Financial Performance - Net sales for the three months ended March 31, 2025, were 0.6million,adecreaseof0.2 million (27%) compared to 0.8millionforthesameperiodintheprioryear,primarilyduetolowerdemandfortissueproducts[106].−Costofproductssoldduringthesameperiodwas0.2 million, a decrease of 0.3million(560.5 million for the same period in the prior year, attributed to reduced net sales and changes in product mix [107]. - Loss before income taxes from continuing operations was 21.9millionforQ12025,anincreaseof5.8 million (36%) compared to Q1 2024 [112]. - Net cash used in operating activities during Q1 2025 was 21.5million,anincreaseof6.0 million (38%) compared to 15.5millioninQ12024[119].−CashandcashequivalentsasofMarch31,2025,were49.0 million, down from 70.5millionasofDecember31,2024[115].−TheaccumulateddeficitasofMarch31,2025,was298.3 million, up from 276.4 million as of December 31, 2024 [114]. Research and Development - R&D expenses increased to 16.5 million, an increase of 4.9million(4211.6 million for the same period in the prior year, driven by upscaling manufacturing capabilities and preparatory activities for the Pivotal Trial [108]. - The company anticipates requiring substantial additional funds to achieve long-term goals and complete R&D of current products [116]. - The company expects to continue incurring substantial losses in the near future until regulatory approval is obtained for its products [116]. Operational Activities - The company has treated over 100 patients with the DurAVR® THV system across the United States, Canada, and Europe as of March 31, 2025 [85]. - The company is expanding global manufacturing capacity to support the PARADIGM Trial, aiming to increase capacity to at least three times the 2024 levels [96]. Capital and Financing - The initial public offering on December 12, 2024, raised net proceeds of 80.0millionafterdeductingunderwritingdiscountsandexpenses[86].−Capitalcommitmentsrelatingtopropertyleaseswere1.3 million as of March 31, 2025 [115]. - The company had commitments to purchase 0.2millionofplantandequipmentasofMarch31,2025[124].OtherIncomeandExpenses−Selling,generalandadministrativeexpensesdecreasedto5.7 million, a reduction of 0.8million(136.5 million for the same period in the prior year, mainly due to lower costs associated with the initial public offering [109]. - Other non-operating income decreased to 0.1million,adeclineof0.3 million (78%) compared to 0.4millionforthesameperiodintheprioryear,primarilyduetotherecognitionofadditionalgovernmentgrantsinthepreviousyear[110].−Netforeignexchangelosseswere0.2 million, a change of 1.5million(1181.2 million for the same period in the prior year, influenced by fluctuations in foreign exchange rates [111]. Cash Flow Activities - Net cash provided by investing activities during Q1 2025 was 1.1million,achangeof1.8 million (255%) compared to cash outflows of 0.7millioninQ12024[120].−NetcashusedinfinancingactivitiesduringQ12025was1.1 million, a change of 2.6million(1701.6 million in Q1 2024 [121].