Stereotaxis(US:STXS)2025-11-12 20:39Regulatory Approvals and Product Development - The company completed the acquisition of Access Point Technologies EP, Inc. on July 31, 2024, enhancing its in-house catheter development and manufacturing capabilities[155]. - The GenesisX RMN System received CE Mark approval in Q3 2024 and FDA 510(k) clearance in Q4 2025, aimed at improving accessibility and reducing installation time for robotic systems[157]. - The Stereotaxis MAGiC catheter obtained CE marking in Europe in Q1 2025, and the MAGiC Sweep™ catheter received FDA 510(k) clearance in July 2025, expanding the product portfolio for cardiac ablation procedures[158]. - The Genesis RMN System and GenesisX RMN System have received regulatory approvals in the U.S., Europe, and China, facilitating market expansion[152]. - The company is pursuing regulatory approvals for the EMAGIN 5F catheter guide, designed for navigating complex vascular structures[158]. - The company plans to advance the adoption of its robotic magnetic navigation systems and proprietary devices in markets where regulatory clearance has been received in 2025[173]. Financial Performance - Revenue decreased from $9.2 million for the three months ended September 30, 2024, to $7.5 million for the three months ended September 30, 2025, a decrease of 19%[192]. - Revenue from the sales of systems decreased to $1.9 million for the three months ended September 30, 2025, from $4.4 million for the same period in 2024, driven by decreased sales volume[192]. - Revenue from sales of disposable interventional devices, service, and accessories increased to approximately $5.6 million for the three months ended September 30, 2025, from $4.8 million for the same period in 2024, an increase of approximately 17%[192]. - Revenue increased from $20.6 million for the nine months ended September 30, 2024, to $23.7 million for the nine months ended September 30, 2025, an increase of approximately 15%[198]. - Revenue from sales of disposable interventional devices, service, and accessories increased to $16.9 million for the nine months ended September 30, 2025, from $13.3 million for the nine months ended September 30, 2024, an increase of approximately 27%[198]. Expenses and Losses - Cumulative net losses incurred by the company reached approximately $577.8 million as of September 30, 2025[173]. - The company anticipates incurring additional losses in 2025 as it continues product development and commercialization efforts[173]. - Cost of revenue increased from $9.2 million for the nine months ended September 30, 2024, to $11.0 million for the nine months ended September 30, 2025, an increase of approximately 19%[199]. - Overall gross margin decreased to 54% for the nine months ended September 30, 2025, from 55% for the nine months ended September 30, 2024[199]. - General and administrative expenses increased from $12.1 million for the nine months ended September 30, 2024, to $13.7 million for the nine months ended September 30, 2025, an increase of approximately 13%[203]. - Research and development expenses decreased from $7.0 million for the nine months ended September 30, 2024, to $6.7 million for the nine months ended September 30, 2025, a decrease of 4%[200]. - Sales and marketing expenses decreased from $9.5 million for the nine months ended September 30, 2024, to $9.4 million for the nine months ended September 30, 2025, a decrease of approximately 1%[201]. Cash Flow and Financial Position - As of September 30, 2025, the company had $10.5 million of cash and cash equivalents and working capital of $6.3 million[205]. - The company generated approximately $7.8 million of cash from financing activities during the nine months ended September 30, 2025, compared to $0.1 million during the same period in 2024[209]. - The company did not have any debt as of September 30, 2025[210]. Market and Economic Factors - The global tariff environment remains fluid, with potential impacts on cost structure and product launch timing due to recent tariff changes[159]. - The company anticipates less than a 1% increase in expenses for H2 2025 if current reduced reciprocal tariffs remain in place[165]. - Supply chain disruptions and geopolitical factors continue to pose risks to future operations and liquidity[168]. - The company continues to monitor the impact of macroeconomic factors on project timing, regulatory approvals, and operating results[173]. - The company expects to fund operations primarily through proceeds from past and future public offerings and private sales of equity securities[173]. - The company cannot guarantee that additional funding will not be needed in the future due to the macroeconomic environment[174]. Patient Treatment and Clinical Support - The company has treated over 150,000 arrhythmia patients globally using its robotic technology, supported by over 500 clinical publications[146]. - The Odyssey Solution is being replaced by next-generation solutions, Synchrony and SynX, which enhance procedure efficiency and remote connectivity[149].