Revenue Performance - Total revenue for the three months ended June 30, 2024, was 2,207,000,a1041,081,000 for the same period in 2023[9] - Product revenue increased to 1,396,000forthethreemonthsendedJune30,2024,comparedto298,000 for the same period in 2023, representing a 368% growth[9] - Total revenue for the six months ended June 30, 2024, reached 3,330million,comparedto2,057 million for the same period in 2023, marking a 62% increase[39] - Total U.S. revenue for the three months ended June 30, 2024, was 184thousand,comparedto133 thousand in the same period of 2023, reflecting a 38% increase[39] - Total OUS revenue for the three months ended June 30, 2024, was 2.023million,significantlyhigherthan948 thousand in the same period of 2023, indicating a 113% growth[39] Financial Losses - Net loss for the three months ended June 30, 2024, was (25,749,000),comparedto(20,662,000) for the same period in 2023, indicating a 25% increase in losses[9] - The company reported a comprehensive loss of (25,922,000)forthethreemonthsendedJune30,2024,comparedto(20,388,000) for the same period in 2023[9] - The company reported a net loss of 48.246millionforthesixmonthsendedJune30,2024,comparedtoanetlossof42.880 million for the same period in 2023, indicating an increase in losses[18] - The company had an accumulated deficit of 987.6millionasofJune30,2024,highlightingongoingfinancialchallenges[24]OperatingExpenses−TotaloperatingexpensesforthethreemonthsendedJune30,2024,were23,090,000, up from 18,870,000forthesameperiodin2023,reflectinga2215,722,000, down from 19,119,000forthesameperiodin2023,adecreaseof183.273 million, slightly down from 3.894millioninthesameperiodof2023[18]CashandLiquidity−Cashandcashequivalentsdecreasedto7,782,000 as of June 30, 2024, down from 17,096,000asofDecember31,2023[11]−Thecompanyexperiencedanetcashusedinoperatingactivitiesof28.228 million for the six months ended June 30, 2024, compared to 35.204millionforthesameperiodin2023,indicatingimprovedcashflowmanagement[18]−Cashandcashequivalentsattheendoftheperiodwere9.299 million, compared to 9.029millionattheendofthesameperiodin2023,showingaslightincrease[18]AssetsandLiabilities−Totalcurrentliabilitiesincreasedsignificantlyto39,920,000 as of June 30, 2024, compared to 12,628,000asofDecember31,2023[11]−Thetotalassetsofthecompanywere38,502,000 as of June 30, 2024, a decrease from 59,086,000asofDecember31,2023[11]−TotalliabilitiesasofJune30,2024,amountedto19,997,000, including warrant liabilities of 5,597,000[49]−Contingentconsiderationincreasedsignificantlyfrom2,220,000 on December 31, 2023, to 14,400,000onJune30,2024,duetotheprobability−weightedfairvaluerelatedtoapotentialmerger[57]MergerandStrategicDevelopments−ThecompanyenteredintoaMergerAgreementwithKARLSTORZEndoscopy−America,Inc.,whereeachshareofcommonstockwillbeconvertedinto0.35 in cash upon completion of the merger[23] - The company is developing the LUNA™ Surgical System, a next-generation robotic and instrument system aimed at enhancing surgical outcomes through digital technology[21] - The company is focused on the commercialization of the Senhance System, which is the first digital multi-port laparoscopic platform designed to enhance minimally invasive surgery[21] - The company requires additional capital to fund operating losses and continue its business plan, raising concerns about its ability to continue as a going concern[25] Customer Concentration and Revenue Distribution - The Company had three customers accounting for 26%, 13%, and 11% of net accounts receivable as of June 30, 2024[44] - The Company had two customers contributing 43% and 11% of revenue for the three months ended June 30, 2024, compared to no customers exceeding 10% in the same period last year[99] - For the three months ended June 30, 2024, the Company generated 8% of its revenue from the U.S., down from 12% in the same period last year[99] - EMEA accounted for 84% of revenue for the three months ended June 30, 2024, an increase from 67% year-over-year[99] Tax and Regulatory Matters - The company incurred a total tax expense of approximately 0.07millionforthethreemonthsendedJune30,2024,comparedtoataxbenefitof0.01 million for the same period in 2023[73] - The effective tax rate for the three months ended June 30, 2024, was (0.3)%, compared to 0.1% for the same period in 2023[72] - The Company is currently evaluating the impact of recently issued accounting standards, including ASU No. 2023-07 and ASU No. 2023-09, which may affect future disclosures[31][34] Stock and Equity - Stock options outstanding increased to 15,886,489 as of June 30, 2024, with a weighted average exercise price of 2.07[82]−Thecompanygranted14,953,974restrictedstockunitsduringthesixmonthsendedJune30,2024,resultinginunvestedsharestotaling20,427,833[85]−Thetotalpotentialcommonsharesnotincludedinthecomputationofdilutednetlosspershareincreasedto61,144,822asofJune30,2024[94]FutureOutlookandRisks−TheCompanyanticipatespotentialrisksrelatedtotheMerger,includingaterminationfeeof3.6 million if the agreement is not completed[105] - The Company’s financial performance is subject to various risks and uncertainties that could impact future results, particularly regarding the Merger[105]