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Nuwellis Inc (NUWE) is a leader in developing medical devices for fluid overload management and renal monitoring. This page serves as the definitive source for verified news and official announcements about the company’s innovations in critical care technology.
Access real-time updates on Aquadex SmartFlow System deployments, RenalSense Clarity RMS clinical validations, and strategic partnerships. Investors and healthcare professionals will find essential information about regulatory milestones, research findings, and operational developments directly impacting patient care standards.
Our curated collection includes earnings reports, product launch details, and peer-reviewed study outcomes. All content is rigorously verified to ensure accuracy while maintaining accessibility for both medical experts and general investors.
Bookmark this page for streamlined access to NUWE’s latest advancements in ultrafiltration therapy and kidney function monitoring technologies. Return regularly to stay informed about developments shaping the future of fluid management solutions.
Nuwellis (Nasdaq: NUWE) reported third quarter 2025 results on Nov 12, 2025, delivering $2.2 million total revenue, down 6% year‑over‑year and up 29% sequentially.
The company reported a 65.2% gross margin, operating expenses of $4.1 million (up 30% YoY) and an operating loss of $2.7 million. Nuwellis ended the quarter with $3.1 million cash, no debt, and raised $1.9 million through an ATM.
Operational milestones include first Aquadex therapies delivered in hospital‑based outpatient settings under a new CMS code, U.S. launch of a 24‑hour circuit and dual‑lumen extended‑length catheter, accelerated pediatric development via an NIH‑funded collaboration and a newly issued U.S. patent, plus a manufacturing transition and international wind‑down to focus on U.S. growth.
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.
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