657,333 | 209,940 | ||||||||||||||||||||||
Common Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||||
Warrants [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants outstanding (in shares) | 6,532 | 6,532 | ||||||||||||||||||||||
Warrants [Member] | October 2023 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Financing expense | $ | $ 2.7 | |||||||||||||||||||||||
Gross proceeds before deducting placement agent fees and commissions and offering expenses | $ | $ 2,250,000 | |||||||||||||||||||||||
Net proceeds after deducting placement agent fees and commissions and offering expenses | $ | $ 1,500,000 | |||||||||||||||||||||||
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) | $ / shares | $ 189,000 | $ 89,040 | ||||||||||||||||||||||
Number of consecutive trading days considered for expiration | 20 days | |||||||||||||||||||||||
Number of consecutive trading days | 30 days | |||||||||||||||||||||||
Preferred stock issued (in shares) | 18,000 | 127 | 127 | |||||||||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 96 | |||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 127 | 127 | ||||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||
Aggregate cash fee paid to underwriter or placement agent | 8% | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Percentage of volume weighted average price of common stock | 300% | |||||||||||||||||||||||
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) | $ / shares | $ 15,750 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 4,230 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 2,983 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | 900 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 25 | $ 250 | ||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2023 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1.01 | |||||||||||||||||||||||
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) | 191 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 189,000 | |||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 4 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 189,000 | |||||||||||||||||||||||
Series H Preferred Stock [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||
Maximum percentage of the applicable Unit offering price, by which exercise price can be lower than adjustment | 10% | |||||||||||||||||||||||
Series H Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 115,173 | |||||||||||||||||||||||
Series I Preferred Stock [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Preferred stock issued (in shares) | 0 | 1,049,280 | ||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 1,049,280 | ||||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||
Series I Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||
Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||||
Class A Unit [Member] | Warrants [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1.5 | |||||||||||||||||||||||
Class B Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 0.25 | |||||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 0 | |||||||||||||||||||||||
Class B Unit [Member] | Warrants [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1.5 | |||||||||||||||||||||||
Series J Convertible Preferred Stock [Member] | October 2023 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 0.5 | |||||||||||||||||||||||
Issuance of common stock, net (in shares) | 150,000 | |||||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 15 | |||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||||
Number of warrants included in each unit | 1 | |||||||||||||||||||||||
Original issue discount percentage | 40% | |||||||||||||||||||||||
Additional shares issuable upon declaration of dividends (in shares) | 362,933 | |||||||||||||||||||||||
Series J Convertible Preferred Stock [Member] | Common Stock [Member] | October 2023 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||||
Series J Convertible Preferred Stock [Member] | Warrants [Member] | October 2023 Offering [Member] | ||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 0.5 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 7.5 | |||||||||||||||||||||||
Warrants term | 3 years |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 670,000 | $ 862,000 |
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 | $ 630,000 | 784,000 |
Research and Development [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 40,000 | $ 78,000 |
Stock Options [Member] | ||
Stock Options Activity [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 10,485 | 7,481 |
Granted (in shares) | 127,353 | 5,833 |
Exercised (in shares) | 0 | 0 |
Forfeited/expired (in shares) | (26,922) | (2,829) |
Outstanding, ending balance (in shares) | 110,916 | 10,485 |
Vested at the end of the year (in shares) | 8,882 | 3,531 |
Weighted Average Exercise Price [Abstract] | ||
Outstanding, beginning balance (in dollars per share) | $ 404.08 | $ 656.05 |
Granted (in dollars per share) | 6.38 | 83.96 |
Exercised (in dollars per share) | 0 | 0 |
Forfeited/expired (in dollars per share) | 39.68 | 410.34 |
Outstanding, ending balance (in dollars per share) | 35.9 | 404.08 |
Vested at the end of the year (in dollars per share) | $ 293.89 | $ 727.26 |
Weighted Average Remaining Contractual Term [Abstract] | ||
Options outstanding, weighted average remaining contractual life | 9 years 2 months 4 days | 9 years 2 months 4 days |
Options vested, weighted average remaining contractual life | 8 years 9 months 14 days | 8 years 9 months 14 days |
Aggregate Intrinsic Value [Abstract] | ||
Fair value of options, vested | $ 614,100 | $ 1,100,000 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||
Expected dividend yield | 0% | 0% |
Risk-free interest rate | 4.16% | 2.13% |
Expected volatility | 152.28% | 132.48% |
Expected life | 6 years 2 months 8 days | 6 years 1 month 24 days |
Additional Disclosures [Abstract] | ||
Weighted-average fair value of options granted (in dollars per share) | $ 6.09 | $ 76.05 |
Total unrecognized compensation costs related to non-vested stock option awards | $ 1,100,000 | |
Unrecognized compensation costs related to non-vested stock option awards, recognition life | 3 years 3 days |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Class of Warrant or Right [Abstract] | ||
Warrants to purchase shares of common stock (in shares) | 2,963,000 | 679,000 |
Exercisable warrants (in shares) | 151,583 | 679,244 |
Minimum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 3.3 | |
Maximum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 189,000 | |
Warrants exercisable period | 4 years 9 months 18 days |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments, Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis (Details) - Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Available-for-sale marketable securities [Abstract] | ||
Marketable securities | $ 0 | $ 569 |
Level 1 [Member] | ||
Available-for-sale marketable securities [Abstract] | ||
Marketable securities | $ 0 | $ 569 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments, Roll-Forward of Fair Value of Level 3 Warrants (Details) - Warrant [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Beginning balance | $ 6,868 | $ 0 |
Ending balance | 2,483 | 6,868 |
October 18, 2022 Series I Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance | 18,695 | |
Issuance of Common Stock for exercise of warrants | (7,623) | |
Change in fair value | 755 | $ (11,827) |
October 17, 2023 Series J Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance | 4,965 | |
Exercise of warrants | (536) | |
Change in fair value | $ (1,586) |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments, Fair Values Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Valuation Technique and Input, Description [Abstract] | ||
Dates and probability of future equity raises | various | various |
Risk-Free Interest Rate, Adjusted for Continuous Compounding [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 0.0397 | |
Risk-Free Interest Rate, Adjusted for Continuous Compounding [Member] | Minimum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 0.0384 | |
Risk-Free Interest Rate, Adjusted for Continuous Compounding [Member] | Maximum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 0.0492 | |
Term [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Term | 6 years 1 month 9 days | |
Term [Member] | Minimum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Term | 2 years 9 months 10 days | |
Term [Member] | Maximum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Term | 3 years | |
Expected Volatility [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 1.453 | |
Expected Volatility [Member] | Minimum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 1.411 | |
Expected Volatility [Member] | Maximum [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 1.464 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Domestic and foreign income (loss) before income taxes [Abstract] | ||
Domestic | $ (20,233) | $ (14,551) |
Foreign | 32 | 35 |
Loss before income taxes | $ (20,201) | $ (14,516) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current [Abstract] | ||
United States and state | $ 0 | $ 0 |
Foreign, net | (8) | (9) |
Deferred [Abstract] | ||
United States and state | 0 | 0 |
Foreign | 0 | 0 |
Total income tax expense | $ (8) | $ (9) |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Effective income tax rate reconciliation [Abstract] | ||
Statutory federal income tax benefit | $ 4,242 | $ 3,048 |
State tax benefit, net of federal taxes | 531 | 783 |
Foreign tax | (1) | (1) |
Nondeductible/nontaxable items | (694) | 548 |
Other | (295) | (41) |
Valuation allowance (increase) decrease | (3,791) | (4,346) |
Total income tax expense | $ (8) | $ (9) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2020 AUD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 25 | $ 397 | |
Stock based compensation | 285 | 360 | |
Net operating loss carryforward | 48,818 | 45,405 | |
Other | 26 | 42 | |
Intangibles | 2,627 | 1,786 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 52,312 | 48,521 | |
Less: valuation allowance | (52,312) | (48,521) | |
Total | 0 | 0 | |
Operating Loss Carryforwards [Abstract] | |||
Increase in valuation allowance | 3,800 | 4,300 | |
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, 2024 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2037 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 212,200 | ||
Net operating loss (NOL) carryforwards with expiration date | 119,700 | ||
Net operating loss (NOL) carryforwards with no expiration date | 92,500 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 61,700 | ||
Foreign [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 0 |
Operating Leases (Details)
Operating Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) ft² $ / ft² | Dec. 31, 2022 USD ($) | |
Operating Leases [Abstract] | ||
Area of property leased under operating lease | ft² | 23,000 | |
Monthly rent and common area maintenance charges | $ 34 | |
Annual base rent (per square foot) | $ / ft² | 10.5 | |
Cost Components of Operating Leases [Abstract] | ||
Operating lease cost | $ 249 | $ 238 |
Variable lease cost | 142 | 127 |
Total | 391 | $ 365 |
Maturities of Lease Liability [Abstract] | ||
2024 | 257 | |
2025 | 264 | |
2026 | 272 | |
2027 | 69 | |
Total lease payments | 862 | |
Less: Interest | (102) | |
Present value of lease liability | $ 760 | |
Remaining lease term | 3 years 3 months | 4 years 3 months |
Discount rate | 6.25% | 6.25% |
Operating cash outflows from operating lease | $ 249 | $ 238 |
Minimum [Member] | ||
Operating Leases [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.32 | |
Maximum [Member] | ||
Operating Leases [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.34 |
Finance Lease Liability (Detail
Finance Lease Liability (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2020 |
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) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 27, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Retirement Plan [Abstract] | |||
Employer's matching contribution | $ 268 | $ 185 | |
SeaStar Medical Holding Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Milestone payments | $ 450 | ||
Payment period after achievement of milestone event | 30 days |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Related Party Transactions [Abstract] | ||
Amount of related party transactions | $ 0 | $ 0 |