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) will convene a pediatric Medical & Nursing Advisory Board on November 18–19, 2026, to support Vivian system development. Vivian is a continuous renal replacement therapy platform under development for children as small as 2.5 kilograms. Approximately a dozen providers, nurses and clinical advisors from 11 U.S. pediatric institutions will evaluate the latest system.
Nuwellis expects the feedback to guide design decisions and development priorities. Separately, it is seeking an Aquadex SmartFlow label expansion to pediatric patients weighing 5 kilograms or more, compared with the current 20-kilogram minimum labeled patient weight.
Nuwellis (NUWE) will participate in four October 2026 medical conferences to highlight its Aquadex SmartFlow system for fluid management. The events cover pediatric care, critical care and heart failure: PPETS in Houston, October 6–8; STS in Baltimore, October 9–10; HFSA in Phoenix, October 9–12; and ASN Kidney Week in Denver, October 21–25.
Nuwellis (NUWE) reported continued commercial momentum for its Aquadex SmartFlow system, with 31 consoles sold year-to-date in 2026, already exceeding full-year console sales achieved in seven of the past 10 years.
This puts 2026 on pace to be one of the company’s top three years for console placements. The expanding installed base is paired with 26% year-over-year U.S. revenue growth in the first half of 2026, driven across pediatric, critical-care, and heart-failure markets. Each new console increases opportunities for recurring revenue from single-use blood circuits, which Nuwellis believes can support a larger, more durable recurring-revenue business in a normalized hospital environment.
Nuwellis (NUWE) appointed Brian Johnson as Director of Quality and Regulatory Affairs, bringing 13 years of medical device quality and regulatory experience.
Johnson has led quality systems, regulatory activities, audits and product development at prior employers, including Baxter/Vantive and ATL Medical, where he helped reduce monthly customer complaints by 80%. He holds a Master of Science in Regulatory Affairs and Services and a Bachelor of Science in Manufacturing Engineering Technology. At Nuwellis, he will oversee quality systems, audits, supplier and contract manufacturer oversight, and regulatory compliance, working cross‑functionally to support product quality, continuous improvement and advancement of the company’s cardiorenal technology portfolio.
Nuwellis (NUWE) reported continued progress in its financial efficiency strategy, highlighted by second-quarter 2026 gross margin of 76%.
The company marks one year since transitioning Aquadex production to contract manufacturer KDI Manufacturing, which has supplied nearly 5,000 AquaFlexFlow blood circuits, 30 Aquadex SmartFlow consoles and serviced more than 200 consoles while maintaining quality inspection rates comparable to pre-transition levels. Gross margin rose from 56% in the prior-year quarter, and cash totaled approximately $8.8 million as of August 31, 2026, which Nuwellis estimates will fund operations into the third quarter of 2027.
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.