Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $2.2 million, a 6% decrease from Q3 2024, primarily due to one-time prior year Seastar Medical Quellimune sales and a decrease in international revenues [9] - On a proforma basis, revenue grew approximately 7% year-over-year after excluding the Seastar Medical revenue and the decrease in international revenue [9] - Gross margin for the quarter was 65.2%, down from 70% in Q3 2024, primarily due to underabsorption of fixed overhead from lower production volumes earlier in the year [10] - Operating loss for the quarter was $2.7 million compared to an operating loss of $1.5 million in Q3 2024 [11] - Net income attributable to common shareholders was $469,000 or $0.56 per share, compared to $2.4 million or $73.23 per share in the prior year quarter [11] Business Line Data and Key Metrics Changes - Heart failure and critical care customer categories saw revenue increases of 41% and 15% year-over-year, respectively, while pediatrics declined by 7% [10] - There was a 15% year-over-year increase in consumables utilization, which partially offset the revenue decline [9] - All customer categories experienced year-over-year growth in circuit sales, with heart failure and critical care benefiting from stronger console demand [10] Market Data and Key Metrics Changes - The company is focusing on three growth areas: critical care, pediatrics, and hospital-based outpatient heart failure therapy, which are expected to define a new standard for precision fluid management [13] - The introduction of new products, such as the 24-hour Aquadex circuit and dual-lumen extended length catheter, is aimed at expanding access and compatibility across care environments [6] Company Strategy and Development Direction - The company is transitioning manufacturing to KDI Precision Manufacturing and exiting European operations to sharpen focus on the U.S. market [7] - The strategy emphasizes clinical value, scalability, and growth in precision fluid management across the cardiorenal continuum [8] - The company aims to build a sustainable growth model centered on technology, evidence, and access to improve patient outcomes [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in Q3, highlighting the growing adoption of Aquadex therapy and its impact on fluid management in hospitals [5] - The company anticipates realizing incremental cost efficiency from the manufacturing transition beginning next year, which should support margin expansion [10] Other Important Information - The company ended the quarter with $3.1 million in cash and cash equivalents and remained debt-free [12] - A net equity raise of $1.9 million in Q3, combined with a $4 million raise in June, provides flexibility for continued execution of the U.S. revenue growth strategy [12] - Recognition was given to Rob Scott for his contributions as Chief Financial Officer during his tenure [13] Q&A Session Summary Question: No questions were asked during the Q&A session - There were no questions from participants during the Q&A session [15]

Core Insights - Nuwellis, Inc. has received a notice of allowance for a new patent related to advanced safety mechanisms for blood return line clamps in extracorporeal blood filtration systems, specifically for the Vivian Pediatric Continuous Renal Replacement Therapy (CRRT) System [1][3] - The patented technology enhances safety by dynamically adjusting clamping force based on environmental factors and improving material stability through thermal insulation [2] - The company emphasizes its commitment to pediatric innovation and safety, with a growing portfolio of intellectual property supporting the Vivian system [3][4] Company Overview - Nuwellis, Inc. is a medical technology company focused on solutions for patients with cardio-renal conditions, headquartered in Minneapolis with a subsidiary in Ireland [6] - The company is dedicated to transforming the lives of patients suffering from fluid overload through innovative therapies, including the Aquadex SmartFlow system [6][7] Product Details - The Aquadex SmartFlow system is designed for ultrafiltration therapy in patients with fluid overload, indicated for both temporary and extended use in adults and pediatric patients weighing 20 kg or more [7] - The Vivian system is a pediatric CRRT platform designed for neonates and children, featuring integrated sensors for real-time monitoring and multiple therapy options [8]

Core Insights - Daxor Corporation has launched a new Blood Volume Analysis (BVA) program at a healthcare center in the Tampa Bay region of Florida, enhancing fluid management and treatment outcomes for various medical conditions [1][3] - The facility will utilize Daxor's CLIA-certified ezBVA Lab, which provides blood volume analysis results within 24 hours [2] - Daxor's technology offers 98% accurate blood volume measurements, allowing for customized fluid management strategies, which can lead to improved patient outcomes and reduced healthcare costs [3] Company Overview - Daxor Corporation is recognized as the global leader in blood volume measurement technology, having developed the BVA-100, the only FDA-cleared diagnostic blood test for quantifying blood volume status [4] - Over 65,000 tests have been conducted at leading hospitals in the U.S., significantly improving performance metrics in various medical conditions, particularly in reducing mortality and readmissions for heart failure and critical care patients [4] - The company is engaged in ongoing trials for heart failure treatment with support from the NIH and is developing analyzers for combat casualty care in collaboration with the U.S. Department of Defense [4]