Nuwellis (NASDAQ:NUWE) executives emphasized a year of restructuring and strategic narrowing during the company’s fourth-quarter 2025 earnings call, pointing to manufacturing changes, a reduced international footprint, and a sharpened commercial focus on cardiorenal patients as key themes.
Management frames 2025 as a “structural change” year
Chairman and CEO John Erb said 2025 was “not a continuation year,” describing it instead as a period of “structural change and deliberate repositioning.” While full-year revenue declined 5% versus 2024, Erb said the company’s focus during the year was strengthening its operating foundation and clarifying long-term strategy.
Erb also said Nuwellis refined its international commercial strategy, reducing exposure in markets with “inconsistent returns” and reallocating resources to geographies where clinical demand and conversion are more predictable. In the Q&A, he pointed specifically to ongoing losses in the European Union and said the company made the decision to exit the EU, which he said reduced cash burn.
Fourth-quarter revenue rises; gross margin improves
New CFO Carisa Schultz reported fourth-quarter 2025 revenue of $2.4 million, up 4% from the prior-year quarter and up 9% sequentially. The year-over-year increase was driven by higher U.S. console sales and pricing, along with higher international revenue tied to distributor “last time buys” in territories the company was exiting.
- U.S. console sales: up 208% year over year, with 8 units sold versus 3 in the prior-year quarter.
- Circuit average selling price: up 11% year over year, according to Schultz.
- International sales: up 59% year over year, largely due to last time buys associated with exited distributor territories.
- Critical care revenue: down 24% year over year, partially offsetting gains elsewhere.
Sequentially, Schultz said revenue growth was driven primarily by increased catheter utilization, partially offset by lower console sales compared to the third quarter.
Gross margin for the fourth quarter was 68.2%, up from 58.4% in the prior-year period. Operating expenses were $4.1 million, up $0.4 million from the year-ago quarter, which Schultz attributed to higher professional services, recruiting activity, and targeted development initiatives. Operating loss was $2.4 million, flat year over year, and net loss attributable to common shareholders was also $2.4 million.
Full-year results: revenue down, heart failure and pediatrics grow
For the full year, Schultz reported revenue of $8.3 million, down 5% from 2024. She attributed the decline to several factors, including lower consumables utilization, lower U.S. console average selling prices, reduced international contributions following strategic rationalization, and prior-year SeaStar sales before that agreement’s termination.
Within the company’s end markets, Schultz said heart failure and pediatrics grew 8% and 14% year over year, respectively, while critical care declined 19%.
Full-year gross margin was 62%, which Schultz said was three percentage points lower than the prior year. Operating expenses were $16.2 million, slightly lower than the prior year, which management attributed to tighter expense discipline and improved forecasting rigor.
Net loss attributable to common shareholders for 2025 was $17.5 million. Schultz said that figure included a $6.4 million non-cash warrant valuation expense and approximately $0.3 million in executive severance expense.
Liquidity, financing, and capital priorities
Management said liquidity management remained a central priority. Schultz reported full-year cash utilization of approximately $10.9 million. The company ended 2025 with approximately $1.2 million in cash and no outstanding debt.
During 2025, Nuwellis raised approximately $7 million in net proceeds through financing activities to support operations during what management described as a period of transition.
Looking into 2026, Schultz said financial priorities include gross margin consistency, disciplined expense management, enhanced visibility into commercial conversion, and prudent capital deployment.
Commercial focus and product portfolio: cardiorenal strategy, Rendiatech, and mid-year relaunch plans
Erb said Nuwellis sharpened its positioning during 2025 around the “cardiorenal continuum,” focusing on patient populations where cardiac and renal conditions are tightly linked and where precision volume management can influence outcomes across both systems. He said growth in heart failure and pediatrics reinforced management’s view that the company’s value proposition is strongest in complex cardiorenal populations.
On pediatrics, Erb said the company expanded intellectual property supporting pediatric device development and received a National Institutes of Health grant to advance its pediatric program. In closing remarks, management said development of “Vivian,” a novel pediatric solution, continues with NIH grant support.
During the Q&A, Erb said the company “reinforced” its direct sales team in 2025 by hiring account managers and clinical specialists after headcount declined earlier in the year. He said the sales organization now totals 24 individuals between account managers and clinical specialists, and he expects to keep that number constant through 2026. Erb also said the company terminated the REVERSE-HF clinical trial, citing expected additional cost and timing; he said the company is working with investigators to publish results from data already collected.
Erb told analysts the company’s sales team is “primarily focused on critical care,” describing ICU cardiorenal issues in post-cardiac surgery patients as a major opportunity. He said the company intends to focus on increasing utilization within existing accounts, including expanding some heart failure accounts into critical care.
Management also discussed an agreement to acquire Rendiatech. Erb described Rendiatech’s technology as a way to measure urine output in the ICU and said the company sees potential to expand that capability to measure analytes and electrolytes at the bedside, which he characterized as relevant biomarkers for kidney health and acute kidney injury. In closing remarks, Erb said the company is actively integrating the acquisition and plans to relaunch the Clarity product mid-year.
About Nuwellis (NASDAQ:NUWE)
Nuwellis (NASDAQ:NUWE) is a medical technology company focused on developing therapies and devices to manage fluid overload in patients with cardiorenal and cardiovascular conditions. The company’s core business revolves around designing, manufacturing and marketing the Aquadex™ FlexFlow® System, a gentle ultrafiltration device intended to remove excess fluid in patients with acute decompensated heart failure, cardiorenal syndrome and other fluid‐overload disorders. By providing an alternative to traditional diuretic therapy, Nuwellis aims to improve patient outcomes and reduce hospital stays.
The Aquadex FlexFlow System operates by drawing blood through a low‐shear filter and returning it to the patient, allowing precise control of fluid removal at the bedside outside of an intensive care setting.
