Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 27, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001625101 | ||
Entity Registrant Name | Pulse Biosciences, Inc. | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-34899 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-5696597 | ||
Entity Address, Address Line One | 3957 Point Eden Way | ||
Entity Address, City or Town | Hayward | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94545 | ||
City Area Code | 510 | ||
Local Phone Number | 906-4600 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | PLSE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 23,793,458 | ||
Entity Common Stock, Shares Outstanding | 37,592,588 | ||
Auditor Firm ID | 34 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | San Jose, California |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 61,139 | $ 28,614 |
Accounts receivable | 0 | 61 |
Inventory | 0 | 5,824 |
Prepaid expenses and other current assets | 1,008 | 2,131 |
Total current assets | 62,147 | 36,630 |
Property and equipment, net | 1,961 | 2,462 |
Intangible assets, net | 2,551 | 3,216 |
Goodwill | 2,791 | 2,791 |
Right-of-use assets | 8,062 | 8,785 |
Other assets | 365 | 365 |
Total assets | 77,877 | 54,249 |
Current liabilities: | ||
Accounts payable | 1,573 | 2,904 |
Accrued expenses | 2,595 | 4,389 |
Deferred revenue | 0 | 16 |
Lease liability, current | 896 | 774 |
Note payable, current | 0 | 436 |
Related party note payable, current | 917 | 0 |
Total current liabilities | 5,981 | 8,519 |
Lease liability, less current portion | 9,144 | 10,040 |
Related party note payable, less current | 65,000 | 0 |
Total liabilities | 80,125 | 18,559 |
Commitments and contingencies (Note 13) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; authorized – 50,000 shares; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value; authorized – 500,000 shares; issued and outstanding – 37,235 shares and 29,716 shares at December 31, 2022 and 2021, respectively | 37 | 29 |
Additional paid-in capital | 292,420 | 271,861 |
Accumulated other comprehensive income (loss) | 0 | 0 |
Accumulated deficit | (294,705) | (236,200) |
Total stockholders’ (deficit) equity | (2,248) | 35,690 |
Total liabilities and stockholders’ equity | $ 77,877 | $ 54,249 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Common stock, shares issued (in shares) | 37,235,000 | 29,716,000 |
Common stock, shares outstanding (in shares) | 37,235,000 | 29,716,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | |||
Total revenues | $ 700 | $ 1,418 | $ 0 |
Cost and expenses: | |||
Cost of revenues | 11,944 | 1,968 | 0 |
Research and development | 20,839 | 28,640 | 26,444 |
Sales and marketing | 12,019 | 14,751 | 7,256 |
General and administrative | 13,955 | 19,073 | 16,265 |
Total cost and expenses | 58,757 | 64,432 | 49,965 |
Loss from operations | (58,057) | (63,014) | (49,965) |
Other income (expense): | |||
Interest income (expense), net | (448) | (646) | 114 |
Total other income (expense) | (448) | (646) | 114 |
Loss from operations, before income taxes | (58,505) | (63,660) | (49,851) |
Income tax benefit | 0 | 0 | 0 |
Net loss | (58,505) | (63,660) | (49,851) |
Other comprehensive gain (loss): | |||
Unrealized gain (loss) on available-for-sale securities | 0 | 1 | (5) |
Comprehensive loss | $ (58,505) | $ (63,659) | $ (49,856) |
Net loss per share: | |||
Basic and diluted net loss per share (in dollars per share) | $ (1.72) | $ (2.28) | $ (2.14) |
Weighted average shares used to compute net loss per common share — basic and diluted (in shares) | 33,935 | 27,964 | 23,248 |
Product [Member] | |||
Revenues: | |||
Total revenues | $ 700 | $ 1,418 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Rights Offering [Member] Common Stock [Member] | Rights Offering [Member] Additional Paid-in Capital [Member] | Rights Offering [Member] AOCI Attributable to Parent [Member] | Rights Offering [Member] Retained Earnings [Member] | Rights Offering [Member] | Private Placement [Member] Common Stock [Member] | Private Placement [Member] Additional Paid-in Capital [Member] | Private Placement [Member] AOCI Attributable to Parent [Member] | Private Placement [Member] Retained Earnings [Member] | Private Placement [Member] | ATM Offering [Member] Common Stock [Member] | ATM Offering [Member] Additional Paid-in Capital [Member] | ATM Offering [Member] AOCI Attributable to Parent [Member] | ATM Offering [Member] Retained Earnings [Member] | ATM Offering [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2019 | 20,825,000 | |||||||||||||||||||
Balance at Dec. 31, 2019 | $ 21 | $ 153,401 | $ 4 | $ (122,689) | $ 30,737 | |||||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 175,000 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 0 | 887 | 0 | 0 | 887 | |||||||||||||||
Issuance of shares under employee stock purchase plan (in shares) | 83,000 | |||||||||||||||||||
Issuance of shares under employee stock purchase plan | $ 0 | 490 | 0 | 0 | 490 | |||||||||||||||
Issuance of shares upon exercise of warrants (in shares) | 187,000 | |||||||||||||||||||
Issuance of shares upon exercise of warrants | $ 0 | 1,127 | 0 | 0 | 1,127 | |||||||||||||||
Issuance of common stock, shares (in shares) | 4,280,000 | |||||||||||||||||||
Issuance of common stock | $ 4 | $ 29,430 | $ 0 | $ 0 | $ 29,434 | |||||||||||||||
Stock-based compensation expense | 0 | 10,075 | 0 | 0 | 10,075 | |||||||||||||||
Unrealized gain (loss) on available-for-sale securities | 0 | 0 | (5) | 0 | (5) | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (49,851) | (49,851) | |||||||||||||||
Balance (in shares) at Dec. 31, 2020 | 25,550,000 | |||||||||||||||||||
Balance at Dec. 31, 2020 | $ 25 | 195,410 | (1) | (172,540) | 22,894 | |||||||||||||||
Issuance of common stock upon exercise of stock options (in shares) | 54,000 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options | $ 0 | 616 | 0 | 0 | 616 | |||||||||||||||
Issuance of shares under employee stock purchase plan (in shares) | 91,000 | |||||||||||||||||||
Issuance of shares under employee stock purchase plan | $ 0 | 810 | 0 | 0 | 810 | |||||||||||||||
Issuance of shares upon exercise of warrants (in shares) | 585,000 | |||||||||||||||||||
Issuance of shares upon exercise of warrants | $ 1 | 3,333 | 0 | 0 | 3,334 | |||||||||||||||
Issuance of common stock, shares (in shares) | 288,000 | 288,490 | ||||||||||||||||||
Issuance of common stock | $ 0 | $ 7,432 | $ 0 | $ 0 | $ 7,432 | |||||||||||||||
Stock-based compensation expense | 0 | 14,601 | 0 | 0 | 14,601 | |||||||||||||||
Unrealized gain (loss) on available-for-sale securities | 0 | 0 | 1 | 0 | 1 | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (63,660) | (63,660) | |||||||||||||||
Issuance of common stock as part of debt extinguishment and private investment, net of issuance cost of $106 (in shares) | 3,049,000 | |||||||||||||||||||
Issuance of common stock as part of debt extinguishment and private investment, net of issuance cost of $106 | $ 3 | $ 49,891 | $ 0 | $ 0 | $ 49,894 | |||||||||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes (in shares) | 99,000 | |||||||||||||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes | $ 0 | (232) | 0 | 0 | (232) | |||||||||||||||
Balance (in shares) at Dec. 31, 2021 | 29,716,000 | |||||||||||||||||||
Balance at Dec. 31, 2021 | $ 29 | 271,861 | 0 | (236,200) | 35,690 | |||||||||||||||
Issuance of shares under employee stock purchase plan (in shares) | 188,000 | |||||||||||||||||||
Issuance of shares under employee stock purchase plan | $ 1 | 485 | 0 | 0 | 486 | |||||||||||||||
Issuance of shares upon exercise of warrants (in shares) | 14,000 | |||||||||||||||||||
Issuance of shares upon exercise of warrants | $ 0 | 26 | 0 | 0 | 26 | |||||||||||||||
Issuance of common stock, shares (in shares) | 7,317,000 | |||||||||||||||||||
Issuance of common stock | $ 7 | $ 14,857 | $ 0 | $ 0 | $ 14,864 | |||||||||||||||
Stock-based compensation expense | 0 | 5,191 | 0 | 0 | 5,191 | |||||||||||||||
Unrealized gain (loss) on available-for-sale securities | 0 | |||||||||||||||||||
Net loss | $ 0 | 0 | 0 | (58,505) | (58,505) | |||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 37,235,000 | |||||||||||||||||||
Balance at Dec. 31, 2022 | $ 37 | $ 292,420 | $ 0 | $ (294,705) | $ (2,248) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Rights Offering [Member] | |||
Offering price per unit (in dollars per share) | $ 7.01 | ||
Issuance cost | $ 136 | $ 565 | |
Private Placement [Member] | |||
Issuance cost | $ 106 | ||
ATM Offering [Member] | |||
Issuance cost | $ 568 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net loss | $ (58,505) | $ (63,660) | $ (49,851) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 690 | 480 | 430 |
Amortization of intangible assets | 665 | 666 | 665 |
Stock-based compensation | 5,191 | 14,601 | 10,075 |
Write-off of excessive and obsolete inventory | 8,477 | 0 | 0 |
Net premium amortization and discount on available-for-sale securities | 0 | 13 | 5 |
Loss on disposal of fixed assets | 185 | 0 | 119 |
Gain on U.S. Treasury securities | 0 | 0 | (8) |
Changes in operating assets and liabilities: | |||
Accounts receivable | 61 | (61) | 0 |
Inventory | (2,653) | (5,824) | 0 |
Prepaid expenses and other current assets | 1,164 | (1,374) | 194 |
Other receivables | (41) | 54 | 0 |
Right-of-use assets | 723 | 653 | 509 |
Other long-term assets | 0 | 0 | 129 |
Accounts payable | (1,304) | 1,160 | (266) |
Accrued expenses | (1,794) | (937) | 2,830 |
Deferred revenue | (16) | 16 | 0 |
Lease liabilities | (774) | (542) | (196) |
Accrued interest on related party note payable | 917 | 0 | 0 |
Accrued interest on note payable | 1 | 658 | 0 |
Net cash used in operating activities | (47,013) | (54,097) | (35,365) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (401) | (437) | (441) |
Purchases of investments | 0 | 0 | (29,025) |
Maturities of investments | 0 | 8,000 | 35,000 |
Sales of investments | 0 | 0 | 4,510 |
Net cash provided by (used in) investing activities | (401) | 7,563 | 10,044 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock under employee stock purchase plan | 486 | 810 | 490 |
Proceeds from exercises of warrants | 26 | 4,217 | 244 |
Proceeds from exercises of stock options | 0 | 786 | 717 |
Proceeds from issuance of common stock | 14,864 | 56,697 | 29,434 |
Proceeds from issuance of related party note | 65,000 | 0 | 0 |
Proceeds from insurance loan agreement | 0 | 1,939 | 0 |
Payments made on insurance loan agreement | (437) | (1,532) | 0 |
Tax payments related to shares withheld for vested restricted stock units | 0 | (232) | 0 |
Net cash provided by financing activities | 79,939 | 62,685 | 30,885 |
Net increase in cash and cash equivalents | 32,525 | 16,151 | 5,564 |
Cash and cash equivalents at beginning of period | 28,614 | 12,463 | 6,899 |
Cash and cash equivalents at end of period | 61,139 | 28,614 | 12,463 |
Supplemental disclosure of noncash investing and financing activities: | |||
Other receivable from exercise of warrants and stock options | 0 | 0 | 1,053 |
Change in unrealized gains on available-for-sale securities | 0 | 1 | (5) |
Equipment purchases included in accounts payable and accrued expenses | (27) | (27) | (20) |
Equipment purchases included in accounts payable and accrued expenses | 27 | 27 | 20 |
Accrued interest settled via issuance of common stock from private placement equity offering | $ 0 | $ 629 | $ 0 |
Note 1 - Description of Busines
Note 1 - Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using its patented Nano-Pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second 2022 The Company was incorporated in Nevada on May 19, 2014. June 18, 2018, The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company does not no |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Basis of Presentation Certain prior period balances have been reclassified to conform to the current period presentation in the consolidated financial statements and the accompanying notes. Sales and marketing expenses are reclassified out of general and administrative expenses, both of which are presented as separate line items. Amortization of intangible assets are reclassified to general and administrative expenses. Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities Exchange Commission (the “SEC”). The consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiaries and intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates that affect the amounts reported in the financial statements and accompanying notes to the financial statements. Estimates include, but are not Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and investments. The Company places its cash equivalents and investments with high credit quality financial institutions and, by policy, limits the amounts invested with any one may not Fair Value of Financial Instruments The Company believes the carrying amounts of its financial instruments, including cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate fair value due to the short-term nature of such instruments. Cash and Cash Equivalents The Company invests its cash primarily in money market funds. The Company considers all highly liquid investments purchased with an original maturity of three Property and Equipment Property and Equipment is recorded at cost and depreciated using the straight-line method over their estimated useful lives, ranging from three five Valuation of Inventory Inventory is stated at lower of cost or net realizable value. The Company establishes the inventory basis by determining the cost based on standard costs approximating the purchase costs on a first first December 31, 2022 Intangible Assets The Company’s intangible assets consist of acquired patents and licenses, which are amortized over their estimated useful lives of twelve Long-Lived Assets The Company reviews long-lived assets, consisting of property and equipment and intangible assets, for impairment during each fiscal year or when events or changes in circumstances indicate the carrying value of these assets may Goodwill The Company records goodwill when the consideration paid in a business acquisition exceeds the fair value of the net tangible assets and the identified intangible assets acquired. The Company reviews goodwill for impairment at the reporting unit level at least annually or whenever changes in circumstances indicate that the carrying value of the goodwill may not Revenue from Contracts with Customers The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. Sales contracts often involve the sale and delivery of multiple products, each of which typically represent a separate performance obligation in the contract. While the Company sells these products on a stand-alone basis at their respective SSP, initial customer contracts will likely involve the bundling of products which will be delivered concurrently to the customer. In such instances, the full consideration of the contract will be recognized upon shipment of the products. The Company generally requires receipt of full payment prior to shipment, however, from time to time, payment terms may 9 Product Warranty The Company provides a standard warranty on eligible products which provides the customer assurances that the products comply with the agreed-upon specifications. The standard warranty does not may Warranty accrual activity consisted of the following (in thousands): Year Ended December 31, 2022 2021 Beginning balance $ 80 $ — Add: Accruals for warranties issued during the period 42 80 Less: Adjustment for inventory at cost and excessive and obsolete inventory (72 ) — Ending balance $ 50 $ 80 Stock-Based Compensation The Company recognizes the cost of stock-based compensation in the financial statements based upon fair value. The fair value of stock options is determined as of the grant date using the Black-Scholes option pricing model. The fair value of Restricted Stock Units (“RSU”) awards is determined based on the number of units granted and the closing price of the Company’s common stock on the grant date. The fair value of each purchase under the employee stock purchase plan (“ESPP”) is estimated at the beginning of the offering period using the Black-Scholes option pricing model. The Company’s determination of the fair value of equity-settled awards is impacted by the price of the Company’s common stock as well as changes in assumptions regarding a number of complex and subjective variables. These variables include, but are not Estimates of the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, are affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value of the award and the stock-based compensation expense recognized. These inputs are subjective and generally require significant analysis and judgment to develop. The Company determines the volatility factor based on its own historical volatility. The risk-free interest rate is based on the yield available on U.S. Treasury zero See Note 6 Research and Development Costs Research and development costs consist primarily of compensation costs, fees paid to consultants and outside service providers and organizations (including university research institutes), costs associated with clinical trials, development prototypes and other expenses relating to the acquisition, design, development and testing of the Company’s product candidates, and certain facilities related costs. Research and development costs incurred by the Company are expensed as incurred, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Patent Costs The Company is the owner of numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one not December 31, 2022, 2021 2020 Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more-likely-than- not not The Company is subject to U.S. federal income taxes and state income taxes in various states. As the Company’s net operating losses have yet to be utilized, previous tax years remain open to examination by federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company is not The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by U.S. GAAP. The tax effects of a position are recognized only if it is more-likely-than- not not not no December 31, 2022 2021 not Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. Net Loss per Share The Company calculates basic net loss per share by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding during the period. For purposes of this calculation, options to purchase common stock and common stock warrants are considered common stock equivalents. Potential common shares that have an anti-dilutive effect ( i.e. The following outstanding stock options, warrants, and RSUs to purchase common stock were excluded from the computation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect: Year Ended December 31, 2022 2021 2020 Common stock warrants 7,303,832 — 612,310 Common stock options 5,250,696 5,996,813 5,039,194 Restricted stock units — — 111,305 Total 12,554,528 5,996,813 5,762,809 Segment and Geographical Information The Company operates in one segment and reports segment information in accordance with ASC 280 , Segment Reporting one not December 31, 2022 2021 , See Note 10 Recent Accounting Pronouncements In May 2014, No. 2014 09, Revenue from Contracts with Customers first 2018. 2021 9 In November 2018, No. 2018 18 Collaborative Arrangements Clarifying the Interaction between Topic 808 606 808, Collaborative Arrangements 606, Revenue from Contracts with Customers 606” 606 not January 1, 2020, not August 2021 not no In December 2019, 2019 12, Income Taxes (Topic 740 740 December 15, 2020, 740 January 1, 2021. not |
Note 3 - Investments and Fair V
Note 3 - Investments and Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 3. Fair Value of Financial Instruments The Company determines the fair value of its financial instruments based on a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three Level 1 1 Level 2 1, 2 Level 3 no not 3 The following table sets forth the fair value of the Company’s financial assets measured on a recurring basis (in thousands): December 31, 2022 Assets Classification Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 57,973 $ — $ — $ 57,973 Total assets measured at fair value $ 57,973 $ — $ — $ 57,973 December 31, 2021 Assets Classification Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 23,675 $ — $ — $ 23,675 Total assets measured at fair value $ 23,675 $ — $ — $ 23,675 During the years ended December 31, 2022 2021 not December 31, 2022 2021 not 1, 2 3 not December 31, 2022 2021 |
Note 4 - Balance Sheet Componen
Note 4 - Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Supplemental Balance Sheet Disclosures [Text Block] | 4. Inventory Inventory consisted of the following (in thousands): Year Ended December 31, 2022 2021 Raw materials $ — $ 2,010 Work in process — 1,371 Finished goods — 2,443 Total inventory $ — $ 5,824 Property and Equipment, net Property and equipment, net consisted of the following (in thousands): December 31, 2022 2021 Leasehold improvements $ 2,519 $ 2,519 Laboratory equipment 1,118 1,019 Furniture, fixtures and equipment 966 932 Software 289 202 Construction in progress 22 186 4,914 4,858 Less: Accumulated depreciation and amortization (2,953 ) (2,396 ) $ 1,961 $ 2,462 Depreciation expense for the years ended December 31, 2022, 2021 2020 Intangible Assets, net Intangible assets primarily consist of a license to utilize certain patents, know-how and technology relating to the Company’s NPS for biomedical applications acquired from Old Dominion University Research Foundation (ODURF), Eastern Virginia Medical School (EVMS), and the University of Southern California. In addition, the Company entered into a sponsored research agreement (“SRA”) with Old Dominion University’s Frank Reidy Research Center for Bioelectrics, a leading research organization in the field, which includes certain intellectual property rights arising from the research. The Company is amortizing the intangible assets over an estimated useful life of 12 years. Intangible assets, net consisted of the following (in thousands): December 31, 2022 2021 Acquired patents and licenses $ 7,985 $ 7,985 Less: Accumulated amortization (5,434 ) (4,769 ) $ 2,551 $ 3,216 A schedule of the amortization of intangible assets is as follows (in thousands): Years ending December 31: 2023 $ 665 2024 665 2025 665 2026 556 $ 2,551 Accrued Expenses Accrued expenses consisted of the following (in thousands): December 31, 2022 2021 Compensation expense $ 1,377 $ 2,932 Controlled launch (Note 8) — 534 Director and officer liability insurance (Note 12) 571 — Clinical trial fees and costs 64 245 Professional fees 318 85 Warranty 50 80 Other 215 513 $ 2,595 $ 4,389 |
Note 5 - Goodwill
Note 5 - Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Goodwill Disclosure [Text Block] | 5. In 2014, 805, Business Combinations The Company reviews goodwill for impairment annually or whenever changes in circumstances indicate that the carrying amount of goodwill may not December 31, 2022 not |
Note 6 - Stockholders' Equity a
Note 6 - Stockholders' Equity and Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 6. Equity and Stock-Based Compensation Preferred Stock The Company has authorized a total of 50,000,000 shares of preferred stock, par value $0.001 per share, none of which were outstanding at December 31, 2022 2021 Common Stock The Company has authorized a total of 500,000,000 shares of common stock, par value $0.001 per share. Rights Offering On June 9, 2022, “2022 one one “2022 one 2022 2022 2022 may 2022 2022 one 2022 fifth 2022 2022 not may not three 2022 Private Placement Securities Purchase Agreement On June 30, 2021, 13 July 2021. At-the-Market Equity Offering On February 4, 2021, may 415 1933, no December 31, 2022 not December 31, 2021 Common Stock Warrants In connection with a private placement in November 2014 seven March 2021, November 2021, In connection with the closing of the Company’s initial public offering in May 2016, five March 2021, May 2021, In connection with a June 2020 “2020 2020 fifth June 16, 2025, 2020 December 16, 2020, six not 2020 December 31, 2020, February 5, 2021, February 5, 2021 December 31, 2022 2020 In connection with the 2022 2022 2022 fifth 2022 2022 not may not three December 31, 2022 December 31, 2022 2022 A summary of total warrants activity for the year ended December 31, 2022 Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Life (in Years) Warrants outstanding at December 31, 2021 — $ — — Issued 7,317,072 2.05 Exercised (13,240 ) 2.05 Expired/Redeemed — — Warrants outstanding and exercisable at December 31, 2022 7,303,832 $ 2.05 4.43 Equity Plans 2017 2017 The Board previously adopted, and the Company’s stockholders approved, the Company’s 2017 “2017 The 2017 may 2017 2015 “2015 not 2017 2017 January 1, 2022 2021, 2017 2017 2017 December 31 December 31, 2022 2017 During November 2017, 2017 The Inducement Plan has a 10-year term and provides for the grant of equity-based awards, including non-statutory stock options, RSUs, restricted stock, stock appreciation rights, performance shares and performance units, and its terms are substantially similar to the 2017 may ten first not May 2021, December 31, 2022 A summary of stock option activity under the 2015 2017 December 31, 2022 Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 5,996,813 $ 15.77 7.33 Options granted 1,440,100 2.97 Options exercised — — Options canceled (1,472,385 ) 14.88 Options expired (713,832 ) 14.62 Balances — December 31, 2022 5,250,696 $ 12.67 6.24 Exercisable — December 31, 2022 3,479,531 $ 15.17 5.06 Time-based Options The Company awards time-based options which vest and become exercisable, subject to the individual’s continued employment or service through the applicable vesting date. Time-based options can have various vesting schedules, most commonly new hire grants which generally vest 25% per year starting upon the first A summary of the time-based stock option activity under the 2015 2017 December 31, 2022 Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 4,796,716 $ 16.44 7.05 Options granted 1,240,100 2.59 Options exercised — — Options canceled (674,465 ) 16.73 Options expired (631,957 ) 15.05 Balances — December 31, 2022 4,730,394 $ 12.95 6.16 Exercisable — December 31, 2022 3,230,670 $ 15.39 5.07 The intrinsic value of time-based options exercised during the years ended December 31, 2022, 2021 2020 The fair value of the time-based options granted to employees and directors during the years ended December 31, 2022, 2021 2020 Performance Options Certain stock options awarded to the Company’s executives and other employees contain performance conditions related to certain financial measures and achievements of strategic/operational milestones. The options will vest and become exercisable once the specific performance condition is fulfilled. A summary of the performance option activity under the 2017 December 31, 2022 Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 1,200,097 $ 13.11 8.44 Options granted 200,000 5.32 Options exercised — — Options canceled (797,920 ) 13.32 Options expired (81,875 ) 11.28 Balances — December 31, 2022 520,302 $ 10.08 7.02 Exercisable — December 31, 2022 248,861 $ 12.25 4.92 The fair value of the performance options granted to employees during the years ended December 31, 2022, 2021 2020 The fair value of employee stock options was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Year Ended December 31, 2022 2021 2020 Expected term in years 5.3 - 6.8 5.3 - 6.1 5.3 - 6.1 Expected volatility 83 88% 78% 70% Risk-free interest rate 1.9 - 3.2% 0.9 - 1.4% 0.3 - 0.5% Dividend yield — — — 2017 The Board previously adopted and the stockholders approved the Company’s 2017 “2017 The 2017 2017 2017 December 31 2020 not January 1, 2021, 2017 2017 December 31, 2022 2021 2017 December 31, 2022 2017 The fair value of ESPP was estimated using the Black-Scholes option-pricing model utilizing the following assumptions: Year Ended December 31, 2022 2021 2020 Expected term in years 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 Expected volatility 83% 78% 70 % Risk-free interest rate 0.6% - 3.5% 0.06% - 0.1% 0.1% - 1.0% Dividend yield — — — Restricted Stock Units The fair value of RSU awards is determined based on the number of units granted and the closing price of the Company’s common stock as of the grant date. The estimated fair value of RSUs is recognized on a straight-line basis over the requisite service period. During the year ended December 31, 2017, June 2018. 2019, 2021, December 31, 2022 December 31, 2022, 2021 2020 December 31, 2022 During the year ended December 31, 2017, June 1, 2019 June 1, 2021. December 31, 2022, 2021 2020 zero December 31, 2022 Stock-based Compensation Total stock-based compensation expense recorded in the consolidated statements of operations and comprehensive loss was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Cost of revenues $ 217 $ 129 $ — Research and development 1,563 5,211 4,013 Sales and marketing 733 2,749 1,187 General and administrative 2,678 6,512 4,875 Total stock-based compensation expense $ 5,191 $ 14,601 $ 10,075 As of December 31, 2022 not In February 2021, not December 31, 2021 In October 2021, ninety ten may 2017 December 31, 2021. Total stock-based compensation expense by award type was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Time-based options $ 4,467 $ 9,235 $ 8,739 Performance options 233 4,840 133 RSU — — 86 ESPP 491 526 1,117 Total stock-based compensation expense $ 5,191 $ 14,601 $ 10,075 At December 31, 2022 |
Note 7 - Research Grants and Ag
Note 7 - Research Grants and Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Research, Development, and Computer Software Disclosure [Text Block] | 7. Sponsored Research Agreement The Company entered into a SRA with ODURF during 2014 August 2018, September 2019, 12 March 2021, May 2021 12 may December 31, 2022, 2021 2020 December 31, 2022 no |
Note 8 - Controlled Launch
Note 8 - Controlled Launch | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Controlled Launch [Text Block] | 8. In February 2021, 510 January 2021, June 2021 February 2021, June 2021, As part of the Controlled Launch, the Company selected 70 physicians and their practices to be the first As patient procedures and surveys were completed under the Controlled Launch program, the Company accrued the value of the credits earned, which were recorded in accrued expenses, with a corresponding charge to sales and marketing expense. During the years ended December 31, 2022 2021 During the year ended December 31, 2022, 9 In September 2022, fourth 2022 |
Note 9 - Revenue
Note 9 - Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 9. The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. This consideration may September 20, 2022, December 31, 2022 2021 Sales contracts often involve the sale and delivery of multiple performance obligations in the contract. Performance Obligations Systems consist of the CellFX console and its embedded software, handpieces, and disposable tips. The console is a physical piece of hardware used by the customer to perform patient procedures. Individually the console and software are not one Handpieces are attached to the console and used in conjunction with tips to perform patient procedures. Generally, upon initial sale of a system to a customer, the Company will include two Disposable treatment tips are single-patient multiple-use products that come in different sizes, each of which are to be used for specific procedures. Tips are attached to the handpiece for use in patient procedures and, upon detachment from the handpiece, a tip cannot be reused, and it must be disposed of. Tips represent a distinct performance obligation which is satisfied either upon shipment, or upon delivery of the tips to the customer, depending on the specific contract. CUs are credits that authorize the customer to perform a procedure, or cycle. Each procedure requires a specific number of CUs, dependent upon type of tip used and procedure level selected. As the procedure is performed, the applicable number of CUs are decremented. When the customer’s balance of CUs on a specific system is depleted, the system will no not Shipping and handling activities are not Transaction Price The transaction price is the consideration to which the Company expects to be entitled to in exchange for providing the promised goods to customers. Customer orders placed for cash contemplate a fixed amount of consideration. Customer orders placed by physicians participating in the Controlled Launch when they elected to purchase the CellFX System were paid for via conversion of accumulated earned credits for prior services provided by the physicians under the terms of their participation in the Controlled Launch. For these transactions, the transaction price included noncash consideration. The services rendered by the physicians in the Controlled Launch were accounted for separately from the subsequent sales of the CellFX Systems because they were distinct from the system sales. They were distinct because they provided the Company with treatment data that could also be procured, and historically had been procured by the Company, without the corresponding system sales. This data was used by the Company to enhance marketing and promotion of its products. The Company evaluates the possible impact of variable consideration in determining the transaction price, in particular the possibility of future returns or credits. Sales agreements allow for a right of return only if the product does not no e.g The Company has made an accounting policy election to exclude from the measurement of the transaction price all taxes which are imposed on and concurrent with a specific revenue-producing transaction and collected by the entity from a customer. When there are multiple performance obligations present, the total transaction price shall be allocated to each of the performance obligations based upon the relative SSPs of those performance obligations. The Company establishes SSPs based on multiple factors including, prices charged by the Company for similar offerings, product-specific business objectives, and the estimated cost to provide the performance obligation. However, upon the sale of a new CellFX System, all performance obligations are delivered concurrently and therefore there is no not no Controlled Launch Agreements In August 2021 8 |
Note 10 - Segment Reporting
Note 10 - Segment Reporting | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Segment Reporting Disclosure [Text Block] | 10. The Company operates and manages the business as one reportable and operating segment. The Company’s Chief Executive Officer acts as the chief operating decision maker ("CODM") of the Company. The CODM reviews the results of the Company on a consolidated basis, however in making certain operating decisions and assessing performance, the CODM will additionally review the disaggregated revenue results by product and geography. All of the Company’s long-lived assets are based in the United States. Revenue by product consisted of the following (in thousands): Year Ended December 31, 2022 2021 2020 Systems $ 560 $ 1,189 $ — Cycle units 140 229 — Total consolidated revenue $ 700 $ 1,418 $ — Revenue by geography consisted of the following (in thousands): Year Ended December 31, 2022 2021 2020 North America $ 517 $ 1,182 $ — Rest of World 183 236 — Total consolidated revenue $ 700 $ 1,418 $ — |
Note 11 - Income Taxes
Note 11 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 11. Income (loss) before income taxes (in thousands): Year Ended December 31, 2022 2021 2020 Domestic $ (58,505 ) $ (63,660 ) $ (49,851 ) Foreign — — — $ (58,505 ) $ (63,660 ) $ (49,851 ) The components of the provision for income taxes are as follows (in thousands): December 31, 2022 2021 2020 Current Federal $ — $ — $ — State 3 3 3 Foreign — — — Total current 3 3 3 Deferred Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 3 $ 3 $ 3 State income taxes are immaterial in amount and therefore have not December 31, 2022, 2021 2020. The provision for income taxes differs from the amount estimated by applying the statutory federal income tax rate to income (loss) before taxes as follows: Year Ended December 31, 2022 2021 2020 Federal tax at statutory rate 21.0 % 21.0 % 21.0 % State tax at statutory rate 8.4 8.4 8.4 Research and development credits 0.9 1.9 2.1 Change in valuation allowance (18.4 ) (26.8 ) (43.3 ) Deferred adjustment (5.3 ) — 8.5 Change in tax rate — — 4.2 Uncertain Tax Position (5.7 ) (2.3 ) — Other (0.9 ) (2.2 ) (0.8 ) Provision for income taxes — % — % — % Deferred income taxes reflect the impact of carryforwards and temporary differences between the amounts of assets and liabilities for financial reporting purposes and such amounts as measured by tax laws. The carryforwards and temporary differences, which give rise to a significant portion of the Company’s deferred tax asset (liability) as of December 31, 2022 2021 December 31, 2022 2021 Deferred tax assets Accruals $ 3,404 $ 1,034 Net operating loss carryforwards 56,447 49,246 Tax credit carryforwards 7,111 6,611 Stock-based compensation 8,784 12,188 R&D Capitalization 3,810 — Lease liability under ASC 842 2,948 3,182 Gross deferred tax assets 82,504 72,261 Valuation allowance (79,779 ) (69,006 ) Total deferred tax assets 2,725 3,255 Deferred tax liabilities Intangibles (117 ) (365 ) ROU asset under ASC 842 (2,593 ) (2,862 ) Fixed assets (15 ) (28 ) Total deferred tax liabilities (2,725 ) (3,255 ) Net deferred tax assets/(liabilities) $ — $ — The Company’s unrecognized tax benefits as of December 31, 2022, 2021 2020 A reconciliation of the beginning and ending amounts of unrecognized tax benefit is as follows (in thousands): December 31, 2022 2021 2020 Unrecognized tax benefits at beginning of year $ 5,140 $ 2,491 $ 1,470 Increases related to current year tax positions 2,055 2,649 1,021 Increases related to prior year tax positions 1,730 — — Unrecognized tax benefits at end of year $ 8,925 $ 5,140 $ 2,491 The Company’s policy is to recognize interest and penalties related to income taxes as components of interest expense and other expense, respectively. The Company did not December 31, 2022 not twelve The Company’s valuation allowance increased by $10.8 million in the year ended December 31, 2022 December 31, 2021 As of December 31, 2022 2034. 80% As of December 31, 2022 2035 The Company is subject to taxation in the United States for Federal and for State, within various states in which the Company operates. All jurisdictions and tax years currently remain open for IRS and state taxing authorities’ examination. As of December 31, 2022 not Internal Revenue Code Section 382 one 5% 50 three may not December 31, 2022 |
Note 12 - Related Party Transac
Note 12 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | 12. On March 11, 2021, 2021 13 On June 30, 2021, 6 13 In May 2022, not May 31, 2022, one third May 31, 2023, one December 31, 2022, On September 20, 2022, 2022 13 |
Note 13 - Commitments and Conti
Note 13 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 13. 2021 On March 11, 2021, July 1, 2021. December 31, 2021, June 2021, 6 2022 On September 20, 2022, “2022 January 1, 2023, March 20, 2024. March 17, 2023, no September 30, 2024. December 31, 2022, 2022 Insurance Loan Agreement On May 13, 2021, February 2022, December 31, 2022, Operating Leases In January 2017, five July 2017. In May 2019, 1 1” 2,” October 2029 1 2. The Company evaluated the lease amendment under the provisions of ASC 842. not 1 November 2019) 2 May 2020) Upon commencement of each lease component, the Company reassessed and calculated the lease liability and right-of-use asset for the respective component. As a result, at the modification date, the Company remeasured its existing lease liability and recorded an additional right-of-use asset and lease liability of $2.0 million. The Company also recorded an additional right-of-use asset and lease liability of $3.0 million and $4.8 million at the commencement of Expansion Premises 1 November 2019 2 May 2020, December 31, 2022 During the years ended December 31, 2022, 2021 2020 Supplemental balance sheet information related to leases (in thousands): Year Ended December 31, Assets: 2022 2021 Right-of-use assets $ 8,062 $ 8,785 Year Ended December 31, Liabilities: 2022 2021 Current operating lease liabilities $ 896 $ 774 Non-current operating lease liabilities 9,144 10,040 Total lease liabilities $ 10,040 $ 10,814 Total cash paid for operating lease liabilities (in thousands): Year Ended December 31, 2022 2021 2020 Cash paid for operating lease liabilities $ 1,806 $ 1,643 $ 1,045 Maturities of operating lease liabilities were as follows (in thousands): Year ending December 31: 2023 $ 1,845 2024 1,910 2025 1,977 2026 2,046 2027 2,117 Thereafter 4,074 Total lease payments 13,969 Less imputed interest (3,929 ) Total lease liabilities $ 10,040 Weighted-average remaining lease term and discount rate, as of December 31, 2022, Weighted-average remaining lease term 6.83 Weighted-average discount rate 10 % Legal Proceedings From time to time, we may may In November 2022, not not March 2023, one not |
Note 14 - Restructuring Charges
Note 14 - Restructuring Charges | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Restructuring and Related Activities Disclosure [Text Block] | 14. On March 31, 2022, March 31, 2022. March 2022 December 31, 2022. December 31, 2022, On September 20, 2022, September 2022 December 31, 2022. December 31, 2022, |
Note 15 - Employee Benefit Plan
Note 15 - Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | 15. The Company sponsors a defined contribution plan under which it may not December 31, 2022, 2021 2020 |
Note 16 - Supplementary Financi
Note 16 - Supplementary Financial Information | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | 16. There are no two |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation Certain prior period balances have been reclassified to conform to the current period presentation in the consolidated financial statements and the accompanying notes. Sales and marketing expenses are reclassified out of general and administrative expenses, both of which are presented as separate line items. Amortization of intangible assets are reclassified to general and administrative expenses. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities Exchange Commission (the “SEC”). The consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiaries and intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates that affect the amounts reported in the financial statements and accompanying notes to the financial statements. Estimates include, but are not |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and investments. The Company places its cash equivalents and investments with high credit quality financial institutions and, by policy, limits the amounts invested with any one may not |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company believes the carrying amounts of its financial instruments, including cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate fair value due to the short-term nature of such instruments. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company invests its cash primarily in money market funds. The Company considers all highly liquid investments purchased with an original maturity of three |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and Equipment is recorded at cost and depreciated using the straight-line method over their estimated useful lives, ranging from three five |
Inventory, Policy [Policy Text Block] | Valuation of Inventory Inventory is stated at lower of cost or net realizable value. The Company establishes the inventory basis by determining the cost based on standard costs approximating the purchase costs on a first first December 31, 2022 |
Goodwill and Intangible Assets, Intangible Assets, Policy [Policy Text Block] | Intangible Assets The Company’s intangible assets consist of acquired patents and licenses, which are amortized over their estimated useful lives of twelve |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-Lived Assets The Company reviews long-lived assets, consisting of property and equipment and intangible assets, for impairment during each fiscal year or when events or changes in circumstances indicate the carrying value of these assets may |
Goodwill and Intangible Assets, Goodwill, Policy [Policy Text Block] | Goodwill The Company records goodwill when the consideration paid in a business acquisition exceeds the fair value of the net tangible assets and the identified intangible assets acquired. The Company reviews goodwill for impairment at the reporting unit level at least annually or whenever changes in circumstances indicate that the carrying value of the goodwill may not |
Revenue from Contract with Customer [Policy Text Block] | Revenue from Contracts with Customers The Company recognizes revenue at a point in time when it satisfies performance obligations by transferring control of promised goods to its customers. The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. Sales contracts often involve the sale and delivery of multiple products, each of which typically represent a separate performance obligation in the contract. While the Company sells these products on a stand-alone basis at their respective SSP, initial customer contracts will likely involve the bundling of products which will be delivered concurrently to the customer. In such instances, the full consideration of the contract will be recognized upon shipment of the products. The Company generally requires receipt of full payment prior to shipment, however, from time to time, payment terms may 9 |
Standard Product Warranty, Policy [Policy Text Block] | Product Warranty The Company provides a standard warranty on eligible products which provides the customer assurances that the products comply with the agreed-upon specifications. The standard warranty does not may Warranty accrual activity consisted of the following (in thousands): Year Ended December 31, 2022 2021 Beginning balance $ 80 $ — Add: Accruals for warranties issued during the period 42 80 Less: Adjustment for inventory at cost and excessive and obsolete inventory (72 ) — Ending balance $ 50 $ 80 |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation The Company recognizes the cost of stock-based compensation in the financial statements based upon fair value. The fair value of stock options is determined as of the grant date using the Black-Scholes option pricing model. The fair value of Restricted Stock Units (“RSU”) awards is determined based on the number of units granted and the closing price of the Company’s common stock on the grant date. The fair value of each purchase under the employee stock purchase plan (“ESPP”) is estimated at the beginning of the offering period using the Black-Scholes option pricing model. The Company’s determination of the fair value of equity-settled awards is impacted by the price of the Company’s common stock as well as changes in assumptions regarding a number of complex and subjective variables. These variables include, but are not Estimates of the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, are affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value of the award and the stock-based compensation expense recognized. These inputs are subjective and generally require significant analysis and judgment to develop. The Company determines the volatility factor based on its own historical volatility. The risk-free interest rate is based on the yield available on U.S. Treasury zero See Note 6 |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs Research and development costs consist primarily of compensation costs, fees paid to consultants and outside service providers and organizations (including university research institutes), costs associated with clinical trials, development prototypes and other expenses relating to the acquisition, design, development and testing of the Company’s product candidates, and certain facilities related costs. Research and development costs incurred by the Company are expensed as incurred, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. |
Patent Costs [Policy Text Block] | Patent Costs The Company is the owner of numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one not December 31, 2022, 2021 2020 |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more-likely-than- not not The Company is subject to U.S. federal income taxes and state income taxes in various states. As the Company’s net operating losses have yet to be utilized, previous tax years remain open to examination by federal authorities and other jurisdictions in which the Company currently operates or has operated in the past. The Company is not The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by U.S. GAAP. The tax effects of a position are recognized only if it is more-likely-than- not not not no December 31, 2022 2021 not |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Share The Company calculates basic net loss per share by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding during the period. For purposes of this calculation, options to purchase common stock and common stock warrants are considered common stock equivalents. Potential common shares that have an anti-dilutive effect ( i.e. The following outstanding stock options, warrants, and RSUs to purchase common stock were excluded from the computation of diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect: Year Ended December 31, 2022 2021 2020 Common stock warrants 7,303,832 — 612,310 Common stock options 5,250,696 5,996,813 5,039,194 Restricted stock units — — 111,305 Total 12,554,528 5,996,813 5,762,809 |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographical Information The Company operates in one segment and reports segment information in accordance with ASC 280 , Segment Reporting one not December 31, 2022 2021 , See Note 10 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2014, No. 2014 09, Revenue from Contracts with Customers first 2018. 2021 9 In November 2018, No. 2018 18 Collaborative Arrangements Clarifying the Interaction between Topic 808 606 808, Collaborative Arrangements 606, Revenue from Contracts with Customers 606” 606 not January 1, 2020, not August 2021 not no In December 2019, 2019 12, Income Taxes (Topic 740 740 December 15, 2020, 740 January 1, 2021. not |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Product Warranty Liability [Table Text Block] | Year Ended December 31, 2022 2021 Beginning balance $ 80 $ — Add: Accruals for warranties issued during the period 42 80 Less: Adjustment for inventory at cost and excessive and obsolete inventory (72 ) — Ending balance $ 50 $ 80 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2022 2021 2020 Common stock warrants 7,303,832 — 612,310 Common stock options 5,250,696 5,996,813 5,039,194 Restricted stock units — — 111,305 Total 12,554,528 5,996,813 5,762,809 |
Note 3 - Investments and Fair_2
Note 3 - Investments and Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | December 31, 2022 Assets Classification Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 57,973 $ — $ — $ 57,973 Total assets measured at fair value $ 57,973 $ — $ — $ 57,973 December 31, 2021 Assets Classification Level 1 Level 2 Level 3 Total Money market funds Cash and cash equivalents $ 23,675 $ — $ — $ 23,675 Total assets measured at fair value $ 23,675 $ — $ — $ 23,675 |
Note 4 - Balance Sheet Compon_2
Note 4 - Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | Year Ended December 31, 2022 2021 Raw materials $ — $ 2,010 Work in process — 1,371 Finished goods — 2,443 Total inventory $ — $ 5,824 |
Property, Plant and Equipment [Table Text Block] | December 31, 2022 2021 Leasehold improvements $ 2,519 $ 2,519 Laboratory equipment 1,118 1,019 Furniture, fixtures and equipment 966 932 Software 289 202 Construction in progress 22 186 4,914 4,858 Less: Accumulated depreciation and amortization (2,953 ) (2,396 ) $ 1,961 $ 2,462 |
Schedule of Finite-Lived Intangible Assets [Table Text Block] | December 31, 2022 2021 Acquired patents and licenses $ 7,985 $ 7,985 Less: Accumulated amortization (5,434 ) (4,769 ) $ 2,551 $ 3,216 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | Years ending December 31: 2023 $ 665 2024 665 2025 665 2026 556 $ 2,551 |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2022 2021 Compensation expense $ 1,377 $ 2,932 Controlled launch (Note 8) — 534 Director and officer liability insurance (Note 12) 571 — Clinical trial fees and costs 64 245 Professional fees 318 85 Warranty 50 80 Other 215 513 $ 2,595 $ 4,389 |
Note 6 - Stockholders' Equity_2
Note 6 - Stockholders' Equity and Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Weighted Average Weighted Remaining Number of Average Contractual Shares Exercise Price Life (in Years) Warrants outstanding at December 31, 2021 — $ — — Issued 7,317,072 2.05 Exercised (13,240 ) 2.05 Expired/Redeemed — — Warrants outstanding and exercisable at December 31, 2022 7,303,832 $ 2.05 4.43 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year Ended December 31, 2022 2021 2020 Cost of revenues $ 217 $ 129 $ — Research and development 1,563 5,211 4,013 Sales and marketing 733 2,749 1,187 General and administrative 2,678 6,512 4,875 Total stock-based compensation expense $ 5,191 $ 14,601 $ 10,075 |
Share-Based Payment Arrangement, Cost by Plan [Table Text Block] | Year Ended December 31, 2022 2021 2020 Time-based options $ 4,467 $ 9,235 $ 8,739 Performance options 233 4,840 133 RSU — — 86 ESPP 491 526 1,117 Total stock-based compensation expense $ 5,191 $ 14,601 $ 10,075 |
Share-Based Payment Arrangement, Option [Member] | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2022 2021 2020 Expected term in years 5.3 - 6.8 5.3 - 6.1 5.3 - 6.1 Expected volatility 83 88% 78% 70% Risk-free interest rate 1.9 - 3.2% 0.9 - 1.4% 0.3 - 0.5% Dividend yield — — — |
Performance Options [Member] | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 1,200,097 $ 13.11 8.44 Options granted 200,000 5.32 Options exercised — — Options canceled (797,920 ) 13.32 Options expired (81,875 ) 11.28 Balances — December 31, 2022 520,302 $ 10.08 7.02 Exercisable — December 31, 2022 248,861 $ 12.25 4.92 |
Time-based Options [Member] | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 4,796,716 $ 16.44 7.05 Options granted 1,240,100 2.59 Options exercised — — Options canceled (674,465 ) 16.73 Options expired (631,957 ) 15.05 Balances — December 31, 2022 4,730,394 $ 12.95 6.16 Exercisable — December 31, 2022 3,230,670 $ 15.39 5.07 |
The 2017 Employee Stock Purchase Plan [Member] | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2022 2021 2020 Expected term in years 0.5 - 1.0 0.5 - 1.0 0.5 - 1.0 Expected volatility 83% 78% 70 % Risk-free interest rate 0.6% - 3.5% 0.06% - 0.1% 0.1% - 1.0% Dividend yield — — — |
The 2015 Plan, 2017 Plan and Inducement Plan [Member] | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Stock Options Outstanding Number of shares Weighted average exercise price Weighted average remaining life (in years) Balances — December 31, 2021 5,996,813 $ 15.77 7.33 Options granted 1,440,100 2.97 Options exercised — — Options canceled (1,472,385 ) 14.88 Options expired (713,832 ) 14.62 Balances — December 31, 2022 5,250,696 $ 12.67 6.24 Exercisable — December 31, 2022 3,479,531 $ 15.17 5.06 |
Note 10 - Segment Reporting (Ta
Note 10 - Segment Reporting (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Year Ended December 31, 2022 2021 2020 Systems $ 560 $ 1,189 $ — Cycle units 140 229 — Total consolidated revenue $ 700 $ 1,418 $ — |
Revenue from External Customers by Geographic Areas [Table Text Block] | Year Ended December 31, 2022 2021 2020 North America $ 517 $ 1,182 $ — Rest of World 183 236 — Total consolidated revenue $ 700 $ 1,418 $ — |
Note 11 - Income Taxes (Tables)
Note 11 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | Year Ended December 31, 2022 2021 2020 Domestic $ (58,505 ) $ (63,660 ) $ (49,851 ) Foreign — — — $ (58,505 ) $ (63,660 ) $ (49,851 ) |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, 2022 2021 2020 Current Federal $ — $ — $ — State 3 3 3 Foreign — — — Total current 3 3 3 Deferred Federal — — — State — — — Foreign — — — Total deferred — — — Total provision for income taxes $ 3 $ 3 $ 3 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 2022 2021 2020 Federal tax at statutory rate 21.0 % 21.0 % 21.0 % State tax at statutory rate 8.4 8.4 8.4 Research and development credits 0.9 1.9 2.1 Change in valuation allowance (18.4 ) (26.8 ) (43.3 ) Deferred adjustment (5.3 ) — 8.5 Change in tax rate — — 4.2 Uncertain Tax Position (5.7 ) (2.3 ) — Other (0.9 ) (2.2 ) (0.8 ) Provision for income taxes — % — % — % |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2022 2021 Deferred tax assets Accruals $ 3,404 $ 1,034 Net operating loss carryforwards 56,447 49,246 Tax credit carryforwards 7,111 6,611 Stock-based compensation 8,784 12,188 R&D Capitalization 3,810 — Lease liability under ASC 842 2,948 3,182 Gross deferred tax assets 82,504 72,261 Valuation allowance (79,779 ) (69,006 ) Total deferred tax assets 2,725 3,255 Deferred tax liabilities Intangibles (117 ) (365 ) ROU asset under ASC 842 (2,593 ) (2,862 ) Fixed assets (15 ) (28 ) Total deferred tax liabilities (2,725 ) (3,255 ) Net deferred tax assets/(liabilities) $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | December 31, 2022 2021 2020 Unrecognized tax benefits at beginning of year $ 5,140 $ 2,491 $ 1,470 Increases related to current year tax positions 2,055 2,649 1,021 Increases related to prior year tax positions 1,730 — — Unrecognized tax benefits at end of year $ 8,925 $ 5,140 $ 2,491 |
Note 13 - Commitments and Con_2
Note 13 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Information Related to Right-of-use Assets and Lease Liabilities [Table Text Block] | Year Ended December 31, Assets: 2022 2021 Right-of-use assets $ 8,062 $ 8,785 Year Ended December 31, Liabilities: 2022 2021 Current operating lease liabilities $ 896 $ 774 Non-current operating lease liabilities 9,144 10,040 Total lease liabilities $ 10,040 $ 10,814 Year Ended December 31, 2022 2021 2020 Cash paid for operating lease liabilities $ 1,806 $ 1,643 $ 1,045 Year ending December 31: 2023 $ 1,845 2024 1,910 2025 1,977 2026 2,046 2027 2,117 Thereafter 4,074 Total lease payments 13,969 Less imputed interest (3,929 ) Total lease liabilities $ 10,040 Weighted-average remaining lease term 6.83 Weighted-average discount rate 10 % |
Note 2 - Summary of Significa_3
Note 2 - Summary of Significant Accounting Policies (Details Textual) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Finite-Lived Intangible Asset, Useful Life (Year) | 12 years | ||
Impairment, Long-Lived Asset, Held-for-Use, Total | $ 0 | ||
Goodwill, Impairment Loss | 0 | ||
Liability for Uncertainty in Income Taxes, Noncurrent | $ 0 | $ 0 | |
Number of Operating Segments | 1 | ||
Geographic Concentration Risk [Member] | Assets, Total [Member] | UNITED STATES | |||
Concentration Risk, Percentage | 100% | 100% | |
General and Administrative Expense [Member] | |||
Patent Costs | $ 500 | $ 600 | $ 500 |
Minimum [Member] | Equipment [Member] | |||
Property, Plant and Equipment, Useful Life (Year) | 3 years | ||
Maximum [Member] | Equipment [Member] | |||
Property, Plant and Equipment, Useful Life (Year) | 5 years |
Note 2 - Summary of Significa_4
Note 2 - Summary of Significant Accounting Policies - Warrant Accrual Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Beginning balance | $ 80 | $ 0 |
Add: Accruals for warranties issued during the period | 42 | 80 |
Less: Adjustment for inventory at cost and excessive and obsolete inventory | (72) | 0 |
Ending balance | $ 50 | $ 80 |
Note 2 - Summary of Significa_5
Note 2 - Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive securities (in shares) | 12,554,528 | 5,996,813 | 5,762,809 |
Warrant [Member] | |||
Antidilutive securities (in shares) | 7,303,832 | 0 | 612,310 |
Share-Based Payment Arrangement, Option [Member] | |||
Antidilutive securities (in shares) | 5,250,696 | 5,996,813 | 5,039,194 |
Restricted Stock Units (RSUs) [Member] | |||
Antidilutive securities (in shares) | 0 | 0 | 111,305 |
Note 3 - Investments and Fair_3
Note 3 - Investments and Fair Value of Financial Instruments (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Impairment of Marketable Securities | $ 0 | $ 0 | |
Fair Value, Level 1, 2 and 3 Transfers, Amount | 0 | 0 | |
Assets, Fair Value Disclosure, Total | 57,973 | 23,675 | |
Fair Value, Nonrecurring [Member] | |||
Liabilities, Fair Value Disclosure, Total | 0 | 0 | $ 0 |
Assets, Fair Value Disclosure, Total | $ 0 | $ 0 | $ 0 |
Note 3 - Investments and Fair_4
Note 3 - Investments and Fair Value of Financial Instruments - Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Total assets measured at fair value | $ 57,973 | $ 23,675 |
Total assets measured at fair value | (57,973) | (23,675) |
Fair Value, Inputs, Level 1 [Member] | ||
Total assets measured at fair value | 57,973 | 23,675 |
Total assets measured at fair value | (57,973) | (23,675) |
Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash equivalents | 0 | |
Total assets measured at fair value | 0 | |
Total assets measured at fair value | 0 | |
Fair Value, Inputs, Level 3 [Member] | ||
Total assets measured at fair value | 0 | 0 |
Total assets measured at fair value | 0 | 0 |
Money Market Funds [Member] | ||
Cash and Cash equivalents | 57,973 | 23,675 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and Cash equivalents | 57,973 | 23,675 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and Cash equivalents | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and Cash equivalents | $ 0 | $ 0 |
Note 4 - Balance Sheet Compon_3
Note 4 - Balance Sheet Components (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Depreciation, Total | $ 690 | $ 480 | $ 430 |
Finite-Lived Intangible Asset, Useful Life (Year) | 12 years |
Note 4 - Balance Sheet Compon_4
Note 4 - Balance Sheet Components - Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Raw materials | $ 0 | $ 2,010 |
Work in process | 0 | 1,371 |
Finished goods | 0 | 2,443 |
Total inventory | $ 0 | $ 5,824 |
Note 4 - Balance Sheet Compon_5
Note 4 - Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment, gross | $ 4,914 | $ 4,858 |
Less: Accumulated depreciation and amortization | (2,953) | (2,396) |
Property and equipment, net | 1,961 | 2,462 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | 2,519 | 2,519 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 1,118 | 1,019 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 966 | 932 |
Software and Software Development Costs [Member] | ||
Property and equipment, gross | 289 | 202 |
Construction in Progress [Member] | ||
Property and equipment, gross | $ 22 | $ 186 |
Note 4 - Balance Sheet Compon_6
Note 4 - Balance Sheet Components - Intangible Assets, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Less: Accumulated amortization | $ (5,434) | $ (4,769) |
Finite-Lived Intangible Assets, Net, Ending Balance | 2,551 | 3,216 |
Acquired Patents and Licenses [Member] | ||
Acquired patents and licenses | $ 7,985 | $ 7,985 |
Note 4 - Balance Sheet Compon_7
Note 4 - Balance Sheet Components - Schedule of Amortization of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
2023 | $ 665 | |
2024 | 665 | |
2025 | 665 | |
2026 | 556 | |
Finite-Lived Intangible Assets, Net, Ending Balance | $ 2,551 | $ 3,216 |
Note 4 - Balance Sheet Compon_8
Note 4 - Balance Sheet Components - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Compensation expense | $ 1,377 | $ 2,932 | |
Controlled launch (Note 8) | 0 | 534 | |
Director and officer liability insurance (Note 12) | 571 | 0 | |
Clinical trial fees and costs | 64 | 245 | |
Professional fees | 318 | 85 | |
Warranty | 50 | 80 | $ 0 |
Other | 215 | 513 | |
Accrued Liabilities, Current, Total | $ 2,595 | $ 4,389 |
Note 5 - Goodwill (Details Text
Note 5 - Goodwill (Details Textual) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2014 USD ($) | Dec. 31, 2021 USD ($) | |
Goodwill, Ending Balance | $ 2,791 | $ 2,791 | |
Goodwill, Impairment Loss | $ 0 | ||
Series of Individually Immaterial Business Acquisitions [Member] | |||
Number of Businesses Acquired | 3 | ||
Business Combination, Consideration Transferred, Total | $ 5,500 | ||
Goodwill, Ending Balance | $ 2,800 |
Note 6 - Stockholders' Equity_3
Note 6 - Stockholders' Equity and Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 7 Months Ended | 12 Months Ended | |||||||||||||||||||
Jun. 09, 2022 | Jun. 30, 2021 | Jun. 01, 2021 | Feb. 05, 2021 | Jan. 01, 2021 | Jun. 01, 2019 | Oct. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | May 31, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Dec. 31, 2017 | Nov. 30, 2017 | Feb. 04, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2017 | Nov. 30, 2021 | Dec. 31, 2016 | Dec. 31, 2014 | |
Preferred Stock, Shares Authorized (in shares) | 50,000,000 | 50,000,000 | ||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||||||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | ||||||||||||||||||||
Common Stock, Shares Authorized (in shares) | 500,000,000 | 500,000,000 | ||||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 14,864 | $ 56,697 | $ 29,434 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.05 | $ 0 | ||||||||||||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 13,240 | |||||||||||||||||||||
Class of Warrant or Right, Outstanding (in shares) | 7,303,832 | 0 | ||||||||||||||||||||
Proceeds from Warrant Exercises | $ 26 | $ 4,217 | 244 | |||||||||||||||||||
Share-Based Payment Arrangement, Expense | 5,191 | 14,601 | 10,075 | |||||||||||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 5,600 | |||||||||||||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 3 months | |||||||||||||||||||||
Time-based Options [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | 800 | 1,600 | ||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Intrinsic Value | $ 2,300 | 15,100 | 6,700 | |||||||||||||||||||
Share-Based Payment Arrangement, Expense | $ 4,467 | 9,235 | 8,739 | |||||||||||||||||||
Time-based Options [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 25% | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 1 year | |||||||||||||||||||||
Performance Options [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Intrinsic Value | $ 800 | 2,500 | 5,500 | |||||||||||||||||||
Share-Based Payment Arrangement, Expense | 233 | 4,840 | 133 | |||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||||||
Share-Based Payment Arrangement, Expense | 0 | 0 | 86 | |||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Granted in 2017 [Member] | Share-Based Payment Arrangement, Employee [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 68,800 | |||||||||||||||||||||
Share-Based Payment Arrangement, Expense | 0 | $ 100 | $ 300 | |||||||||||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | 0 | |||||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Share-Based Payment Arrangement, Tranche One [Member] | Granted in 2017 [Member] | Share-Based Payment Arrangement, Employee [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 50% | |||||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | Granted in 2017 [Member] | Share-Based Payment Arrangement, Employee [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 50% | |||||||||||||||||||||
Modified Performance Options [Member] | ||||||||||||||||||||||
Share-Based Payment Arrangement, Expense | $ 4,100 | |||||||||||||||||||||
The 2017 Plan [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 1,500,000 | 1,500,000 | ||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) | 1,188,657 | 1,022,002 | ||||||||||||||||||||
Increase in Shares Available for Issuance, Threshold of Common Stock Outstanding, Number of Shares (in shares) | 1,200,000 | 1,200,000 | ||||||||||||||||||||
Increase in Shares Available for Issuance, Threshold of Common Stock Outstanding, Percent | 4% | 4% | ||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 2,368,716 | |||||||||||||||||||||
The 2017 Inducement Equity Incentive Plan [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 1,000,000 | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) | 1,000,000 | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,053,767 | |||||||||||||||||||||
The 2017 Inducement Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 25% | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 1 year | |||||||||||||||||||||
The 2017 Employee Stock Purchase Plan [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 250,000 | 250,000 | ||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares) | 383,250 | |||||||||||||||||||||
Increase in Shares Available for Issuance, Threshold of Common Stock Outstanding, Number of Shares (in shares) | 450,000 | 450,000 | ||||||||||||||||||||
Increase in Shares Available for Issuance, Threshold of Common Stock Outstanding, Percent | 1.50% | 1.50% | ||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 460,999 | |||||||||||||||||||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) | 188,097 | 91,378 | ||||||||||||||||||||
Board of Directors Chairman [Member] | Loan Agreement [Member] | ||||||||||||||||||||||
Long-Term Debt, Total | $ 0 | $ 0 | ||||||||||||||||||||
Board of Directors Chairman [Member] | Conversion of Loan Agreement into Common Stock [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 41,000 | |||||||||||||||||||||
Chief Executive Officer [Member] | Restricted Stock Units (RSUs) [Member] | Granted in 2017 [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 160,974 | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Outstanding, Number, Ending Balance (in shares) | 0 | |||||||||||||||||||||
Share-Based Payment Arrangement, Expense | $ 0 | |||||||||||||||||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | 0 | |||||||||||||||||||||
Former Director [Member] | The 2017 Plan [Member] | Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||||||||||||||||
Share-Based Payment Arrangement, Expense | $ 1,400 | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period Upon Resignation (Day) | 90 days | |||||||||||||||||||||
Maximum [Member] | The 2017 Inducement Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||||||||||||||||
Rights Offering Warrants [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 641,571 | 7,317,072 | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.05 | $ 7.01 | $ 2.05 | |||||||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | 5 years | 5 years | |||||||||||||||||||
Class of Warrants or Rights, Redemption Price Per Share (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||||||||||
Class of Warrant or Right, Period of Written Notice for Exercise (Year) | 30 years | 30 days | 30 years | |||||||||||||||||||
Class of Warrant or Right, Percentage Required for Redemption | 200% | 200% | 200% | |||||||||||||||||||
Class of Warrant or Right, Exercise, Consecutive Trading Days (Year) | 20 years | 10 days | 20 years | |||||||||||||||||||
Period of Time Warrants Are Not Able to Be Redeemed (Month) | 3 months | 6 months | ||||||||||||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 5,139 | 636,432 | 13,240 | |||||||||||||||||||
Class of Warrant or Right, Outstanding (in shares) | 0 | 7,303,832 | ||||||||||||||||||||
Proceeds from Warrant Exercises | $ 4,500 | |||||||||||||||||||||
Rights Offering Warrants [Member] | Maximum [Member] | ||||||||||||||||||||||
Additional Proceeds That May be Received Upon Exercise of Warrants | $ 15,000 | |||||||||||||||||||||
Private Placement Warrants [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 299,625 | |||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.67 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 7 years | |||||||||||||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 45,638 | |||||||||||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 40,563 | |||||||||||||||||||||
Class of Warrant or Right, Unexercised and Expired (in shares) | 600 | |||||||||||||||||||||
Class of Warrant or Right, Outstanding (in shares) | 0 | |||||||||||||||||||||
IPO Warrants [Member] | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 574,985 | |||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 5 | |||||||||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||||||||||||||||||
Class of Warrant or Right, Exercised During Period (in shares) | 85,385 | |||||||||||||||||||||
Stock Issued During Period, Shares, Exercise of Warrants (in shares) | 68,958 | |||||||||||||||||||||
Class of Warrant or Right, Outstanding (in shares) | 0 | |||||||||||||||||||||
Rights Offering [Member] | ||||||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||||||||||||
Equity Offering, Units, Sale of Units (in shares) | 7,317,072 | |||||||||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 2.05 | |||||||||||||||||||||
Number of Shares Per Unit Issued (in shares) | 1 | |||||||||||||||||||||
Number of Warrants Per Unit (in shares) | 1 | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 7,317,072 | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 7,317,072 | |||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 15,000 | |||||||||||||||||||||
Rights Offering [Member] | Board of Directors Chairman [Member] | ||||||||||||||||||||||
Investment Owned, Percent of Net Assets | 56% | |||||||||||||||||||||
Private Placement [Member] | Board of Directors Chairman [Member] | ||||||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 16.40 | $ 16.40 | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,048,780 | |||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 8,400 | $ 8,400 | ||||||||||||||||||||
Private Placement [Member] | Board of Directors Chairman [Member] | Conversion of Loan Agreement into Common Stock [Member] | ||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ 41,000 | |||||||||||||||||||||
ATM Offering [Member] | ||||||||||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 27.73 | |||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 288,490 | |||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 7,400 | |||||||||||||||||||||
Equity Offering, Maximum Offering Amount | $ 60,000 |
Note 6 - Stockholders' Equity_4
Note 6 - Stockholders' Equity and Stock-based Compensation - Summary of Warrants Activity (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Warrants outstanding, number of shares (in shares) | shares | 0 |
Warrants outstanding, weighted average exercise price (in dollars per share) | $ / shares | $ 0 |
Warrants issued, number of shares (in shares) | shares | 7,317,072 |
Warrants issued, weighted average exercise price (in dollars per share) | $ / shares | $ 2.05 |
Warrants exercised, number of shares (in shares) | shares | (13,240) |
Warrants exercised (in dollars per share) | $ / shares | $ 2.05 |
Warrants Expired/Redeemed, number of shares (in shares) | shares | 0 |
Warrants Expired/Redeemed, weighted average exercise price (in dollars per share) | $ / shares | $ 0 |
Warrants outstanding, number of shares (in shares) | shares | 7,303,832 |
Warrants outstanding, weighted average exercise price (in dollars per share) | $ / shares | $ 2.05 |
Warrants outstanding, weighted average remaining contractual life (Year) | 4 years 5 months 4 days |
Note 6 - Stockholders' Equity_5
Note 6 - Stockholders' Equity and Stock-based Compensation - Summary of Stock Option Activity (Details) - The 2015 Plan, 2017 Plan and Inducement Plan [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Options balances, number of shares (in shares) | 5,996,813 | |
Options balances, weighted average exercise price (in dollars per share) | $ 15.77 | |
Options balances, weighted average remaining life (Year) | 6 years 2 months 26 days | 7 years 3 months 29 days |
Options granted, number of shares (in shares) | 1,440,100 | |
Options granted, weighted average exercise price (in dollars per share) | $ 2.97 | |
Options exercised, number of shares (in shares) | 0 | |
Options exercised, weighted average exercise price (in dollars per share) | $ 0 | |
Options canceled, number of shares (in shares) | (1,472,385) | |
Options canceled, weighted average exercise price (in dollars per share) | $ 14.88 | |
Options expired, number of shares (in shares) | (713,832) | |
Options expired, weighted average exercise price (in dollars per share) | $ 14.62 | |
Options balances, number of shares (in shares) | 5,250,696 | 5,996,813 |
Options balances, weighted average exercise price (in dollars per share) | $ 12.67 | $ 15.77 |
Options exercisable, number of shares (in shares) | 3,479,531 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 15.17 | |
Options exercisable, weighted average remaining life (Year) | 5 years 21 days |
Note 6 - Stockholders' Equity_6
Note 6 - Stockholders' Equity and Stock-based Compensation - Summary of Time-based Option Activity (Details) - Time-based Options [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Options balances, number of shares (in shares) | 4,796,716 | |
Options balances, weighted average exercise price (in dollars per share) | $ 16.44 | |
Options balances, weighted average remaining life (Year) | 6 years 1 month 28 days | 7 years 18 days |
Options granted, number of shares (in shares) | 1,240,100 | |
Options granted, weighted average exercise price (in dollars per share) | $ 2.59 | |
Options exercised, number of shares (in shares) | 0 | |
Options exercised, weighted average exercise price (in dollars per share) | $ 0 | |
Options canceled, number of shares (in shares) | (674,465) | |
Options canceled, weighted average exercise price (in dollars per share) | $ 16.73 | |
Options expired, number of shares (in shares) | (631,957) | |
Options expired, weighted average exercise price (in dollars per share) | $ 15.05 | |
Options balances, number of shares (in shares) | 4,730,394 | 4,796,716 |
Options balances, weighted average exercise price (in dollars per share) | $ 12.95 | $ 16.44 |
Options exercisable, number of shares (in shares) | 3,230,670 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 15.39 | |
Options exercisable, weighted average remaining life (Year) | 5 years 25 days |
Note 6 - Stockholders' Equity_7
Note 6 - Stockholders' Equity and Stock-based Compensation - Summary of Performance Option Activity (Details) - Performance Options [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Options balances, number of shares (in shares) | 1,200,097 | |
Options balances, weighted average exercise price (in dollars per share) | $ 13.11 | |
Options balances, weighted average remaining life (Year) | 7 years 7 days | 8 years 5 months 8 days |
Options granted, number of shares (in shares) | 200,000 | |
Options granted, weighted average exercise price (in dollars per share) | $ 5.32 | |
Options exercised, number of shares (in shares) | 0 | |
Options exercised, weighted average exercise price (in dollars per share) | $ 0 | |
Options canceled, number of shares (in shares) | (797,920) | |
Options canceled, weighted average exercise price (in dollars per share) | $ 13.32 | |
Options expired, number of shares (in shares) | (81,875) | |
Options expired, weighted average exercise price (in dollars per share) | $ 11.28 | |
Options balances, number of shares (in shares) | 520,302 | 1,200,097 |
Options balances, weighted average exercise price (in dollars per share) | $ 10.08 | $ 13.11 |
Options exercisable, number of shares (in shares) | 248,861 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 12.25 | |
Options exercisable, weighted average remaining life (Year) | 4 years 11 months 1 day |
Note 6 - Stockholders' Equity_8
Note 6 - Stockholders' Equity and Stock-based Compensation - Option Assumptions (Details) - Share-Based Payment Arrangement, Option [Member] | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Expected volatility | 78% | 70% | |
Dividend yield | 0% | 0% | 0% |
Minimum [Member] | |||
Expected term in years (Year) | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days |
Risk-free interest rate | 1.90% | 0.90% | 0.30% |
Maximum [Member] | |||
Expected term in years (Year) | 6 years 9 months 18 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Risk-free interest rate | 3.20% | 1.40% | 0.50% |
Note 6 - Stockholders' Equity_9
Note 6 - Stockholders' Equity and Stock-based Compensation - ESPP Assumptions (Details) - The 2017 Employee Stock Purchase Plan [Member] | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Expected volatility | 83% | 78% | 70% |
Dividend yield | 0% | 0% | 0% |
Minimum [Member] | |||
Expected term in years (Year) | 6 months | 6 months | 6 months |
Risk-free interest rate | 0.60% | 0.06% | 0.10% |
Maximum [Member] | |||
Expected term in years (Year) | 1 year | 1 year | 1 year |
Risk-free interest rate | 3.50% | 0.10% | 1% |
Note 6 - Stockholders' Equit_10
Note 6 - Stockholders' Equity and Stock-based Compensation - Stock-based Compensation Expense by Recorded Location (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total stock-based compensation expense | $ 5,191 | $ 14,601 | $ 10,075 |
Cost of Sales [Member] | |||
Total stock-based compensation expense | 217 | 129 | 0 |
Research and Development Expense [Member] | |||
Total stock-based compensation expense | 1,563 | 5,211 | 4,013 |
Selling and Marketing Expense [Member] | |||
Total stock-based compensation expense | 733 | 2,749 | 1,187 |
General and Administrative Expense [Member] | |||
Total stock-based compensation expense | $ 2,678 | $ 6,512 | $ 4,875 |
Note 6 - Stockholders' Equit_11
Note 6 - Stockholders' Equity and Stock-based Compensation - Stock-based Compensation Expense by Type (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total stock-based compensation expense | $ 5,191 | $ 14,601 | $ 10,075 |
Time-based Options [Member] | |||
Total stock-based compensation expense | 4,467 | 9,235 | 8,739 |
Performance Options [Member] | |||
Total stock-based compensation expense | 233 | 4,840 | 133 |
Restricted Stock Units (RSUs) [Member] | |||
Total stock-based compensation expense | 0 | 0 | 86 |
Employee Stock Purchase Plan Award [Member] | |||
Total stock-based compensation expense | $ 491 | $ 526 | $ 1,117 |
Note 7 - Research Grants and _2
Note 7 - Research Grants and Agreements (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
May 31, 2021 | Mar. 31, 2021 | Sep. 30, 2019 | Aug. 31, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Research and Development Expense, Total | $ 20,839 | $ 28,640 | $ 26,444 | ||||
Old Dominion University Research Foundation [Member] | Sponsored Research Agreement SRA [Member] | |||||||
Research and Development Expense, Total | $ 200 | $ 300 | $ 600 | ||||
Old Dominion University Research Foundation [Member] | Sponsored Research Agreement SRA [Member] | Research and Development Arrangement [Member] | |||||||
Long-Term Purchase Commitment, Amount | $ 300 | $ 300 | $ 800 | $ 800 |
Note 8 - Controlled Launch (Det
Note 8 - Controlled Launch (Details Textual) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Feb. 28, 2021 | |
Number of KOLs | 70 | |||
Controlled Launch, Program Expenses | $ 100 | $ 1,800 | ||
Revenue from Contract with Customer, Excluding Assessed Tax | 700 | 1,418 | $ 0 | |
Redemption of Non Cash Credits [Member] | ||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 400 | $ 1,100 | ||
Minimum [Member] | ||||
Number of Patients Participating in Procedure | 40 | |||
Maximum [Member] | ||||
Number of Patients Participating in Procedure | 50 |
Note 9 - Revenue (Details Textu
Note 9 - Revenue (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue from Contract with Customer, Excluding Assessed Tax | $ 700 | $ 1,418 | $ 0 |
Redemption of Non Cash Credits [Member] | |||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 400 | $ 1,100 |
Note 10 - Segment Reporting (De
Note 10 - Segment Reporting (Details Textual) | 12 Months Ended |
Dec. 31, 2022 | |
Number of Reportable Segments | 1 |
Note 10 - Segment Reporting - R
Note 10 - Segment Reporting - Revenue by Product (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenues | $ 700 | $ 1,418 | $ 0 |
System Products [Member] | |||
Total revenues | 560 | 1,189 | 0 |
Cycle Units Products [Member] | |||
Total revenues | $ 140 | $ 229 | $ 0 |
Note 10 - Segment Reporting -_2
Note 10 - Segment Reporting - Revenue by Geography (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenues | $ 700 | $ 1,418 | $ 0 |
North America [Member] | |||
Total revenues | 517 | 1,182 | 0 |
Rest of World [Member] | |||
Total revenues | $ 183 | $ 236 | $ 0 |
Note 11 - Income Taxes (Details
Note 11 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized Tax Benefits, Ending Balance | $ 8,925 | $ 5,140 | $ 2,491 | $ 1,470 |
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | 0 | |||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 10,800 | $ 17,000 | ||
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2034 | |||
Domestic Tax Authority [Member] | ||||
Operating Loss Carryforwards | $ 199,900 | |||
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2035 | |||
Operating Loss Carryforwards, Not Subject to Expiration | $ 174,300 | |||
Tax Credit Carryforward, Amount | 5,800 | |||
State and Local Jurisdiction [Member] | ||||
Operating Loss Carryforwards | 204,600 | |||
Tax Credit Carryforward, Amount | $ 5,500 |
Note 11 - Income Taxes - Income
Note 11 - Income Taxes - Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Domestic | $ (58,505) | $ (63,660) | $ (49,851) |
Foreign | 0 | 0 | 0 |
Loss from operations, before income taxes | $ (58,505) | $ (63,660) | $ (49,851) |
Note 11 - Income Taxes - Compon
Note 11 - Income Taxes - Components of Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 3 | 3 | 3 |
Foreign | 0 | 0 | 0 |
Total current | 3 | 3 | 3 |
Deferred | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred | 0 | 0 | 0 |
Total provision for income taxes | $ 3 | $ 3 | $ 3 |
Note 11 - Income Taxes - Reconc
Note 11 - Income Taxes - Reconciliation of Provision for Income Taxes (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Federal tax at statutory rate | 21% | 21% | 21% |
State tax at statutory rate | 8.40% | 8.40% | 8.40% |
Research and development credits | 0.90% | 1.90% | 2.10% |
Change in valuation allowance | (18.40%) | (26.80%) | (43.30%) |
Deferred adjustment | (5.30%) | 0% | 8.50% |
Change in tax rate | 0% | 0% | 4.20% |
Uncertain Tax Position | (5.70%) | (2.30%) | 0% |
Other | (0.90%) | (2.20%) | (0.80%) |
Provision for income taxes | 0% | 0% | 0% |
Note 11 - Income Taxes - Deferr
Note 11 - Income Taxes - Deferred Tax Asset (Liability) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accruals | $ 3,404 | $ 1,034 |
Net operating loss carryforwards | 56,447 | 49,246 |
Tax credit carryforwards | 7,111 | 6,611 |
Stock-based compensation | 8,784 | 12,188 |
R&D Capitalization | 3,810 | 0 |
Lease liability under ASC 842 | 2,948 | 3,182 |
Gross deferred tax assets | 82,504 | 72,261 |
Valuation allowance | (79,779) | (69,006) |
Total deferred tax assets | 2,725 | 3,255 |
Intangibles | (117) | (365) |
ROU asset under ASC 842 | (2,593) | (2,862) |
Fixed assets | (15) | (28) |
Total deferred tax liabilities | (2,725) | (3,255) |
Net deferred tax assets/(liabilities) | $ 0 | $ 0 |
Note 11 - Income Taxes - Reco_2
Note 11 - Income Taxes - Reconciliation of Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Unrecognized tax benefits at beginning of year | $ 5,140 | $ 2,491 | $ 1,470 |
Increases related to current year tax positions | 2,055 | 2,649 | 1,021 |
Increases related to prior year tax positions | 1,730 | 0 | 0 |
Unrecognized tax benefits at beginning of year | $ 8,925 | $ 5,140 | $ 2,491 |
Note 12 - Related Party Trans_2
Note 12 - Related Party Transactions (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||
Sep. 20, 2022 | Jun. 30, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | May 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | May 13, 2021 | May 11, 2021 | |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Proceeds from Issuance of Common Stock | $ 14,864 | $ 56,697 | $ 29,434 | |||||||
Board of Directors Chairman [Member] | Letter Agreement [Member] | ||||||||||
Related Party Transaction, Amounts of Transaction | $ 600 | |||||||||
Board of Directors Chairman [Member] | Conversion of Loan Agreement into Common Stock [Member] | ||||||||||
Debt Conversion, Original Debt, Amount | $ 41,000 | |||||||||
Board of Directors Chairman [Member] | Private Placement [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,048,780 | |||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 16.40 | $ 16.40 | ||||||||
Stock Issued During Period, Value, New Issues | $ 50,000 | |||||||||
Proceeds from Issuance of Common Stock | 8,400 | $ 8,400 | ||||||||
Board of Directors Chairman [Member] | Private Placement [Member] | Conversion of Loan Agreement into Common Stock [Member] | ||||||||||
Debt Conversion, Original Debt, Amount | 41,000 | |||||||||
Board of Directors Chairman [Member] | Loan Agreement [Member] | ||||||||||
Debt Instrument, Face Amount | $ 41,000 | $ 41,000 | ||||||||
Long-Term Debt, Total | $ 0 | $ 0 | ||||||||
Robert W. Duggan [Member] | Letter Agreement [Member] | ||||||||||
Directors and Officers Liability Insurance, Period (Year) | 1 year | |||||||||
Due to Related Parties, Total | $ 1,000 | |||||||||
Related Party Transaction, Amounts of Transaction | $ 65,000 | |||||||||
Robert W. Duggan [Member] | Letter Agreement [Member] | Subsequent Event [Member] | ||||||||||
Directors and Officers Liability Insurance, Period (Year) | 1 year |
Note 13 - Commitments and Con_3
Note 13 - Commitments and Contingencies (Details Textual) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
May 13, 2021 USD ($) | Jun. 30, 2021 USD ($) | May 31, 2020 USD ($) | Nov. 30, 2019 USD ($) | May 31, 2019 USD ($) a | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Sep. 20, 2022 USD ($) | May 11, 2021 USD ($) | Jul. 31, 2017 a | |
Director and Officer Insurance Premium Payable | $ 2,600 | |||||||||||
Payment to Acquire Life Insurance Policy, Investing Activities | 700 | |||||||||||
Increase (Decrease) in Operating Lease Right of Use Asset | $ (723) | $ (653) | $ (509) | |||||||||
Operating Lease, Right-of-Use Asset | 8,062 | 8,785 | ||||||||||
Operating Lease, Liability, Total | 10,040 | 10,814 | ||||||||||
Operating Lease, Expense | 2,100 | $ 1,900 | $ 1,700 | |||||||||
Corporate Headquarters in Hayward, California [Member] | ||||||||||||
Lessee, Operating Lease, Term of Contract (Year) | 5 years | |||||||||||
Area of Real Estate Property (Acre) | a | 15,700 | |||||||||||
Increase (Decrease) in Operating Lease Right of Use Asset | $ 2,000 | |||||||||||
Operating Lease, Right-of-Use Asset | 8,100 | |||||||||||
Operating Lease, Liability, Total | 10,000 | |||||||||||
Corporate Headquarters in Hayward, California [Member] | Expansion Premises 1 [Member] | ||||||||||||
Area of Real Estate Property (Acre) | a | 13,300 | |||||||||||
Increase (Decrease) in Operating Lease Right of Use Asset | $ 3,000 | |||||||||||
Corporate Headquarters in Hayward, California [Member] | Expansion Premises 2 [Member] | ||||||||||||
Area of Real Estate Property (Acre) | a | 21,300 | |||||||||||
Increase (Decrease) in Operating Lease Right of Use Asset | $ 4,800 | |||||||||||
Board of Directors Chairman [Member] | Conversion of Loan Agreement into Common Stock [Member] | ||||||||||||
Debt Conversion, Original Debt, Amount | $ 41,000 | |||||||||||
Interest Payable | $ 600 | |||||||||||
Debt Conversion, Converted Instrument, Rate | 16.40% | |||||||||||
Loan Agreement [Member] | Board of Directors Chairman [Member] | ||||||||||||
Debt Instrument, Face Amount | 41,000 | $ 41,000 | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5% | |||||||||||
Interest Expense, Total | 600 | |||||||||||
Two Thousand Twenty Two Loan Agreement [Member] | Robert W. Duggan [Member] | ||||||||||||
Debt Instrument, Face Amount | $ 65,000 | |||||||||||
Debt Instrument Quarterly Interest Rate | 5 | |||||||||||
Debt Instrument, Increase, Accrued Interest | $ 900 | |||||||||||
Insurance Loan Agreement [Member] | ||||||||||||
Debt Instrument, Face Amount | $ 1,900 | |||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.69% | |||||||||||
Interest Expense, Total | $ 1 |
Note 13 - Commitments and Con_4
Note 13 - Commitments and Contingencies - Information Related to Right-of-use Assets and Lease Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Right-of-use assets | $ 8,062 | $ 8,785 | |
Current operating lease liabilities | 896 | 774 | |
Non-current operating lease liabilities | 9,144 | 10,040 | |
Total lease liabilities | 10,040 | 10,814 | |
Cash paid for operating lease liabilities | 1,806 | $ 1,643 | $ 1,045 |
2023 | 1,845 | ||
2024 | 1,910 | ||
2025 | 1,977 | ||
2026 | 2,046 | ||
2027 | 2,117 | ||
Thereafter | 4,074 | ||
Total lease payments | 13,969 | ||
Less imputed interest | $ (3,929) | ||
Weighted-average remaining lease term (Year) | 6 years 9 months 29 days | ||
Weighted-average discount rate | 10% |
Note 14 - Restructuring Charg_2
Note 14 - Restructuring Charges (Details Textual) - Employee Severance [Member] - USD ($) $ in Millions | 1 Months Ended | |
Sep. 30, 2022 | Mar. 31, 2022 | |
March 2022 Restructuring Plan [Member] | ||
Payments for Restructuring | $ 0.7 | |
September 2022 Restructuring Plan [Member] | ||
Payments for Restructuring | $ 0.2 | |
Total Cost and Expenses [Member] | March 2022 Restructuring Plan [Member] | ||
Restructuring Charges, Total | $ 0.7 | |
Total Cost and Expenses [Member] | September 2022 Restructuring Plan [Member] | ||
Restructuring Charges, Total | $ 0.2 |
Note 15 - Employee Benefit Pl_2
Note 15 - Employee Benefit Plans (Details Textual) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0 |