Revenue Performance - Product revenue for the year ended December 31, 2022 decreased to 4.3millioncomparedto5.4 million for the year ended December 31, 2021, a decrease of approximately 20.4%[244] - Service revenue for the year ended December 31, 2022 decreased to 1.4millioncomparedto1.5 million for the year ended December 31, 2021, a decrease of approximately 6.7%[244] - Total revenue for the year 2022 was 7,087,000,adecreaseof13.98,232,000 in 2021[307] - Total U.S. revenue decreased to 767thousandin2022from1.033 million in 2021, representing a decline of 25.7%[373] - Total revenue outside of the U.S. (OUS) was 6.320millionin2022,down12.27.199 million in 2021[373] Expenses and Losses - R&D expenses for the year ended December 31, 2022 increased 50% to 28.9millioncomparedto19.3 million for the year ended December 31, 2021[249] - Sales and marketing expenses for the year ended December 31, 2022 increased 10% to 14.8millioncomparedto13.4 million for the year ended December 31, 2021[250] - General and administrative expenses for the year ended December 31, 2022 increased 5% to 20.2millioncomparedto19.3 million for the year ended December 31, 2021[251] - Net loss for 2022 was (75,561,000),comparedtoanetlossof(62,462,000) in 2021, representing a 21% increase in losses[307] - The company experienced a total loss from operations before taxes of 75.243millionin2022,whichisadeclinefromalossof62.237 million in 2021, representing a 20.9% increase in losses[410] Cash Flow and Financial Position - Cash and cash equivalents, excluding restricted cash, totaled approximately 74.4millionasofDecember31,2022,expectedtomeetcashneedsintoQ12024[256]−Netcashusedinoperatingactivitieswas58.9 million in 2022, compared to 40.7millionin2021,withanetlossof75.6 million in 2022[262] - Cash and cash equivalents decreased to 6,329,000in2022from18,129,000 in 2021, a decline of 65%[304] - The company had an accumulated deficit of 860.9millionandworkingcapitalof76.5 million as of December 31, 2022[317] - The company plans to obtain additional financing through equity sales, traditional loans, or strategic collaborations to support its operations[318] Assets and Liabilities - Total current assets decreased to 86,873,000in2022,down23.4113,297,000 in 2021[304] - Total liabilities decreased to 16,408,000in2022from17,227,000 in 2021, a reduction of 4.7%[304] - Stockholders' equity decreased to 99,645,000in2022from169,246,000 in 2021, a decline of 41%[304] - The net carrying amount of property and equipment was 9,542thousandasofDecember31,2022,adecreasefrom10,971 thousand in 2021, which is a decline of about 13.0%[396] - Total assets measured at fair value as of December 31, 2022, amounted to 75,530thousand,comparedto136,980 thousand as of December 31, 2021, indicating a decrease of approximately 44.7%[385] Research and Development - The company anticipates continued investment in research and development to enhance the LUNA Surgical System and digital laparoscopy platform[248] - The Company plans to continue substantial investments in research and development for the LUNA System and digital solutions platform[267] - Research and development expenses rose to 28,942,000in2022,anincreaseof49.519,348,000 in 2021[307] - Research and development expenses are expensed as incurred, focusing on engineering, product development, and regulatory expenses[363] Regulatory and Market Presence - The Senhance System is available for sale in multiple countries, including the U.S., Europe, Japan, and Taiwan, with regulatory approvals for various surgical procedures[232][233] - The company received FDA clearance for the ISU in March 2020, which is the only FDA cleared device for machine vision technology in abdominal robotic surgery[235] - For the year ended December 31, 2022, operations outside of the United States accounted for 89% of revenue, primarily concentrated in Europe[288] Stock and Compensation - Stock options granted in 2022 totaled 3.154 million shares, with a weighted average exercise price of 0.70[421]−ThebalanceofstockoptionsatDecember31,2022,was7.585millionshares,withaweightedaverageexercisepriceof4.22[421] - The company granted 6,996,822 restricted stock units in 2022, with an average grant date fair value of 0.71,resultingin8,483,491unvestedrestrictedstockunitsbyDecember31,2022[426]−Stock−basedcompensationexpensetotaled8.416 million for the year ended December 31, 2022, a decrease from 9.429millionin2021[428]ImpairmentsandContingencies−TheCompanyrecordedapropertyandequipmentimpairmentchargeof1.4 million in 2022, associated with Senhance Systems under operating leases, with no impairment charge in 2021[253] - The Company recorded a non-cash asset impairment charge of 1.4millionforpropertyandequipmentduringtheyearendedDecember31,2022[341]−Theallowanceforexpectedcreditlosseswas1.6 million as of December 31, 2022, compared to 1.7millionasofDecember31,2021[334]Taxation−TheCompanyreportedanincometaxexpenseof0.3 million in 2022, up from 0.2millionin2021,mainlyfromprofitableforeignjurisdictions[255]−Thetotalincometaxexpensefor2022was318,000, compared to 225,000in2021,reflectinganincreaseof41.3419.4 million as of December 31, 2022, with $253 million expected to expire unused due to limitations[412]