Revenue and Sales Performance - The company generated revenue of 13.0millionfortheninemonthsendedSeptember30,2024,comparedto4.8 million for the same period in 2023, indicating a significant increase [187]. - Revenue for the three months ended September 30, 2024, was 5.3million,a1562.1 million in the same period of 2023, primarily due to increased sales volume of left-heart access products through Medtronic [217]. - Revenue for the nine months ended September 30, 2024, was 13.0million,anincreaseof8.2 million, or 170%, compared to 4.8millionforthesameperiodin2023,drivenbyincreasedsalesvolumesofleft−heartaccessproductsthroughMedtronic[230].−FortheninemonthsendedSeptember30,2024,revenuefromcontinuingoperationswasentirelyU.S.−based[200].FinancialLossesandGains−Thenetlossfromcontinuingoperationswas3.2 million for the nine months ended September 30, 2024, compared to a net loss of 9.9millionforthesameperiodin2023[187].−Netlossondiscontinuedoperationswas4.9 million for the nine months ended September 30, 2024, a significant decrease of 33.1millioncomparedtoanetlossof38.0 million for the same period in 2023 [239]. - For the nine months ended September 30, 2024, net losses from continuing operations were 3.2million,comparedto9.9 million for the same period in 2023, indicating a reduction in losses [240]. Costs and Expenses - Cost of products sold for the three months ended September 30, 2024, was 4.9million,up553.1 million in the same period of 2023, attributed to increased sales volumes and improved manufacturing efficiencies [218]. - Cost of products sold was 13.0millionfortheninemonthsendedSeptember30,2024,anincreaseof5.2 million, or 66%, compared to 7.8millionforthesameperiodin2023[231].−Selling,general,andadministrativeexpensesforthethreemonthsendedSeptember30,2024,were2.3 million, a slight decrease from 2.4millioninthesameperiodof2023[214].−Selling,generalandadministrativeexpenseswere7.9 million for the nine months ended September 30, 2024, a decrease of 1.6million,or179.5 million for the same period in 2023 [233]. - The company expects costs of products sold to increase in absolute dollars as revenue grows in future periods [201]. Restructuring and Workforce Changes - The company recognized 24.1millionofestimatedpre−taxrestructuringandexit−relatedcharges,with19.0 million attributed to non-cash impairment charges [186]. - The company has reduced its workforce by approximately 65% as part of its restructuring efforts [185]. - The restructuring included workforce reductions and is expected to lead to decreased SG&A expenses in the upcoming years [204]. - The restructuring is expected to incur total costs between 7.0millionand12.0 million, of which 5.1millionhasalreadybeenpaid[250].CashandLiquidity−Thecompanyhasaworkingcapitalof12.5 million as of September 30, 2024, down from 27.3millionasofDecember31,2023[187].−AsofSeptember30,2024,thecompanyhadcash,cashequivalents,restrictedcash,andmarketablesecuritiestotaling12.6 million, down from 29.4millionasofDecember31,2023[240].−Thecompanyhasanobligationtomaintainaminimumliquidityof10 million at all times as per the recent amendments to the 2022 Credit Agreement [256]. Asset Sales and Earnouts - The company recognized a gain of 79.5millionfromthesaleofcertainassetstoMedtronicin2022,alongwithpotentialearnoutstotaling37 million [207]. - The company achieved net sales earnout payments of 13.2millionduringtheninemonthsendedSeptember30,2024,aspartofitsagreementwithMedtronic[243].−ThequarterlymeasurementperiodforNetSalesEarnoutsbeganonJanuary30,2023,with17.7 million earned from inception to September 30, 2024 [184]. Research and Development - The company has no research and development expenses following the restructuring, which aligns with its new business model [204]. - Research and development expenses were 0.0millionfortheninemonthsendedSeptember30,2024,adecreaseof2.8 million, or 100%, compared to 2.8millionforthesameperiodin2023[232].OtherFinancialMetrics−Thecompanyhasanaccumulateddeficitof608.1 million as of September 30, 2024, compared to 600.0millionasofDecember31,2023[187].−Interestincomedecreasedby1.6 million for the nine months ended September 30, 2024, compared to the same period in 2023, due to decreased cash and marketable securities balances [237]. - The change in fair value of warrant liability decreased by 0.1millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodin2023,primarilyduetoadeclineinthecompany′sstockprice[236].−Thecompanyhasrecordednoimpairmentstoorwrite−offsofaccountsreceivablesinceinception,withtotalaccountsreceivableof9.97 million as of September 30, 2024 [244]. - There have been no material changes to critical accounting policies and estimates from those disclosed in the previous annual report [274].