Welcome to our dedicated page for Nuwellis news (Ticker: NUWE), a resource for investors and traders seeking the latest updates and insights on Nuwellis stock.
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology and medical device company centered on precision fluid management for patients with cardio-renal conditions and fluid overload. News about Nuwellis frequently highlights clinical data, regulatory milestones, pediatric innovation, and business updates related to its Aquadex SmartFlow® ultrafiltration system and its Vivian™ pediatric continuous renal replacement therapy (CRRT) platform in development.
Readers of this NUWE news page can follow company announcements on topics such as new patents for extracorporeal safety technologies, NIH grant-supported development of the Vivian pediatric system, and multi-center registries like ULTRA-Peds that examine real-world Aquadex use in critically ill children. Nuwellis also issues news about clinical experiences at hospitals, including studies presented at nephrology conferences that explore Aquadex applications in acute kidney injury, post-cardiac-surgery fluid overload, and complex critical-care cases.
In addition to clinical and technology updates, Nuwellis regularly reports quarterly financial results, at-the-market equity offering arrangements, and other material events through press releases and SEC-referenced communications. These updates provide insight into revenue trends, product launches such as new catheter sizes or circuits, and strategic steps like focusing on U.S. market growth.
Investors, clinicians, and researchers can use this news feed to track how Nuwellis is advancing its Aquadex platform, expanding into pediatric and hospital-based outpatient settings, and progressing the Vivian pediatric CRRT system. Returning to this page allows users to monitor ongoing developments in the company’s cardio-renal strategy, intellectual property portfolio, and regulatory and clinical milestones associated with NUWE.
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.
Nuwellis (Nasdaq: NUWE), a medical technology company specializing in fluid management, has announced the postponement of its Q2 2025 earnings release and conference call from August 12 to August 14, 2025.
The delay is attributed to the company requiring additional time for completing valuations and allowing their auditor, Baker Tilly US, LLP, to finish related audit procedures. The company clarified there are no disagreements with their auditor. The rescheduled conference call will take place at 9:00 AM ET on August 14, with both webcast and dial-in options available for investors.
Nuwellis (Nasdaq: NUWE) has achieved a significant milestone with the first successful treatment of patients using its Aquadex SmartFlow® ultrafiltration therapy in a hospital-based outpatient setting. This advancement follows the recent CMS decision to increase outpatient reimbursement from $413 to $1,639 per treatment day.
The treatment, performed at a leading healthcare institution in the southeastern United States, demonstrates Nuwellis's progress in expanding access to fluid management therapy. The outpatient model allows for treatment using existing venous access and care teams without requiring hospitalization, potentially reducing hospital readmissions while maintaining the same trusted clinical protocols used in inpatient settings.
Nuwellis (Nasdaq: NUWE), a medical technology company specializing in fluid management, announced that stockholders approved all proposals at their Special Meeting. The key approvals include: warrant exercise authorization for the June 2025 financing, an increase in authorized common stock from 100 million to 200 million shares, and authorization for a potential reverse stock split at a ratio between 1-for-5 and 1-for-70.
The reverse split authorization aims to maintain Nasdaq listing compliance, while the other measures are designed to enhance financial flexibility and support strategic growth initiatives.
Nuwellis (NUWE) announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. CEO John Erb presented at the event, sharing insights about his leadership journey, commitment to the company, and passion for Nuwellis' development programs.
The presentation is now accessible to investors through the Virtual Investor platform and Nuwellis' corporate website in the Investors section.
Nuwellis (Nasdaq: NUWE), a medical technology company specializing in fluid management solutions, has successfully regained compliance with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2). The company received formal confirmation from Nasdaq on July 22, 2025, resolving their previously disclosed bid price deficiency.
As a result, the scheduled hearing with the Nasdaq Hearings Panel for August 12, 2025, has been cancelled, and Nuwellis' common stock will continue trading on the Nasdaq Capital Market under the ticker "NUWE".
Nuwellis (Nasdaq: NUWE), a medical technology company specializing in fluid overload treatments, has scheduled its second quarter 2025 financial results announcement for August 12, 2025. The company will host a conference call and webcast at 9:00 AM ET to discuss the results and provide business updates.
Investors can access the live webcast through the company's investor relations website at ir.nuwellis.com, or join the conference call by dialing 1-800-245-3047 (U.S.) or 1-203-518-9765 (international) using conference ID: NUWEQ2.
Nuwellis (NASDAQ:NUWE) announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for fluid management in hospitalized heart failure patients. The company will redirect its focus toward outpatient heart failure care, pediatric, and critical care markets.
The trial, which began in 2022, had enrolled 167 patients before termination. This strategic decision is expected to save $4.0 million over 2.5 years. The company plans to analyze existing data for potential clinical publications. Importantly, the termination was not due to device performance or safety concerns, and the Nuwellis SmartFlow® remains FDA-cleared for fluid overload treatment.
Nuwellis (Nasdaq: NUWE) has been granted U.S. Patent No. 12,357,734 for its innovative blood filtering technology. The patent, titled "Extracorporeal Blood Filtering Machine and Methods," focuses on improving fluid balance calculation accuracy in continuous renal replacement therapy (CRRT) systems.
The patented technology addresses a critical issue in CRRT systems by accounting for varying fluid densities, moving beyond the standard assumption of 1 g/mL. This advancement enables more precise volumetric flow tracking, potentially reducing clinically relevant fluid balance errors.
The patent strengthens Nuwellis' intellectual property portfolio and reinforces its position in the fluid management therapy sector.