Nuwellis (NASDAQ:NUWE) reported second-quarter revenue growth, improved gross margin and an expanded installed base for its Aquadex fluid-management platform, as newly appointed President and Chief Executive Officer Mike McCormick outlined priorities centered on recurring circuit revenue, pediatric expansion and critical-care development.
Revenue for the quarter ended June 30, 2026, rose 14% year over year to $1.97 million. U.S. revenue increased 17%, while revenue for the first six months of 2026 increased 20% to $4.37 million. U.S. revenue rose 24% during the first half, Chief Financial Officer Carisa Schultz said.
Installed Base and Recurring Revenue Focus
McCormick, who was making his first earnings-call appearance as CEO, said the company’s commercial focus is to translate console placements into sustained Aquadex use and recurring circuit sales. Nuwellis sold 24 consoles in the first half of 2026, compared with five in the first half of 2025.
“Each of those placements expands the opportunity for recurrent circuit utilization,” McCormick said. He said the company will focus on training, protocol development and identifying appropriate patients at accounts that have acquired consoles.
The company plans to measure commercial progress through consistent utilization across accounts, patient treatment volumes and recurring circuit revenue, rather than console placements alone, McCormick said.
U.S. circuit average selling prices increased about 5% from the prior-year quarter, while console average selling prices increased about 3%, according to Schultz. She attributed the increases primarily to pricing adjustments implemented in the third quarter of 2025.
Pediatric Expansion and FDA Submission Plans
Nuwellis continued to expand its pediatric footprint during the quarter, including further growth within a major South Carolina health system and the opening of its first pediatric programs in Michigan and Wisconsin, McCormick said.
The company also highlighted clinical education efforts, including a case presented by University of Iowa clinicians at the International Society for Heart and Lung Transplantation meeting involving Aquadex use in a complex pediatric cardiac patient with recurrent fluid overload. Nuwellis also marked five years of support for the Pediatric Cardiac Critical Care Consortium.
McCormick said Nuwellis completed a pre-submission meeting with the Food and Drug Administration concerning a proposed expansion of Aquadex’s indication to patients weighing at least 5 kilograms, compared with the current indication for patients weighing 20 kilograms and above. The company plans to submit the proposed label expansion to the FDA in the fourth quarter of 2026.
The regulatory pathway is expected to include bench testing, toxicology assessments and supporting pediatric clinical evidence, he said. Nuwellis is also making software updates intended to improve workflow efficiency, treatment precision and ease of therapy use.
Critical Care and Cardiorenal Platform Development
Nuwellis is pursuing a strategic development initiative to broaden Aquadex’s capabilities for critical-care settings. The work includes higher-flow capabilities intended to support new filtration technologies and use in more complex, high-pressure extracorporeal environments.
The company is also developing an enhanced user interface called SmartView, which McCormick said is intended to simplify Aquadex use, improve clinical workflows and support greater utilization. More than 280 physicians attended a critical-care cardiac education summit during the quarter that included hands-on Aquadex training, according to McCormick.
Meanwhile, Nuwellis is progressing development and integration plans for ClarityPRIME, an automated kidney-function monitoring system obtained through its first-quarter acquisition of Rendiatech. The company expects to launch ClarityPRIME in 2027.
McCormick said Aquadex is designed to remove fluid with precision, while ClarityPRIME could provide earlier and more continuous insight into kidney-function changes. The company is also evaluating complementary pediatric technologies, including urine-output monitoring and non-invasive cardiac monitoring, while emphasizing a selective and capital-efficient approach.
Nuwellis received a notice of allowance during the quarter for its dual-lumen midline catheter technology, which McCormick said could support less invasive peripheral access for extracorporeal therapies. The patent issued in mid-July.
Margin Improvement, Loss and Financing Activity
Second-quarter gross profit was approximately $1.5 million, producing a gross margin of 76%, compared with 56% in the prior-year period. Schultz said the 20-percentage-point improvement reflected higher circuit and console selling prices, favorable product mix and benefits from the company’s transition to contract manufacturing.
Operating expenses totaled approximately $4.7 million, up from about $3.9 million a year earlier but down from approximately $6.3 million in the first quarter. The year-over-year increase reflected investments in commercial expansion and product development, while the sequential decline resulted from efforts to align spending with priority programs, Schultz said.
Nuwellis reported a net loss of approximately $4.8 million for the second quarter, compared with a loss of approximately $12.6 million in the prior-year quarter. The latest result included about $1.7 million in warrant valuation expense tied to June financing activity.
The company completed a $6 million registered public offering in June and had approximately $3.9 million in cash and cash equivalents and no debt as of June 30. After the quarter ended, Nuwellis raised an additional $3.4 million through a registered direct offering and received $3.3 million from cash warrant exercises.
McCormick said the company does not provide formal financial guidance but is targeting consistent double-digit revenue growth, strong gross margins, increased installed-base utilization and lower cash use over time.
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.
