Nuwellis Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter

MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC).

Advancing a broader fluid management platform:

This clearance supports Nuwellis’ multi-year plan to build a comprehensive fluid management platform—combining therapy delivery, dedicated venous access, and practical implementation support—so hospitals and clinics can standardize how they identify patients, begin ultrafiltration therapy earlier, and sustain programs from the ICU to step-down and hospital-based outpatient settings. The company’s strategy centers on three growth drivers: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.

“Clinicians have asked for dependable peripheral access that works across inpatient units and emerging outpatient programs,” said John Erb, Chief Executive Officer of Nuwellis. “With two extended lengths and coil reinforcement, the dELC helps teams match access to the patient and care setting, streamlining workflow, and delivering therapy with increased confidence. This new length is another step in strengthening our technology platform and enabling consistent, repeatable use of Aquadex across care pathways.”

Why it matters for clinicians:

• Peripheral access, central-line performance — Coil reinforcement and dual-lumen design enable consistent blood flow for ultrafiltration therapy.
• Choice of lengths — 11 cm and 15 cm options help match patient size and site-of-care needs.
• Fits existing workflows — Configured for compatibility with the Aquadex SmartFlow® systems used in hospitalized and outpatient heart failure pathways.

Indications for Use:

The dELC is indicated for use up to 72 hours in attaining venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy.

The dELC is designed to provide reliable peripheral venous access to support extracorporeal fluid removal with the Aquadex® system, aligning with Nuwellis’ strategy to make precise fluid management simpler and more accessible across care settings. The cleared portfolio now includes two coil-reinforced, 6F catheters with 11 cm and 15 cm insertable lengths to accommodate a range of patient anatomies and clinical workflows.

For more information, visit www.nuwellis.com.

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 known as 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:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
nuwe@jtcir.com

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

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