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. reported steady performance and key milestones in critical care, pediatrics, and hospital-based outpatient therapy, focusing on cardiorenal conditions [1][3] Financial Performance - Total revenue for Q3 2025 was $2.2 million, a decrease of 6% year-over-year but an increase of 29% sequentially from Q2 2025 [4][7] - On a pro-forma basis, revenue grew approximately 7% year-over-year after excluding one-time revenue from SeaStar Medical [4][7] - Gross margin was 65.2%, down from 70.0% in the prior year quarter, attributed to unfavorable manufacturing utilization [5] - Operating expenses totaled $4.1 million, up 30% year-over-year, reflecting investments in rebuilding the U.S. sales force and sustaining engineering [6] - The operating loss was $2.7 million, compared to $1.5 million in the previous year [6][19] Business Developments - The company launched a new 24-hour circuit and dual-lumen extended-length catheter, enhancing provider flexibility in therapy delivery [7] - The first Aquadex therapies were delivered in a hospital-based outpatient setting, marking a significant step in expanding access to ultrafiltration therapy [7] - Pediatric product development accelerated through an NIH-funded collaboration for the Vivian™ pediatric CRRT system [7] - Nuwellis initiated a manufacturing transition to KDI Precision Manufacturing and began winding down international operations to focus on U.S. market growth [7] Cash Position - The company ended the quarter with $3.1 million in cash and cash equivalents and remains debt-free [6][19]

Core Insights - The ULTRA-Peds registry reveals that Aquadex therapy is well-tolerated in critically ill children, highlighting significant gaps in pediatric care and Nuwellis' commitment to innovation in this field [1][3][4] Study Overview - The ULTRA-Peds registry enrolled 91 pediatric patients across eight U.S. centers, with diagnoses including congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%) [2] - The registry provides a comprehensive real-world dataset for understanding treatment in this vulnerable population [2] Results and Findings - The results indicate strong survival rates, with 92% of patients surviving their treatment course and 66% surviving to hospital discharge [7] - 86% of circuits completed their intended treatment course without interruption, demonstrating the feasibility of Aquadex therapy in this demographic [7] Future Developments - Nuwellis is advancing the development of Vivian, a dedicated pediatric continuous renal replacement therapy (CRRT) system designed for neonates and small children weighing between 2.5 kg and 20 kg [6] - Vivian aims to address the unique physiological needs of infants, providing a safer and more precise tool for kidney support [6][11] Company Strategy - The company's roadmap focuses on moving from evidence to innovation to leadership in pediatric kidney support, supported by NIH funding and new intellectual property [5][6] - The ULTRA-Peds registry serves as a foundation for Nuwellis' pediatric and cardio-renal strategy, emphasizing the urgent need for dedicated technology in this area [6][8]

Core Insights - Nuwellis, Inc. has been granted U.S. Patent No. 12,415,021 for a technology related to hemolysis sensors in extracorporeal blood filtration systems, enhancing patient safety in fluid management [1][2]. Group 1: Patent and Technology - The patent focuses on the integration of hemolysis sensors with systems like ultrafiltration therapy and continuous renal replacement therapy (CRRT) to detect red blood cell destruction [2][4]. - This technology allows for the assessment of hemolysis origins, whether from outside the system or within the extracorporeal circuit, enabling timely responses from care teams [4][5]. Group 2: Importance of Hemolysis Monitoring - Hemolysis, the destruction of red blood cells, can significantly impact patient safety by reducing oxygen-carrying capacity and potentially leading to misinterpretation of filter issues [3]. - Standard blood-leak detectors may not effectively identify hemolyzed blood, highlighting the need for advanced monitoring solutions [3]. Group 3: Product Development - Nuwellis is developing a pediatric CRRT system named Vivian, designed specifically for neonates and children, featuring integrated sensors for real-time monitoring [6]. - Vivian supports multiple therapies on a single platform and is tailored for patients weighing between 2.5 kg and 20 kg, emphasizing safety and ease of use [6]. Group 4: Company Overview - Nuwellis, Inc. is dedicated to improving the lives of patients with fluid overload through innovative medical devices and is focused on commercializing the Aquadex SmartFlow system [8]. - The company is headquartered in Minneapolis and has a subsidiary in Ireland, indicating a global operational footprint [8].