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. develops and commercializes medical technology for patients with cardiorenal conditions, including Aquadex SmartFlow ultrafiltration therapy for fluid removal in fluid overload. Company news commonly covers financial results, Aquadex software and product updates, patent activity for catheter technology, clinical case studies in pediatric and heart-failure care, medical-meeting participation, commercial territory expansion, and hospital-support initiatives.
Nuwellis (Nasdaq: NUWE) entered a staged co-promotion and distribution agreement with Atrility Medical for its FDA-cleared AtriAmp device, expanding Nuwellis’ pediatric and critical care portfolio and creating a milestone-based pathway to broader U.S. distribution.
The initial six-month pilot covers three Nuwellis sales territories across approximately nine Western and five Southeastern states. Nuwellis will support Atrility’s existing accounts, pursue new customers, and receive commissions on sales in these territories. Upon successful completion of the pilot, Nuwellis is expected to become Atrility’s exclusive U.S. distributor for much of the country, purchasing products directly and assuming sales, distribution and order-fulfillment responsibilities.
Nuwellis (Nasdaq: NUWE) reported second quarter 2026 revenue of $2.0 million, up 14% year over year, with U.S. revenue up 17%. First-half 2026 revenue was $4.4 million, a 20% increase, driven primarily by higher U.S. circuit and console sales and stronger pediatrics, critical care, and heart failure segments.
Second quarter gross margin improved to 76% from 56% a year earlier, reflecting pricing actions, favorable mix, and the transition to contract manufacturing. Operating expenses rose to $4.7 million, and net loss was $4.8 million, including $1.7 million of non-cash warrant valuation expense, versus a $12.6 million loss in the prior-year quarter.
Nuwellis raised approximately $12.7 million in gross proceeds across June and July financings and warrant exercises, extending its cash runway through the second quarter of 2027 and ending June 30, 2026 with $3.9 million in cash and equivalents. The company also sold nine consoles in the quarter, advanced an Aquadex label expansion for smaller pediatric patients following a successful FDA pre-submission meeting, and appointed Mike McCormick as President and CEO effective June 30, 2026.
Nuwellis (Nasdaq: NUWE) announced a digital transformation program for its Aquadex SmartFlow® System to position it as a connected extracorporeal therapy platform for intensive care settings. The initiative uses Philips Capsule™ interoperability technology and a next-generation tablet-based user interface to enhance EHR connectivity and clinician workflow.
The program comprises integration with leading electronic health record systems so Aquadex therapy data can flow automatically into patient records, and a modern UI to display key therapy and device status information. According to Nuwellis, these research-stage enhancements are not yet FDA approved and are not available for commercial or clinical use.
Nuwellis (Nasdaq: NUWE) appointed veteran medical device engineer Dale Brady as Principal R&D Engineer, strengthening its product development organization for cardiorenal solutions. According to Nuwellis, Brady joins the research and development team to advance existing and new product development programs.
Brady brings more than 25 years of experience across R&D, operations, manufacturing, quality systems and commercialization. He has led multidisciplinary teams taking products from concept through regulatory submission, manufacturing scale-up and commercial launch at startups and public device companies, and is inventor or co-inventor on 10 issued U.S. patents and 16 pending applications.
Nuwellis (Nasdaq: NUWE) announced strategic development initiatives to evolve its Aquadex SmartFlow® System from a focused ultrafiltration device into a broader extracorporeal therapy platform. The program aims to support higher blood flow rates, expanded pressure ranges, and compatibility with advanced therapies such as immunomodulation, blood purification, and extracorporeal life support.
According to Nuwellis, this research-stage effort is intended to expand its long-term addressable market and enable collaborations with developers of extracorporeal therapies. The company emphasized that these new applications are in development, are not FDA-approved, and are not available for commercial sale or clinical use.
Nuwellis (Nasdaq: NUWE) entered a definitive securities purchase agreement with institutional investors for a registered direct offering of 1,310,890 common shares at $2.59 per share, for approximately $3.4 million in gross proceeds, priced at-the-market under Nasdaq rules.
According to Nuwellis, it also received about $3.1 million in gross proceeds from the exercise of warrants issued in its June 2026 public offering. In a concurrent private placement, investors will receive five-year warrants to purchase up to 1,310,890 additional shares at $2.59 per share. Closing is expected on or about August 3, 2026, subject to customary conditions, with Ladenburg Thalmann acting as exclusive placement agent.
Nuwellis (Nasdaq: NUWE) reported that a single-center retrospective study on its Aquadex ultrafiltration therapy in critically ill pediatric patients has been accepted for publication in Frontiers in Pediatrics. The study evaluated epoprostenol, a short-acting agent that inhibits platelet clumping, as the sole anticoagulant during Aquadex therapy.
The review of 46 children (52 treatment courses) at UPMC Children's Hospital of Pittsburgh (September 2022–September 2025) found that circuit performance was maintained, vasoactive support did not increase, platelet counts were stable or modestly higher, and no bleeding events were attributed to epoprostenol. The authors describe the work as a feasibility report rather than proof of superiority. Nuwellis said it only provided modest funding for open-access publication, with no support for conducting the research.
Nuwellis (Nasdaq: NUWE) announced its entry into Wisconsin’s pediatric critical care market through the first installations of its Aquadex SmartFlow® systems at a leading pediatric academic medical center. The collaboration aims to build clinical pathways and integrate Aquadex therapy into the hospital’s pediatric program.
The company continues to focus on pediatric and critical care expansion, targeting fluid-overloaded patients unresponsive to diuretics and weighing 20 kilograms or more. Nuwellis recently completed a pre-submission meeting with the FDA on expanding the Aquadex label to patients 5 kilograms and above and anticipates a 510(k) submission by the end of 2026.
Nuwellis (Nasdaq: NUWE) released unaudited preliminary results for the quarter ended June 30, 2026, expecting 14% year-over-year revenue growth for the second quarter and 20% growth for the first six months of 2026. Management attributes this performance to continued commercial momentum and increasing adoption of the Aquadex Ultrafiltration platform.
According to Nuwellis, final second-quarter and first-half 2026 financial results will be reported on August 13, 2026, before the U.S. market open, followed by a conference call and webcast at 9:00 a.m. Eastern time.
Nuwellis (Nasdaq: NUWE) announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,678,592 for the company’s Dual Lumen Catheter, a peripheral dual-lumen catheter intended for extracorporeal therapies such as ultrafiltration, dialysis, and continuous renal replacement therapy (CRRT). The patent was issued on July 14, 2026.
According to Nuwellis, the design uses a reinforcing stainless-steel coil to help prevent catheter collapse under negative pressure from blood pumps while allowing clinicians to trim the catheter to a patient-specific length without compromising structural integrity. The company states that this may improve blood flow, support longer filter life, and provide greater flexibility across adult and pediatric patient populations, further expanding its intellectual property portfolio in cardiorenal fluid management.