Nuwellis has expanded its collaboration with a South Carolina healthcare system to integrate its Aquadex SmartFlow devices into a children's hospital. The provider also upgraded to the latest Aquadex devices at its two locations that already use the technology. This expansion aims to help clinicians provide controlled, predictable fluid removal for pediatric patients.

The Aquadex system is designed to provide precise ultrafiltration therapy for adult and pediatric patients weighing 20 kg and above who are suffering from fluid overload. The therapy supports improved patient management and may help reduce rehospitalizations associated with heart failure and related conditions.

"Expanding this important collaboration will bring our Aquadex therapy to more pediatric patients in need," said Nuwellis' CEO John Erb. "This further validates Nuwellis' ultrafiltration system as a clinically important and increasingly adopted solution for managing fluid overload, while reinforcing our growing leadership and continued momentum in the pediatric category."

Nuwellis recently completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) to propose expansion of the Aquadex SmartFlow System's label to support pediatric patients weighing 5 kg and above. The Company anticipates submitting to the FDA by the end of 2026.

Nuwellis, Inc. (NASDAQ: NUWE) has closed a registered public offering of common stock and pre-funded warrants, generating gross proceeds of approximately $6.0 million. The offering included 1,903,338 shares of common stock and pre-funded warrants to purchase 18,096,662 shares of common stock. Each share and pre-funded warrant was accompanied by Series C Warrants to purchase up to 60,000,000 shares of common stock and Series D Warrants to purchase up to 20,000,000 shares of common stock.

The public offering price per share of common stock and accompanying warrants was $0.30. The public offering price per pre-funded warrant and accompanying warrants was $0.2999. Each pre-funded warrant has an exercise price of $0.0001 and is immediately exercisable until fully exercised. The Series C and Series D Warrants have an exercise price of $0.30 and are exercisable for five years following stockholder approval and the effective date of a reverse stock split.

Offering Details

The Series C Warrants include a one-time reset of the exercise price if the company implements a reverse stock split. The reset price will be the greater of 20% of the combined public offering price or 90% of the lowest daily volume weighted average price for the five trading days following the reverse stock split. The Series D Warrants include a zero cash exercise option, allowing holders to receive shares without additional payment.

Ladenburg Thalmann & Co. Inc. acted as the sole book-running manager for the offering. The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-296198), declared effective by the U.S. Securities and Exchange Commission (SEC) on June 4, 2026, and a registration statement on Form S-1 (File No. 333-296518) filed on June 5, 2025.

Nuwellis, Inc. is a medical technology company focused on delivering solutions for patients with cardiorenal conditions. The company develops technologies for monitoring, therapy, and clinical decision-making in acute and chronic care settings.