Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 09, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | Ra Medical Systems, Inc. | |
Entity Central Index Key | 0001716621 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2021 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | RMED | |
Security Exchange Name | NYSEAMER | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 7,029,438 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Emerging Growth Company | true | |
Entity Small Business | true | |
Entity Ex Transition Period | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-38677 | |
Entity Tax Identification Number | 38-3661826 | |
Entity Address, Address Line One | 2070 Las Palmas Drive | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92011 | |
City Area Code | 760 | |
Local Phone Number | 804-1648 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 20,220 | $ 23,906 |
Accounts receivable, net | 228 | 238 |
Inventories | 2,323 | 2,218 |
Prepaid expenses and other current assets | 1,306 | 1,258 |
Total current assets | 24,077 | 27,620 |
Property and equipment, net | 2,661 | 3,211 |
Operating lease right-of-use-assets | 2,300 | 2,484 |
Other non-current assets | 121 | 123 |
TOTAL ASSETS | 29,159 | 33,438 |
Current Liabilities | ||
Accounts payable | 1,077 | 571 |
Accrued expenses | 2,021 | 4,348 |
Current portion of deferred revenue | 1,787 | 1,801 |
Current portion of equipment financing | 265 | |
Current portion of promissory note | 421 | |
Current portion of operating lease liabilities | 320 | 356 |
Total current liabilities | 5,205 | 7,762 |
Deferred revenue | 566 | 686 |
Promissory note | 1,579 | |
Operating lease liabilities | 2,125 | 2,264 |
Total liabilities | 7,896 | 12,291 |
Commitments and contingencies (Note 13) | ||
Stockholders’ Equity | ||
Preferred stock, $0.0001 par value, 10,000,000 authorized; none issued | ||
Common stock, $0.0001 par value, 300,000,000 shares authorized; 5,902,612 and 3,188,679 issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 7 | 7 |
Additional paid-in capital | 186,943 | 174,342 |
Accumulated deficit | (165,687) | (153,202) |
Total stockholders’ equity | 21,263 | 21,147 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 29,159 | $ 33,438 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 5,902,612 | 3,188,679 |
Common stock, shares outstanding | 5,902,612 | 3,188,679 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Net revenue | ||||
Total net revenue | $ 1,005 | $ 900 | $ 2,123 | $ 2,274 |
Cost of revenue | ||||
Total cost of revenue | 1,488 | 1,167 | 2,861 | 2,751 |
Gross loss | (483) | (267) | (738) | (477) |
Operating expenses | ||||
Selling, general and administrative | 3,741 | 7,896 | 7,855 | 14,181 |
Research and development | 3,018 | 1,953 | 5,834 | 3,248 |
Total operating expenses | 6,759 | 9,849 | 13,689 | 17,429 |
Operating loss | (7,242) | (10,116) | (14,427) | (17,906) |
Other income (expense), net | ||||
Gain on extinguishment of debt | 2,023 | 2,023 | ||
Interest income | 1 | 10 | 2 | 124 |
Interest expense | (31) | (15) | (83) | (40) |
Total other income (expense), net | 1,993 | (5) | 1,942 | 84 |
Loss before income tax expense | (5,249) | (10,121) | (12,485) | (17,822) |
Net loss | $ (5,249) | $ (10,121) | $ (12,485) | $ (17,822) |
Basic and diluted net loss per share | $ (1.28) | $ (10.71) | $ (3.56) | $ (23.83) |
Basic and diluted weighted average common shares outstanding | 4,089 | 945 | 3,506 | 748 |
Product Sales [Member] | ||||
Net revenue | ||||
Total net revenue | $ 318 | $ 154 | $ 724 | $ 740 |
Cost of revenue | ||||
Total cost of revenue | 861 | 624 | 1,651 | 1,588 |
Service and Other [Member] | ||||
Net revenue | ||||
Total net revenue | 687 | 746 | 1,399 | 1,534 |
Cost of revenue | ||||
Total cost of revenue | $ 627 | $ 543 | $ 1,210 | $ 1,163 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (5,249) | $ (10,121) | $ (12,485) | $ (17,822) |
Other comprehensive loss: | ||||
Unrealized losses related to short-term investments | (4) | (26) | ||
Total other comprehensive loss | (4) | (26) | ||
Comprehensive loss | $ (5,249) | $ (10,125) | $ (12,485) | $ (17,848) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||
Net loss | $ (12,485) | $ (17,822) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Gain on extinguishment of debt (promissory note) | $ (2,023) | (2,023) | ||
Depreciation and amortization | 881 | 1,214 | ||
Provision for doubtful accounts | 25 | |||
Stock-based compensation | 1,865 | 2,080 | ||
Gain on sale of property and equipment | (493) | |||
Changes in operating assets and liabilities: | ||||
Accounts receivable | 10 | 287 | ||
Inventories | (108) | 33 | ||
Prepaid expenses and other assets | (46) | 650 | ||
Accounts payable | 368 | 107 | ||
Accrued expenses | (2,359) | 1,295 | ||
Deferred revenue | (134) | (556) | ||
Other liabilities | (175) | (156) | ||
Net cash used in operating activities | (14,699) | (12,843) | $ (28,300) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||
Proceeds from maturities of available-for-sale securities | 16,000 | |||
Proceeds from sale of property and equipment | 534 | |||
Purchases of property and equipment | (76) | (49) | ||
Net cash provided by investing activities | 458 | 15,951 | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||
Proceeds from issuance of common stock and warrants, net of placement agent fees of $351 and $1,008, respectively | 11,022 | 8,992 | ||
Proceeds from issuance of common stock in connection with the exercise of warrants | 827 | |||
Proceeds from issuance of common stock in connection with the employee stock purchase plan | 26 | 27 | ||
Proceeds from PPP promissory note | 2,000 | |||
Payments on equipment financing | (265) | (145) | ||
Payments of offering costs related to the issuance of common stock and warrants | (228) | (13) | ||
Net cash provided by financing activities | 10,555 | 11,688 | ||
NET CHANGE IN CASH AND CASH EQUIVALENTS | (3,686) | 14,796 | ||
CASH AND CASH EQUIVALENTS, beginning of period | 23,906 | 14,584 | 14,584 | |
CASH AND CASH EQUIVALENTS, end of period | 20,220 | 20,220 | 29,380 | $ 23,906 |
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||
Unpaid offering costs | $ 84 | 84 | 231 | |
Transfer from inventories to property and equipment for lasers | 3 | 40 | ||
Unpaid property and equipment | 109 | |||
SUPPLEMENTAL CASH FLOW INFORMATION: | ||||
Cash payments for interest | 2 | $ 16 | ||
Cash payments for taxes | 2 | |||
Promissory Note | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Gain on extinguishment of debt (promissory note) | $ (2,023) |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Statement Of Cash Flows [Abstract] | ||
Common stock and warrants, net of placement agent fees | $ 351 | $ 1,008 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Accumulated DeficitCumulative Effect, Period of Adoption, Adjustment |
Balances at Dec. 31, 2019 | $ 33,150 | $ 1 | $ 150,280 | $ 26 | $ (117,157) | ||
Balance (in shares) at Dec. 31, 2019 | 551,000 | ||||||
Common stock issued (in shares) | 5,000 | ||||||
Stock-based compensation | 1,047 | 1,047 | |||||
Other comprehensive Income (loss) | (22) | (22) | |||||
Net loss | (7,701) | (7,701) | |||||
Balances at Mar. 31, 2020 | 26,474 | $ 1 | 151,327 | 4 | (124,858) | ||
Balance (in shares) at Mar. 31, 2020 | 556,000 | ||||||
Balances at Dec. 31, 2019 | 33,150 | $ 1 | 150,280 | 26 | (117,157) | ||
Balance (in shares) at Dec. 31, 2019 | 551,000 | ||||||
Other comprehensive Income (loss) | (26) | ||||||
Net loss | (17,822) | ||||||
Balances at Jun. 30, 2020 | 26,984 | $ 4 | 161,959 | (134,979) | |||
Balance (in shares) at Jun. 30, 2020 | 1,527,000 | ||||||
Balances at Mar. 31, 2020 | 26,474 | $ 1 | 151,327 | 4 | (124,858) | ||
Balance (in shares) at Mar. 31, 2020 | 556,000 | ||||||
Common stock issued, net | 5,284 | $ 2 | 5,282 | ||||
Common stock issued (in shares) | 889,000 | ||||||
Warrants issued, net | 3,464 | 3,464 | |||||
Exercise of warrants | 827 | $ 1 | 826 | ||||
Exercise of warrants (in shares) | 73,000 | ||||||
Common stock issued pursuant to the vesting of restricted stock units and ESPP | 27 | 27 | |||||
Common stock issued pursuant to the vesting of restricted stock units and ESPP (in shares) | 9,000 | ||||||
Stock-based compensation | 1,033 | 1,033 | |||||
Other comprehensive Income (loss) | (4) | $ (4) | |||||
Net loss | (10,121) | (10,121) | |||||
Balances at Jun. 30, 2020 | 26,984 | $ 4 | 161,959 | (134,979) | |||
Balance (in shares) at Jun. 30, 2020 | 1,527,000 | ||||||
Balances at Dec. 31, 2020 | 21,147 | $ 7 | 174,342 | (153,202) | |||
Balance (in shares) at Dec. 31, 2020 | 3,189,000 | ||||||
Common stock issued, net | 65 | 65 | |||||
Common stock issued (in shares) | 35 | ||||||
Accounting Standards Update [Extensible List] | us-gaap:AccountingStandardsUpdate201807Member | us-gaap:AccountingStandardsUpdate201807Member | |||||
Stock-based compensation | 1,169 | 1,169 | |||||
Stock-based compensation (In shares) | 35 | ||||||
Net loss | (7,236) | (7,236) | |||||
Balances at Mar. 31, 2021 | 15,145 | $ 7 | 175,576 | (160,438) | |||
Balance (in shares) at Mar. 31, 2021 | 3,259,000 | ||||||
Balances at Dec. 31, 2020 | 21,147 | $ 7 | 174,342 | (153,202) | |||
Balance (in shares) at Dec. 31, 2020 | 3,189,000 | ||||||
Net loss | (12,485) | ||||||
Balances at Jun. 30, 2021 | 21,263 | $ 7 | 186,943 | (165,687) | |||
Balance (in shares) at Jun. 30, 2021 | 5,903,000 | ||||||
Balances at Mar. 31, 2021 | 15,145 | $ 7 | 175,576 | (160,438) | |||
Balance (in shares) at Mar. 31, 2021 | 3,259,000 | ||||||
Common stock issued, net | 10,645 | 10,645 | |||||
Common stock issued (in shares) | 2,582 | ||||||
Common stock issued pursuant to the vesting of restricted stock units and ESPP | 26 | 26 | |||||
Common stock issued pursuant to the vesting of restricted stock units and ESPP (in shares) | 6 | ||||||
Stock-based compensation | 696 | 696 | |||||
Stock-based compensation (In shares) | 56 | ||||||
Net loss | (5,249) | (5,249) | |||||
Balances at Jun. 30, 2021 | $ 21,263 | $ 7 | $ 186,943 | $ (165,687) | |||
Balance (in shares) at Jun. 30, 2021 | 5,903,000 |
Organization and Nature of Oper
Organization and Nature of Operations | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Nature of Operations | Note 1—Organization and Nature of Operations Ra Medical Systems, Inc. (the “Company”) was formed on September 4, 2002, in the state of California and reincorporated in Delaware on July 14, 2018. The Company is a medical device company that develops and manufactures advanced excimer laser systems for use in the treatment of vascular and dermatological diseases. The Company’s product development centers around proprietary applications of its advanced excimer laser technology for use as a tool in the treatment of peripheral artery disease (“PAD”) and psoriasis, vitiligo, atopic dermatitis and leukoderma. Reverse Stock Split — On November 16, 2020, the Company filed a certificate of amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a reverse stock split of the Company’s common stock at a ratio of one-for-twenty-five (“Reverse Stock Split”). The Reverse Stock Split became effective as of 4:01 p.m. Eastern time on November 16, 2020, and the Company’s common stock began trading on the New York Stock Exchange (“NYSE”) on a post-split basis on November 17, 2020. Unless otherwise noted, all share and per share numbers contained in these financial statements are reflected on a post-split basis. COVID-19 — The global spread of the novel coronavirus (COVID-19) has created significant volatility, uncertainty and economic disruption. The ultimate effects of the COVID-19 on the Company’s business, operations and financial condition are unknown at this time. In the near term, the Company expects that its revenue will continue to be adversely impacted and enrollment in its atherectomy clinical trial will continue to be delayed or slowed, as patients elect to postpone voluntary treatments and many physicians’ offices have been either closed or operating at a reduced capacity. In addition, some customers are requesting more flexible payment terms on a temporary basis. The Company’s manufacturing facility located in Carlsbad, California is currently operational. The Company has experienced delays in receiving shipments of certain parts, which has affected the timing of its key engineering efforts. To date, the delays have not materially impacted the Company’s ability to support its atherectomy indication clinical trial. However, the extent to which COVID-19 impacts its business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain it or treat its impact, among others. Going Concern —The Company has experienced recurring net losses from operations and negative cash flows from operating activities, has a significant accumulated deficit and expects to continue to incur net losses into the foreseeable future. The Company had an accumulated deficit of $165.7 million at June 30, 2021. For the year ended December 31, 2020 the Company used $28.3 million in cash for operating activities. As of June 30, 2021, the Company had cash and cash equivalents of $20.2 million. Management expects operating losses and negative cash flows to continue for the foreseeable future with the Company’s reduced commercial footprint, and as the Company continues to incur costs related to its atherectomy clinical trial, engineering efforts to improve the shelf life of its catheters and develop next generation products and legal costs associated with ongoing litigation. In September 2020, the Company paused commercial sales of DABRA catheters not being used for the atherectomy clinical trial while it conducted further studies on the stability of its shelf life. The Company submitted additional test data with respect to the DABRA catheter shelf life in March 2021, which was cleared by the FDA in July 2021. Although eligible, the Company has not resumed commercial shipments and is evaluating its commercial catheter strategy. The Company also expects the COVID-19 pandemic to have a continued negative impact on its revenue and the timing of enrollment in its atherectomy clinical trial as well as the Company’s ability to secure additional financing in a timely manner or on favorable terms, if at all. Management believes that based on the Company’s liquidity resources, there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. Although the Company bolstered its liquidity resources in 2020 and 2021, it has an effective shelf registration statement and an “at the market” offering to allow it to raise additional capital when the opportunities permit and may receive additional funds from the exercise of its warrants depending on market conditions, management concluded that the aforementioned conditions, including the ongoing uncertainty related to the negative impacts of the COVID-19 pandemic, continue to raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of the financial statements. Management plans to address this uncertainty by raising additional funds, if necessary, through public or private equity or debt financings as well as by engaging in regular and ongoing reviews of our business model and strategic options to help ensure that the Company is focusing its cash resources on advancing its key corporate initiatives. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders. The financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2—Significant Accounting Policies Interim condensed financial information —The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and reflect all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed balance sheets, results of operations, cash flows and statements of stockholders’ equity for the periods presented. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The balance sheet as of December 31, 2020 included herein was derived from the audited financial statements as of that date. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2021. Use of estimates —The financial statements of the Company have been prepared by management in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and reported disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. The Company’s financial statements are based upon a number of estimates, including but not limited to, allowance for doubtful accounts, evaluation of impairment of assets, reserves for warranty costs including product recalls, evaluation of probable loss contingencies, fair value of stock option awards granted and revenue recognition for multiple performance obligations. Fair value measurements — Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier value hierarchy is used to identify inputs used in measuring fair value as follows: Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets. Level 2—Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. The Company measures its cash and cash equivalents and short-term investments at fair value. Inventories —Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. Cost includes materials, labor and manufacturing overhead related to the purchase and production of inventories. The Company reduces the carrying value of inventories for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technological developments or other economic factors. Catheters are manufactured in-house and each catheter is tested at various stages of the manufacturing process for adherence to quality standards. Catheters that do not meet functionality specification at each test point are destroyed and immediately written off, with the expense recorded in cost of revenue in the statement s of operations. Once manufactured, completed catheters that pass quality assurance, are sent to a third-party for sterilization and sealed in a sterile container. Upon return from the third-party sterilizer, a sample of catheters from each batch are re-tested. If the sample tests are successful, the batch is accepted into finished goods inventory and if the sample tests are unsuccessful, the entire batch is written off, with the expense recorded in cost of revenue in the statement s of operations. Revenue —The Company generates revenue from the sale of products and services. Product sales consist of the sale of Pharos laser systems, the sale of catheters for use with the DABRA laser, and the sale of consumables and replacement parts. The Company’s vascular segment has paused selling commercial product and is only selling catheters for use in the Company’s atherectomy clinical trial. The Company’s sales agreements generally do not include right-of-return provisions for any form of consideration including partial refund or credit against amounts owed to the Company. Services and other revenue primarily consist of sales of extended warranty and billable services, including repair activity and income from rental of lasers. Catheter Revenue When engaged in commercial sales, the Company enters into a DABRA laser commercial usage agreement or DABRA laser placement acknowledgement with each customer that is supplied a DABRA laser, collectively the “usage agreement”. The usage agreement provides for specific terms of continued use of DABRA laser, including a nominal periodic fee. The terms of a usage agreement typically allow the Company to place a DABRA laser at a customer’s specified location without a specified contract term. Under the usage agreement terms, the Company retains all ownership rights to the DABRA laser and is permitted to request the return of the equipment within 10 business days of notification. While the laser periodic fees are nominal, the laser usage agreements provide the Company the exclusive rights to supply related single-use catheters to the customer which aggregate the majority of the vascular segment revenue. There are no specified minimum purchase commitments for the catheters. The Company recognizes revenue associated with the usage agreement and catheter supply arrangements in accordance with Topic 606 as the contract primarily includes variable payments, the catheters are priced at their standalone selling price and the laser equipment is insignificant in the context of the contract. Revenue is recognized when the performance obligation is satisfied, which is generally upon shipment of the catheter. Laser Sales Sales of laser systems are included in product sales in the statements of operations. The Company recognizes revenue on laser sales at the point in time that control transfers to the customer. Control of the product typically transfers upon shipment. Warranty Service Revenue The Company typically provides a 12-month warranty with the purchase of its laser systems. Customers can extend the warranty period through the purchase of extended warranty service contracts. Extended warranty service contracts are sold with contract terms ranging from 12 to 60 months and cover periods after the end of the initial 12-month warranty period. The warranty provides the customer with maintenance services in addition to the assurance that the laser product complies with agreed-upon specifications. Therefore, the warranty service is treated as a separate performance obligation from the laser system. Warranty services are a stand-ready obligation, and the Company recognizes revenue on a straight-line basis over the service contract term. Warranty service revenue is included in service and other revenue in the statements of operations. Deferred revenue at January 1, 2021 and 2020 was $2.5 million and $3.3 million, respectively. Revenue recognized in each of the three months ended June 30, 2021 and 2020 relating to amounts previously included in deferred revenue was $0.5 and $0.6 million, respectively. Revenue recognized in each of the six months ended June 30, 2021 and 2020 was $1.1 million and $1.3 million, respectively. The deferred revenue greater than one year will be recognized during the remaining service period through 2024. As of June 30, 2021 and 2020, deferred revenue greater than one year was $0.5 million and $0.8 million, respectively. Distributor Transactions In certain markets outside the U.S., the Company sells products and provides services to customers through distributors that specialize in medical device products. The terms of sales transactions through distributors are generally consistent with the terms of direct sales to customers. The Company accounts for these transactions in accordance with the Company’s revenue recognition policy described herein. Contract Costs The Company capitalizes costs to obtain contracts that are considered incremental and recoverable, such as sales commissions. The capitalized costs are amortized to selling, general and administrative expense over the estimated period of benefit of the asset, which is the contract term. The Company elected to use the practical expedient to expense the costs to obtain a contract when the amortization period is less than one year . The Company has contract costs of $ million capitalized at June 30, 2021 and December 31, 20 20 . Rental Income The Company also derives income pursuant to product lease agreements for its Pharos laser systems, as operating leases. Consequently, the Company retains title to the equipment and the equipment remains on Company’s balance sheet within property and equipment. Depreciation expense on these leased lasers is recorded to cost of revenues on a straight-line basis. The costs to maintain these leased lasers are charged to cost of revenues as incurred. These lease arrangements contain one lease component (the laser) and one nonlease component (warranty service) for which the Company elected the practical expedient to not separate the nonlease component from the lease component. The Company accounts for the combined lease component as an operating lease and recognizes lease income on a straight-line basis over the lease term. Rental income from lease arrangements was $0.1 for each of the three months ended June 30, 2021 and 2020. Rental income from lease arrangements for each of the six months ended June 30, 2021 and 2020 was $0.3 million. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 3—Fair Value Measurements The following table presents the hierarchy for assets measured at fair value on a recurring basis (in thousands): Total Fair Value Quoted Market Prices for Identical Assets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) As of June 30, 2021 Money market funds $ 9,395 $ 9,395 $ — $ — As of December 31, 2020 Money market funds $ 18,394 $ 18,394 $ — $ — |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories consisted of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 1,918 $ 1,739 Work in process 306 270 Finished goods 99 209 Inventories $ 2,323 $ 2,218 |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment Net [Abstract] | |
Property and Equipment, Net | Note 5—Property and Equipment, net Property and equipment consisted of the following (in thousands): June 30, 2021 December 31, 2020 Lasers $ 4,407 $ 4,677 Machinery and equipment 950 866 Computer hardware and software 353 353 Automobiles 100 1,054 Leasehold improvements 119 119 Furniture and fixtures 48 48 Construction in progress 152 51 Property and equipment, gross 6,129 7,168 Accumulated depreciation (3,468 ) (3,957 ) Property and equipment, net $ 2,661 $ 3,211 Depreciation expense was $0.3 million and $0.5 million for the three months ended June 30, 2021 and 2020, respectively and $0.7 million and $1.0 million for the six months ended June 30, 2021 and 2020, respectively |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Note 6—Accrued Expenses Accrued expenses consisted of the following (in thousands): June 30, 2021 December 31, 2020 Compensation and related benefits $ 725 $ 2,602 Accrued warranty (Note 7) 237 242 Accrued services 1,059 1,504 Accrued expenses $ 2,021 $ 4,348 |
Accrued Warranty
Accrued Warranty | 6 Months Ended |
Jun. 30, 2021 | |
Product Warranties Disclosures [Abstract] | |
Accrued Warranty | Note 7—Accrued Warranty Activity in the product warranty accrual is included in accrued expenses above and consists of the following (in thousands): Six Months Ended June 30, 2021 Year Ended December 31, 2020 Balance at beginning of period $ 242 $ 338 Increase in warranty accrual 39 87 Change in liability for pre-existing warranties — (2 ) Claims satisfied (44 ) (181 ) Accrued warranty $ 237 $ 242 Warranty expense was $15,000 and $8,000 for the three months ended June 30, 2021 and 2020, respectively and $39,000 and $40,000 for the six months ended June 30, 2021 and 2020, respectively of catheters, which occurred in September 2019. |
Accrued Warranty (Tables)
Accrued Warranty (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Product Warranties Disclosures [Abstract] | |
Schedule Product Warranty Accrual Included in Accrued Expenses | Activity in the product warranty accrual is included in accrued expenses above and consists of the following (in thousands): Six Months Ended June 30, 2021 Year Ended December 31, 2020 Balance at beginning of period $ 242 $ 338 Increase in warranty accrual 39 87 Change in liability for pre-existing warranties — (2 ) Claims satisfied (44 ) (181 ) Accrued warranty $ 237 $ 242 |
Paycheck Protection Program Pro
Paycheck Protection Program Promissory Note | 6 Months Ended |
Jun. 30, 2021 | |
Paycheck Protection Program Promissory Note [Abstract] | |
Paycheck Protection Program Promissory Note | Note 8—Paycheck Protection Program Promissory Note In May 2020, the Company entered into a $2.0 million Paycheck Protection Program Promissory Note and Agreement (“PPP Promissory Note”) with a commercial bank under the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. The PPP Promissory Note bore an interest rate of 1.0% per annum. Under the terms of the PPP Promissory Note, payments would have been due monthly beginning November 1, 2020 and the principal amount of the PPP Promissory Note along with any unpaid interest would be due on May 3, 2022. On June 5, 2020, the Paycheck Protection Program Flexibility Act of 2020 (the “PPPFA”) extended the deferral period for all loans to 10 months after the last day of the covered period. Under the revised terms, payments would have been due beginning August 2021 and the principal amount along with unpaid interest would be due in May 2022. The principal and interest may be forgiven if the proceeds are used for forgivable purposes as defined by the terms in the PPP Promissory Note. The Company applied for full forgiveness under the provisions of the CARES Act in March 2021 and received approval by the Small Business Administration on June 24, 2021. Gain on extinguishment of the PPP promissory note is recorded in other income on the condensed statements of operations. Interest expense for the three months ended June 30, 2021 and 2020 was approximately $5,000 and $3,000, respectively. Interest expense for the six months ended June 30, 2021 and 2020 was approximately $10,000 and $3,000, respectively. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | Note 9—Leases The Company has two operating leases for office and manufacturing space which requires it to pay base rent and certain utilities. Monthly rent expense is recognized on a straight-line basis over the terms of the leases, which expire in 2027 and 2021. At June 30, 2021, the weighted average remaining lease term was 6.5 years. The operating leases are included in the balance sheets at the present value of the lease payments at a 7% discount rate, which approximates using the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments in a similar economic environment as the leases do not provide an implicit rate. For each of the three months ended June 30, 2021 and 2020, operating lease expense and cash paid for leases were $0.1 million. For each of the six months ended June 30, 2021 and 2020, operating lease expense and cash paid was $0.3 million. The following table presents the lease liabilities within the condensed balance sheet, related to the Company’s operating leases as of June 30, 2021 (in thousands): Years Ending December 31, 2021 (remaining six months) $ 264 2022 432 2023 445 2024 459 2025 472 2026 486 Thereafter 501 Total operating lease payments $ 3,059 Less: imputed interest (614 ) Total operating lease liabilities $ 2,445 |
Loss per Share
Loss per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Loss per Share | Note 10—Loss per Share The Company calculates basic loss per share by dividing net loss by the weighted average number of common shares outstanding during the reporting period. A net loss cannot be diluted, so when the Company is in a net loss position, basic and diluted loss per common share are the same. If in the future the Company achieves profitability, the denominator of a diluted earnings per common share calculation will include both the weighted-average number of shares outstanding and the number of common stock equivalents, if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards and units using the treasury stock method, along with the effect, if any, from outstanding convertible securities. The Company’s outstanding warrants to purchase common stock have participation rights to any dividends that may be declared in the future and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to the participating securities since the holders have no contractual obligation to share in the losses of the Company. Anti-dilutive common share equivalents excluded from the computation of diluted net loss per share at June 30, 2021 consisted of warrants of 2,345,033, stock options of 132,477, restricted stock units of 54,924, restricted stock awards of 355,598 and Employee Stock Purchase Plan shares of 10,557. Anti-dilutive common share equivalents excluded from the computation of diluted net loss per share at June 30, 2020 consisted of warrants of 877,604, stock options of 145,765 and restricted stock units of 7,876, restricted stock awards of 5,000 and Employee Stock Purchase Plan shares of 3,771. |
Equity Offerings
Equity Offerings | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Equity Offerings | Note 11—Equity Offerings In February 2021, the Company completed an “at the market offering” of 35,768 shares of common stock, at a price of $8.3921 per share. The Company received approximately $0.3 million in net proceeds, after deducting placement agent’s fees. The Company also incurred $0.2 million in offering and other expenses payable by it in association with filing the related Registration Statement on Form S-3 with the Securities and Exchange Commission. On various dates in May and June 2021, the Company completed “at the market offerings” of 2,582,019 shares of common stock, at a weighted average price of $4.29 per share. The Company received approximately $10.7 million in net proceeds, after deducting placement agent’s fees. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | Note 12—Stock-Based Compensation A summary of the activity and related information of the stock options issued under the 2018 Plan Compensation Plan Stock Options Weighted Average Exercise Price Weighted Average Remaining Life (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 124,171 $ 363.31 6.42 $ — Forfeited (9,694 ) 82.61 Outstanding at June 30, 2021 114,477 $ 387.08 5.85 $ — Exercisable at June 30, 2021 95,116 $ 459.60 5.50 $ — Vested and expected to vest at June 30, 2021 114,477 $ 387.08 5.85 $ — A summary of the activity and related information of the restricted stock units issued under the 2018 Plan is presented below: Restricted Stock Units Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 33,548 $ 21.93 Granted 29,614 3.99 Vested and released (1,845 ) 64.80 Forfeited (6,393 ) 15.40 Outstanding at June 30, 2021 54,924 $ 11.58 A summary of the activity and related information of the restricted stock awards issued under the 2018 Plan is presented below: Restricted Stock Awards (in shares) Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 286,161 $ 4.77 Granted 103,939 4.82 Forfeited (13,531 ) 6.40 Vested (24,721 ) 6.92 Outstanding at June 30, 2021 351,848 $ 4.57 Stock options issued and outstanding under the 2020 Plan is 18,000 with a weighted average grant date fair value of $25.50 as of December 31, 2020 and June 30, 2021. Stock options aggregating 5,625 were exercisable as of June 30, 2021, under the 2020 Plan. A summary of the activity and related information of the restricted stock awards issued under the 2020 Plan is presented below: Restricted Stock Awards (in shares) Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 4,375 $ 25.50 Vested (625 ) 25.50 Outstanding at June 30, 2021 3,750 $ 25.50 Stock-based compensation expense recorded in operating expenses was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Selling, general and administrative $ 541 $ 843 $ 1,503 $ 1,705 Research and development 95 103 224 202 Stock-based compensation in operating expenses $ 636 $ 946 $ 1,727 $ 1,907 Stock-based compensation amounts of Stock-based compensation of $0.1 million and $0.2 million were capitalized to inventory and property and equipment during the six months ended June 30, 2021 and 2020, respectively. Unrecognized compensation expense for stock options issued as of June 30, 2021 was $0.5 million and is expected to be recognized over a weighted-average period of 2.0 years. Unrecognized compensation expense for the restricted stock units as of June 30, 2021 was $0.4 million and is expected to be recognized over a weighted-average period of 2.0 years. Unrecognized compensation expense for the restricted stock awards as of June 30, 2021 was $1.3 million and is expected to be recognized over a weighted-average period of 2.2 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 13—Commitments and Contingencies Legal —In the normal course of business, the Company is at times subject to pending and threatened legal actions. In management’s opinion, any potential loss resulting from the resolution of these matters will not have a material effect on the results of operations, financial position or cash flows of the Company. Securities Litigation On June 7, 2019, a putative securities class action complaint captioned Derr v. Ra Medical Systems, Inc., et. al., On March 24, 2021, the court issued an order granting defendants’ motion to dismiss claims under the Securities Act in full and certain claims under the Exchange Act, and denying defendants’ motion to dismiss certain Exchange Act claims. Plaintiffs filed their second amended complaint on April 19, 2021, realleging the Securities Act claims and certain of the previously dismissed Exchange Act claims. On June 10, 2021 defendants moved to dismiss the second amended complaint. A hearing on the motion to dismiss is scheduled for October 12, 2021. On October 1, 2019, a shareholder derivative complaint captioned Noel Borg v. Dean Irwin, et. al Governmental Investigations As previously announced in the Form 8-K filed on August 12, 2019, the Audit Committee of Ra Medical’s Board of Directors (the “Audit Committee”) conducted an investigation of certain allegations raised by a former employee. The Company announced the Audit Committee’s findings in the Form 8-K filed on October 31, 2019. The primary investigative findings were: (i) the DABRA catheter frequently failed to calibrate and occasionally overheated, posing a risk of injury to physicians and patients; (ii) the Company’s explanations regarding its fourth quarter 2018 and first quarter 2019 sales created a risk of confusion because they did not explicitly reference inconsistent DABRA catheter performance and catheter failures; (iii) the Company failed to timely make at least two Medical Device Reports, or MDRs, to the FDA; (iv) the Company, out of a concern for the DABRA catheters’ performance, engaged in systematic efforts to replace product held by customers, which constituted product recalls, but were not documented as such, (v) the Company lack documentation of sufficient detail and specificity to support certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which could be perceived as an improper attempt to obtain business or to gain special advantage, (vi) while the indication for use in the 510(k) clearance the Company obtained for the DABRA system is not for atherectomy, the Company’s salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes, (vii) the Company’s determinations to direct potentially valuable benefits and opportunities to doctors were informed in part by sales prospects, and (viii) the Company received complaints regarding regulatory or compliance concerns that, because they implicated executive officers, should have been brought to the attention of the Board or the Audit Committee, but were not. On December 28, 2020, the Company entered into a Settlement Agreement with the United States of America, acting through the DOJ and on behalf of the OIG, to resolve the pending DOJ investigation and a related civil action concerning our marketing of the DABRA laser system and DABRA-related remuneration to certain physicians. In connection with the Settlement Agreement, the Company also has reached agreements with the participating states that resolve previously disclosed related investigations conducted by certain state attorneys general. The Settlement Agreement recites that a complaint filed by a former employee on behalf of the federal government in the United States District Court for the Eastern District of Michigan, and subsequently amended to assert claims on behalf of certain states, alleged, among other things, that the Company violated the False Claims Act, 31 U.S.C. § 3729, and certain state false claims acts by paying kickbacks to certain physicians in order to induce them to use the DABRA laser system, promoting off-label use of the DABRA laser system, failing to report adverse events to the United States Food and Drug Administration, marketing a device that does not work as advertised, and failing to adhere to Current Good Manufacturing Practices. The complaint, which was settled in connection with the Settlement Agreement, also alleged that we unlawfully retaliated against the former employee. Under the Settlement Agreement, and the agreements with the participating states, the Company is required to make an initial payment of $2.5 million, of which the Company paid $2.4 million in December 2020 and $0.1 million in April 2021. Pursuant to the terms of the Settlement Agreement, (a) if its revenue exceeds $10 million in any of the next four fiscal years (2021-2024), it also is required to pay an additional amount in settlement for the corresponding year: $500,000 for 2021, $750,000 for 2022, $1 million for 2023, and $1.25 million for 2024; (b) if it is acquired or is otherwise involved in a change in control transaction in the years 2020 through 2024, it is required to pay an additional settlement amount of $5 million, plus 4% of the value attributed to the Company in the transaction, so long as the attributed value is in excess of $100 million, with the total change in control payment never to exceed $28 million; and (c) if its obligations under the Settlement Agreement are avoided by bankruptcy, the United States may rescind the releases and bring an action against the Company in which the Company agrees is not subject to an automatic stay, is not subject to any statute of limitations, estoppel or laches defense, and is a valid claim in the amount of $56 million, minus any prior change in control payments. Under the Settlement Agreement, the Company also paid the former employee’s reasonable expenses, costs and attorneys’ fees, which amount to $0.2 million. The Company has expensed $2.7 million during the year ended December 31, 2020 and all amounts have been paid. The OIG has agreed, conditioned upon full payment of amounts owed in the Settlement Agreement, and in consideration of the Company’s obligations under a Corporate Integrity Agreement, to release its permissive exclusion rights and refrain from instituting any administrative action seeking to exclude it from participating in Medicare, Medicaid, or other federal health care programs as a result of the Covered Conduct. The Corporate Integrity Agreement has a five-year term and imposes monitoring, reporting, certification, documentation, oversight, screening, and training obligations on the Company, including the hiring of a compliance officer and independent review organization. Pursuant to the terms of the Settlement Agreement, the United States and the former employee have dismissed the complaint against the Company with prejudice and have released the Company from any civil or administrative monetary liability arising under the Covered Conduct. The Settlement Agreement does not include a release for any conduct other than the Covered Conduct or any criminal liability related to the Covered Conduct. The Settlement Agreement does not release any claims under investigation by the SEC. As also previously announced, the Company voluntarily contacted the SEC’s Enforcement Division regarding the Audit Committee’s investigation. O n November 13, 2019, the notified the Company that it was conducting an investigation. The Company cooperated fully with the SEC in this investigation. On August 3, 2021 the Company received notice that the SEC has concluded its investigation and does not intend to recommend an enforcement action by the SEC against the Company. On November 21, 2019, the Company became aware that the Criminal Division, Fraud Section of the DOJ has an open investigation related to the Company. At this time, it is unclear if the Company is a target in this investigation. The Company has been, and intends to continue, cooperating with the DOJ in its active and ongoing investigation. The Company is unable to predict the ultimate outcome and is unable to make a meaningful estimate of the amount or range of loss, if any, that could result from any unfavorable outcome. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2021 | |
Segment Reporting [Abstract] | |
Segment Information | Note 14—Segment Information The Company has organized its business into two operating segments based on the product specialties: the vascular segment and the dermatology segment. In deciding how to allocate resources and assess performance, the Company’s chief operating decision maker regularly evaluates the sales and gross profit of these segments. Amounts included within selling, general and administrative expense and research and development expense are not evaluated by the Company’s chief operating decision maker on a segmented basis. The following tables summarize segment performance (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Vascular $ 9 $ 78 $ 13 $ 191 Dermatology 996 822 2,110 2,083 Net revenue $ 1,005 $ 900 $ 2,123 $ 2,274 Vascular $ 466 $ 417 $ 865 $ 1,078 Dermatology 1,022 750 1,996 1,673 Cost of revenue $ 1,488 $ 1,167 $ 2,861 $ 2,751 Vascular $ (457 ) $ (339 ) $ (852 ) $ (887 ) Dermatology (26 ) 72 114 410 Gross loss $ (483 ) $ (267 ) $ (738 ) $ (477 ) Generally, all assets are common assets, except for lasers placed with customers, which are a subset of property and equipment. The net book value of the lasers in the vascular segment was $1.5 million and $1.9 million as of June 30, 2021 and December 31, 2020, respectively. The net book value of the lasers in the dermatology segment was $0.4 million and $0.7 million as of June 30, 2021 and December 31, 2020, respectively. No sales to an individual customer or country other than the United States accounted for more than 10% of revenue for the three and six months ended June 30, 2021 and 2020. Net revenue, classified by the major geographic areas in which our customers are located, was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 994 $ 881 $ 2,057 $ 2,067 All other countries 11 19 66 207 Net revenue $ 1,005 $ 900 $ 2,123 $ 2,274 |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Note 15—Subsequent Events On August 3, 2021 the Company received notice that the SEC has concluded its investigation and does not intend to recommend an enforcement action by the SEC against the Company. Between July 1, 2021 and August 2, 2021, the Company completed “at the market offerings” of 1,139,306 shares of common stock and received approximately $4.4 million in net proceeds, after deducting placement agent’s fees. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Interim Consolidated Financial Information | Interim condensed financial information —The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and reflect all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed balance sheets, results of operations, cash flows and statements of stockholders’ equity for the periods presented. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The balance sheet as of December 31, 2020 included herein was derived from the audited financial statements as of that date. These unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2021. |
Use of Estimates | Use of estimates —The financial statements of the Company have been prepared by management in accordance with accounting principles generally accepted in the United States of America. The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and reported disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. The Company’s financial statements are based upon a number of estimates, including but not limited to, allowance for doubtful accounts, evaluation of impairment of assets, reserves for warranty costs including product recalls, evaluation of probable loss contingencies, fair value of stock option awards granted and revenue recognition for multiple performance obligations. |
Fair Value Measurements | Fair value measurements — Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier value hierarchy is used to identify inputs used in measuring fair value as follows: Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets. Level 2—Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. The hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. The Company measures its cash and cash equivalents and short-term investments at fair value. |
Inventories | Inventories —Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. Cost includes materials, labor and manufacturing overhead related to the purchase and production of inventories. The Company reduces the carrying value of inventories for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technological developments or other economic factors. Catheters are manufactured in-house and each catheter is tested at various stages of the manufacturing process for adherence to quality standards. Catheters that do not meet functionality specification at each test point are destroyed and immediately written off, with the expense recorded in cost of revenue in the statement s of operations. Once manufactured, completed catheters that pass quality assurance, are sent to a third-party for sterilization and sealed in a sterile container. Upon return from the third-party sterilizer, a sample of catheters from each batch are re-tested. If the sample tests are successful, the batch is accepted into finished goods inventory and if the sample tests are unsuccessful, the entire batch is written off, with the expense recorded in cost of revenue in the statement s of operations. |
Revenue | Revenue —The Company generates revenue from the sale of products and services. Product sales consist of the sale of Pharos laser systems, the sale of catheters for use with the DABRA laser, and the sale of consumables and replacement parts. The Company’s vascular segment has paused selling commercial product and is only selling catheters for use in the Company’s atherectomy clinical trial. The Company’s sales agreements generally do not include right-of-return provisions for any form of consideration including partial refund or credit against amounts owed to the Company. Services and other revenue primarily consist of sales of extended warranty and billable services, including repair activity and income from rental of lasers. Catheter Revenue When engaged in commercial sales, the Company enters into a DABRA laser commercial usage agreement or DABRA laser placement acknowledgement with each customer that is supplied a DABRA laser, collectively the “usage agreement”. The usage agreement provides for specific terms of continued use of DABRA laser, including a nominal periodic fee. The terms of a usage agreement typically allow the Company to place a DABRA laser at a customer’s specified location without a specified contract term. Under the usage agreement terms, the Company retains all ownership rights to the DABRA laser and is permitted to request the return of the equipment within 10 business days of notification. While the laser periodic fees are nominal, the laser usage agreements provide the Company the exclusive rights to supply related single-use catheters to the customer which aggregate the majority of the vascular segment revenue. There are no specified minimum purchase commitments for the catheters. The Company recognizes revenue associated with the usage agreement and catheter supply arrangements in accordance with Topic 606 as the contract primarily includes variable payments, the catheters are priced at their standalone selling price and the laser equipment is insignificant in the context of the contract. Revenue is recognized when the performance obligation is satisfied, which is generally upon shipment of the catheter. Laser Sales Sales of laser systems are included in product sales in the statements of operations. The Company recognizes revenue on laser sales at the point in time that control transfers to the customer. Control of the product typically transfers upon shipment. Warranty Service Revenue The Company typically provides a 12-month warranty with the purchase of its laser systems. Customers can extend the warranty period through the purchase of extended warranty service contracts. Extended warranty service contracts are sold with contract terms ranging from 12 to 60 months and cover periods after the end of the initial 12-month warranty period. The warranty provides the customer with maintenance services in addition to the assurance that the laser product complies with agreed-upon specifications. Therefore, the warranty service is treated as a separate performance obligation from the laser system. Warranty services are a stand-ready obligation, and the Company recognizes revenue on a straight-line basis over the service contract term. Warranty service revenue is included in service and other revenue in the statements of operations. Deferred revenue at January 1, 2021 and 2020 was $2.5 million and $3.3 million, respectively. Revenue recognized in each of the three months ended June 30, 2021 and 2020 relating to amounts previously included in deferred revenue was $0.5 and $0.6 million, respectively. Revenue recognized in each of the six months ended June 30, 2021 and 2020 was $1.1 million and $1.3 million, respectively. The deferred revenue greater than one year will be recognized during the remaining service period through 2024. As of June 30, 2021 and 2020, deferred revenue greater than one year was $0.5 million and $0.8 million, respectively. Distributor Transactions In certain markets outside the U.S., the Company sells products and provides services to customers through distributors that specialize in medical device products. The terms of sales transactions through distributors are generally consistent with the terms of direct sales to customers. The Company accounts for these transactions in accordance with the Company’s revenue recognition policy described herein. Contract Costs The Company capitalizes costs to obtain contracts that are considered incremental and recoverable, such as sales commissions. The capitalized costs are amortized to selling, general and administrative expense over the estimated period of benefit of the asset, which is the contract term. The Company elected to use the practical expedient to expense the costs to obtain a contract when the amortization period is less than one year . The Company has contract costs of $ million capitalized at June 30, 2021 and December 31, 20 20 . Rental Income The Company also derives income pursuant to product lease agreements for its Pharos laser systems, as operating leases. Consequently, the Company retains title to the equipment and the equipment remains on Company’s balance sheet within property and equipment. Depreciation expense on these leased lasers is recorded to cost of revenues on a straight-line basis. The costs to maintain these leased lasers are charged to cost of revenues as incurred. These lease arrangements contain one lease component (the laser) and one nonlease component (warranty service) for which the Company elected the practical expedient to not separate the nonlease component from the lease component. The Company accounts for the combined lease component as an operating lease and recognizes lease income on a straight-line basis over the lease term. Rental income from lease arrangements was $0.1 for each of the three months ended June 30, 2021 and 2020. Rental income from lease arrangements for each of the six months ended June 30, 2021 and 2020 was $0.3 million. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Hierarchy for Assets Measured at Fair Value on a Recurring Basis | The following table presents the hierarchy for assets measured at fair value on a recurring basis (in thousands): Total Fair Value Quoted Market Prices for Identical Assets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) As of June 30, 2021 Money market funds $ 9,395 $ 9,395 $ — $ — As of December 31, 2020 Money market funds $ 18,394 $ 18,394 $ — $ — |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 1,918 $ 1,739 Work in process 306 270 Finished goods 99 209 Inventories $ 2,323 $ 2,218 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment Net [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): June 30, 2021 December 31, 2020 Lasers $ 4,407 $ 4,677 Machinery and equipment 950 866 Computer hardware and software 353 353 Automobiles 100 1,054 Leasehold improvements 119 119 Furniture and fixtures 48 48 Construction in progress 152 51 Property and equipment, gross 6,129 7,168 Accumulated depreciation (3,468 ) (3,957 ) Property and equipment, net $ 2,661 $ 3,211 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): June 30, 2021 December 31, 2020 Compensation and related benefits $ 725 $ 2,602 Accrued warranty (Note 7) 237 242 Accrued services 1,059 1,504 Accrued expenses $ 2,021 $ 4,348 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Schedule of Operating Lease Maturities | The following table presents the lease liabilities within the condensed balance sheet, related to the Company’s operating leases as of June 30, 2021 (in thousands): Years Ending December 31, 2021 (remaining six months) $ 264 2022 432 2023 445 2024 459 2025 472 2026 486 Thereafter 501 Total operating lease payments $ 3,059 Less: imputed interest (614 ) Total operating lease liabilities $ 2,445 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Restricted Stock Units Activity | A summary of the activity and related information of the restricted stock units issued under the 2018 Plan is presented below: Restricted Stock Units Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 33,548 $ 21.93 Granted 29,614 3.99 Vested and released (1,845 ) 64.80 Forfeited (6,393 ) 15.40 Outstanding at June 30, 2021 54,924 $ 11.58 |
Schedule of Stock-based Compensation Expense Recorded in Operating Expenses | Stock-based compensation expense recorded in operating expenses was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Selling, general and administrative $ 541 $ 843 $ 1,503 $ 1,705 Research and development 95 103 224 202 Stock-based compensation in operating expenses $ 636 $ 946 $ 1,727 $ 1,907 |
Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Options Activity | A summary of the activity and related information of the stock options issued under the 2018 Plan Compensation Plan Stock Options Weighted Average Exercise Price Weighted Average Remaining Life (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 124,171 $ 363.31 6.42 $ — Forfeited (9,694 ) 82.61 Outstanding at June 30, 2021 114,477 $ 387.08 5.85 $ — Exercisable at June 30, 2021 95,116 $ 459.60 5.50 $ — Vested and expected to vest at June 30, 2021 114,477 $ 387.08 5.85 $ — |
Two Thousand Eighteen Restricted Stock Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Restricted Stock Awards Activity | A summary of the activity and related information of the restricted stock awards issued under the 2018 Plan is presented below: Restricted Stock Awards (in shares) Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 286,161 $ 4.77 Granted 103,939 4.82 Forfeited (13,531 ) 6.40 Vested (24,721 ) 6.92 Outstanding at June 30, 2021 351,848 $ 4.57 |
Two Thousand Twenty Restricted Stock Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Restricted Stock Awards Activity | Stock options issued and outstanding under the 2020 Plan is 18,000 with a weighted average grant date fair value of $25.50 as of December 31, 2020 and June 30, 2021. Stock options aggregating 5,625 were exercisable as of June 30, 2021, under the 2020 Plan. A summary of the activity and related information of the restricted stock awards issued under the 2020 Plan is presented below: Restricted Stock Awards (in shares) Weighted Average Grant Date Fair Value Outstanding at December 31, 2020 4,375 $ 25.50 Vested (625 ) 25.50 Outstanding at June 30, 2021 3,750 $ 25.50 |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Segment Reporting [Abstract] | |
Schedule of Segment Performance | The following tables summarize segment performance (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Vascular $ 9 $ 78 $ 13 $ 191 Dermatology 996 822 2,110 2,083 Net revenue $ 1,005 $ 900 $ 2,123 $ 2,274 Vascular $ 466 $ 417 $ 865 $ 1,078 Dermatology 1,022 750 1,996 1,673 Cost of revenue $ 1,488 $ 1,167 $ 2,861 $ 2,751 Vascular $ (457 ) $ (339 ) $ (852 ) $ (887 ) Dermatology (26 ) 72 114 410 Gross loss $ (483 ) $ (267 ) $ (738 ) $ (477 ) |
Schedule of Net Revenue Classified by Major Geographical Areas | Net revenue, classified by the major geographic areas in which our customers are located, was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 United States $ 994 $ 881 $ 2,057 $ 2,067 All other countries 11 19 66 207 Net revenue $ 1,005 $ 900 $ 2,123 $ 2,274 |
Organization and Nature of Op_2
Organization and Nature of Operations - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Accumulated deficit | $ 165,687 | $ 153,202 | |
Net cash used in operating activities | 14,699 | $ 12,843 | 28,300 |
Cash and cash equivalents | $ 20,220 | $ 23,906 |
Significant Accounting Polici_3
Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred revenue | $ 2.5 | $ 3.3 | ||||
Deferred revenue, recognized | $ 0.5 | $ 0.6 | $ 1.1 | $ 1.3 | ||
Remaining service period to recognize deferred revenue, description | 2024 | |||||
Deferred revenue amount greater than one year | 0.5 | 0.8 | $ 0.5 | 0.8 | ||
Capitalized contract cost, net | 0.2 | 0.2 | $ 0.2 | |||
Laser revenue | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.3 | ||
Minimum [Member] | ||||||
Regular warranty service contracts term | 12 months | |||||
Maximum [Member] | ||||||
Extended warranty service contracts term | 60 months | |||||
Capitalized contract cost amortization period | 1 year |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Hierarchy for Assets Measured at Fair Value on a Recurring Basis (Detail) - Fair Value, Measurements, Recurring [Member] - Money market Funds [Member] - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Fair Value | $ 9,395 | $ 18,394 |
Quoted Market Prices for Identical Assets (Level 1) [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Fair Value | $ 9,395 | $ 18,394 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,918 | $ 1,739 |
Work in process | 306 | 270 |
Finished goods | 99 | 209 |
Inventories | $ 2,323 | $ 2,218 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 6,129 | $ 7,168 |
Accumulated depreciation | (3,468) | (3,957) |
Property and equipment, net | 2,661 | 3,211 |
Lasers | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 4,407 | 4,677 |
Machinery and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 950 | 866 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 353 | 353 |
Automobiles | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 100 | 1,054 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 119 | 119 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 48 | 48 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 152 | $ 51 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Property Plant And Equipment [Line Items] | ||||
Depreciation expense | $ 0.3 | $ 0.5 | $ 0.7 | $ 1 |
Automobiles | General and Administrative Expense | ||||
Property Plant And Equipment [Line Items] | ||||
Gain on Sale of Property and Equipment | $ 0.5 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | |||
Compensation and related benefits | $ 725 | $ 2,602 | |
Accrued warranty (Note 7) | 237 | 242 | $ 338 |
Accrued services | 1,059 | 1,504 | |
Accrued expenses | $ 2,021 | $ 4,348 |
Accrued Warranty - Schedule Pro
Accrued Warranty - Schedule Product Warranty Accrual Included in Accrued Expenses (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Product Warranties Disclosures [Abstract] | ||
Balance at beginning of period, Accrued warranty | $ 242 | $ 338 |
Increase in warranty accrual | 39 | 87 |
Change in liability for pre-existing warranties | (2) | |
Claims satisfied | (44) | (181) |
Balance at ending of period, Accrued warranty | $ 237 | $ 242 |
Accrued Warranty - Additional I
Accrued Warranty - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Product Warranty Liability [Line Items] | ||||||
Warranty expense | $ 15,000 | $ 8,000 | $ 39,000 | $ 40,000 | ||
Accrued warranty (Note 7) | 237,000 | 237,000 | $ 242,000 | $ 338,000 | ||
Catheters [Member] | Product Recall [Member] | ||||||
Product Warranty Liability [Line Items] | ||||||
Accrued warranty (Note 7) | $ 100,000 | $ 100,000 | $ 100,000 |
Paycheck Protection Program P_2
Paycheck Protection Program Promissory Note - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
May 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Interest expense | $ 31,000 | $ 15,000 | $ 83,000 | $ 40,000 | |
Promissory Note | Corona Virus Aid Relief Economic Security Act | |||||
Paycheck protection program, amount | $ 2,000,000 | ||||
Interest rate | 1.00% | ||||
Payments due, beginning date | Nov. 1, 2020 | ||||
Payments due, ending date | May 3, 2022 | ||||
Interest expense | $ 5,000 | $ 3,000 | $ 10,000 | $ 3,000 | |
Debt instrument, description | payments would have been due beginning August 2021 and the principal amount along with unpaid interest would be due in May 2022. The principal and interest may be forgiven if the proceeds are used for forgivable purposes as defined by the terms in the PPP Promissory Note. |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)Lease | Jun. 30, 2020USD ($) | |
Operating Leased Assets [Line Items] | ||||
Number of leases | Lease | 2 | |||
Operating lease, discount rate | 7.00% | 7.00% | ||
Operating lease, weighted average remaining lease term | 6 years 6 months | 6 years 6 months | ||
Operating lease expense | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.3 |
Operating lease , cash payment | 0.1 | 0.1 | 0.3 | 0.3 |
Operating lease right-of-use-assets amortization | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 |
Office Building [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Lease expiration period | 2027 | |||
Manufacturing Facility [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Lease expiration period | 2021 |
Leases - Lease Liabilities Rela
Leases - Lease Liabilities Related to Operating Leases Presented within Condensed Balance Sheet (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Leases [Abstract] | |
2021 (remaining six months) | $ 264 |
2022 | 432 |
2023 | 445 |
2024 | 459 |
2025 | 472 |
2026 | 486 |
Thereafter | 501 |
Total operating lease payments | 3,059 |
Less: imputed interest | (614) |
Total operating lease liabilities | $ 2,445 |
Loss per Share - Additional Inf
Loss per Share - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Loss allocated to participating securities | $ 0 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents excluded from computation of diluted net loss per share | 132,477 | 145,765 |
Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents excluded from computation of diluted net loss per share | 2,345,033 | 877,604 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents excluded from computation of diluted net loss per share | 54,924 | 7,876 |
Restricted Stock Awards (RSAs) [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents excluded from computation of diluted net loss per share | 355,598 | 5,000 |
Employee Stock Purchase Plan [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents excluded from computation of diluted net loss per share | 10,557 | 3,771 |
Equity Offerings - Additional I
Equity Offerings - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 28, 2021 | Jun. 30, 2021 | Dec. 31, 2019 |
Class Of Stock [Line Items] | |||
Common stock, shares authorized | 300,000,000 | 300,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
At The Market Offering | |||
Class Of Stock [Line Items] | |||
Common stock, shares authorized | 35,768 | 2,582,019 | |
Common stock, par value | $ 8.3921 | $ 4.29 | |
Proceeds from issuance of common stock | $ 0.3 | ||
Other offering expenses | $ 0.2 | $ 10.7 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Options Activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Weighted Average Remaining Life (in years) | ||
Weighted Average Remaining Life (in years) | 2 years | |
Stock Options [Member] | ||
Options outstanding | ||
Beginning balance | 124,171 | |
Forfeited | (9,694) | |
Ending balance | 114,477 | 124,171 |
Exercisable at the end of the period | 95,116 | |
Vested and expected to vest at the end of the period | 114,477 | |
Weighted Average Remaining Life (in years) | ||
Weighted Average Remaining Life (in years) | 5 years 10 months 6 days | 6 years 5 months 1 day |
Exercisable at the end of the period | 5 years 6 months | |
Vested and expected to vest at the end of the period | 5 years 10 months 6 days | |
Weighted Average Exercise Price | ||
Beginning balance | $ 363.31 | |
Forfeited | 82.61 | |
Ending balance | 387.08 | $ 363.31 |
Exercisable at the end of the period | 459.60 | |
Vested and expected to vest at the end of the period | $ 387.08 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member] | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Restricted Stock Units | |
Beginning balance | shares | 33,548 |
Granted | shares | 29,614 |
Vested and released | shares | (1,845) |
Forfeited | shares | (6,393) |
Ending balance | shares | 54,924 |
Weighted Average Grant Date Fair Value | |
Beginning balance | $ / shares | $ 21.93 |
Granted | $ / shares | 3.99 |
Vested and released | $ / shares | 64.80 |
Forfeited | $ / shares | 15.40 |
Ending balance | $ / shares | $ 11.58 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Restricted Stock Awards Activity (Details) - Restricted Stock Awards (RSAs) [Member] | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Two Thousand Eighteen Restricted Stock Plan | |
Restricted Stock Units | |
Beginning balance | 351,848 |
Granted | 103,939 |
Forfeited | (13,531) |
Vested | (24,721) |
Beginning balance | $ / shares | $ 4.77 |
Granted | $ / shares | 4.82 |
Forfeited | $ / shares | 6.40 |
Vested | $ / shares | 6.92 |
Ending balance | $ / shares | $ 4.57 |
Beginning balance | 286,161 |
Vested | (24,721) |
Ending balance | 351,848 |
Two Thousand Twenty Restricted Stock Plan | |
Restricted Stock Units | |
Beginning balance | 3,750 |
Vested | (625) |
Beginning balance | $ / shares | $ 25.50 |
Vested | $ / shares | 25.50 |
Ending balance | $ / shares | $ 25.50 |
Beginning balance | 4,375 |
Vested | (625) |
Ending balance | 3,750 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock-based compensation | $ 1,865,000 | $ 2,080,000 | |||
Weighted Average Remaining Life (in years) | 2 years | ||||
Stock Options [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock option outstanding | 114,477 | 114,477 | 124,171 | ||
Exercisable at the end of the period | 95,116 | 95,116 | |||
Stock-based compensation | $ 100,000 | $ 100,000 | $ 100,000 | $ 200,000 | |
Unrecognized compensation expense for stock options issued | $ 500,000 | $ 500,000 | |||
Weighted Average Remaining Life (in years) | 5 years 10 months 6 days | 6 years 5 months 1 day | |||
Restricted Stock Units (RSUs) [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
weighted average grant date fair value | $ 11.58 | $ 11.58 | $ 21.93 | ||
Unrecognized compensation expense for stock options issued | $ 400,000 | $ 400,000 | |||
Weighted-average recognized period | 2 years | ||||
Restricted Stock Awards (RSAs) [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Unrecognized compensation expense for stock options issued | $ 1,300 | $ 1,300 | |||
Weighted-average recognized period | 2 years 2 months 12 days | ||||
2020 Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock option outstanding | 18,000 | 18,000 | 18,000 | ||
weighted average grant date fair value | $ 25.50 | $ 25.50 | $ 25.50 | ||
Exercisable at the end of the period | 5,625 | 5,625 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of Stock-based Compensation Expense Recorded in Operating Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation in operating expenses | $ 636 | $ 946 | $ 1,727 | $ 1,907 |
Selling, General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation in operating expenses | 541 | 843 | 1,503 | 1,705 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation in operating expenses | $ 95 | $ 103 | $ 224 | $ 202 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Dec. 28, 2020 | Apr. 30, 2021 | Oct. 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 |
Loss Contingencies [Line Items] | ||||||||
Audit committee findings | The primary investigative findings were: (i) the DABRA catheter frequently failed to calibrate and occasionally overheated, posing a risk of injury to physicians and patients; (ii) the Company’s explanations regarding its fourth quarter 2018 and first quarter 2019 sales created a risk of confusion because they did not explicitly reference inconsistent DABRA catheter performance and catheter failures; (iii) the Company failed to timely make at least two Medical Device Reports, or MDRs, to the FDA; (iv) the Company, out of a concern for the DABRA catheters’ performance, engaged in systematic efforts to replace product held by customers, which constituted product recalls, but were not documented as such, (v) the Company lack documentation of sufficient detail and specificity to support certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which could be perceived as an improper attempt to obtain business or to gain special advantage, (vi) while the indication for use in the 510(k) clearance the Company obtained for the DABRA system is not for atherectomy, the Company’s salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes, (vii) the Company’s determinations to direct potentially valuable benefits and opportunities to doctors were informed in part by sales prospects, and (viii) the Company received complaints regarding regulatory or compliance concerns that, because they implicated executive officers, should have been brought to the attention of the Board or the Audit Committee, but were not. | |||||||
Payments to physicians that lack documentation of sufficient detail | $ 300,000 | |||||||
Total net revenue | $ 1,005,000 | $ 900,000 | $ 2,123,000 | $ 2,274,000 | ||||
Settlement Agreement | ||||||||
Loss Contingencies [Line Items] | ||||||||
Allegations description | The Settlement Agreement recites that a complaint filed by a former employee on behalf of the federal government in the United States District Court for the Eastern District of Michigan, and subsequently amended to assert claims on behalf of certain states, alleged, among other things, that the Company violated the False Claims Act, 31 U.S.C. § 3729, and certain state false claims acts by paying kickbacks to certain physicians in order to induce them to use the DABRA laser system, promoting off-label use of the DABRA laser system, failing to report adverse events to the United States Food and Drug Administration, marketing a device that does not work as advertised, and failing to adhere to Current Good Manufacturing Practices. The complaint, which was settled in connection with the Settlement Agreement, also alleged that we unlawfully retaliated against the former employee. Separate from the former employee’s allegations in the civil action, the United States and the participating states contend that from May 1, 2017 through October 31, 2019, the Company (a) paid illegal remuneration to certain physicians to induce them to use the DABRA laser system in violation of the federal anti-kickback statute and (b) marketed the DABRA laser system for off-label use in atherectomy procedures despite product performance issues causing calibration and overheating problems, which posed a risk to physicians and patients (the “Covered Conduct”). The Company denies the allegations in the civil action and those asserted by the United States and the participating states, and the settlement does not constitute an admission of liability or wrongdoing by the Company. | |||||||
Litigation settlement amount | $ 2,500,000 | |||||||
Payment for legal settlement | $ 100,000 | $ 2,400,000 | ||||||
Settlement amount , year 2021 | $ 500,000 | |||||||
Settlement year one | 2021 | |||||||
Settlement amount , year 2022 | $ 750,000 | |||||||
Settlement year two | 2022 | |||||||
Settlement amount , year 2023 | $ 1,000,000 | |||||||
Settlement year three | 2023 | |||||||
Settlement amount , year 2024 | $ 1,250,000 | |||||||
Settlement year four | 2024 | |||||||
Business acquisition, settlement amount | $ 5,000,000 | |||||||
Business acquisition additional settlement percentage | 4.00% | |||||||
Business acquisition, transaction costs | $ 100,000,000 | |||||||
Business acquisition change In control payments | 28,000,000 | |||||||
Settlement claim | 56,000,000 | |||||||
Settlement expense | 200,000 | |||||||
Loss contingency, payments | 2,700,000 | |||||||
Settlement Agreement | Maximum [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Total net revenue | $ 10,000,000 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020 | Jun. 30, 2021USD ($)Segment | Jun. 30, 2020 | Dec. 31, 2020USD ($) | |
Segment Reporting Information [Line Items] | |||||
Number of operating segments | Segment | 2 | ||||
Property and equipment, net | $ 2,661 | $ 2,661 | $ 3,211 | ||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Concentration risk, percentage | 10.00% | 10.00% | 10.00% | 10.00% | |
Vascular [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Property and equipment, net | $ 1,500 | $ 1,500 | 1,900 | ||
Dermatology [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Property and equipment, net | $ 400 | $ 400 | $ 700 |
Segment Reporting - Summary of
Segment Reporting - Summary of Segment Performance (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Segment Reporting Information [Line Items] | ||||
Net revenue | $ 1,005 | $ 900 | $ 2,123 | $ 2,274 |
Cost of revenue | 1,488 | 1,167 | 2,861 | 2,751 |
Gross profit (loss) | (483) | (267) | (738) | (477) |
Vascular [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 9 | 78 | 13 | 191 |
Cost of revenue | 466 | 417 | 865 | 1,078 |
Gross profit (loss) | (457) | (339) | (852) | (887) |
Dermatology [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Net revenue | 996 | 822 | 2,110 | 2,083 |
Cost of revenue | 1,022 | 750 | 1,996 | 1,673 |
Gross profit (loss) | $ (26) | $ 72 | $ 114 | $ 410 |
Segment Reporting - Summary o_2
Segment Reporting - Summary of Net Revenue Classified by Major Geographic Areas (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues From External Customers And Long Lived Assets [Line Items] | ||||
Net revenue | $ 1,005 | $ 900 | $ 2,123 | $ 2,274 |
United States [Member] | ||||
Revenues From External Customers And Long Lived Assets [Line Items] | ||||
Net revenue | 994 | 881 | 2,057 | 2,067 |
All other countries [Member] | ||||
Revenues From External Customers And Long Lived Assets [Line Items] | ||||
Net revenue | $ 11 | $ 19 | $ 66 | $ 207 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) - Common Stock - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Aug. 02, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | |
Subsequent Event [Line Items] | |||||
Common stock shares issued | 2,582 | 35 | 889,000 | 5,000 | |
Subsequent Event | At The Market Offerings | |||||
Subsequent Event [Line Items] | |||||
Common stock shares issued | 1,139,306 | ||||
Proceeds from issuance of common stock | $ 4.4 |