MINNEAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today announced that it will release financial results for the third quarter 2025 on November 12, 2025. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webca ...

ULTRA-Peds Registry, the largest multi-center dataset of its kind, shows Aquadex therapy was well-tolerated in critically ill children, a population with extremely limited treatment options Results highlight life-threatening gaps in pediatric care and underscore Nuwellis’ commitment to pediatric innovation and integrated cardio-renal care MINNEAPOLIS, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-rena ...

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]

MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care w ...

Core Insights - Nuwellis, Inc. has successfully treated the first patients with Aquadex ultrafiltration therapy in a hospital-based outpatient setting, marking a significant advancement in fluid management access and care [1][2][3] - The transition to outpatient therapy is supported by a recent increase in reimbursement rates, which enhances the economic viability for healthcare systems [3][4] Company Developments - The treatments were conducted at a leading healthcare institution in the southeastern United States, utilizing the Aquadex SmartFlow system and established clinical protocols [2] - Nuwellis is actively collaborating with healthcare providers to develop hospital-based outpatient programs, focusing on training, protocols, and workflow integration [5] Economic Impact - Outpatient reimbursement rates have increased from approximately $413 to $1,639 per treatment day, providing a sustainable model for health systems to manage complex patients and reduce readmissions [3] - The outpatient setting allows for treatment without hospitalization, optimizing resource management for healthcare systems [4] Product Information - The Aquadex SmartFlow system is designed for patients suffering from fluid overload, offering a clinically proven method for fluid removal [7] - The system is indicated for both temporary and extended use in adult and pediatric patients, requiring administration by trained healthcare providers [7]

Core Insights - Nuwellis, Inc. has announced the termination of its REVERSE-HF clinical trial to focus resources on outpatient markets with higher potential for impact and growth [1][2] - The company aims to redirect investments towards outpatient heart failure, pediatric, and critical care areas, anticipating savings of approximately $4.0 million over the next 2.5 years from this decision [2][3] Company Strategy - The decision to terminate the REVERSE-HF trial is part of a strategic commitment to prioritize areas that demonstrate the greatest potential for patient impact and business growth [1][2] - Nuwellis is experiencing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs, indicating a shift in focus towards this high-potential area [2] Clinical Trial Details - The REVERSE-HF trial began enrolling patients in 2022 and had enrolled 167 patients at the time of termination [3] - The company plans to collaborate with the steering committee and biostatisticians to derive statistical value from the existing data for future clinical publications [3] Product Information - The Nuwellis SmartFlow device remains on the market as an FDA-cleared treatment for fluid overload, and the termination of the trial was not related to device performance or patient safety concerns [4][6] - The Aquadex SmartFlow system is designed for ultrafiltration therapy, indicated for both adult and pediatric patients suffering from hypervolemia [6]