Nuwellis Announces the First Successful Outpatient Application of the Aquadex Smartflow® System Under New CMS Code

Supported by the recent CMS decision to increase the reimbursement rate, which facilitates broader use of the therapy in outpatient settings

MINNEAPOLIS, Aug. 05, 2025 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming fluid management, today announced that the first patients have been successfully treated with Aquadex^® ultrafiltration therapy in a hospital-based outpatient setting. This milestone reflects a major advancement in the company’s mission to improve access to fluid management and support better care across the continuum.

The treatments were performed at a leading healthcare institution in the southeastern United States using the same Aquadex SmartFlow^® system and clinical protocols trusted in inpatient environments. By enabling therapy in a hospital-based outpatient setting, Nuwellis is helping to reimagine how and where patients with fluid overload can be supported—offering a potential new model for earlier, more proactive care.

“For patients struggling with fluid overload, access to consistent, effective therapy can make a life-changing difference,” said John Erb, CEO of Nuwellis. “This milestone represents more than just a shift in setting—it reflects our vision for expanding how care is delivered and making fluid management more flexible, scalable, and patient-centered.”

In addition to the clinical benefits, hospitals may also realize significant economic advantages by transitioning appropriate therapies to outpatient care. With outpatient reimbursement increasing from approximately $413 to $1,639 per treatment day, this model offers a more sustainable path forward for health systems facing pressure to reduce readmissions while managing complex patients more effectively.

The hospital-based outpatient setting provides an opportunity to treat patients using existing venous access and care teams, without requiring hospitalization. This approach may offer significant advantages to patients who are repeatedly admitted due to volume challenges, while also helping healthcare systems manage resources more efficiently.

Nuwellis continues to work closely with providers to support hospital-based outpatient program development, including training, protocols, and workflow integration. The company sees this as a foundational step in building sustainable access to ultrafiltration therapy—and a key part of its long-term strategy to expand the impact of Aquadex.

For more information, please visit www.nuwellis.com and to learn more about the Company’s reimbursement for outpatient, please visit the reimbursement page.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow^® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly Twitter.

About the Aquadex SmartFlow^® System 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). The Aquadex SmartFlow system is indicated 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 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

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 2025 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.

For further information, please contact:

Investor Relations:
Robert Scott
Chief Financial Officer
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com