Nuwellis (NUWE) FDA Approvals

Nuwellis' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuwellis (NUWE). Over the past two years, Nuwellis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Aquadex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Aquadex SmartFlow® FDA Regulatory Events

Aquadex SmartFlow® is a drug developed by Nuwellis for the following indication: For patients suffering from hypervolemia (fluid overload). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - August 5,2025

• Drug: Aquadex SmartFlow®
• Announced Date: August 5, 2025
• Indication: For patients suffering from hypervolemia (fluid overload).

Nuwellis, Inc. announced that the first patients have been successfully treated with Aquadex® ultrafiltration therapy in a hospital-based outpatient setting.

Nuwellis, Inc. announced that the first patients have been successfully treated with its Aquadex ultrafiltration therapy in a hospital-based outpatient setting. The treatments used the same Aquadex SmartFlow system and clinical protocols trusted in hospitals. By moving therapy outside the inpatient unit, Nuwellis hopes to reach patients earlier and offer a more proactive model for fluid overload care. The approach uses existing venous access and care teams, so patients avoid hospital stays yet still get safe, effective fluid removal.

This new outpatient model could also save hospitals money. Outpatient reimbursement has jumped from about $413 to $1,639 per treatment day, making the approach more sustainable. Nuwellis is working with healthcare providers to set up outpatient programs, including training, workflow integration, and protocol support. The company sees this milestone as a key step toward expanding access and improving patient-centered fluid management.

Publication - August 27,2024

• Drug: Aquadex SmartFlow®
• Announced Date: August 27, 2024
• Indication: For patients suffering from hypervolemia (fluid overload).

Nuwellis, Inc. is pleased to announce the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60 day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who are otherwise resistant to diuretic treatment.

Nuwellis, Inc. announced a new study published in Current Problems in Cardiology that shows Aquadex® ultrafiltration therapy effectively reduces 60-day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who do not respond well to diuretic treatment. The study, conducted in a community hospital setting, involved 30 patients and focused on evaluating whether the Aquadex therapy could lower the high rehospitalization rates often seen in these patients.

Key findings revealed that the therapy led to significant volume loss and weight reduction without harming renal function. Importantly, patients experienced a drop in heart failure readmissions, with rates falling from 26.7% before treatment to 16.7% after therapy initiation. This research supports Aquadex ultrafiltration as a promising treatment option for managing fluid overload in ADHF patients resistant to standard diuretic therapies.

Nuwellis FDA Events - Frequently Asked Questions

Has Nuwellis received FDA approval?

As of now, Nuwellis (NUWE) has not received any FDA approvals for its therapy in the last two years.

What drugs has Nuwellis submitted to the FDA?

In the past two years, Nuwellis (NUWE) has reported FDA regulatory activity for Aquadex SmartFlow®.

What is the most recent FDA event for Nuwellis?

The most recent FDA-related event for Nuwellis occurred on August 5, 2025, involving Aquadex SmartFlow®. The update was categorized as "Provided Update," with the company reporting: "Nuwellis, Inc. announced that the first patients have been successfully treated with Aquadex® ultrafiltration therapy in a hospital-based outpatient setting."

What conditions do Nuwellis' current drugs treat?

Currently, Nuwellis has one therapy (Aquadex SmartFlow®) targeting the following condition: For patients suffering from hypervolemia (fluid overload)..