Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
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 $0.0001 per share | |
Trading Symbol | NUWE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 31,531,650 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 12,053 | $ 24,205 |
Accounts receivable | 1,100 | 750 |
Inventories | 2,919 | 2,843 |
Other current assets | 368 | 328 |
Total current assets | 16,440 | 28,126 |
Property, plant and equipment, net | 1,027 | 1,188 |
Operating lease right-of-use asset | 949 | 1,082 |
Other assets | 21 | 21 |
TOTAL ASSETS | 18,437 | 30,417 |
Current liabilities | ||
Accounts payable | 1,561 | 1,414 |
Accrued compensation | 1,751 | 1,664 |
Current portion of operating lease liability | 191 | 167 |
Current portion of finance lease liability | 35 | 26 |
Other current liabilities | 73 | 36 |
Total current liabilities | 3,611 | 3,307 |
Operating lease liability | 810 | 956 |
Finance lease liability | 0 | 28 |
Other long-term liability | 0 | 179 |
Total liabilities | 4,421 | 4,470 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of September 30, 2022 and December 31, 2021, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 10,537,606 shares | 1 | 1 |
Additional paid-in capital | 279,570 | 278,873 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (10) | (11) |
Accumulated deficit | (265,545) | (252,916) |
Total stockholders' equity | 14,016 | 25,947 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 18,437 | 30,417 |
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 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,873 | 39,969,873 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 10,537,606 | 10,537,606 |
Common stock, shares outstanding (in shares) | 10,537,606 | 10,537,606 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||
Net sales | $ 2,065 | $ 1,853 | $ 6,204 | $ 6,279 |
Cost of goods sold | 806 | 733 | 2,780 | 2,682 |
Gross profit | 1,259 | 1,120 | 3,424 | 3,597 |
Operating expenses: | ||||
Selling, general and administrative | 4,251 | 4,645 | 12,920 | 14,945 |
Research and development | 928 | 1,726 | 3,141 | 3,847 |
Total operating expenses | 5,179 | 6,371 | 16,061 | 18,792 |
Loss from operations | (3,920) | (5,251) | (12,637) | (15,195) |
Other income (expense), net | 52 | (19) | 14 | (22) |
Loss before income taxes | (3,868) | (5,270) | (12,623) | (15,217) |
Income tax expense | (2) | (2) | (6) | (7) |
Net loss | $ (3,870) | $ (5,272) | $ (12,629) | $ (15,224) |
Basic loss per share (in dollars per share) | $ (0.37) | $ (0.75) | $ (1.2) | $ (2.72) |
Diluted loss per share (in dollars per share) | $ (0.37) | $ (0.75) | $ (1.2) | $ (2.72) |
Weighted average shares outstanding - basic (in shares) | 10,538 | 7,098 | 10,538 | 5,624 |
Weighted average shares outstanding - diluted (in shares) | 10,538 | 7,098 | 10,538 | 5,624 |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | $ 2 | $ 0 | $ 1 | $ (3) |
Total comprehensive loss | $ (3,868) | $ (5,272) | $ (12,628) | $ (15,227) |
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, 2020 | $ 0 | $ 249,663 | $ (7) | $ (233,338) | $ 16,318 |
Balance (in shares) at Dec. 31, 2020 | 2,736,060 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (5,221) | (5,221) |
Foreign currency translation adjustment | 0 | 0 | (3) | 0 | (3) |
Stock-based compensation, net | $ 0 | 355 | 0 | 0 | 355 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common, net | $ 0 | 18,902 | 0 | 0 | 18,902 |
Issuance of common, net (in shares) | 3,795,816 | ||||
Exercise of warrants | $ 0 | 1 | 0 | 0 | 1 |
Exercise of warrants (in shares) | 66 | ||||
Balance at Mar. 31, 2021 | $ 0 | 268,921 | (10) | (238,559) | 30,352 |
Balance (in shares) at Mar. 31, 2021 | 6,531,942 | ||||
Balance at Dec. 31, 2020 | $ 0 | 249,663 | (7) | (233,338) | 16,318 |
Balance (in shares) at Dec. 31, 2020 | 2,736,060 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (15,224) | ||||
Foreign currency translation adjustment | (3) | ||||
Balance at Sep. 30, 2021 | $ 1 | 278,552 | (10) | (248,562) | 29,981 |
Balance (in shares) at Sep. 30, 2021 | 10,537,606 | ||||
Balance at Mar. 31, 2021 | $ 0 | 268,921 | (10) | (238,559) | 30,352 |
Balance (in shares) at Mar. 31, 2021 | 6,531,942 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,731) | (4,731) |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Stock-based compensation, net | $ 0 | 381 | 0 | 0 | 381 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (6) | 0 | 0 | (6) |
Exercise of warrants | $ 0 | 0 | 0 | 0 | 0 |
Exercise of warrants (in shares) | 76 | ||||
Balance at Jun. 30, 2021 | $ 0 | 269,296 | (10) | (243,290) | 25,996 |
Balance (in shares) at Jun. 30, 2021 | 6,532,018 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (5,272) | (5,272) |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Stock-based compensation, net | $ 0 | 257 | 0 | 0 | 257 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common, net | $ 1 | 8,999 | 0 | 0 | 9,000 |
Issuance of common, net (in shares) | 4,005,588 | ||||
Balance at Sep. 30, 2021 | $ 1 | 278,552 | (10) | (248,562) | 29,981 |
Balance (in shares) at Sep. 30, 2021 | 10,537,606 | ||||
Balance at Dec. 31, 2021 | $ 1 | 278,873 | (11) | (252,916) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 10,537,606 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,473) | (4,473) |
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 | $ 1 | 279,114 | (13) | (257,389) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 10,537,606 | ||||
Balance at Dec. 31, 2021 | $ 1 | 278,873 | (11) | (252,916) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 10,537,606 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,629) | ||||
Foreign currency translation adjustment | 1 | ||||
Balance at Sep. 30, 2022 | $ 1 | 279,570 | (10) | (265,545) | 14,016 |
Balance (in shares) at Sep. 30, 2022 | 10,537,606 | ||||
Balance at Mar. 31, 2022 | $ 1 | 279,114 | (13) | (257,389) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 10,537,606 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,286) | (4,286) |
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 | $ 1 | 279,350 | (12) | (261,675) | 17,664 |
Balance (in shares) at Jun. 30, 2022 | 10,537,606 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (3,870) | (3,870) |
Foreign currency translation adjustment | 0 | 0 | 2 | 0 | 2 |
Stock-based compensation, net | $ 0 | 220 | 0 | 0 | 220 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Sep. 30, 2022 | $ 1 | $ 279,570 | $ (10) | $ (265,545) | $ 14,016 |
Balance (in shares) at Sep. 30, 2022 | 10,537,606 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Activities: | ||
Net loss | $ (12,629,000) | $ (15,224,000) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 301,000 | 383,000 |
Stock-based compensation expense, net | 697,000 | 993,000 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (350,000) | (164,000) |
Inventory | (113,000) | (105,000) |
Other current assets | (40,000) | (183,000) |
Other assets and liabilities | (142,000) | 279,000 |
Accounts payable and accrued expenses | 254,000 | 333,000 |
Net cash used in operating activities | (12,022,000) | (13,688,000) |
Investing Activities: | ||
Purchases of property and equipment | (103,000) | (191,000) |
Net cash used in investing activities | (103,000) | (191,000) |
Financing Activities: | ||
Proceeds from public stock offerings, net | 0 | 27,896,000 |
Proceeds from warrant exercises | 0 | 1,300 |
Payments on finance lease liability | (28,000) | (21,000) |
Net cash (used in) provided by financing activities | (28,000) | 27,876,000 |
Effect of exchange rate changes on cash | 1,000 | (3,000) |
Net increase (decrease) in cash and cash equivalents | (12,152,000) | 13,994,000 |
Cash and cash equivalents - beginning of period | 24,205,000 | 14,437,000 |
Cash and cash equivalents - end of period | 12,053,000 | 28,431,000 |
Supplemental cash flow information | ||
Inventory transferred to property, plant and equipment | $ 37,000 | $ 257,000 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
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: The accompanying condensed consolidated balance sheet as of September 30, 2022, which has been derived from the consolidated audited financial statements and the unaudited condensed consolidated financial statements has been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates. 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, 2021. Liquidity: The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings and in 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, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $27.9 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. In addition, during 2021 we received approximately $1,300 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 the Company will be successful in raising additional capital. Revenue Recognition: Accounts Receivable: 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) September 30, 2022 December 31, 2021 Finished Goods $ 1,180 $ 1,409 Work in Process 223 276 Raw Materials 1,516 1,158 Total $ 2,919 $ 2,843 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 nine months ended September 30, 2021 includes a deemed dividend of $33,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 offering. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30, 2022 2021 Stock options 1,200,259 738,946 Warrants to purchase common stock 1,630,627 1,631,801 Series F convertible preferred stock 50,800 50,800 Total 2,881,686 2,421,547 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (in thousands, except per share amounts) Net loss $ (3,870 ) $ (5,272 ) $ (12,629 ) $ (15,224 ) Deemed dividend to preferred shareholders (see note 3) — — — (75 ) Net loss after deemed dividend (3,870 ) (5,272 ) (12,629 ) (15,299 ) Weighted average shares outstanding 10,538 7,098 10,538 5,624 Basic and diluted loss per share $ (0.37 ) $ (0.75 ) $ (1.20 ) $ (2.72 ) Subsequent events: |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 – Revenue Recognition Net Sales: The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Colombia, The Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Panama, Romania, Singapore, Slovakia, 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. 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 nine months ended September 30, 2022, and 2021. 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 product 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 | 9 Months Ended |
Sep. 30, 2022 | |
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 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 an initial conversion price of $1,890.00 per share. Each share of Series F convertible preferred stock was accompanied by a Series 1 warrant (which expired on the first anniversary of its issuance) to purchase 16 shares of the Company’s common stock at an exercise price of $1,890.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $1,890.00 per share. The Series F convertible preferred stock has full ratchet price based anti-dilution protection, subject to customary carve-outs, in the event of a down-round financing at a price per share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price-based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F convertible preferred stock initially convertible into 9,557 shares of common stock and warrants to purchase 19,122 shares of common stock were issued in the offering. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced from $890.40 to $157.50, the per share price to the public of the Series G convertible preferred stock issued in the March 2019 Offering. Effective October 25, 2019, the conversion price of the Series F convertible preferred stock was reduced from $157.50 to $42.30, and further reduced on November 6, 2019, from $42.30 to $29.83, the per share price to the public in the October and November 2019 transactions, respectively. Effective January 28, 2020, the conversion price of the Series F convertible preferred stock was reduced from $29.83 to $16.50, the per share price to the public of the Series H convertible preferred stock, which closed in an underwritten public offering on January 28, 2020, described below. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $16.50 to $9.00, the per share price to the public in the March 2020 transaction, described below. In connection with the September 2021 offering, the conversion price of the Series F convertible preferred stock was reduced from $5.50 to $2.50, the per share price to the public in the September 2021 offering, described below. As of September 30, 2022, and December 31, 2021, 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 3,795,816 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. In connection with the March 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 Offering. September 2021 Offering : On September 17, 2021, the Company closed on an underwritten public offering of 4,005,588 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 $5.50 to $2.50, the per share price to the public in the September 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $5.50 to $2.50, the per share price to the public in the September 2021 Offering. Placement Agent Fees : 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. 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 3,334 shares of the Company’s common stock at an exercise price of $95.40 per share, 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. The warrant was valued at $57.90 per share using the Monte Carlo valuation methodology and was expensed over the term of the consulting engagement, which was twelve months. Significant inputs used for the Monte Carlo valuation were the expected stock price volatility of 136.21%, and management’s expectations regarding the timing of regulatory clearance for an expanded label in pediatrics. None of these warrants had vested as of September 30, 2022. Reverse Stock Split : On October 6, 2020, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-5 1-for-30 1-for-30 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, Nine months ended September 30, (in thousands) 2022 2021 2022 2021 Selling, general and administrative expense $ 199 $ 216 $ 624 $ 894 Research and development expense 21 40 73 99 Total stock-based compensation expense $ 220 $ 256 $ 697 $ 993 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes [Abstract] | |
Income Taxes | Note 5 – 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 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 September 30, 2022, 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, 2021. |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2022 | |
Operating Leases [Abstract] | |
Operating Leases | Note 6—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for |
Finance Lease Liability
Finance Lease Liability | 9 Months Ended |
Sep. 30, 2022 | |
Finance Lease Liability [Abstract] | |
Finance Lease Liability | Note 7—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 | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 8—Commitments and Contingencies Employee Retirement Plan: Non-refundable Technology License Fee: |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 9 – Subsequent Events On October 18, 2022, the Company closed on an underwritten public offering of 20,994,044 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 $9.8 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) 20,994,044 Class A Units, priced at a public offering price of $0.25 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 $0.25 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, and 1.5 warrants to purchase one share of common stock with an exercise price of $0.25 per share. The warrants will be 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 stockholder meetings will be held on or before December 9, 2022. The conversion price of the preferred stock issued in the transaction is 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 $2.50 to $0.25, 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 $2.50 to $1.65, based on ”reset” provisions in the Warrant agreement. On October 28, 2022, the Company filed a preliminary proxy statement seeking stockholder approval for a reverse stock split of our outstanding common stock at a ratio in the range of 1-for-50 1-for-100 |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Nature of Business and Basis of Presentation [Abstract] | |
Principles of Consolidation | Principles of Consolidation: The accompanying condensed consolidated balance sheet as of September 30, 2022, which has been derived from the consolidated audited financial statements and the unaudited condensed consolidated financial statements has been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates. 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, 2021. |
Liquidity | Liquidity: The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings and in 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, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $27.9 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. In addition, during 2021 we received approximately $1,300 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 the Company will be successful in raising additional capital. |
Revenue Recognition | Revenue Recognition: |
Accounts Receivable | Accounts Receivable: |
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) September 30, 2022 December 31, 2021 Finished Goods $ 1,180 $ 1,409 Work in Process 223 276 Raw Materials 1,516 1,158 Total $ 2,919 $ 2,843 |
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 nine months ended September 30, 2021 includes a deemed dividend of $33,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 offering. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30, 2022 2021 Stock options 1,200,259 738,946 Warrants to purchase common stock 1,630,627 1,631,801 Series F convertible preferred stock 50,800 50,800 Total 2,881,686 2,421,547 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (in thousands, except per share amounts) Net loss $ (3,870 ) $ (5,272 ) $ (12,629 ) $ (15,224 ) Deemed dividend to preferred shareholders (see note 3) — — — (75 ) Net loss after deemed dividend (3,870 ) (5,272 ) (12,629 ) (15,299 ) Weighted average shares outstanding 10,538 7,098 10,538 5,624 Basic and diluted loss per share $ (0.37 ) $ (0.75 ) $ (1.20 ) $ (2.72 ) |
Subsequent events | Subsequent events: |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Nature of Business and Basis of Presentation [Abstract] | |
Inventories | Inventories consisted of the following: (in thousands) September 30, 2022 December 31, 2021 Finished Goods $ 1,180 $ 1,409 Work in Process 223 276 Raw Materials 1,516 1,158 Total $ 2,919 $ 2,843 |
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: September 30, 2022 2021 Stock options 1,200,259 738,946 Warrants to purchase common stock 1,630,627 1,631,801 Series F convertible preferred stock 50,800 50,800 Total 2,881,686 2,421,547 |
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 nine months ended September 30: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (in thousands, except per share amounts) Net loss $ (3,870 ) $ (5,272 ) $ (12,629 ) $ (15,224 ) Deemed dividend to preferred shareholders (see note 3) — — — (75 ) Net loss after deemed dividend (3,870 ) (5,272 ) (12,629 ) (15,299 ) Weighted average shares outstanding 10,538 7,098 10,538 5,624 Basic and diluted loss per share $ (0.37 ) $ (0.75 ) $ (1.20 ) $ (2.72 ) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, Nine months ended September 30, (in thousands) 2022 2021 2022 2021 Selling, general and administrative expense $ 199 $ 216 $ 624 $ 894 Research and development expense 21 40 73 99 Total stock-based compensation expense $ 220 $ 256 $ 697 $ 993 |
Nature of Business and Basis _4
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventories (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 17, 2021 USD ($) | Sep. 30, 2022 USD ($) Customer | Sep. 30, 2021 Customer | Sep. 30, 2022 USD ($) Customer | Sep. 30, 2021 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | |
Going Concern [Abstract] | ||||||
Accumulated deficit | $ (265,545,000) | $ (265,545,000) | $ (252,916,000) | |||
Net proceeds from issuance of convertible preferred stock | $ 27,900,000 | |||||
Proceeds from exercise of investor warrants | $ 0 | $ 1,300 | ||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Accounts receivables maximum credit period from invoice date | 30 days | |||||
Allowance for doubtful accounts | 0 | $ 0 | 0 | |||
Inventories [Abstract] | ||||||
Finished Goods | 1,180,000 | 1,180,000 | 1,409,000 | |||
Work in Process | 223,000 | 223,000 | 276,000 | |||
Raw Materials | 1,516,000 | 1,516,000 | 1,158,000 | |||
Total | $ 2,919,000 | $ 2,919,000 | $ 2,843,000 | |||
Accounts Receivable [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Number of major customers | Customer | 1 | 2 | ||||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Concentration risk percentage | 19% | 12% | ||||
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Concentration risk percentage | 11% | |||||
ASC 606 [Member] | Net Sales [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Number of major customers | Customer | 1 | 2 | 2 | 2 | ||
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Concentration risk percentage | 12% | 14% | 12% | |||
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition and Accounts Receivable [Abstract] | ||||||
Concentration risk percentage | 12% | 13% | 11% | |||
ASC 606 [Member] | Customer Three [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition and Accounts Receivable [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 | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Loss per share [Abstract] | ||||||||
Net deemed dividends resulting from subsequent reduction in exercise price of warrants | $ 33 | |||||||
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) | 2,881,686 | 2,421,547 | ||||||
Reported net loss with reported net loss per share [Abstract] | ||||||||
Net loss | $ (3,870) | $ (4,286) | $ (4,473) | $ (5,272) | $ (4,731) | $ (5,221) | $ (12,629) | $ (15,224) |
Deemed dividend to preferred shareholders (see note 3) | 0 | 0 | 0 | (75) | ||||
Net loss after deemed dividend | $ (3,870) | $ (5,272) | $ (12,629) | $ (15,299) | ||||
Weighted average shares outstanding - basic (in shares) | 10,538,000 | 7,098,000 | 10,538,000 | 5,624,000 | ||||
Weighted average shares outstanding - diluted (in shares) | 10,538,000 | 7,098,000 | 10,538,000 | 5,624,000 | ||||
Basic loss per share (in dollars per share) | $ (0.37) | $ (0.75) | $ (1.2) | $ (2.72) | ||||
Diluted loss per share (in dollars per share) | $ (0.37) | $ (0.75) | $ (1.2) | $ (2.72) | ||||
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) | 1,200,259 | 738,946 | ||||||
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) | 1,630,627 | 1,631,801 | ||||||
Series F Convertible Preferred Stock [Member] | ||||||||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||||||||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 50,800 | 50,800 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-04-01 | ||||
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) | 9 Months Ended | |||||||||||||
Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Oct. 09, 2020 | Oct. 06, 2020 | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 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] | ||||||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 27,900,000 | |||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 0 | 0 | ||||||||||||
Reverse stock split | 0.03 | |||||||||||||
Minimum [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Reverse stock split | 0.2 | |||||||||||||
Maximum [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Reverse stock split | 0.03 | |||||||||||||
Expected Stock Price Volatility [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants measurement input | 1.3621 | |||||||||||||
January 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.5 | |||||||||||||
March 2021 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Issuance of common stock, net (in shares) | shares | 3,795,816 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 20,900,000 | |||||||||||||
Net proceeds from public stock offering | $ | $ 18,900,000 | |||||||||||||
September 2021 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Issuance of common stock, net (in shares) | shares | 4,005,588 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 10,000,000 | |||||||||||||
Net proceeds from public stock offering | $ | $ 9,000,000 | |||||||||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Number of warrants vested (in shares) | shares | 0 | |||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 3,334 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 57.9 | $ 95.4 | ||||||||||||
Series F Convertible Preferred Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000,000 | |||||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200,000 | |||||||||||||
Conversion price (in dollars per share) | $ 1,890 | $ 890.4 | ||||||||||||
Number of consecutive trading days considered for expiration | 20 days | |||||||||||||
Number of consecutive trading days | 30 days | |||||||||||||
Preferred stock issued (in shares) | shares | 18,000 | 127 | 127 | |||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | shares | 9,557 | |||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 127 | 127 | ||||||||||||
Aggregate cash placement fee | 8% | |||||||||||||
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) | $ 157.5 | |||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 42.3 | |||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 29.83 | |||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 16.5 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 9 | |||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 9 | |||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 5.5 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 5.5 | |||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ 2.5 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.5 | |||||||||||||
Series F Convertible Preferred Stock [Member] | Warrants to Purchase Common Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 19,122 | |||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 16 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 1,890 | |||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 16 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 1,890 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | $ 220 | $ 256 | $ 697 | $ 993 |
Selling, General and Administrative Expense [Member] | ||||
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | 199 | 216 | 624 | 894 |
Research and Development Expense [Member] | ||||
Stock-Based Compensation Expense Items [Abstract] | ||||
Stock-based compensation expense | $ 21 | $ 40 | $ 73 | $ 99 |
Operating Leases (Details)
Operating Leases (Details) | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / ft² ft² | |
Operating Lease s [Abstract] | |
Area of property leased under operating lease | ft² | 23,000 |
Monthly rent and common area maintenance charges | $ | $ 29,000 |
Annual base rent (per square foot) | 10.5 |
Minimum [Member] | |
Operating Lease s [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.32 |
Maximum [Member] | |
Operating Lease s [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] | 12 Months Ended | ||
Aug. 05, 2021 USD ($) Installment | Dec. 31, 2021 USD ($) | Sep. 30, 2022 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 | ||
Accounts Payable [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee | $ 285,440 |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, $ in Millions | 3 Months Ended | |||||||||
Oct. 28, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Oct. 09, 2020 | Oct. 06, 2020 | Sep. 30, 2021 shares | Mar. 31, 2021 shares | Sep. 30, 2022 $ / shares | Jan. 28, 2020 $ / shares | Jul. 03, 2018 $ / shares | Nov. 27, 2017 $ / shares | |
Class of Stock Disclosures [Abstract] | ||||||||||
Reverse stock split | 0.03 | |||||||||
Minimum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Reverse stock split | 0.2 | |||||||||
Maximum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Reverse stock split | 0.03 | |||||||||
January 2020 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ 2.5 | |||||||||
Series F Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Conversion price (in dollars per share) | $ 890.4 | $ 1,890 | ||||||||
Series F Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Conversion price (in dollars per share) | $ 2.5 | |||||||||
Series F Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Conversion price (in dollars per share) | $ 16.5 | |||||||||
Exercise price of warrants (in dollars per share) | $ 9 | |||||||||
Common Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of stock (in shares) | shares | 4,005,588 | 3,795,816 | ||||||||
Subsequent Event [Member] | 2017 Equity Incentive Plan [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Shares authorized for issuance (in shares) | shares | 66,226,752 | |||||||||
Subsequent Event [Member] | Minimum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Reverse stock split | 0.02 | |||||||||
Subsequent Event [Member] | Minimum [Member] | 2017 Equity Incentive Plan [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Shares authorized to be issued as percentage of common stock outstanding | 20% | |||||||||
Subsequent Event [Member] | Maximum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Reverse stock split | 0.01 | |||||||||
Subsequent Event [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Gross proceeds from public stock offering | $ | $ 11 | |||||||||
Net proceeds from public stock offering | $ | $ 9.8 | |||||||||
Subsequent Event [Member] | January 2020 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ 1.65 | |||||||||
Subsequent Event [Member] | Series I Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of stock (in shares) | shares | 23,157,124 | |||||||||
Number of share in one unit (in shares) | shares | 1 | |||||||||
Subsequent Event [Member] | Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of stock (in shares) | shares | 20,994,044 | |||||||||
Common stock offering price per share (in dollars per share) | $ 0.25 | |||||||||
Common stock exercise price per share (in dollars per share) | $ 0.25 | |||||||||
Subsequent Event [Member] | Class B Unit [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of stock (in shares) | shares | 23,157,124 | |||||||||
Common stock offering price per share (in dollars per share) | $ 0.25 | |||||||||
Common stock exercise price per share (in dollars per share) | 0.25 | |||||||||
Subsequent Event [Member] | Series F Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Conversion price (in dollars per share) | $ 0.25 | |||||||||
Subsequent Event [Member] | Common Stock [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of stock (in shares) | shares | 20,994,044 | |||||||||
Subsequent Event [Member] | Common Stock [Member] | Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Number of share in one unit (in shares) | shares | 1 | |||||||||
Subsequent Event [Member] | Warrant [Member] | Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Number of share in one unit (in shares) | shares | 1.5 | |||||||||
Subsequent Event [Member] | Warrant [Member] | Class B Unit [Member] | October 2022 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Number of share in one unit (in shares) | shares | 1.5 |