Nuwellis Inc Stock Price, News & Analysis

Nuwellis (NASDAQ:NUWE) has secured U.S. Patent No. 12,415,021 for innovative hemolysis sensing technology in blood filtration systems. The patent, issued on September 16, 2025, specifically supports their pediatric device Vivian and future platform developments.

The technology enables detection of red blood cell destruction through hemolysis sensors placed at the circuit inlet and ultrafiltrate line, helping medical teams distinguish between external hemolysis and issues within the extracorporeal circuit. This advancement is particularly significant for improving the safety of ultrafiltration therapy and continuous renal replacement therapy (CRRT).

Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, announced its participation in a Virtual Investor segment to discuss a significant $3 million NIH grant awarded to its development partner, Koronis Biomedical Technologies Corporation (KBT).

The grant will support the development of Vivian™, a pediatric continuous renal replacement therapy (CRRT) device designed for patients under 20 kilograms. Additionally, the funding will help advance core software and firmware development that will benefit Nuwellis' broader product portfolio.

Nuwellis (Nasdaq: NUWE) has secured a significant $3 million multi-year NIH grant through its development partner Koronis Biomedical Technologies Corporation. The funding will accelerate the development of Vivian™, a dedicated pediatric continuous renal replacement therapy (CRRT) device designed for patients weighing between 2.5 and 20 kg.

The grant will support firmware and software development and fund an FDA investigational device study targeting approximately 15 patients. Vivian builds upon Nuwellis' Aquadex SmartFlow® technology, currently approved for patients 20 kg and above, addressing a critical gap in pediatric renal care where therapeutic options are limited.

Nuwellis (NASDAQ:NUWE) announced the upcoming launch of a new 24-hour circuit for Aquadex therapy in the United States this fall. This addition complements their existing 72-hour circuit option, enabling hospitals to better match supply with care settings while maintaining consistent therapy delivery.

The new circuit is specifically designed for single-day outpatient sessions, supporting hospitals in building outpatient Aquadex programs that deliver scheduled fluid removal treatment without requiring hospital admission. The innovation aims to streamline clinic operations, enhance scheduling efficiency, and increase treatment capacity while providing patients with convenient same-day visits.

Nuwellis (Nasdaq: NUWE) has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The catheter, available in 11 cm and 15 cm lengths, is designed for peripheral venous access to support ultrafiltration therapy with the Aquadex system for up to 72 hours.

The clearance advances Nuwellis' strategy to build a comprehensive fluid management platform across various care settings, from ICU to outpatient facilities. The dELC features coil reinforcement and dual-lumen design for consistent blood flow, supporting the company's focus on three growth areas: critical care, cardiac surgery recovery, and hospital-based outpatient heart failure programs.

Nuwellis (Nasdaq: NUWE) has signed a non-binding letter of intent to acquire Rendiatech Ltd., an Israeli medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The proposed acquisition would add Rendiatech's FDA-cleared Clarity RMS monitoring system and its next-generation Clarity Prime system to Nuwellis' portfolio.

The strategic acquisition aims to expand Nuwellis' technology platform beyond ultrafiltration into continuous renal health monitoring. The deal targets improved patient outcomes in acute kidney injury (AKI) management, which affects 20-50% of ICU patients with over 50% mortality rate. The transaction is expected to close in Q4 2025, following a 45-day due diligence period and subject to final approvals.

Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for critically ill patients, will participate in the upcoming Webull Financial Corporate Connect Webinar Series focused on Biotech/MedTech companies.

The virtual presentation will be delivered by John Erb, President and Chief Executive Officer, on Thursday, August 21, 2025 at 2:40 PM ET. The event is part of a broader virtual conference taking place from August 19-21, 2025.

Nuwellis (Nasdaq: NUWE) reported Q2 2025 financial results, with revenue declining to $1.7 million from $2.2 million in Q2 2024, primarily due to industry-wide sterilization vendor issues. The company's gross margin contracted to 55.5% from 67.2% year-over-year.

Key developments include expanding to 47 pediatric centers, completing a $5 million gross capital raise, and executing a manufacturing outsourcing plan to KDI Precision Manufacturing. The company reported a net loss of $12.6 million, or $60.99 per share, compared to $7.7 million loss in Q2 2024. As of June 30, 2025, Nuwellis maintained $4.5 million in cash and remained debt-free.

Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, has announced its strategic decision to exit international operations to concentrate exclusively on the U.S. market. The company is making this move to capitalize on strong growth and clinical demand in U.S. cardiac surgery and pediatric programs, as well as expanding opportunities in hospital-based outpatient settings.

Led by CEO John Erb, Nuwellis will implement a structured wind-down of international operations while intensifying its focus on high-acuity and hospital-based outpatient settings in the U.S. market. The strategic realignment aims to prioritize investment in areas showing the strongest momentum and growth potential, particularly in cardiac surgery, pediatrics, and outpatient models.