Nuwellis (NUWE) FDA Events

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.

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 27, 2024, involving Aquadex SmartFlow®. The update was categorized as "Publication," with the company reporting: "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."

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)..