Welcome to our dedicated page for Nuwellis news (Ticker: NUWE), a resource for investors and traders seeking the latest updates and insights on Nuwellis stock.
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology and medical device company centered on precision fluid management for patients with cardio-renal conditions and fluid overload. News about Nuwellis frequently highlights clinical data, regulatory milestones, pediatric innovation, and business updates related to its Aquadex SmartFlow® ultrafiltration system and its Vivian™ pediatric continuous renal replacement therapy (CRRT) platform in development.
Readers of this NUWE news page can follow company announcements on topics such as new patents for extracorporeal safety technologies, NIH grant-supported development of the Vivian pediatric system, and multi-center registries like ULTRA-Peds that examine real-world Aquadex use in critically ill children. Nuwellis also issues news about clinical experiences at hospitals, including studies presented at nephrology conferences that explore Aquadex applications in acute kidney injury, post-cardiac-surgery fluid overload, and complex critical-care cases.
In addition to clinical and technology updates, Nuwellis regularly reports quarterly financial results, at-the-market equity offering arrangements, and other material events through press releases and SEC-referenced communications. These updates provide insight into revenue trends, product launches such as new catheter sizes or circuits, and strategic steps like focusing on U.S. market growth.
Investors, clinicians, and researchers can use this news feed to track how Nuwellis is advancing its Aquadex platform, expanding into pediatric and hospital-based outpatient settings, and progressing the Vivian pediatric CRRT system. Returning to this page allows users to monitor ongoing developments in the company’s cardio-renal strategy, intellectual property portfolio, and regulatory and clinical milestones associated with NUWE.
Nuwellis (Nasdaq: NUWE) announced a notice of allowance from the U.S. Patent and Trademark Office dated Nov 10, 2025 for a patent covering advanced safety mechanisms for blood return line clamps used in extracorporeal blood filtration systems, including the Vivian Pediatric CRRT System in development.
The technology dynamically adjusts clamping force, reconditions tubing under defined thermal conditions, and adds thermal insulation to improve material stability. This patent supplements a Sept 2025 patent for hemolysis sensing and complements NIH grant-funded research and Aquadex pediatric use data to inform Vivian design.
Nuwellis (Nasdaq: NUWE) will release its third quarter 2025 financial results on November 12, 2025. The company will host a conference call and live webcast at 9:00 AM ET to discuss results and provide a general business update.
Investors can access the live webcast on the company's Investors page at https://ir.nuwellis.com or join the call by dialing 1-800-274-8461 (U.S.) or 1-203-518-9814 (international) using conference ID NUWEQ3. An audio archive will be posted on the Investors page after the call.
Nuwellis (Nasdaq: NUWE) announced groundbreaking results from their ULTRA-Peds registry study evaluating the Aquadex System in pediatric patients with kidney conditions. The multi-center study, involving 91 pediatric patients across 8 U.S. centers, demonstrated remarkable outcomes with a 92% survival rate during treatment and 66% survival to hospital discharge.
The study included patients with congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%). The Aquadex therapy showed strong procedural success, with 86% of circuits completing treatment without interruption. Building on these results, Nuwellis is developing Vivian, a dedicated pediatric CRRT system for infants weighing 2.5-20kg, supported by a $3 million NIH grant.
Nuwellis (NASDAQ:NUWE) has secured U.S. Patent No. 12,415,021 for innovative hemolysis sensing technology in blood filtration systems. The patent, issued on September 16, 2025, specifically supports their pediatric device Vivian and future platform developments.
The technology enables detection of red blood cell destruction through hemolysis sensors placed at the circuit inlet and ultrafiltrate line, helping medical teams distinguish between external hemolysis and issues within the extracorporeal circuit. This advancement is particularly significant for improving the safety of ultrafiltration therapy and continuous renal replacement therapy (CRRT).
Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, announced its participation in a Virtual Investor segment to discuss a significant $3 million NIH grant awarded to its development partner, Koronis Biomedical Technologies Corporation (KBT).
The grant will support the development of Vivian™, a pediatric continuous renal replacement therapy (CRRT) device designed for patients under 20 kilograms. Additionally, the funding will help advance core software and firmware development that will benefit Nuwellis' broader product portfolio.
Nuwellis (Nasdaq: NUWE) has secured a significant $3 million multi-year NIH grant through its development partner Koronis Biomedical Technologies Corporation. The funding will accelerate the development of Vivian™, a dedicated pediatric continuous renal replacement therapy (CRRT) device designed for patients weighing between 2.5 and 20 kg.
The grant will support firmware and software development and fund an FDA investigational device study targeting approximately 15 patients. Vivian builds upon Nuwellis' Aquadex SmartFlow® technology, currently approved for patients 20 kg and above, addressing a critical gap in pediatric renal care where therapeutic options are limited.
Nuwellis (NASDAQ:NUWE) announced the upcoming launch of a new 24-hour circuit for Aquadex therapy in the United States this fall. This addition complements their existing 72-hour circuit option, enabling hospitals to better match supply with care settings while maintaining consistent therapy delivery.
The new circuit is specifically designed for single-day outpatient sessions, supporting hospitals in building outpatient Aquadex programs that deliver scheduled fluid removal treatment without requiring hospital admission. The innovation aims to streamline clinic operations, enhance scheduling efficiency, and increase treatment capacity while providing patients with convenient same-day visits.
Nuwellis (Nasdaq: NUWE) has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The catheter, available in 11 cm and 15 cm lengths, is designed for peripheral venous access to support ultrafiltration therapy with the Aquadex system for up to 72 hours.
The clearance advances Nuwellis' strategy to build a comprehensive fluid management platform across various care settings, from ICU to outpatient facilities. The dELC features coil reinforcement and dual-lumen design for consistent blood flow, supporting the company's focus on three growth areas: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.
Nuwellis (Nasdaq: NUWE) has signed a non-binding letter of intent to acquire Rendiatech Ltd., an Israeli medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The proposed acquisition would add Rendiatech's FDA-cleared Clarity RMS monitoring system and its next-generation Clarity Prime system to Nuwellis' portfolio.
The strategic acquisition aims to expand Nuwellis' technology platform beyond ultrafiltration into continuous renal health monitoring. The deal targets improved patient outcomes in acute kidney injury (AKI) management, which affects 20-50% of ICU patients with over 50% mortality rate. The transaction is expected to close in Q4 2025, following a 45-day due diligence period and subject to final approvals.
Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for critically ill patients, will participate in the upcoming Webull Financial Corporate Connect Webinar Series focused on Biotech/MedTech companies.
The virtual presentation will be delivered by John Erb, President and Chief Executive Officer, on Thursday, August 21, 2025 at 2:40 PM ET. The event is part of a broader virtual conference taking place from August 19-21, 2025.