Core Insights - Nuwellis, Inc. has reinforced its leadership in precision ultrafiltration for patients with acute kidney injury and fluid overload through new real-world data presented at the 2025 ASN Kidney Week [1][2] Group 1: Study Findings - A retrospective analysis reviewed 69 cases treated with Aquadex from 2018 to 2024, demonstrating effective fluid removal in patients with various underlying conditions [2] - The analysis revealed an average of 6.4 liters of ultrafiltrate removed over a mean duration of 78 hours, with stable hemodynamics even among patients on vasopressor support [3] - The study emphasizes that Aquadex can be safely applied across a wide range of complex patients, aiding clinicians in achieving euvolemia when other measures are insufficient [4] Group 2: Clinical Relevance - The findings support precision ultrafiltration as a complement to traditional kidney replacement therapy, with moderate and individualized ultrafiltration rates linked to improved outcomes in critically ill patients [5] - Aquapheresis is increasingly relevant in nephrology and critical care, where controlled fluid removal can stabilize hemodynamics and support renal recovery [6] - The study reflects a shift in fluid management practices, highlighting its importance as a vital sign of patient stability [7] Group 3: Company Overview - Nuwellis, Inc. is dedicated to advancing cardio-renal care by enabling earlier, safer, and more controlled fluid management for patients [8] - The Aquadex SmartFlow system is designed for ultrafiltration therapy, indicated for patients with fluid overload unresponsive to medical management [9]

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 - Nuwellis, Inc. will release its financial results for Q3 2025 on November 12, 2025, and will host a conference call at 9:00 AM ET to discuss these results and provide a business update [1] Company Overview - Nuwellis, Inc. is a medical technology company focused on solutions for patients with cardio-renal conditions, particularly addressing the relationship between the heart and kidneys [1] - The company is dedicated to transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - Nuwellis is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow system is designed for ultrafiltration therapy, effectively removing excess fluid from patients suffering from hypervolemia [4] - The system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [4]

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].

Core Insights - Nuwellis, Inc. announced participation in a Virtual Investor segment discussing a significant NIH grant awarded to its development partner, Koronis Biomedical Technologies Corporation [2][3] - The NIH grant, approximately $3 million, aims to accelerate the development of Nuwellis' pediatric continuous renal replacement therapy device, Vivian™, for patients under 20 kilograms [3] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions for critically ill patients, with a commitment to innovation and collaboration [5] - The company is commercializing the Aquadex SmartFlow system for ultrafiltration therapy and is headquartered in Minneapolis, with a subsidiary in Ireland [5]

Core Insights - Nuwellis, Inc. plans to launch a new 24-hour circuit for Aquadex therapy in the U.S. this fall, designed for single-day outpatient sessions, complementing the existing 72-hour option for multi-day therapy or inpatient care [1][3] - The introduction of the 24-hour circuit aligns with the growing trend of hospitals establishing outpatient Aquadex programs, aiming to provide predictable, scheduled care for patients needing fluid removal without hospital admission [2][3] Company Overview - Nuwellis, Inc. is a medical device company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration, with a primary focus on the Aquadex SmartFlow system for ultrafiltration therapy [5] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5] Product Details - The Aquadex SmartFlow system is clinically proven for removing excess fluid from patients suffering from hypervolemia, indicated for temporary (up to 8 hours) or extended use in patients weighing 20 kg or more [6] - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [6]

Core Viewpoint - Nuwellis, Inc. has signed a non-binding letter of intent to acquire Rendiatech, Ltd., aiming to enhance its fluid management technology offerings, particularly in continuous renal health monitoring [1][3]. Company Overview - Nuwellis, Inc. is a medical technology company focused on improving patient outcomes through advanced fluid management, currently commercializing the Aquadex SmartFlow system for ultrafiltration therapy [7]. - Rendiatech, Ltd. specializes in real-time urine flow and acute kidney injury monitoring technologies, with its key product being the Clarity RMS, an FDA-cleared critical care monitoring system [6]. Proposed Acquisition Details - The acquisition will potentially add Rendiatech's Clarity RMS and the next-generation Clarity Prime system to Nuwellis' product portfolio, enhancing real-time urine monitoring capabilities [2][5]. - The transaction is expected to close in the fourth quarter of 2025, pending due diligence and final Board approval [5]. Strategic Importance - The acquisition aligns with Nuwellis' growth strategy to achieve cash flow positivity and enhance its comprehensive fluid management offerings [3]. - Real-time urine output monitoring is critical for detecting acute kidney injury (AKI), which affects 10% to 20% of emergency hospital admissions, with higher rates in ICU settings [4]. Market Impact - The integration of Rendiatech's technologies is anticipated to improve clinical outcomes through earlier detection of AKI and dehydration, particularly in complex ICU patients [4].

Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions for critically ill patients [3] - The company is dedicated to transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - Nuwellis is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Upcoming Event - Nuwellis will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech, held virtually from August 19-21, 2025 [1] - The presentation is scheduled for August 21, 2025, at 2:40 PM ET, and will be led by John Erb, President and CEO [1] - Registration for the event is available through a provided link [1] Industry Context - Webull Financial is a leading online brokerage platform that empowers self-directed investors with innovative tools and technology [2] - The platform offers low-cost trading on a wide range of assets and advanced charting tools, catering to millions of users globally [2] - Webull Financial is registered with the SEC and CFTC, and is a member of FINRA, NFA, and SIPC [2]

Core Insights - Nuwellis, Inc. reported a revenue of $1.7 million for Q2 2025, down from $2.2 million in Q2 2024, primarily due to a product backorder linked to an industry-wide sterilization vendor issue [3][5][7] - The company is focusing on high-impact growth areas in pediatric and cardiac surgery care while preparing for expansion in outpatient heart failure [2][3] - Nuwellis completed a $5 million gross capital raise during the quarter and has a cash position of $4.5 million as of June 30, 2025 [5][7] Financial Performance - Gross margin decreased to 55.5% in Q2 2025 from 67.2% in Q2 2024, attributed to lower production volumes [4] - Operating loss for the quarter was $2.9 million, compared to a loss of $2.3 million in Q2 2024 [5][15] - Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to a net loss of $7.7 million, or a loss of $791.82 per share in Q2 2024 [5][15] Business Developments - The pediatric category remains a key driver of sustained demand, with 47 pediatric centers adopting Aquadex therapy [7] - The company executed a transition plan to outsource manufacturing to KDI Precision Manufacturing [7] - Nuwellis expanded its intellectual property portfolio with a new U.S. patent covering a fluid bag design that passively drains once full [7]