Nuwellis Inc Stock Price, News & Analysis

Nuwellis (Nasdaq: NUWE) announced real-world data from Lenox Hill Hospital presented at ASN Kidney Week 2025 showing Aquadex ultrafiltration used across critical-care indications including oliguric AKI, post-cardiac-surgery volume overload, and pre-operative ESRD optimization.

The retrospective review of 69 cases (2018–2024) reported an average 6.4 liters removed per patient over a mean 78 hours with stable hemodynamics, including patients on vasopressors, supporting broader clinical utility of precision ultrafiltration.

Nuwellis (Nasdaq: NUWE) announced that a leading children’s hospital in the Northeast U.S. has initiated an Aquadex Ultrafiltration Program on Dec. 4, 2025. Pediatric nephrology and cardiology teams are adopting Aquadex for its minimal extracorporeal volume and real-time hematocrit monitoring to manage fluid-sensitive, high-acuity pediatric patients.

The company says Aquadex usage is expanding across leading children’s hospitals nationwide and is being integrated into care pathways for complex cardiac, cardio-renal, and critical care cases, supporting Nuwellis’ pediatric growth strategy.

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.