Nuwellis, Inc.
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- Nuwellis, Inc. (Nasdaq: NUWE) develops, manufactures, and commercializes medical devices for ultrafiltration therapy to treat fluid overload in patients with heart failure, critical illness, and related conditions; its core products include the Aquadex SmartFlow and Aquadex FlexFlow systems, comprising consoles, disposable blood circuit sets, disposable catheters, and a new U.S.-launched 24-hour circuit alongside FDA-cleared dual-lumen extended-length catheters. The company, founded in 1999 and headquartered in Eden Prairie, Minnesota, sells directly to hospitals and clinics in the United States while distributing through independent partners in countries including Austria, Brazil, Germany, India, Israel, Italy, Singapore, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom; it targets critical care, cardiology, nephrology, and pediatric segments with approximately 47 pediatric centers adopting Aquadex therapy. Recent developments encompass a May 2024 purchase agreement with a top-25 U.S. integrated delivery network for Aquadex deployment across 50 hospitals, a strategic manufacturing transition to KDI Precision Manufacturing, a $5 million capital raise in Q2 2025, expanded CMS reimbursement enabling first hospital-based outpatient therapies, new U.S. patents for fluid bag designs and blood return line clamps, participation in a $3 million NIH grant via partner Koronis Biomedical for the Vivian pediatric CRRT system, and an August 2025 non-binding letter of intent to acquire Rendiatech Ltd. for its FDA-cleared Clarity RMS real-time urine flow and acute kidney injury monitoring technologies, anticipated to close in Q4 2025.
Nuwellis Awarded U.S. Patent for Novel Catheter Technology Designed to Enhance Extracorporeal Therapies
Nuwellis to Showcase Aquadex Therapy at KidneyBee Summit 2026
Nuwellis Celebrates Five Years of Support of the Pediatric Cardiac Critical Care Consortium (PC⁴)
Nuwellis Announces Pediatric Expansion in Michigan with First Aquadex SmartFlow® Installations
Incoming Nuwellis CEO Mike McCormick Underscores Strategic Priorities for Continued Market Expansion in Pediatric Category and Revenue Generation in Letter to Shareholders
Nuwellis Expands Critical Care Education with Aquadex Training at University of Minnesota Critical Care Cardiology Education Summit
Nuwellis Appoints Mike McCormick as Chief Executive Officer
Nuwellis Expands Collaboration with Major South Carolina Healthcare System to Install New Aquadex SmartFlow® Devices at One of its Children's Hospitals
Nuwellis Announces Closing of $6.0 Million Registered Public Offering
Nuwellis Announces Pricing of $6 Million Public Offering
Nuwellis Announces Successful Completion of FDA Pre-Submission 510(k) Meeting to Expand Aquadex Label
Nuwellis, Inc. (NUWE) Q1 2026 Earnings Call Transcript
Nuwellis, Inc. Announces First Quarter 2026 Financial Results
Nuwellis, Inc. To Announce First Quarter 2026 Financial Results on May 12, 2026
Nuwellis Highlights Case Study Featuring Precision Ultrafiltration Therapy in Pediatric Cardiorenal Care at ISHLT 2026 Annual Meeting
Nuwellis Highlights Case Study Featuring Precision Ultrafiltration Therapy in Pediatric Cardiorenal Care at ISHLT 2026 Annual Meeting
Nuwellis Announces Receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for Innovative Dual Lumen Midline Catheter Technology
Nuwellis to Participate in the AATS 106th Annual Meeting and ERAS Cardiac Spring Retreat
Nuwellis Announces Aquadex Software Update
Nuwellis Welcomes Back Three Former Team Members to Accelerate Commercial and Clinical Momentum