Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
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 $0.0001 per share | |
Trading Symbol | NUWE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,864,265 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 8,896 | $ 17,737 |
Marketable securities | 0 | 569 |
Accounts receivable | 1,176 | 1,406 |
Inventories, net | 2,733 | 2,661 |
Other current assets | 943 | 396 |
Total current assets | 13,748 | 22,769 |
Property, plant and equipment, net | 875 | 980 |
Operating lease right-of-use asset | 810 | 903 |
Other assets | 120 | 21 |
TOTAL ASSETS | 15,553 | 24,673 |
Current liabilities | ||
Accounts payable and accrued liabilities | 2,311 | 2,245 |
Accrued compensation | 1,234 | 2,161 |
Current portion of operating lease liability | 206 | 196 |
Current portion of finance lease liability | 14 | 28 |
Other current liabilities | 60 | 58 |
Total current liabilities | 3,825 | 4,688 |
Common stock warrant liability | 0 | 6,868 |
Operating lease liability | 654 | 760 |
Total liabilities | 4,479 | 12,316 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of June 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,864,265 and 536,394 shares, respectively | 0 | 0 |
Additional paid-in capital | 289,845 | 279,736 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (24) | (18) |
Unrealized gain on marketable securities | 0 | 56 |
Accumulated deficit | (278,747) | (267,417) |
Total stockholders' equity | 11,074 | 12,357 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 15,553 | 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 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,873 | 39,969,873 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 1,864,265 | 536,394 |
Common stock, shares outstanding (in shares) | 1,864,265 | 536,394 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 127 | 127 |
Preferred stock, shares issued (in shares) | 127 | 127 |
Preferred stock, shares outstanding (in shares) | 127 | 127 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||
Net sales | $ 2,075 | $ 2,213 | $ 3,901 | $ 4,139 |
Cost of goods sold | 928 | 1,150 | 1,687 | 1,974 |
Gross profit | 1,147 | 1,063 | 2,214 | 2,165 |
Operating expenses: | ||||
Selling, general and administrative | 4,664 | 4,257 | 10,154 | 8,669 |
Research and development | 1,505 | 1,107 | 2,933 | 2,213 |
Total operating expenses | 6,169 | 5,364 | 13,087 | 10,882 |
Loss from operations | (5,022) | (4,301) | (10,873) | (8,717) |
Other income (expense), net | 179 | 17 | 302 | (38) |
Change in fair value of warrant liability | 0 | 0 | (755) | 0 |
Loss before income taxes | (4,843) | (4,284) | (11,326) | (8,755) |
Income tax expense | (2) | (2) | (4) | (4) |
Net loss | $ (4,845) | $ (4,286) | $ (11,330) | $ (8,759) |
Basic loss per share (in dollars per share) | $ (3.65) | $ (40.67) | $ (9.23) | $ (83.12) |
Diluted loss per share (in dollars per share) | $ (3.65) | $ (40.67) | $ (9.23) | $ (83.12) |
Weighted average shares outstanding - basic (in shares) | 1,328 | 105 | 1,227 | 105 |
Weighted average shares outstanding - diluted (in shares) | 1,328 | 105 | 1,227 | 105 |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | $ 1 | $ 1 | $ (6) | $ (1) |
Total comprehensive loss | $ (4,844) | $ (4,285) | $ (11,336) | $ (8,760) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 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 | (4,473) | (4,473) |
Unrealized foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation, net | $ 0 | 241 | 0 | 0 | 241 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
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 | (8,759) | ||||
Balance at Jun. 30, 2022 | $ 0 | 279,351 | (36) | (261,651) | 17,664 |
Balance (in shares) at Jun. 30, 2022 | 105,376 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,286) | (4,286) |
Unrealized foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation, net | $ 0 | 236 | 0 | 0 | 236 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Jun. 30, 2022 | $ 0 | 279,351 | (36) | (261,651) | 17,664 |
Balance (in shares) at Jun. 30, 2022 | 105,376 | ||||
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 | (6,485) | (6,485) |
Unrealized foreign currency translation adjustment | 0 | 0 | (7) | 0 | (7) |
Unrealized gain on marketable securities | 0 | 0 | 6 | 0 | 6 |
Stock-based compensation, net | $ 0 | 181 | 0 | 0 | 181 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (11) | 0 | 0 | (11) |
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 10,493 | ||||
Reclassification of warrants to equity | $ 0 | 7,623 | 0 | 0 | 7,623 |
Conversion of warrants into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of warrants into common stock (in shares) | 660,045 | ||||
Balance at Mar. 31, 2023 | $ 0 | 287,529 | 37 | (273,902) | 13,664 |
Balance (in shares) at Mar. 31, 2023 | 1,206,932 | ||||
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 | (11,330) | ||||
Balance at Jun. 30, 2023 | $ 0 | 289,845 | (24) | (278,747) | 11,074 |
Balance (in shares) at Jun. 30, 2023 | 1,864,265 | ||||
Balance at Mar. 31, 2023 | $ 0 | 287,529 | 37 | (273,902) | 13,664 |
Balance (in shares) at Mar. 31, 2023 | 1,206,932 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,845) | (4,845) |
Unrealized foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Unrealized gain on marketable securities | (61) | (61) | |||
Stock-based compensation, net | $ 0 | 197 | 0 | 0 | 197 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (98) | 0 | 0 | (98) |
Issuance of common stock from ATM offering | $ 0 | 2,217 | 0 | 0 | 2,217 |
Issuance of common stock from ATM offering (in shares) | 657,333 | ||||
Balance at Jun. 30, 2023 | $ 0 | $ 289,845 | $ (24) | $ (278,747) | $ 11,074 |
Balance (in shares) at Jun. 30, 2023 | 1,864,265 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating Activities | ||
Net loss | $ (11,330) | $ (8,759) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 169 | 206 |
Stock-based compensation expense, net | 378 | 477 |
Change in fair value of warrant liability | 755 | 0 |
Net realized gain on marketable securities | (65) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 230 | (563) |
Inventory, net | (72) | (167) |
Other current assets | (547) | 76 |
Other assets and liabilities | (20) | (152) |
Accounts payable and accrued expenses | (856) | 117 |
Net cash used in operating activities | (11,358) | (8,765) |
Investing activities: | ||
Proceeds from sale of marketable securities | 578 | 0 |
Additions to intangible assets | (99) | 0 |
Purchases of property and equipment | (64) | (81) |
Net cash provided by (used in) investing activities | 415 | (81) |
Financing activities: | ||
Proceeds from ATM stock offerings, net | 2,108 | 0 |
Payments on finance lease liability | 0 | (13) |
Net cash provided by (used in) financing activities | 2,108 | (13) |
Effect of exchange rate changes on cash | (6) | (1) |
Net decrease in cash and cash equivalents | (8,841) | (8,860) |
Cash and cash equivalents - beginning of period | 17,737 | 24,205 |
Cash and cash equivalents - end of period | $ 8,896 | $ 15,345 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Nature of Business and Basis of Presentation [Abstract] | |
Nature of Business and Basis of Presentation | Note 1 — Nature of Business and Basis of Presentation Nature of Business: 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 pediatric applications. Principles of Consolidation: These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021 and through June 30, 2023, 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 June 30, 2023, the Company had an accumulated deficit of $278.7 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 the next twelve months. 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 its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex System, During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. On March 3, 2023, we entered into a Sales Agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to create an at-the-market offering program under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Ladenburg was entitled to a commission at a fixed rate equal to 3% of the gross proceeds. For the three months ending June 20, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. Revenue Recognition: For the six months ended June 30, 2023, two customers each represented 14% and 13% of net sales. les. For the six months ended June 30, 2022, two customers each represented 14% and 12% of net sales. Accounts Receivable: outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and 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 Inventories : Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following: (in thousands) June 30, 2023 December 31, 2022 Finished Goods $ 918 $ 993 Work in Process 275 204 Raw Materials 1,702 1,609 Inventory Reserves (162 ) (145 ) Total $ 2,733 $ 2,661 Loss per Share — 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 period presented: June 30 2023 2022 Stock options 114,004 11,979 Warrants to purchase common stock 1,308,271 16,306 Series F convertible preferred stock 5,080 508 Total 1,427,355 28,793 The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30: Three months ended June 30 Six months ended June 30 2023 2022 2023 2022 (in thousands, except per share amounts) Net loss $ (4,845 ) $ (4,286 ) $ (11,330 ) $ (8,759 ) Weighted average shares outstanding 1,328 105 1,227 105 Basic and diluted loss per share $ (3.65 ) $ (40.67 ) $ (9.23 ) $ (83.12 ) Subsequent Events: |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2023 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 — Revenue Recognition Net Sales: Revenue from product sales is recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point unless the customer requests that control and title to the inventory transfer upon delivery. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers whose related revenue is recognized over time. This revenue represents less than 1% of net sales for the three and six months ended June 30, 2023 and 2022. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns : The Company offers customers a limited right of return for its products in case of non-conformity or performance issues. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using available industry data and its own historical sales and returns information. The Company has not received any returns to date and believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 3 — Stockholders’ Equity Series F Convertible Preferred Stock : On November 27, 2017, the Company closed on an underwritten public offering of Series F convertible preferred stock and warrants to purchase shares of common stock for gross proceeds of $18.0 million. Net proceeds totaled approximately $16.2 million after deducting the underwriting discounts and commissions and other costs associated with the offering. 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 expired 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 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 offering consummated by the Company on January 28, 2020 (the “January 2020 Offering”) was reduced from $900 to $550, the per share price to the public in the March 2021 Offering. As of June 30, 2023 and December 31, 2022, 127 shares of the Series F convertible preferred stock remained outstanding. March 2021 Offering : On March 19, 2021, the Company closed on an underwritten public offering of 37,958 shares of common stock, for gross proceeds of approximately $20.9 million (the “March 2021 Offering”). Net proceeds totaled approximately $18.9 million after deducting the underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. September 2021 Offering : On September 17, 2021, the Company closed on an underwritten public offering of 40,056 shares of common stock, for gross proceeds of approximately $10.0 million (the “September 2021 Offering”). Net proceeds totaled approximately $9.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. 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 : On October 18, 2022, the Company closed on an underwritten public offering of 209,940 shares of common stock and 23,157,124 shares of Series I convertible preferred stock, for gross proceeds of approximately $11.0 million (the “October 2022 Offering”). Net proceeds totaled approximately $9.4 million after deducting underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. The offering was comprised of (1) 209,940 Class A Units, priced at a public offering price of $25 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 $25 per share, and (2) 23,157,124 Class B Units, priced at a public offering price of $0.25 per Class B Unit, with each Class B Unit consisting of one share of Series I convertible preferred stock, convertible into one share of common stock for every one hundred shares of Series I convertible preferred stock, and 1.5 warrants to purchase one share of common stock for every one hundred shares of Series I convertible preferred stock. The warrants included a cashless exercise provision that upon becoming exercisable, the warrant holders could exercise the warrants for common stock at a zero-dollar 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 (i) such reverse stock split and (ii) of the exercisability of the warrants under Nasdaq rules, and they expire on the sixth anniversary of the initial exercise date. On December 8, 2022, following a special meeting of stockholders, the Company’s board of directors approved a one-for-one hundred Reverse Stock Split On December 9, 2022, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect the Reverse Stock Split. The Reverse Stock Split became effective as of 5:00 p.m. Eastern Time on December 9, 2022, and the Company’s common stock began trading on a split-adjusted basis when the market opened on December 12, 2022. The conversion price of the preferred stock issued in the October 2022 offering 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. This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation, as amended. All share and per-share amounts in this quarterly report have been retroactively adjusted to reflect the reverse stock splits for all periods presented. On January 4, 2023, the Company secured stockholder approval for the exercisability of the common stock warrants issued in the October 2022 Offering. Upon stockholder approval, the warrants were determined to be equity-classified warrants. Concurrent with stockholder approval, the warrants were marked to market, then reclassified to the equity section of the balance sheet. Through June 30, 2023, 660,046 common stock warrants had converted into 660,046 shares of common stock at a zero-dollar 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. 2023 At-the-Market Program: Placement Agent Fees : In connection with the offerings described above, the Company paid the placement agent an aggregate cash placement fee equal to 8% of the aggregate gross proceeds raised in each of the offerings, except with respect to the issuances made in each of May and June 2023 pursuant to the At-the-Market Program, for which the placement fee was equal to 3% of the aggregate gross proceeds. Market-Based Warrants : On May 30, 2019, the Company granted a market-based warrant to a consultant in exchange for investor relations services. The warrant represents the right to acquire up to 33 shares of the Company’s common stock at an exercise price of $9,540 per share, based on the closing stock price of the Company’s common shares on May 30, 2019. The warrant is subject to a vesting schedule based on the Company achieving certain market stock prices within a specified period of time. The warrant expires on May 30, 2024. None of these warrants had vested as of June 30, 2023. Supply Agreement Warrants “Supply Agreement” “DaVita” “Pilot” “Ultrafiltration Services Approval” 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 (the “DaVita Warrant” 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 the DaVita Warrant should be classified as an equity instrument on the balance sheet as of June 30, 2023. In accordance with this treatment, Management concluded none of the performance-based vesting conditions of the DaVita warrant had been met as of June 30, 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 | 6 Months Ended |
Jun. 30, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 4 — Stock-Based Compensation Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period. The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended June 30 Six months ended June 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $ 179 $ 211 $ 351 $ 425 Research and development expense 18 25 27 52 Total stock-based compensation expense $ 197 $ 236 $ 378 $ 477 During the three months ended June 30, 2023 and 2022, under the 2017 Equity Incentive Plan, the 2021 Inducement Plan, and the 2013 Non-Employee Directors’ Equity Incentive Plan, the Company granted 11,654 and 900 stock options, respectively, to its directors, officers and employees. During the six months ended June 30, 2023 and 2022, the Company granted 106,767 and 5,208, respectively, to its directors, officers, employees and consultants. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition, although vesting acceleration is provided under one grant in the event that a certain milestone is met. The weighted-average grant date fair value of the stock-options issued during the three months ended June 30, 2023 and 2022 was $2.69 and $55.71 per share, respectively. The weighted-average grant date fair value of the stock options issued during the six months ended June 30, 2023 and 2022 was $6.97 and $80.39 per share, respectively. The total number of stock options outstanding as of June 30, 2023 and June 30, 2022 was 114,004 and 11,979, respectively. The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months ended June 30, 2023 and 2022: Three months ended Six months ended June 30 June 30 2023 2022 2023 2022 Expected volatility 132.13 % 132.38 % 156.35 % 132.29 % Expected Life of options (years) 6.08 5.59 6.23 6.14 Expected dividend yield 0 % 0 % 0 % 0 % Risk-free interest rate 3.75 % 2.75 % 4.13 % 1.98 % During the three months ended June 30, 2023 and 2022, 1,178 and 1,620 stock options vested, respectively, and 2,946 and 664 stock options were forfeited or expired during these periods, respectively. During the six months ended June 30, 2023 and 2022, 5,921 and 1,907 stock options vested, respectively, and 3,248 and 805 stock options were forfeited or expired during these periods, respectively. During the three and six months ended June 30, 2023 and 2022, no options were exercised. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 5 — 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 Accounting Standards Codification (“ASC”) Topic 820 “Fair Value Measurement,” the Company’s financial assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: ● Level 1 — Financial instruments with unadjusted quoted prices listed on active market exchanges. ● Level 2 — Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over-the-counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. ● Level 3 — Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques. 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. June 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $ 0 $ 0 $ 569 $ 569 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2022 Offering was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. The following is a roll-forward of the fair value of the Level 3 warrants: (in thousands) Balance at December 31, 2022 $ 6,868 Change in fair value 755 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at June 30, 2023 $ — |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | Note 6 — Income Taxes The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of its deferred tax assets. The Company has established a full valuation allowance for its 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 condensed consolidated financial statements. As of June 30, 2023, there were no material changes to what the Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2022. |
Operating Leases
Operating Leases | 6 Months Ended |
Jun. 30, 2023 | |
Operating Leases [Abstract] | |
Operating Leases | Note 7 — Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for |
Finance Lease Liability
Finance Lease Liability | 6 Months Ended |
Jun. 30, 2023 | |
Finance Lease Liability [Abstract] | |
Finance Lease Liability | Note 8 — 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 | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 9 — Commitments and Contingencies Employee Retirement Plan: Non-refundable Technology License Fee: and the Company fully paid the license fee in the second quarter of 2023 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Nature of Business and Basis of Presentation [Abstract] | |
Principles of Consolidation | Principles of Consolidation: These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. |
Going Concern | Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021 and through June 30, 2023, 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 June 30, 2023, the Company had an accumulated deficit of $278.7 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 the next twelve months. 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 its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex System, During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. On March 3, 2023, we entered into a Sales Agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to create an at-the-market offering program under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Ladenburg was entitled to a commission at a fixed rate equal to 3% of the gross proceeds. For the three months ending June 20, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. |
Revenue Recognition | Revenue Recognition: For the six months ended June 30, 2023, two customers each represented 14% and 13% of net sales. les. For the six months ended June 30, 2022, two customers each represented 14% and 12% of net sales. |
Accounts Receivable | Accounts Receivable: outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and 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 |
Inventories | Inventories : Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following: (in thousands) June 30, 2023 December 31, 2022 Finished Goods $ 918 $ 993 Work in Process 275 204 Raw Materials 1,702 1,609 Inventory Reserves (162 ) (145 ) Total $ 2,733 $ 2,661 |
Loss per Share | Loss per Share — 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 period presented: June 30 2023 2022 Stock options 114,004 11,979 Warrants to purchase common stock 1,308,271 16,306 Series F convertible preferred stock 5,080 508 Total 1,427,355 28,793 The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30: Three months ended June 30 Six months ended June 30 2023 2022 2023 2022 (in thousands, except per share amounts) Net loss $ (4,845 ) $ (4,286 ) $ (11,330 ) $ (8,759 ) Weighted average shares outstanding 1,328 105 1,227 105 Basic and diluted loss per share $ (3.65 ) $ (40.67 ) $ (9.23 ) $ (83.12 ) |
Subsequent Events | Subsequent Events: |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Nature of Business and Basis of Presentation [Abstract] | |
Inventories | Inventories consisted of the following: (in thousands) June 30, 2023 December 31, 2022 Finished Goods $ 918 $ 993 Work in Process 275 204 Raw Materials 1,702 1,609 Inventory Reserves (162 ) (145 ) Total $ 2,733 $ 2,661 |
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 period presented: June 30 2023 2022 Stock options 114,004 11,979 Warrants to purchase common stock 1,308,271 16,306 Series F convertible preferred stock 5,080 508 Total 1,427,355 28,793 |
Reconciliation of Reported Net Loss with Reported Net Loss Per Share | The following table reconciles reported net loss with reported net loss per share for each of the three and six months ended June 30: Three months ended June 30 Six months ended June 30 2023 2022 2023 2022 (in thousands, except per share amounts) Net loss $ (4,845 ) $ (4,286 ) $ (11,330 ) $ (8,759 ) Weighted average shares outstanding 1,328 105 1,227 105 Basic and diluted loss per share $ (3.65 ) $ (40.67 ) $ (9.23 ) $ (83.12 ) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stock-Based Compensation [Abstract] | |
Classification of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended June 30 Six months ended June 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $ 179 $ 211 $ 351 $ 425 Research and development expense 18 25 27 52 Total stock-based compensation expense $ 197 $ 236 $ 378 $ 477 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and six months ended June 30, 2023 and 2022: Three months ended Six months ended June 30 June 30 2023 2022 2023 2022 Expected volatility 132.13 % 132.38 % 156.35 % 132.29 % Expected Life of options (years) 6.08 5.59 6.23 6.14 Expected dividend yield 0 % 0 % 0 % 0 % Risk-free interest rate 3.75 % 2.75 % 4.13 % 1.98 % |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 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. June 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $ 0 $ 0 $ 569 $ 569 |
Roll-Forward of Fair Value of Level 3 Warrants | The following is a roll-forward of the fair value of the Level 3 warrants: (in thousands) Balance at December 31, 2022 $ 6,868 Change in fair value 755 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at June 30, 2023 $ — |
Nature of Business and Basis _4
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventories (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2023 USD ($) Customer | Jun. 30, 2022 Customer | Jun. 30, 2023 USD ($) Customer | Jun. 30, 2022 Customer | Dec. 31, 2022 USD ($) Customer | Mar. 03, 2023 USD ($) | |
Going Concern [Abstract] | ||||||
Accumulated deficit | $ (278,747) | $ (278,747) | $ (267,417) | |||
Net proceeds from issuance of public offering | 9,400 | |||||
Revenue Recognition [Abstract] | ||||||
Accounts receivables maximum credit period from invoice date | 30 days | |||||
Allowance for doubtful accounts | 0 | $ 0 | 0 | |||
Inventories [Abstract] | ||||||
Finished Goods | 918 | 918 | 993 | |||
Work in Process | 275 | 275 | 204 | |||
Raw Materials | 1,702 | 1,702 | 1,609 | |||
Inventory Reserves | (162) | (162) | (145) | |||
Total | 2,733 | $ 2,733 | $ 2,661 | |||
Ladenburg Thalmann & Co. [Member] | ||||||
Going Concern [Abstract] | ||||||
Percentage of fixed commission rate | 3% | |||||
Net proceeds from public stock offering | $ 2,100 | |||||
Ladenburg Thalmann & Co. [Member] | Maximum [Member] | ||||||
Going Concern [Abstract] | ||||||
Aggregate offering price | $ 10,000 | |||||
Accounts Receivable [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Number of major customers | Customer | 1 | 2 | ||||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 20% | 15% | ||||
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 10% | |||||
ASC 606 [Member] | Net Sales [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Number of major customers | Customer | 2 | 3 | 2 | 2 | ||
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 16% | 14% | 14% | 14% | ||
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 13% | 13% | 13% | 12% | ||
ASC 606 [Member] | Customer Three [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 10% |
Nature of Business and Basis _5
Nature of Business and Basis of Presentation, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 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) | 1,427,355 | 28,793 | ||
Reported net loss with reported net loss per share [Abstract] | ||||
Net loss | $ (4,845) | $ (4,286) | $ (11,330) | $ (8,759) |
Weighted average shares outstanding - basic (in shares) | 1,328,000 | 105,000 | 1,227,000 | 105,000 |
Weighted average shares outstanding - diluted (in shares) | 1,328,000 | 105,000 | 1,227,000 | 105,000 |
Basic loss per share (in dollars per share) | $ (3.65) | $ (40.67) | $ (9.23) | $ (83.12) |
Diluted loss per share (in dollars per share) | $ (3.65) | $ (40.67) | $ (9.23) | $ (83.12) |
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) | 114,004 | 11,979 | ||
Warrants to Purchase Common Stock [Member] | ||||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 1,308,271 | 16,306 | ||
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) | 5,080 | 508 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-04-01 | ||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||
Expected timing of satisfaction, period | 1 year | 1 year | ||
Sales Revenue [Member] | Customer Concentration Risk [Member] | ASC 606 [Member] | Maximum [Member] | ||||
Revenue, Performance Obligation [Abstract] | ||||
Percentage of net sales | 1% | 1% | 1% | 1% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 2 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||||||||||
Jun. 19, 2023 Tranches $ / shares shares | Dec. 08, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 $ / shares shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 $ / shares shares | Oct. 31, 2022 $ / shares | Sep. 30, 2022 $ / shares | Mar. 23, 2020 $ / shares | Jan. 28, 2020 $ / shares | Nov. 06, 2019 $ / shares | Oct. 25, 2019 $ / shares | May 30, 2019 $ / shares shares | Jul. 03, 2018 $ / shares | |
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0 | $ 0 | $ 0 | $ 0 | |||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,108,000 | $ 0 | |||||||||||||||||||
Reverse stock split | 0.01 | ||||||||||||||||||||
Number of common stock warrants converted into common stock (in shares) | 660,046 | ||||||||||||||||||||
Number of shares of common stock issued upon conversion of common stock warrants (in shares) | 660,046 | ||||||||||||||||||||
January 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 25 | $ 250 | |||||||||||||||||||
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 | ||||||||||||||||||||
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 placement fee | 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 | ||||||||||||||||||||
Supply Agreement [Member] | Maximum [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Period for ultrafiltration services | 10 years | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 1,289,081 | ||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.2996 | ||||||||||||||||||||
Number of warrants vested (in shares) | 0 | ||||||||||||||||||||
Number of tranches | Tranches | 4 | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche One [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Two [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 12 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Three [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 24 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Four [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 36 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Maximum [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to be exercised for amount of shares ownership percentage in entity | 19.90% | ||||||||||||||||||||
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 | ||||||||||||||||||||
Percentage of volume weighted average price of common stock | 300% | ||||||||||||||||||||
Trading volume for each trading day | $ | $ 200,000 | ||||||||||||||||||||
Preferred stock issued (in shares) | 18,000 | 127 | 127 | 127 | 127 | 127 | |||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 96 | ||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 127 | 127 | 127 | 127 | 127 | ||||||||||||||||
Aggregate cash placement fee | 8% | ||||||||||||||||||||
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 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (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 | $ 25 | $ 250 | ||||||||||||||||||
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 I Preferred Stock [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Preferred stock issued (in shares) | 0 | 0 | 0 | 0 | 1,049,280 | ||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | 1,049,280 | ||||||||||||||||
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 share 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 | ||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 25 | ||||||||||||||||||||
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 | ||||||||||||||||||||
Common Stock [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | 657,333 | ||||||||||||||||||||
Common Stock [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | ||||||||||||||||||||
Number of share in one unit (in shares) | 1 | ||||||||||||||||||||
Warrants [Member] | Class A Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Number of share in one unit (in shares) | 1.5 | ||||||||||||||||||||
Warrants [Member] | Class B Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Number of share in one unit (in shares) | 1.5 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | $ 197 | $ 236 | $ 378 | $ 477 |
Selling, General and Administrative Expense [Member] | ||||
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | 179 | 211 | 351 | 425 |
Research and Development Expense [Member] | ||||
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | $ 18 | $ 25 | $ 27 | $ 52 |
Stock Options [Member] | ||||
Additional Disclosures [Abstract] | ||||
Stock options granted (in shares) | 11,654 | 900 | 106,767 | 5,208 |
Vesting period | 48 months | |||
Weighted average grant date fair value of stock options issued (in dollars per share) | $ 2.69 | $ 55.71 | $ 6.97 | $ 80.39 |
Outstanding stock options (in shares) | 114,004 | 11,979 | 114,004 | 11,979 |
Stock options vested (in shares) | 1,178 | 1,620 | 5,921 | 1,907 |
Stock options forfeited and expired (in shares) | 2,946 | 664 | 3,248 | 805 |
Exercise of stock options (in shares) | 0 | 0 | 0 | 0 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||||
Expected volatility | 132.13% | 132.38% | 156.35% | 132.29% |
Expected Life of options (years) | 6 years 29 days | 5 years 7 months 2 days | 6 years 2 months 23 days | 6 years 1 month 20 days |
Expected dividend yield | 0% | 0% | 0% | 0% |
Risk-free interest rate | 3.75% | 2.75% | 4.13% | 1.98% |
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 | Jun. 30, 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 | 6 Months Ended | |
Jan. 04, 2023 | Jun. 30, 2023 | |
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Beginning balance | $ 6,868 | $ 7,623 |
Change in fair value | 755 | |
Warrants reclassified to equity | (7,623) | |
Ending balance | $ 7,623 | $ 0 |
Operating Leases (Details)
Operating Leases (Details) | 6 Months Ended |
Jun. 30, 2023 USD ($) $ / ft² ft² | |
Operating Leases [Abstract] | |
Area of property leased under operating lease | ft² | 23,000 |
Monthly rent and common area maintenance charges | $ | $ 31,000 |
Annual base rent (per square foot) | 10.5 |
Minimum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.32 |
Maximum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.34 |
Finance Lease Liability (Detail
Finance Lease Liability (Details) | Dec. 31, 2020 USD ($) |
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) - Koronis Biomedical Corporation [Member] | 3 Months Ended | 12 Months Ended | |
Aug. 05, 2021 USD ($) Installment | Jun. 30, 2023 USD ($) | Dec. 31, 2021 USD ($) | |
Commitments and Contingencies [Abstract] | |||
Amount of grant approval received | $ 1,700,000 | ||
Non-refundable technology license fee | $ 428,160 | ||
Number of equal monthly installments | Installment | 12 | ||
Research and Development Expense [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee expenses | $ 428,160 | ||
Non-refundable technology license fee expenses paid | $ 428,160 |