Cover
| Cover - shares | 3 Months Ended | |
| Mar. 31, 2022 | May 05, 2022 | |
| Cover [Abstract] | ||
| Document Type | 10-Q | |
| Document Quarterly Report | true | |
| Document Period End Date | Mar. 31, 2022 | |
| Document Transition Report | false | |
| Entity File Number | 001-34822 | |
| Entity Registrant Name | ClearPoint Neuro, Inc. | |
| Entity Incorporation, State or Country Code | DE | |
| Entity Tax Identification Number | 58-2394628 | |
| Entity Address, Address Line One | 120 S. Sierra Ave. | |
| Entity Address, Address Line Two | Suite 100 | |
| Entity Address, City or Town | Solana Beach | |
| Entity Address, State or Province | CA | |
| Entity Address, Postal Zip Code | 92075 | |
| City Area Code | (888) | |
| Local Phone Number | 287-9109 | |
| Title of 12(b) Security | Common Stock, $0.01 par value per share | |
| Trading Symbol | CLPT | |
| Security Exchange Name | NASDAQ | |
| Entity Current Reporting Status | Yes | |
| Entity Interactive Data Current | Yes | |
| Entity Filer Category | Non-accelerated Filer | |
| Entity Small Business | true | |
| Entity Emerging Growth Company | false | |
| Entity Shell Company | false | |
| Entity Common Stock, Shares Outstanding | 23,717,281 | |
| Entity Central Index Key | 0001285550 | |
| Current Fiscal Year End Date | --12-31 | |
| Document Fiscal Year Focus | 2022 | |
| Document Fiscal Period Focus | Q1 | |
| Amendment Flag | false |
Condensed Consolidated Balance
| Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
| Current assets: | ||
| Cash and cash equivalents | $ 49,658 | $ 54,109 |
| Accounts receivable, net | 2,243 | 2,337 |
| Inventory, net | 5,732 | 4,938 |
| Prepaid expenses and other current assets | 380 | 508 |
| Total current assets | 58,013 | 61,892 |
| Property and equipment, net | 709 | 539 |
| Operating lease rights of use | 2,116 | 2,241 |
| Software license inventory | 484 | 519 |
| Licensing rights | 352 | 265 |
| Other assets | 94 | 125 |
| Total assets | 61,768 | 65,581 |
| Current liabilities: | ||
| Accounts payable | 965 | 427 |
| Accrued compensation | 1,344 | 2,604 |
| Other accrued liabilities | 602 | 537 |
| Operating lease liabilities, current portion | 521 | 507 |
| Deferred product and service revenue, current portion | 541 | 678 |
| Total current liabilities | 3,973 | 4,753 |
| Operating lease liabilities, net of current portion | 1,806 | 1,939 |
| Deferred product and service revenue, net of current portion | 408 | 264 |
| 2020 senior secured convertible notes payable, net | 9,851 | 9,838 |
| Total liabilities | 16,038 | 16,794 |
| Commitments and contingencies | ||
| Stockholders’ equity: | ||
| Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at March 31, 2022 and December 31, 2021 | 0 | 0 |
| Common stock, $0.01 par value; 200,000,000 shares authorized; 23,708,118 shares issued and outstanding at March 31, 2022; and 23,665,991 issued and outstanding at December 31, 2021 | 237 | 237 |
| Additional paid-in capital | 183,384 | 182,482 |
| Accumulated deficit | (137,891) | (133,932) |
| Total stockholders’ equity | 45,730 | 48,787 |
| Total liabilities and stockholders’ equity | $ 61,768 | $ 65,581 |
Condensed Consolidated Balanc_2
| Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
| Statement of Financial Position [Abstract] | ||
| Preferred stock par value (in dollars per share) | $ 0.01 | $ 0.01 |
| Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
| Preferred stock, shares outstanding (in shares) | 0 | 0 |
| Preferred stock, shares issued (in shares) | 0 | 0 |
| Common stock par value (in dollars per share) | $ 0.01 | $ 0.01 |
| Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
| Common stock, shares issued (in shares) | 23,708,118 | 23,665,991 |
| Common stock, shares outstanding (in shares) | 23,708,118 | 23,665,991 |
Condensed Consolidated Statemen
| Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
| Mar. 31, 2022 | Mar. 31, 2021 | |
| Revenue: | ||
| Total revenue | $ 5,031 | $ 4,030 |
| Cost of revenue | 1,785 | 1,416 |
| Gross profit | 3,246 | 2,614 |
| Research and development costs | 2,533 | 1,563 |
| Sales and marketing expenses | 1,845 | 1,575 |
| General and administrative expenses | 2,732 | 1,657 |
| Operating loss | (3,864) | (2,181) |
| Other expense: | ||
| Other income (expense), net | 11 | (25) |
| Interest expense, net | (106) | (332) |
| Net loss | $ (3,959) | $ (2,538) |
| Net loss per share attributable to common stockholders: | ||
| Basic (in dollars per share) | $ (0.17) | $ (0.13) |
| Diluted (in dollars per share) | $ (0.17) | $ (0.13) |
| Weighted average shares used in computing net loss per share: | ||
| Basic (in shares) | 23,682,442 | 18,852,828 |
| Diluted (in shares) | 23,682,442 | 18,852,828 |
| Product revenue | ||
| Revenue: | ||
| Total revenue | $ 3,163 | $ 3,162 |
| Service and other revenue | ||
| Revenue: | ||
| Total revenue | $ 1,868 | $ 868 |
Condensed Consolidated Statem_2
| Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Revision of Prior Period, Accounting Standards Update, Adjustment | Common Stock | Additional Paid-in Capital | Additional Paid-in CapitalRevision of Prior Period, Accounting Standards Update, Adjustment | Accumulated Deficit |
| Beginning balance (in shares) at Dec. 31, 2020 | 17,047,584 | |||||
| Beginning balance at Dec. 31, 2020 | $ 2,377 | $ (3,107) | $ 170 | $ 121,729 | $ (3,107) | $ (119,522) |
| Issuances of common stock: | ||||||
| Public offering of common stock (in shares) | 2,127,660 | |||||
| Public offering of common stock | 46,785 | $ 21 | 46,764 | |||
| Share-based compensation (in shares) | 20,709 | |||||
| Share-based compensation | 320 | $ 1 | 319 | |||
| Warrant and option exercises (cash and cashless) (in shares) | 1,482,327 | |||||
| Warrant and option exercises (cash and cashless) | 145 | $ 15 | 130 | |||
| Net Income (Loss) Attributable to Parent | (2,538) | (2,538) | ||||
| Ending balance (in shares) at Mar. 31, 2021 | 20,678,280 | |||||
| Ending balance at Mar. 31, 2021 | 43,982 | $ 207 | 165,835 | (122,060) | ||
| Beginning balance (in shares) at Dec. 31, 2021 | 23,665,991 | |||||
| Beginning balance at Dec. 31, 2021 | 48,787 | $ 237 | 182,482 | (133,932) | ||
| Issuances of common stock: | ||||||
| Share-based compensation (in shares) | 29,916 | |||||
| Share-based compensation | 899 | 899 | ||||
| Warrant and option exercises (cash and cashless) (in shares) | 12,211 | |||||
| Warrant and option exercises (cash and cashless) | 3 | 3 | ||||
| Net Income (Loss) Attributable to Parent | (3,959) | (3,959) | ||||
| Ending balance (in shares) at Mar. 31, 2022 | 23,708,118 | |||||
| Ending balance at Mar. 31, 2022 | $ 45,730 | $ 237 | $ 183,384 | $ (137,891) |
Condensed Consolidated Statem_3
| Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
| Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
| Cash flows from operating activities: | |||
| Net loss | $ (3,959) | $ (2,538) | |
| Adjustments to reconcile net loss to net cash flows from operating activities: | |||
| Allowance for doubtful accounts | (61) | 3 | |
| Depreciation and amortization | 86 | 15 | |
| Share-based compensation | 899 | 320 | |
| Payment-in-kind interest | 0 | 94 | |
| Amortization of debt issuance costs and original issue discounts | 13 | 35 | |
| Amortization of lease rights of use, net of accretion in lease liabilities | 133 | 133 | |
| Increase (decrease) in cash resulting from changes in: | |||
| Accounts receivable | 155 | (126) | |
| Inventory, net | (880) | 47 | |
| Prepaid expenses and other current assets | 128 | (10) | |
| Other assets | 30 | 3 | |
| Accounts payable and accrued expenses | (692) | (54) | |
| Lease liabilities | (128) | (94) | |
| Deferred revenue | 7 | 41 | |
| Net cash flows from operating activities | (4,269) | (2,131) | $ (12,700) |
| Cash flows from investing activities: | |||
| Purchases of property and equipment | (69) | (40) | |
| Acquisition of licensing rights | (116) | 0 | |
| Net cash flows from investing activities | (185) | (40) | |
| Cash flows from financing activities: | |||
| Proceeds from public offering of common stock, net of offering costs | 0 | 46,785 | |
| Proceeds from stock option and warrant exercises | 3 | 145 | |
| Net cash flows from financing activities | 3 | 46,930 | |
| Net change in cash and cash equivalents | (4,451) | 44,759 | |
| Cash and cash equivalents, beginning of period | 54,109 | 20,099 | 20,099 |
| Cash and cash equivalents, end of period | 49,658 | 64,858 | $ 54,109 |
| Cash paid for: | |||
| Income taxes | 0 | 0 | |
| Interest | $ 100 | $ 214 | |
Condensed Consolidated Statem_4
| Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Millions | Jan. 01, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
| Statement of Cash Flows [Abstract] | |||
| Capital expenditures accrued, not yet paid | $ 0.1 | ||
| Net transfers of reusable components from loaned systems | $ 0.1 | $ 0.1 | |
| Reduction of additional paid-in-capital | $ 3.1 |
Description of the Business and
| Description of the Business and Financial Condition | 3 Months Ended |
| Mar. 31, 2022 | |
| Description Of Business And Liquidity [Abstract] | |
| Description of the Business and Financial Condition | 1. Description of the Business and Financial Condition ClearPoint Neuro, Inc. (the “Company”) is a commercial-stage medical device company focused on the development and commercialization of innovative platforms for performing minimally invasive surgical procedures in the brain. From the Company’s inception in 1998, the Company deployed significant resources to fund its efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies it develops. In 2021, the Company’s efforts expanded beyond the MRI suite to encompass development and commercialization of new neurosurgical device products for the operating room setting, as well as consulting services for pharmaceutical companies. The Company’s initial product offering, the ClearPoint system, is an integrated system comprised of capital equipment and disposable products, designed to allow minimally invasive procedures in the brain to be performed in an MRI suite. The ClearPoint Array Neuro Navigation System and its principal disposable component, introduced in 2021, can be deployed in an operating room setting, while also being usable in an MRI suite. Both systems provide guidance for the placement and operation of instruments or devices during the planning and operation of neurosurgical procedures. The Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) in 2010 to market the ClearPoint system in the United States for general neurosurgical interventional procedures; in February 2011, the Company also obtained CE marking approval for its ClearPoint system. In 2011 and 2018 the Company received 510(k) clearance and CE marking approval, respectively, for its SmartFlow cannula which is being used, or is under evaluation, by approximately 45 pharmaceutical companies having a focus on biologics and drug delivery. COVID-19 The extraordinary measures taken beginning in 2020 by federal, state and local governmental authorities in response to the novel strain of the coronavirus (“COVID-19”) pandemic, including “stay-at-home” directives and mandates that substantially restricted daily activities and curtailed or ceased normal business operations, led to reduced economic activity, including the postponement or cancellation of elective surgical procedures, which historically have represented approximately 80% of the number of surgical procedures using the Company’s ClearPoint system. Although economic activity is returning to normalized levels, new variants of COVID-19, such as Delta and Omicron, continue to spread in the United States and across the globe. The ultimate impact of the COVID-19 pandemic cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among the population, the effectiveness of vaccines against different variants and the response by governmental bodies and regulators. Management is unable to determine the timing, adoption or viability of periodic resumption, if any, of elective procedures; and the resulting length of time that the COVID-19 pandemic will adversely affect the Company’s product revenues. Furthermore, recessionary conditions on the global economy caused by the COVID-19 pandemic could have a material adverse effect on the Company’s business. Although most segments of the United States economy have reopened, future surges of COVID-19 due to new variants could occur in the future. Accordingly, reinstatement of directives and mandates requiring businesses to again curtail or cease normal operations, including the postponement or cancellation of elective surgeries, remains a possibility. Additionally, global economic and supply chain disruptions, labor shortages which may affect the Company’s ability to retain and attract new talent, and inflationary conditions caused by the COVID-19 pandemic could have a material adverse effect on the Company’s business. The rapid development and fluidity of the situation precludes any prediction as to the ultimate impact COVID-19 will have on the Company’s business, financial condition, results of operation and cash flows, which will depend largely on future developments directly or indirectly relating to the duration and scope of the COVID-19 outbreak in the United States. Liquidity The Company has incurred net losses since its inception, which has resulted in a cumulative deficit at March 31, 2022 of $137.9 million. In addition, the Company’s use of cash from operations amounted to $4.3 million for the three months ended March 31, 2022 and $12.7 million for the year ended December 31, 2021. Since its inception, the Company has financed its operations principally from the sale of equity securities and the issuance of notes payable. In January 2020, the Company entered into a Securities Purchase Agreement (the “SPA”) with two investors (each, a “2020 Convertible Noteholder,” and together, the “2020 Convertible Noteholders”) under which the Company issued an aggregate principal amount of $17.5 million of floating rate secured convertible notes with a five-year term (the “First Closing Notes”), resulting in proceeds, net of financing costs and a commitment fee paid to one of the 2020 Convertible Noteholders, of approximately $16.8 million. The SPA also gave the Company the right, but not the obligation, to request one of the 2020 Convertible Noteholders to purchase an additional $5.0 million in principal amount of a note (the “Second Closing Note”, and, together with the First Closing Note, the “2020 Secured Notes”). On December 29, 2020, under the terms of an amendment to the SPA (the “Amendment”) which, among other provisions, increased the principal amount of the Second Closing Note, the Company issued the Second Closing Note in the principal amount of $7.5 million to one of the 2020 Convertible Noteholders. See Note 5 for additional information with respect to the 2020 Secured Notes. As discussed in Note 7, on February 23, 2021, the Company completed a public offering of 2,127,660 shares of its common stock. Net proceeds from the offering were approximately $46.8 million after deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company. Based on the foregoing, in management’s opinion, cash and cash equivalent balances at March 31, 2022 are sufficient to support the Company’s operations and meet its obligations for at least the next twelve months. |
Basis of Presentation and Summa
| Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
| Mar. 31, 2022 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2021 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with generally accepted accounting principles in the U.S. (“GAAP”). The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2021 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three months ended March 31, 2022 may not be indicative of the results to be expected for the entire year or any future periods. Inventory Inventory is carried at the lower of cost (first-in, first-out method) or net realizable value. Items in inventory relate predominantly to the Company’s ClearPoint system. Software license inventory related to ClearPoint systems undergoing on-site customer evaluation is included in inventory in the accompanying condensed consolidated balance sheets. All other software license inventory is classified as a non-current asset. The Company periodically reviews its inventory for obsolete items and provides a reserve upon identification of potentially obsolete items. Intangible Assets The Company is a party to certain license agreements that provide rights to the Company for the development and commercialization of products. Under the terms of those license agreements, the Company made payments to the licensors upon execution of the license agreements for access to the underlying technologies and will make future payments based on the achievement of regulatory and commercialization milestones as defined in the license agreements. In conformity with Accounting Standards Codification Section 350, “Intangibles – Goodwill and Other,” the Company amortizes its investment in the license rights described above over an expected useful life of five years. In addition, the Company periodically evaluates the recoverability of its investment in the license rights and records an impairment charge in the event such evaluation indicates that the Company’s investment is not likely to be recovered. Revenue Recognition The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of functional neurosurgery, navigation, therapy, and biologics and drug delivery disposable products; (2) product revenue resulting from the sale of ClearPoint capital equipment and software; (3) revenue resulting from the service, installation, training and shipping related to ClearPoint capital equipment and software; and (4) consultation revenue and clinical case support revenue in connection with customer-sponsored clinical trials. The Company recognizes revenue when control of the Company’s products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation customarily charged by the Company. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. Lines of Business; Timing of Revenue Recognition • Functional neurosurgery navigation product, biologics and drug delivery systems product, and therapy product sales: Revenue from the sale of functional neurosurgery navigation products (consisting of disposable products sold commercially and related to cases utilizing the Company’s ClearPoint system), biologics and drug delivery systems (consisting primarily of disposable products related to customer-sponsored clinical trials utilizing the ClearPoint system), and therapy products (consisting primarily of disposable laser-related products used in non-neurosurgical procedures), is generally based on customer purchase orders, the predominance of which require delivery within one week of the order having been placed, and are generally recognized at the point in time of shipping to the customer, which is the point at which legal title, and risks and rewards of ownership, transfer to the customer. For certain customers, legal title and risks and rewards of ownership transfer upon delivery to the customer as stated in their respective contracts. • Capital equipment and software sales ◦ Capital equipment and software sales preceded by evaluation periods: The predominance of capital equipment and software sales (consisting of integrated computer hardware and software that are integral components of the Company’s ClearPoint system) are preceded by customer evaluation periods. During these evaluation periods, installation of, and training of customer personnel on, the systems have been completed and the systems have been in operation. Accordingly, revenue from capital equipment and software sales following such evaluation periods is recognized at the point in time the Company is in receipt of an executed purchase agreement or purchase order. ◦ Capital equipment and software sales not preceded by evaluation periods: Revenue from sales of capital equipment and software not having been preceded by an evaluation period is recognized at the point in time that the equipment has been delivered to the customer. For both types of capital equipment and software sales described above, the Company’s determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment. • Functional neurosurgery navigation and therapy services: The Company recognizes revenue for such services at the point in time that the performance obligation has been satisfied. • Biologics and drug delivery services: ◦ Consultation Services: The Company recognizes consultation revenue at the point in time such services are performed. ◦ Clinical Service Access Fees: For contracts in which the Company receives a periodic fixed fee, irrespective of the number of cases attended by Company personnel or hours of services provided to the customer during such periods, revenue is recognized ratably over the period covered by such fees. A time-elapsed output method is used for such fees because the Company transfers control evenly by providing a stand-ready service. ◦ Clinical Service Procedure-Based Fees: The Company recognizes revenue at the point in time a case is attended by Company personnel. • Capital equipment-related services: ◦ Equipment service: Revenue from service of ClearPoint capital equipment and software previously sold to customers is based on agreements with terms ranging from one The Company may also enter into contracts with customers who own ClearPoint capital equipment, which bundle maintenance and support services and access to software and hardware upgrades made commercially available over the term of the contract, for a single contract price, typically paid on an annual basis. The Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation and recognizes the revenue ratably on a monthly basis. In line with equipment service, a time-elapsed output method is used as the Company is providing a stand-ready service. ◦ Installation, training and shipping: Consistent with the Company’s recognition of revenue for capital equipment and software sales as described above, fees for installation, training and shipping in connection with sales of capital equipment and software that have been preceded by customer evaluation periods are recognized as revenue at the point in time the Company is in receipt of an executed purchase order for the equipment and software. Installation, training and shipping fees related to capital equipment and software sales not having been preceded by an evaluation period are recognized as revenue at the point in time that the related services are performed. The Company operates in one industry segment, and the vast majority of its sales are to U.S.-based customers. Payment terms under contracts with customers generally are in a range of 30-60 days after the customers’ receipt of the Company’s invoices. The Company’s terms and conditions do not provide for a right of return unless for: (a) product defects; or (b) other conditions subject to the Company’s approval. See Note 3 for additional information regarding revenue recognition. Net Loss Per Share The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which comprise the entire amount of the Company’s outstanding common stock options and warrants, as described in Note 7, and the potential conversion of the First Closing Note, as described in Note 5, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations. Concentration Risks and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company holds substantially all its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At March 31, 2022, the Company had approximately $44.0 million in bank balances that were in excess of the insured limits. At March 31, 2022, there were two customers (one of which is a related party as discussed below) whose accounts receivable balances represented 13% and 11% of accounts receivable at that date. At December 31, 2021, one customer accounted for 15% of accounts receivable at that date. One pharmaceutical customer, a related party who is a stockholder, a noteholder, and who has a representative on the Company's Board of Directors (see Note 5), for whom the Company provides hardware, software, clinical services and market development services in support of the customer's clinical trials, and from whom the Company earns a quarterly fee, accounted for 19% and 17% of total sales in the three-month periods ended March 31, 2022 and 2021, respectively. Prior to granting credit, the Company performs credit evaluations of its customers’ financial condition, and generally does not require collateral from its customers. The Company will provide an allowance for doubtful accounts when collections become doubtful. The allowance for doubtful accounts at March 31, 2022 and December 31, 2021 was $0.2 million and $0.3 million, respectively. The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results. Adoption of New Accounting Standard Effective January 1, 2021, the Company adopted, on a modified retrospective method of transition, the provisions of Accounting Standards Update No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) – Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (the “ASU”). The ASU is effective for public companies, other than smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, and for smaller reporting companies, which is the Company’s current classification, for fiscal years beginning after December 31, 2023. However, the ASU permits early adoption no earlier than for fiscal years beginning after December 31, |
Revenue Recognition
| Revenue Recognition | 3 Months Ended |
| Mar. 31, 2022 | |
| Revenue from Contract with Customer [Abstract] | |
| Revenue Recognition | 3. Revenue Recognition Revenue by Service Line Three Months Ended March 31, (in thousands) 2022 2021 Functional neurosurgery navigation and therapy Disposable products $ 1,863 $ 1,917 Services 375 — Subtotal – Functional neurosurgery navigation and therapy 2,238 1,917 Biologics and drug delivery Disposable products 850 914 Services 1,304 746 Subtotal – Biologics and drug delivery revenue 2,154 1,660 Capital equipment and software Systems and software products 450 331 Services 189 122 Subtotal – Capital equipment and software revenue 639 453 Total revenue $ 5,031 $ 4,030 Contract Balances • Contract assets – Substantially all the Company’s contracts with customers are based on customer-issued purchase orders for distinct products or services. Customers are billed upon delivery of such products or services, and the related contract assets comprise the accounts receivable balances included in the accompanying condensed consolidated balance sheets. • Contract liabilities – The Company generally bills and collects capital equipment and software-related service fees at the inception of the service agreements, which have terms ranging from one During the three months ended March 31, 2022, the Company recognized capital equipment and software-related service revenue of approximately $0.1 million, which was previously included in deferred revenue in the accompanying condensed consolidated balance sheet at December 31, 2021. The Company offers an upgraded version of its software at no additional charge to customers purchasing a three-year systems service agreement. The transaction prices of the software and the service agreement are determined through an allocation of the service agreement price based on the standalone prices of the software and the service agreements customarily charged by the Company. The transaction price of the software is recognized as revenue upon its installation and comprised less than $0.1 million of unbilled accounts receivable at March 31, 2022 and December 31, 2021. |
Inventory
| Inventory | 3 Months Ended |
| Mar. 31, 2022 | |
| Inventory Disclosure [Abstract] | |
| Inventory | 4. Inventory Inventory consists of the following as of March 31, 2022 and 2021: (in thousands) March 31, December 31, Raw materials and work in process $ 3,620 $ 2,718 Software licenses 210 210 Finished goods 1,902 2,010 Inventory, net, included in current assets 5,732 4,938 Software licenses – non-current 484 519 Total $ 6,216 $ 5,457 |
Notes Payable
| Notes Payable | 3 Months Ended |
| Mar. 31, 2022 | |
| Debt Disclosure [Abstract] | |
| Notes Payable | 5. Notes Payable As a result of the transactions described below, an aggregate principal amount of $10 million of the 2020 Secured Convertible Notes was outstanding at March 31, 2022. At the option of the holder, who is a customer and has a representative on the Company's Board of Directors, at any time prior to maturity, the principal amount may be convertible to the Company’s common stock at a conversion price of $6.00, subject to adjustments as set forth in the SPA and the note agreement. On January 29, 2020 (the “Closing Date”), the Company completed a financing transaction (the “2020 Financing Transaction”) with two investors (the "2020 Convertible Noteholders"), whereby the Company issued an aggregate principal amount of $17.5 million of First Closing Notes pursuant to the SPA, which, unless earlier converted or redeemed, mature on the fifth anniversary of the Closing Date and bear interest at a rate equal to the sum of (i) the greater of (a) the three (3)-month London Interbank Offered Rate (“LIBOR”) and (b) two percent (2%), plus (ii) a margin of 2% on the outstanding balance of the First Closing Notes, payable quarterly on the first business day of each calendar quarter. The First Closing Notes may be converted at a price of $6.00 per share, subject to certain adjustments set forth in the SPA, and may not be pre-paid without the consent of the noteholder, provided that the Company must offer to pre-pay such other noteholder on the same terms and conditions. In May 2021, one of the 2020 Convertible Noteholders (the “Converting Noteholder”) converted the entire $7.5 million principal amount of such Converting Noteholder’s First Closing Note, and related accrued interest, amounting to approximately $0.04 million, into 1,256,143 shares of the Company’s common stock. At the Closing Date, the SPA gave the Company the right, but not the obligation, to request at any time on or prior to January 11, 2022, that one of the 2020 Convertible Noteholders purchase an additional $5.0 million in aggregate principal amount of Second Closing Note and an additional $10.0 million in aggregate principal amount of Third Closing Note (as defined in the SPA; together, with the Second Closing Note, the “Additional Convertible Notes”), provided that such 2020 Convertible Noteholder has the right, but not the obligation, to purchase such notes. The Additional Convertible Notes would also mature on the fifth anniversary of the Closing Date. On December 29, 2020, the Company and the 2020 Convertible Noteholders entered into the Amendment to the SPA, the terms of which, among other provisions, provided for: (a) an increase in the principal amount of the Second Closing Note to $7.5 million; (b) a revision of the interest rate to be borne by the Second Closing Note to consist of: (i) cash interest of 2% per annum, payable quarterly; and (ii) payment-in-kind interest of 5% per annum, accruable quarterly as an addition to the unpaid principal balance of the Second Closing Note; and (c) an increase in the conversion price of the Second Closing Notes to $10.14 per share, subject to certain adjustments set forth in the SPA. Upon execution of the Amendment, the Company issued the Second Closing Note to one of the 2020 Convertible Noteholders. On November 3, 2021, the holder of the Second Closing Note converted the entire $7.5 million principal amount of such note, along with related accrued and payment in-kind interest aggregating $0.3 million, into 773,446 shares of the Company's common stock. The aggregate carrying amounts of the First Closing Notes in the accompanying March 31, 2022 and December 31, 2021 condensed consolidated balance sheets are presented net of financing costs, comprised of commissions and legal expenses, having an unamortized balance of $0.1 million and $0.2 million at those respective dates. Prior to the conversion of the First Closing Note, the aggregate carrying amount was presented net of a discount, comprised of a commitment fee paid to the Converting Noteholder, amounting to $0.2 million. Upon conversion of the related note, the discount was reversed, with a corresponding amount being recorded as a reduction of additional paid-in capital. The unamortized balances of the financing costs and the discount, during the period prior to the conversion of the related First Closing Note, were charged to interest expense over the respective terms of the First Closing Notes under the effective interest method. Upon issuance of the Second Closing Note, the carrying amount was presented net of a discount, amounting to approximately $3.1 million, which represented the value of the deemed beneficial conversion feature embedded in the Second Closing Note. A conversion feature is deemed to be beneficial when the conversion price, discussed above, is lower than the closing price per share of the Company’s common stock, which was $14.34 on the date of issuance of the Second Closing Note. As discussed in Note 2, effective January 1, 2021, the Company adopted the provisions of ASU 2020-06 which no longer required such beneficial conversion features to be separately accounted for, and as a result, the accompanying December 31, 2021 condensed consolidated balance sheet reflects the elimination of both the discount and a corresponding increase to additional paid-in capital. Under the terms of the SPA, as amended, the Company had the right, but not the obligation, to request a 2020 Convertible Noteholder to purchase the Third Closing Note, and the 2020 Convertible Noteholder had the right, but not the obligation, to purchase such note. As of January 11, 2022, the Company's right expired. The 2020 Secured Notes are secured by all the assets of the Company. An executive officer of one of the 2020 Convertible Noteholders is a member of the Company’s Board of Directors. Pursuant to the terms of the SPA and a Board Observer Agreement entered into by the other 2020 Convertible Noteholder and the Company, the other 2020 Convertible Noteholder appointed a representative to attend and observe meetings of the Company’s Board of Directors. On February 25, 2021, such 2020 Convertible Noteholder terminated the Board Observer Agreement, thus precluding its representative from attending future meetings of the Company’s Board of Directors. Scheduled Notes Payable Maturities Scheduled principal payments as of March 31, 2022 with respect to notes payable are summarized as follows: Year ending December 31, (in thousands) 2025 $ 10,000 Total scheduled principal payments 10,000 Less: Unamortized financing costs (149) Total 9,851 |
Leases
| Leases | 3 Months Ended |
| Mar. 31, 2022 | |
| Leases [Abstract] | |
| Leases | 6. Leases The Company leases space in Irvine, California that houses office space and a manufacturing facility under a non-cancellable lease. The lease term commenced on October 1, 2018 and expires in September 2023. The Company has the option to renew the lease for two additional periods of five years each. The Company also leases office space in Solana Beach, California that serves as its corporate headquarters and houses certain management and research and development personnel. The lease term commenced on December 15, 2020, is set to expire on December 31, 2026, and is renewable for an additional five-year period, at the Company’s option, provided that the Company’s landlord has entered into an extension of its lease for the office space that encompasses the Company’s office space for at least five years. Both leases are classified as operating leases in conformity with GAAP. The aggregate lease costs, included in general and administrative expense, were $0.1 million for each of the three months ended March 31, 2022 and 2021. |
Stockholders_ Equity
| Stockholders’ Equity | 3 Months Ended |
| Mar. 31, 2022 | |
| Equity [Abstract] | |
| Stockholders' Equity | 7. Stockholders’ Equity 2021 Public Offering On February 23, 2021, the Company completed a public offering of 2,127,660 shares of its common stock, composed of 1,850,140 shares of common stock initially offered at a public offering price of $23.50 per share and an additional 277,520 shares of common stock sold pursuant to the exercise of the underwriters’ option to purchase additional shares at the price of $22.09 per share. Net proceeds from the offering totaled approximately $46.8 million after deducting underwriting discounts and commissions, and other offering expenses paid by the Company. The underwriting agreement contains representations, warranties, agreements and indemnification obligations by the Company that are customary for this type of transaction. Share-Based Compensation Expense The Company records share-based compensation expense on a straight-line basis over the related vesting period and recognizes forfeitures as they occur. The following table sets forth share-based compensation expense included in selling, general and administrative expense in the condensed consolidated statements of operations: Three Months Ended March 31, (in thousands) 2022 2021 $899 $320 As of March 31, 2022, there was $0.9 million and $2.7 million of total unrecognized compensation expense related to stock options and restricted stock, respectively, which is expected to be recognized over a weighted-average period of 1.8 years and 2.1 years, respectively. Stock Option Activity Stock option activity under all of the Company’s Plans during the three months ended March 31, 2022 is summarized below: Stock Options Weighted-average Weighted-average Intrinsic Value (1) (in thousands) Outstanding at December 31, 2021 1,350,473 $ 10.10 Granted — — Exercised (1,000) $ 2.60 Forfeited or expired (24,933) $ 37.68 Outstanding at March 31, 2022 1,324,540 $ 9.59 6.25 $ 7,499 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. Restricted Stock Activity Restricted stock award ("RSA") activity for the three months ended March 31, 2022 is summarized below: Restricted Stock Award Weighted - Average Outstanding at December 31, 2021 380,105 $ 10.41 Granted 39,916 $ 8.63 Vested (10,089) $ 9.77 Forfeited or expired (10,000) $ 20.45 Outstanding at March 31, 2022 399,932 $ 9.79 ESPP On June 3, 2021, the Company’s stockholders adopted and approved the ClearPoint Neuro, Inc. Employee Stock Purchase Plan (the “ESPP”), which allows eligible employees to acquire shares of the Company’s common stock through payroll deductions at a discount to market price. A total of 400,000 shares of the Company’s common stock are available for issuance pursuant to the terms of the ESPP. During the year ended December 31, 2021, 22,918 shares were purchased at an average per share price of $9.78. As of March 31, 2022, 377,082 shares of common stock were available for issuance under the Purchase Plan. Warrants Warrants to purchase shares of the Company's common stock were issued in connection with financing transactions in 2015 and 2017, and are for a term of generally five years. These warrants contain net exercise provisions giving the holder the option of acquiring a number of shares having a value equal to the difference between the exercise price and the current stock price, in lieu of paying the exercise price to acquire the full number of stated shares. All of the warrants outstanding at March 31, 2022 will terminate in 2022 and 2023. Common stock warrant activity for the three months ended March 31, 2022 is as follows: Warrant Weighted-average Intrinsic Value (1) (in thousands) Outstanding at December 31, 2021 668,907 $ 2.97 Exercised (14,728) $ 2.20 Outstanding at March 31, 2022 654,179 $ 2.98 $ 5,071 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the warrant exercise price of in-the-money warrants. |
Basis of Presentation and Sum_2
| Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
| Mar. 31, 2022 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2021 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with generally accepted accounting principles in the U.S. (“GAAP”). The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2021 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three months ended March 31, 2022 may not be indicative of the results to be expected for the entire year or any future periods. |
| Inventory | Inventory Inventory is carried at the lower of cost (first-in, first-out method) or net realizable value. Items in inventory relate predominantly to the Company’s ClearPoint system. Software license inventory related to ClearPoint systems undergoing on-site customer evaluation is included in inventory in the accompanying condensed consolidated balance sheets. All other software license inventory is classified as a non-current asset. The Company periodically reviews its inventory for obsolete items and provides a reserve upon identification of potentially obsolete items. |
| Intangible Assets | Intangible Assets The Company is a party to certain license agreements that provide rights to the Company for the development and commercialization of products. Under the terms of those license agreements, the Company made payments to the licensors upon execution of the license agreements for access to the underlying technologies and will make future payments based on the achievement of regulatory and commercialization milestones as defined in the license agreements. In conformity with Accounting Standards Codification Section 350, “Intangibles – Goodwill and Other,” the Company amortizes its investment in the license rights described above over an expected useful life of five years. In addition, the Company periodically evaluates the recoverability of its investment in the license rights and records an impairment charge in the event such evaluation indicates that the Company’s investment is not likely to be recovered. |
| Revenue Recognition | Revenue Recognition The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of functional neurosurgery, navigation, therapy, and biologics and drug delivery disposable products; (2) product revenue resulting from the sale of ClearPoint capital equipment and software; (3) revenue resulting from the service, installation, training and shipping related to ClearPoint capital equipment and software; and (4) consultation revenue and clinical case support revenue in connection with customer-sponsored clinical trials. The Company recognizes revenue when control of the Company’s products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation customarily charged by the Company. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. Lines of Business; Timing of Revenue Recognition • Functional neurosurgery navigation product, biologics and drug delivery systems product, and therapy product sales: Revenue from the sale of functional neurosurgery navigation products (consisting of disposable products sold commercially and related to cases utilizing the Company’s ClearPoint system), biologics and drug delivery systems (consisting primarily of disposable products related to customer-sponsored clinical trials utilizing the ClearPoint system), and therapy products (consisting primarily of disposable laser-related products used in non-neurosurgical procedures), is generally based on customer purchase orders, the predominance of which require delivery within one week of the order having been placed, and are generally recognized at the point in time of shipping to the customer, which is the point at which legal title, and risks and rewards of ownership, transfer to the customer. For certain customers, legal title and risks and rewards of ownership transfer upon delivery to the customer as stated in their respective contracts. • Capital equipment and software sales ◦ Capital equipment and software sales preceded by evaluation periods: The predominance of capital equipment and software sales (consisting of integrated computer hardware and software that are integral components of the Company’s ClearPoint system) are preceded by customer evaluation periods. During these evaluation periods, installation of, and training of customer personnel on, the systems have been completed and the systems have been in operation. Accordingly, revenue from capital equipment and software sales following such evaluation periods is recognized at the point in time the Company is in receipt of an executed purchase agreement or purchase order. ◦ Capital equipment and software sales not preceded by evaluation periods: Revenue from sales of capital equipment and software not having been preceded by an evaluation period is recognized at the point in time that the equipment has been delivered to the customer. For both types of capital equipment and software sales described above, the Company’s determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment. • Functional neurosurgery navigation and therapy services: The Company recognizes revenue for such services at the point in time that the performance obligation has been satisfied. • Biologics and drug delivery services: ◦ Consultation Services: The Company recognizes consultation revenue at the point in time such services are performed. ◦ Clinical Service Access Fees: For contracts in which the Company receives a periodic fixed fee, irrespective of the number of cases attended by Company personnel or hours of services provided to the customer during such periods, revenue is recognized ratably over the period covered by such fees. A time-elapsed output method is used for such fees because the Company transfers control evenly by providing a stand-ready service. ◦ Clinical Service Procedure-Based Fees: The Company recognizes revenue at the point in time a case is attended by Company personnel. • Capital equipment-related services: ◦ Equipment service: Revenue from service of ClearPoint capital equipment and software previously sold to customers is based on agreements with terms ranging from one The Company may also enter into contracts with customers who own ClearPoint capital equipment, which bundle maintenance and support services and access to software and hardware upgrades made commercially available over the term of the contract, for a single contract price, typically paid on an annual basis. The Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation and recognizes the revenue ratably on a monthly basis. In line with equipment service, a time-elapsed output method is used as the Company is providing a stand-ready service. ◦ Installation, training and shipping: Consistent with the Company’s recognition of revenue for capital equipment and software sales as described above, fees for installation, training and shipping in connection with sales of capital equipment and software that have been preceded by customer evaluation periods are recognized as revenue at the point in time the Company is in receipt of an executed purchase order for the equipment and software. Installation, training and shipping fees related to capital equipment and software sales not having been preceded by an evaluation period are recognized as revenue at the point in time that the related services are performed. The Company operates in one industry segment, and the vast majority of its sales are to U.S.-based customers. Payment terms under contracts with customers generally are in a range of 30-60 days after the customers’ receipt of the Company’s invoices. The Company’s terms and conditions do not provide for a right of return unless for: (a) product defects; or (b) other conditions subject to the Company’s approval. See Note 3 for additional information regarding revenue recognition. |
| Net Loss Per Share | Net Loss Per Share The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which comprise the entire amount of the Company’s outstanding common stock options and warrants, as described in Note 7, and the potential conversion of the First Closing Note, as described in Note 5, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations. |
| Concentration Risks and Other Risks and Uncertainties | Concentration Risks and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company holds substantially all its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At March 31, 2022, the Company had approximately $44.0 million in bank balances that were in excess of the insured limits. At March 31, 2022, there were two customers (one of which is a related party as discussed below) whose accounts receivable balances represented 13% and 11% of accounts receivable at that date. At December 31, 2021, one customer accounted for 15% of accounts receivable at that date. One pharmaceutical customer, a related party who is a stockholder, a noteholder, and who has a representative on the Company's Board of Directors (see Note 5), for whom the Company provides hardware, software, clinical services and market development services in support of the customer's clinical trials, and from whom the Company earns a quarterly fee, accounted for 19% and 17% of total sales in the three-month periods ended March 31, 2022 and 2021, respectively. Prior to granting credit, the Company performs credit evaluations of its customers’ financial condition, and generally does not require collateral from its customers. The Company will provide an allowance for doubtful accounts when collections become doubtful. The allowance for doubtful accounts at March 31, 2022 and December 31, 2021 was $0.2 million and $0.3 million, respectively. The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results. |
| Adoption of New Accounting Standard | Adoption of New Accounting Standard Effective January 1, 2021, the Company adopted, on a modified retrospective method of transition, the provisions of Accounting Standards Update No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) – Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (the “ASU”). The ASU is effective for public companies, other than smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, and for smaller reporting companies, which is the Company’s current classification, for fiscal years beginning after December 31, 2023. However, the ASU permits early adoption no earlier than for fiscal years beginning after December 31, |
Revenue Recognition (Tables)
| Revenue Recognition (Tables) | 3 Months Ended |
| Mar. 31, 2022 | |
| Revenue from Contract with Customer [Abstract] | |
| Revenue from External Customers by Products and Services | Three Months Ended March 31, (in thousands) 2022 2021 Functional neurosurgery navigation and therapy Disposable products $ 1,863 $ 1,917 Services 375 — Subtotal – Functional neurosurgery navigation and therapy 2,238 1,917 Biologics and drug delivery Disposable products 850 914 Services 1,304 746 Subtotal – Biologics and drug delivery revenue 2,154 1,660 Capital equipment and software Systems and software products 450 331 Services 189 122 Subtotal – Capital equipment and software revenue 639 453 Total revenue $ 5,031 $ 4,030 |
Inventory (Tables)
| Inventory (Tables) | 3 Months Ended |
| Mar. 31, 2022 | |
| Inventory Disclosure [Abstract] | |
| Schedule of Inventory | Inventory consists of the following as of March 31, 2022 and 2021: (in thousands) March 31, December 31, Raw materials and work in process $ 3,620 $ 2,718 Software licenses 210 210 Finished goods 1,902 2,010 Inventory, net, included in current assets 5,732 4,938 Software licenses – non-current 484 519 Total $ 6,216 $ 5,457 |
Notes Payable (Tables)
| Notes Payable (Tables) | 3 Months Ended |
| Mar. 31, 2022 | |
| Debt Disclosure [Abstract] | |
| Schedule of Notes Payable | Scheduled principal payments as of March 31, 2022 with respect to notes payable are summarized as follows: Year ending December 31, (in thousands) 2025 $ 10,000 Total scheduled principal payments 10,000 Less: Unamortized financing costs (149) Total 9,851 |
Stockholders_ Equity (Tables)
| Stockholders’ Equity (Tables) | 3 Months Ended |
| Mar. 31, 2022 | |
| Equity [Abstract] | |
| Share-Based Compensation Expense | Share-Based Compensation Expense The Company records share-based compensation expense on a straight-line basis over the related vesting period and recognizes forfeitures as they occur. The following table sets forth share-based compensation expense included in selling, general and administrative expense in the condensed consolidated statements of operations: Three Months Ended March 31, (in thousands) 2022 2021 $899 $320 |
| Schedule of Stock Option Activity | Stock option activity under all of the Company’s Plans during the three months ended March 31, 2022 is summarized below: Stock Options Weighted-average Weighted-average Intrinsic Value (1) (in thousands) Outstanding at December 31, 2021 1,350,473 $ 10.10 Granted — — Exercised (1,000) $ 2.60 Forfeited or expired (24,933) $ 37.68 Outstanding at March 31, 2022 1,324,540 $ 9.59 6.25 $ 7,499 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. |
| Schedule of Restricted Stock Awards Activity | Restricted Stock Activity Restricted stock award ("RSA") activity for the three months ended March 31, 2022 is summarized below: Restricted Stock Award Weighted - Average Outstanding at December 31, 2021 380,105 $ 10.41 Granted 39,916 $ 8.63 Vested (10,089) $ 9.77 Forfeited or expired (10,000) $ 20.45 Outstanding at March 31, 2022 399,932 $ 9.79 |
| Schedule of Common Stock Warrant Activity | Common stock warrant activity for the three months ended March 31, 2022 is as follows: Warrant Weighted-average Intrinsic Value (1) (in thousands) Outstanding at December 31, 2021 668,907 $ 2.97 Exercised (14,728) $ 2.20 Outstanding at March 31, 2022 654,179 $ 2.98 $ 5,071 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the warrant exercise price of in-the-money warrants. |
Description of the Business a_2
| Description of the Business and Financial Condition (Details) $ in Thousands | Feb. 23, 2021USD ($)shares | Dec. 29, 2020USD ($) | Jan. 31, 2020USD ($) | Mar. 31, 2022USD ($)company | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) |
| Number of pharmaceutical companies | company | 45 | |||||
| Cumulative net loss | $ 137,891 | $ 133,932 | ||||
| Net cash used in operations | 4,269 | $ 2,131 | 12,700 | |||
| Secured convertible notes | 9,851 | $ 9,838 | ||||
| Public offering (in shares) | shares | 2,127,660 | |||||
| Net proceeds from offering | $ 46,800 | $ 0 | $ 46,785 | |||
| Security Purchase Agreement | 2020 Convertible Noteholders | ||||||
| Secured convertible notes | $ 17,500 | |||||
| Term of secured notes | 5 years | |||||
| Security Purchase Agreement | 2020 Convertible Noteholders | One 2020 Convertible Noteholder | ||||||
| Proceeds from debt, net of issuance costs | $ 16,800 | |||||
| Security Purchase Agreement | Second Closing Note | One 2020 Convertible Noteholder | ||||||
| Increase in secured convertible notes | $ 7,500 | |||||
| Security Purchase Agreement | 2020 Secured Notes | One 2020 Convertible Noteholder | ||||||
| Additional rights, principal amount | $ 5,000 |
Basis of Presentation and Sum_3
| Basis of Presentation and Summary of Significant Accounting Policies (Details) $ in Millions | 3 Months Ended | 12 Months Ended | |
| Mar. 31, 2022USD ($)segment | Mar. 31, 2021 | Dec. 31, 2021USD ($) | |
| Product Information [Line Items] | |||
| Number of operating segments | segment | 1 | ||
| Cash, uninsured amount | $ 44 | ||
| Allowance for doubtful accounts | $ 0.2 | $ 0.3 | |
| Adjustments to additional paid in capital, convertible debt | $ 3.1 | ||
| Accounts Receivable | Customer Concentration Risk | Customer 1 | |||
| Product Information [Line Items] | |||
| Concentration risk, percentage | 13.00% | ||
| Accounts Receivable | Customer Concentration Risk | Customer 2 | |||
| Product Information [Line Items] | |||
| Concentration risk, percentage | 11.00% | ||
| Accounts Receivable | Customer Concentration Risk | One Customer | |||
| Product Information [Line Items] | |||
| Concentration risk, percentage | 15.00% | ||
| Revenue Benchmark | Customer Concentration Risk | Investor | |||
| Product Information [Line Items] | |||
| Concentration risk, percentage | 19.00% | 17.00% | |
| Minimum | |||
| Product Information [Line Items] | |||
| Estimated useful life (in years) | 5 years | ||
| Term of service agreements (in years) | 1 year | ||
| Payment terms (in days) | 30 days | ||
| Maximum | |||
| Product Information [Line Items] | |||
| Term of service agreements (in years) | 3 years | ||
| Payment terms (in days) | 60 days | ||
Revenue Recognition - Schedule
| Revenue Recognition - Schedule of Revenue Recognition (Details) - USD ($) $ in Thousands | 3 Months Ended | |
| Mar. 31, 2022 | Mar. 31, 2021 | |
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | $ 5,031 | $ 4,030 |
| Functional Neurosurgery Navigation and Therapy - Disposable Products | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 1,863 | 1,917 |
| Functional Neurosurgery Navigation and Therapy - Services | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 375 | 0 |
| Functional Neurosurgery Navigation and Therapy | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 2,238 | 1,917 |
| Biologics and Drug Delivery - Disposable Products | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 850 | 914 |
| Biologics and Drug Delivery - Services | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 1,304 | 746 |
| Biologics and Drug Delivery | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 2,154 | 1,660 |
| Capital Equipment and Software - Systems and Software Products | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 450 | 331 |
| Capital Equipment and Software - Services | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | 189 | 122 |
| Capital Equipment and Software | ||
| Disaggregation of Revenue [Line Items] | ||
| Total revenue | $ 639 | $ 453 |
Revenue Recognition - Narrative
| Revenue Recognition - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
| Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
| Disaggregation of Revenue [Line Items] | |||
| Total revenue | $ 5,031 | $ 4,030 | |
| Unbilled contracts receivable | $ 100 | $ 100 | |
| Minimum | |||
| Disaggregation of Revenue [Line Items] | |||
| Contract liabilities, service agreements, terms (in years) | 1 year | ||
| Maximum | |||
| Disaggregation of Revenue [Line Items] | |||
| Contract liabilities, service agreements, terms (in years) | 3 years | ||
| Capital Equipment Related Service Revenue | |||
| Disaggregation of Revenue [Line Items] | |||
| Total revenue | $ 100 | ||
| Remaining Performance Obligations Capital Equipment-Related Service Revenue | |||
| Disaggregation of Revenue [Line Items] | |||
| Revenue, remaining performance obligation amount | $ 900 | ||
| Capital Equipment and Software-Related Service | |||
| Disaggregation of Revenue [Line Items] | |||
| Revenue, remaining performance obligation, percentage | 54.00% | ||
Inventory - Schedule of Invento
| Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
| Inventory Disclosure [Abstract] | ||
| Raw materials and work in process | $ 3,620 | $ 2,718 |
| Software licenses | 210 | 210 |
| Finished goods | 1,902 | 2,010 |
| Inventory, net, included in current assets | 5,732 | 4,938 |
| Software licenses – non-current | 484 | 519 |
| Total | $ 6,216 | $ 5,457 |
Notes Payable - Narratives (Det
| Notes Payable - Narratives (Details) $ / shares in Units, $ in Thousands | Nov. 03, 2021USD ($)$ / sharesshares | Jan. 29, 2020USD ($)$ / shares | May 31, 2021USD ($)shares | Mar. 31, 2022USD ($)$ / shares | Dec. 31, 2021USD ($) | Dec. 29, 2020USD ($)$ / shares |
| Debt Instrument [Line Items] | ||||||
| Secured convertible notes | $ 9,851 | $ 9,838 | ||||
| Security Purchase Agreement | First Closing Notes | ||||||
| Debt Instrument [Line Items] | ||||||
| Debt related commitment fees and debt issuance costs | $ 200 | |||||
| Security Purchase Agreement | First Closing Notes | Convertible Debt | ||||||
| Debt Instrument [Line Items] | ||||||
| Secured convertible notes | 100 | $ 200 | ||||
| Debt instrument, conversion price (in usd per share) | $ / shares | $ 6 | |||||
| Debt instrument, conversion amount | $ 7,500 | |||||
| Debt conversion, shares issued (in shares) | shares | 1,256,143 | |||||
| Debt instrument, face amount | $ 17,500 | |||||
| Accrued Interest Included in the Conversion of Debt | $ 40 | |||||
| Debt Instrument, Basis Spread on Variable Rate | 2.00% | |||||
| Debt Instrument, Variable Interest Rate | 0.02 | |||||
| Security Purchase Agreement | Second Closing Note | Convertible Debt | ||||||
| Debt Instrument [Line Items] | ||||||
| Secured convertible notes | $ 3,100 | |||||
| Debt conversion, shares issued (in shares) | shares | 773,446,000 | |||||
| Additional rights, principal amount | $ 5,000 | |||||
| Amount of accrued and paid-in-kind interest included in converted debt | $ 300 | |||||
| Share price (in usd per share) | $ / shares | $ 14.34 | |||||
| Security Purchase Agreement | Third Closing Note | Convertible Debt | ||||||
| Debt Instrument [Line Items] | ||||||
| Additional rights, principal amount | $ 10,000 | |||||
| Security Purchase Agreement | Investor | 2020 Convertible Notes | Convertible Debt | ||||||
| Debt Instrument [Line Items] | ||||||
| Secured convertible notes | $ 10,000 | |||||
| Debt instrument, conversion price (in usd per share) | $ / shares | $ 6 | |||||
| Security Purchase Agreement Amended | Second Closing Note | Convertible Debt | ||||||
| Debt Instrument [Line Items] | ||||||
| Debt instrument, conversion price (in usd per share) | $ / shares | $ 10.14 | |||||
| Debt instrument, face amount | $ 7,500 | $ 7,500 | ||||
| Cash interest rate | 2.00% | |||||
| Payment in-kind interest rate | 5.00% |
Notes Payable - Maturities Of N
| Notes Payable - Maturities Of Notes Payable (Details) $ in Thousands | Mar. 31, 2022USD ($) |
| Debt Disclosure [Abstract] | |
| 2025 | $ 10,000 |
| Total scheduled principal payments | 10,000 |
| Less: Unamortized financing costs | (149) |
| Total | $ 9,851 |
Leases (Details)
| Leases (Details) - USD ($) $ in Millions | 3 Months Ended | |
| Mar. 31, 2022 | Mar. 31, 2021 | |
| Lessee, Lease, Description [Line Items] | ||
| Lease cost | $ 0.1 | $ 0.1 |
| Office Lease - Irvine, California | ||
| Lessee, Lease, Description [Line Items] | ||
| Renew the lease for two additional periods | 5 years | |
| Lessee, operating lease, term of contract | 5 years | |
| Office Lease - Solana Beach, California | ||
| Lessee, Lease, Description [Line Items] | ||
| Renew the lease for two additional periods | 5 years | |
| Lessee, operating lease, term of contract | 5 years | |
Stockholders_ Equity - Narrativ
| Stockholders’ Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 23, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Jun. 03, 2021 |
| Subsidiary, Sale of Stock [Line Items] | |||||
| Public offering (in shares) | 2,127,660 | ||||
| Proceeds from public offering of common stock, net of offering costs | $ 46,800 | $ 0 | $ 46,785 | ||
| Unrecognized compensation expense | $ 900 | ||||
| Weighted average period (in years) | 1 year 9 months 18 days | ||||
| Purchase plan, shares purchased (in shares) | 22,918 | ||||
| Warrants, terms (in years) | 5 years | ||||
| Restricted Stock | |||||
| Subsidiary, Sale of Stock [Line Items] | |||||
| Unrecognized compensation expense | $ 2,700 | ||||
| Weighted average period (in years) | 2 years 1 month 6 days | ||||
| Employee Stock Purchase Plan | |||||
| Subsidiary, Sale of Stock [Line Items] | |||||
| Grant (in shares) | 377,082 | 400,000 | |||
| Purchase plan, per share weighted average price of shares purchased (in dollars per share) | $ 9.78 | ||||
| IPO | |||||
| Subsidiary, Sale of Stock [Line Items] | |||||
| Public offering (in shares) | 2,127,660 | ||||
| Common stock initially offered at public offering (in shares) | 1,850,140 | ||||
| Sale of stock, price per share (in dollars per share) | $ 23.50 | ||||
| Shares sold pursuant to exercise of underwriters option (in shares) | 277,520 | ||||
| Price per share for underwriters option to purchase (in dollars per share) | $ 22.09 | ||||
| Proceeds from public offering of common stock, net of offering costs | $ 46,800 |
Stockholders' Equity - Summary
| Stockholders' Equity - Summary of Share Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
| Mar. 31, 2022 | Mar. 31, 2021 | |
| Equity [Abstract] | ||
| Share-based compensation expense | $ 899 | $ 320 |
Stockholders_ Equity - Schedule
| Stockholders’ Equity - Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
| Mar. 31, 2022USD ($)$ / sharesshares | |
| Stock Options | |
| Outstanding, beginning balance (in shares) | shares | 1,350,473 |
| Granted (in shares) | shares | 0 |
| Exercised (in shares) | shares | (1,000) |
| Forfeited or expired (in shares) | shares | (24,933) |
| Outstanding, ending balance (in shares) | shares | 1,324,540 |
| Weighted-average Exercise price per share | |
| Outstanding, beginning balance (in dollars per share) | $ / shares | $ 10.10 |
| Granted (in dollars per share) | $ / shares | 0 |
| Exercised (in dollars per share) | $ / shares | 2.60 |
| Forfeited or expired (in dollars per share) | $ / shares | 37.68 |
| Outstanding, ending balance (in dollars per share) | $ / shares | $ 9.59 |
| Weighted-average Remaining Contractual Life (in years) and Intrinsic Value | |
| Outstanding, at ending (in years) | 6 years 3 months |
| Intrinsic value | $ | $ 7,499 |
Stockholders_ Equity - Schedu_2
| Stockholders’ Equity - Schedule of Restricted Stock Award Activity (Details) - Restricted Stock - $ / shares | 3 Months Ended | |
| Mar. 31, 2022 | Dec. 31, 2021 | |
| Restricted Stock Award | ||
| Outstanding, beginning balance (in shares) | 399,932 | 380,105 |
| Granted (in shares) | 39,916 | |
| Vested (in shares) | (10,089) | |
| Forfeited or expired (in shares) | (10,000) | |
| Outstanding, ending balance (in shares) | 399,932 | |
| Weighted - Average Grant Date Fair Value | ||
| Outstanding, beginning balance (in dollars per share) | $ 10.41 | |
| Granted (in dollars per share) | 8.63 | |
| Vested (in dollars per share) | 9.77 | |
| Forfeited or expired (in dollars per share) | 20.45 | |
| Outstanding, ending balance (in dollars per share) | $ 9.79 |
Stockholders_ Equity - Schedu_3
| Stockholders’ Equity - Schedule of Common Stock Warrant Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
| Mar. 31, 2022USD ($)$ / sharesshares | |
| Weighted-average Exercise price per share | |
| Beginning balance (in dollars per share) | $ / shares | $ 2.97 |
| Exercised (in dollars per share) | $ / shares | 2.20 |
| Ending balance (in dollars per share) | $ / shares | $ 2.98 |
| Intrinsic Value | |
| Outstanding, intrinsic value | $ | $ 5,071 |
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
| ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsOutstandingWeightedAverageExercisePrice | $ / shares | $ 2.98 |
| ShareBasedCompensationArrangementsByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsExercisedWeightedAverageExercisePrice | $ / shares | $ 2.20 |
| Outstanding, intrinsic value | $ | $ 5,071 |
| Common Stock Warrants | |
| Restricted Stock Award | |
| Outstanding, beginning balance (in shares) | shares | 668,907 |
| Exercised (in shares) | shares | (14,728) |
| Outstanding, ending balance (in shares) | shares | 654,179 |
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
| Outstanding, beginning balance (in shares) | shares | 654,179 |
| Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | shares | 14,728 |