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].

As filed with the Securities and Exchange Commission on April 17, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TABLE OF CONTENTS Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on March 13, 2024 Registration No. 333-276562 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (I.R.S. Employer Identif ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 17, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) 12988 Valley View Road Eden Prairie, Minnesota 55344 (952) 345-4200 (Add ...