Financial Performance - Device sales for the three months ended June 30, 2023, increased by 1.6million,or140.66.016 million, a 97.8% increase from 3.042millioninthesameperiodof2022[106].−ThegrossmarginforthethreemonthsendedJune30,2023,was1.444 million, compared to a loss of 165,indicatingasignificantimprovementinprofitability[106].−Servicesalesincreasedby0.4 million, or 57.5%, for the six months ended June 30, 2023 compared to the same period in 2022, driven by an increase in the install base [108]. - Device sales increased by 2.6million,or109.410.637 million, a 54.1% reduction from a net loss of 23.159millioninthesameperiodof2022[106].−Thecompanyreportedanetlossof22.8 million for the six months ended June 30, 2023, with an accumulated deficit of 232.3millionasofthesamedate[124].−ThenetlossforthesixmonthsendedJune30,2023,was22.8 million, compared to a net loss of 46.9millionforthesameperiodin2022[131][132].ExpensesandCostManagement−Researchanddevelopmentexpensesdecreasedby3110.792 million for the six months ended June 30, 2023, down from 15.599millioninthesameperiodof2022[106].−OperatingexpensesforthethreemonthsendedJune30,2023,werereducedby4313.136 million compared to 23.027millioninthesameperiodof2022[106].−Researchanddevelopmentexpensesdecreasedby4.8 million, or 30.8%, for the six months ended June 30, 2023 compared to the same period in 2022, primarily due to reduced personnel and consulting costs [113]. - General and administrative expenses decreased by 11.9million,or50.82.9 million, or 36.2%, for the six months ended June 30, 2023 compared to the same period in 2022, mainly due to lower personnel and marketing event costs [118]. - Total cost of sales increased by 294thousand,or9.493.9 million, which is expected to support operations for at least the next 12 months [125]. - For the six months ended June 30, 2023, net cash used in operating activities was 23.2million,adecreasefrom44.2 million in the same period of 2022 [131][132]. - Net cash used in investing activities remained consistent at 0.3millionforboththesixmonthsendedJune30,2023,and2022,attributedtofixedassetpurchases[133][134].−Netcashprovidedbyfinancingactivitiesincreasedto0.1 million in the first half of 2023 from 2,000inthesameperiodof2022,primarilyfromoptionexercises[135][136].−AsofJune30,2023,thecompanyhad95 million in cash, cash equivalents, and restricted cash, primarily in money market funds and savings accounts [146]. Market and Product Development - The total installed base of the Swoop® system reached 131 units as of June 30, 2023, up from 92 units in the same period of 2022, representing a growth of 42.4% [97]. - The company received FDA clearance for the latest update of the Swoop® system software in February 2023, which significantly improves diffusion-weighted imaging (DWI) quality [94]. - The Swoop® system is positioned to expand the 32 billion imaging market by increasing access to MRI technology in various healthcare settings [91]. - The company has deployed 20 Swoop® system units to hospitals in low-middle income settings through funding from the Bill & Melinda Gates Foundation [104]. - The company received a 3.4 million grant from the BMGF in May 2023 to develop a scalable approach to measuring neurodevelopment in low-to-middle income countries, with 0.5millionreceivedbyJune30,2023[138].RisksandFutureOutlook−Thecompanyanticipatescontinuedcashburnandnetlossesuntilproductandservicesalesgeneratesufficientgrossprofittocoveroperatingexpenses[124].−A0.5percentagepointdecreaseininterestrateswoulddecreaseearningsbeforeincometaxesby0.5 million based on the balance sheet position at June 30, 2023 [146]. - Inflationary pressures may increase manufacturing costs, which could adversely affect the company's financial condition and results of operations [147]. - The company operates primarily in U.S. dollars and does not have significant exposure to foreign exchange risk [148].