Nuwellis Inc Stock Price, News & Analysis

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.

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.