MINNEAPOLIS, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced strategic development initiatives to expand the capabilities of its Aquadex SmartFlow® System into a broader extracorporeal therapy platform. The program is intended to enhance the system's operating parameters by supporting higher blood flow rates, expanded operating pressure ranges, and broader compatibility with advanced extracorporeal therapies, creating the foundation for future therapeutic applications beyond ultrafiltration.
This strategic initiative is intended to expand the Company's long-term addressable market beyond fluid overload into additional critical care applications, including blood purification, immunomodulation and extracorporeal life support. Importantly, the broader platform is anticipated to enable strategic collaborations with developers of blood purification and other extracorporeal therapies by leveraging Nuwellis' expertise in precise fluid management to support integrated critical care solutions.
"We believe Aquadex has the potential to evolve from a differentiated ultrafiltration system into a versatile extracorporeal therapy platform. This initiative reflects our commitment to disciplined innovation while leveraging the significant engineering, regulatory, and clinical expertise we have built around the Aquadex platform," said Mike McCormick, Nuwellis President and Chief Executive Officer. "We believe the future of critical care will increasingly rely on integrated extracorporeal therapies that address multiple aspects of complex disease simultaneously. By expanding the operating capabilities of our platform, we are positioning Nuwellis at the forefront of the fastest-growing areas of critical care medicine, including immunomodulation, blood purification, and advanced life support."
Extracorporeal blood purification technologies have attracted growing clinical interest for their potential role in managing conditions including sepsis, systemic inflammatory response syndrome, acute kidney injury, liver failure, and other critical illnesses where removal of inflammatory mediators or circulating toxins may improve patient outcomes. As new therapies continue to emerge, clinicians are increasingly seeking flexible extracorporeal platforms capable of supporting multiple treatment modalities within the intensive care unit.
Nuwellis expects to provide future updates regarding technical milestones, regulatory strategy, and commercialization plans as the program progresses. The foregoing development initiatives are research-stage applications currently in development and are not yet approved, cleared, or licensed by the U.S. Food and Drug Administration (FDA). They are not currently available for commercial sale, distribution, or clinical use.
About Aquadex
The Aquadex SmartFlow System is currently indicated for the continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
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