Nuwellis Stock Price, News & Analysis

Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology and medical device company focused on precision fluid management for patients with complex cardio-renal conditions, including those suffering from fluid overload and acute kidney injury. According to company disclosures, Nuwellis is dedicated to transforming the lives of patients with fluid overload through science, collaboration, and innovation, and is advancing technologies that make fluid balance measurable, controllable, and consistent across acute and chronic care settings.

The company is headquartered in Minneapolis, Minnesota, and has a wholly owned subsidiary in Ireland. Nuwellis’ primary commercial focus is the Aquadex SmartFlow^® system, a medical device platform used for ultrafiltration therapy. The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). It 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, including diuretics. Treatments are administered in inpatient or outpatient clinical settings by trained healthcare providers under physician prescription.

Nuwellis describes itself as advancing precision fluid management technologies across the cardio-renal continuum. Its portfolio includes both commercially available and development-stage technologies that address complex cardio-renal conditions, with an emphasis on safety, precision, and scalability across diverse patient populations. The company highlights monitoring, therapy, and data-informed clinical decision-making as core elements of its approach.

Core technology: Aquadex SmartFlow system

The Aquadex SmartFlow system is central to Nuwellis’ business. Company materials explain that Aquadex provides controlled ultrafiltration for patients with hypervolemia whose fluid overload has not responded to diuretics. The system is used in adult and pediatric patients (20 kg and above) and is designed to support both temporary (up to 8 hours) and extended (longer than 8 hours in hospitalized patients) treatments. All therapies must be delivered by healthcare professionals trained in extracorporeal therapies, within clinical environments under physician oversight.

Nuwellis emphasizes that Aquadex therapy can be applied across critical care, heart failure, nephrology, and hospital-based outpatient settings. Real-world data presented from institutions such as Lenox Hill Hospital and multi-center registries like ULTRA-Peds have examined Aquadex use in patients with acute kidney injury, post-cardiac-surgery volume overload, and other complex fluid management scenarios. The company points to these experiences as evidence of the system’s utility in managing fluid overload in critically ill and fluid-sensitive patients.

Pediatric and cardio-renal focus

A distinctive aspect of Nuwellis’ strategy is its focus on pediatric and cardio-renal care. The company reports growing adoption of Aquadex in high-acuity pediatric environments, including children’s hospitals and specialized nephrology and cardiology teams. These clinicians use Aquadex in complex cardiac, cardio-renal, and critical care cases where precise control of fluid volume is essential.

Nuwellis also sponsors and highlights pediatric research, such as the ULTRA-Peds registry, which examined real-world Aquadex use in children with acute kidney injury, fluid overload, or congenital kidney failure. According to company communications, the registry provides insight into how young children and infants are treated with ultrafiltration and modified dialysis using the Aquadex device and underscores the need for pediatric-specific technologies.

Vivian™ pediatric CRRT system in development

Beyond its commercial Aquadex platform, Nuwellis is developing Vivian™, a dedicated pediatric continuous renal replacement therapy (CRRT) system. Company descriptions state that Vivian is a purpose-built pediatric CRRT system designed for neonates and children, intended for patients between 2.5 kg and 20 kg. Vivian targets an extracorporeal blood volume of 29–67 mL and incorporates integrated hematocrit and SvO₂ sensors for real-time monitoring.

Nuwellis reports that Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. The system is described as having a guided, clinician-informed interface with on-screen prompts to streamline setup and reduce training burden, and a 6-port circuit to provide flexible vascular-access options. The company notes that Vivian was developed with direct input from pediatric intensive care and nephrology teams to prioritize safety, precision, and simplicity for fragile patients.

According to Nuwellis, Vivian is an investigational device under development and is not available for sale. Features and specifications are subject to change, and the company is working toward an investigational device study to support the path to U.S. regulatory clearance. Nuwellis has also disclosed that a multi-year grant from the National Institutes of Health (NIH) to its development partner, Koronis Biomedical Technologies Corporation, is supporting Vivian’s software and firmware development and an initial investigational study.

Intellectual property and safety-focused innovation

Nuwellis highlights a growing intellectual property portfolio that supports its pediatric roadmap and broader fluid management platform. The company has announced U.S. patents related to hemolysis sensing in extracorporeal blood filtration systems and advanced safety mechanisms for blood return line clamps. These patents are described as supporting Vivian and future platform innovation, particularly in detecting red blood cell destruction within extracorporeal circuits and enhancing clamp safety to improve reliability and consistency of blood flow control.

The company states that these safety-focused design innovations are especially relevant for pediatric applications, where precision and protection are critical. Nuwellis positions this intellectual property as part of a broader strategy to build a foundation of protected technology in pediatric extracorporeal therapy and cardio-renal care.

Regulatory and product developments

In addition to its core systems, Nuwellis reports regulatory and product milestones that support its fluid management platform. For example, the company has disclosed that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter, which is associated with Aquadex therapy. Nuwellis has also referenced the launch of a new 24-hour circuit and extended-length catheter options to enhance provider flexibility across inpatient and hospital-based outpatient programs.

On the capital markets side, Nuwellis trades on the Nasdaq under the symbol NUWE. The company has entered into an at-the-market (ATM) offering agreement that allows it to sell shares of common stock from time to time through a sales agent, under an effective shelf registration statement and prospectus supplement. The company has also reported the use of this ATM facility to raise capital.

Business model and segment focus

Based on company descriptions, Nuwellis operates as a medical device and medical technology business that develops, manufactures, and commercializes fluid management technologies. Earlier descriptions note that Nuwellis has one reportable segment focused on fluid overload. Its revenue model is centered on commercializing the Aquadex SmartFlow system and associated disposables and accessories used in ultrafiltration therapy in hospital and clinical settings.

The company’s strategy, as described in its communications, is to expand precision fluid management across critical care, pediatrics, heart failure, nephrology, and hospital-based outpatient therapy. Nuwellis also indicates that it is exploring the expansion of its technology platform beyond ultrafiltration, including potential acquisitions in renal health monitoring technologies aimed at providing earlier insight into fluid status and kidney function.

Research, grants, and clinical collaboration

Nuwellis supports clinical research and registry programs to generate evidence around its technologies. The ULTRA-Peds registry, funded by the company, is described as a multi-center observational study of Aquadex use in pediatric patients with acute kidney injury, fluid overload, or congenital kidney failure. The company states that this registry highlights gaps in pediatric care and informs its Vivian development program.

Nuwellis also collaborates with academic and clinical partners, as reflected in data presentations at nephrology conferences and joint work with hospital-based investigators. The NIH grant supporting Vivian’s development through Koronis Biomedical Technologies Corporation is another example of external funding aligned with the company’s pediatric and cardio-renal focus.

Geographic footprint

According to its public statements and SEC filings, Nuwellis is headquartered in Minneapolis, Minnesota, and maintains a wholly owned subsidiary in Ireland. The company has also referenced international operations in its financial reporting and has noted activities related to winding down certain international operations to focus on U.S. market growth.

Frequently asked questions (FAQ)

• What does Nuwellis, Inc. do?
  Nuwellis, Inc. is a medical technology and medical device company that develops, manufactures, and commercializes precision fluid management technologies for patients with fluid overload and cardio-renal conditions. Its primary commercial platform is the Aquadex SmartFlow system for ultrafiltration therapy.
• What is the Aquadex SmartFlow system?
  The Aquadex SmartFlow system is a medical device that delivers clinically proven ultrafiltration therapy to remove excess fluid from patients with hypervolemia (fluid overload) that is unresponsive to medical management, including diuretics. It is indicated for adult and pediatric patients weighing 20 kg or more and is used in inpatient and outpatient clinical settings by trained healthcare providers.
• How is Nuwellis involved in pediatric care?
  Nuwellis reports growing use of Aquadex in high-acuity pediatric settings, including children’s hospitals and pediatric nephrology and cardiology teams. The company funds pediatric research such as the ULTRA-Peds registry and is developing Vivian, a dedicated pediatric CRRT system for neonates and small children.
• What is the Vivian pediatric CRRT system?
  Vivian is an investigational, purpose-built pediatric continuous renal replacement therapy (CRRT) system designed for neonates and children between 2.5 kg and 20 kg. It targets low extracorporeal blood volumes and integrates hematocrit and SvO₂ sensors, multiple CRRT therapies, closed-loop ultrafiltration control tailored to patient weight, and a guided user interface. Vivian is under development and not available for sale.
• How does Nuwellis describe its cardio-renal strategy?
  The company describes its strategy as advancing precision fluid management therapies to improve recovery and outcomes for patients with cardiorenal conditions. This includes commercializing Aquadex, expanding into hospital-based outpatient therapy, supporting pediatric innovation, and developing technologies such as Vivian and potential renal health monitoring solutions.
• Where is Nuwellis headquartered?
  Nuwellis states that it is headquartered in Minneapolis, Minnesota, and that it has a wholly owned subsidiary in Ireland.
• What role does intellectual property play for Nuwellis?
  Nuwellis highlights a growing portfolio of issued and pending patents that support its pediatric systems and broader platform, including patents related to hemolysis sensing in extracorporeal circuits and advanced clamp safety mechanisms for blood return lines. These patents are intended to strengthen safety and performance in pediatric extracorporeal therapies.
• Is Vivian commercially available?
  No. Company disclosures specify that Vivian is an investigational device under development and is not available for sale. Its features and specifications are subject to change, and Nuwellis is working toward an investigational device study to support regulatory review.
• On which exchange does Nuwellis trade and under what ticker?
  Nuwellis, Inc. trades on the Nasdaq under the ticker symbol NUWE.
• Does Nuwellis focus on a specific business segment?
  Earlier company descriptions indicate that Nuwellis has one reportable segment focused on fluid overload. Its commercial and development activities center on technologies for fluid management in cardio-renal and critical care settings.