Nuwellis (NASDAQ:NUWE) reported flat third-quarter revenue of $2.2 million as growth in pediatric sales was offset by a comparison with a prior-year period that benefited from back-order fulfillment. The company narrowed its operating loss and said it had submitted an application to expand the use of its Aquadex system in smaller pediatric patients.
Revenue rose approximately 12% from the second quarter of 2026, while revenue for the first nine months of the year increased 13% to $6.6 million, Chief Financial Officer Carisa Schultz said. Pediatric net sales rose 20% in the third quarter and 26% in the first nine months from the corresponding periods a year earlier.
President and CEO Mike McCormick said the third-quarter comparison was affected by approximately $400,000 in accumulated back orders fulfilled in the prior-year quarter. Excluding that benefit, he said, underlying performance grew 20%.
Margins Improve as Expenses Decline
Third-quarter gross profit was approximately $1.5 million, producing a gross margin of 70%, compared with 65% a year earlier. Schultz attributed the improvement to higher average selling prices for circuits and consoles, favorable product mix and benefits from the company’s transition to contract manufacturing.
Operating expenses fell to approximately $3.6 million from $4.1 million a year earlier and $4.7 million in the second quarter. Schultz said the year-over-year decline primarily reflected lower administrative costs and sales-related compensation.
The operating loss narrowed 24% to approximately $2.1 million from $2.7 million. Nuwellis reported a net loss of approximately $2 million, compared with net income of approximately $500,000 a year earlier. Schultz said the prior-year result included a significant noncash gain from changes in the fair value of warrant liabilities.
Nuwellis sold eight Aquadex consoles during the quarter, down from 12 a year earlier. For the first nine months, console sales rose to 32 from 17. McCormick said each console added to the installed base creates an opportunity for recurring circuit revenue.
Pediatric Application and Clinical Data
On November 5, Nuwellis submitted a 510(k) application to the U.S. Food and Drug Administration seeking to expand the Aquadex SmartFlow System indication to patients weighing as little as 5 kilograms, from the current threshold of 20 kilograms, McCormick said. The expanded indication would require FDA clearance.
McCormick said data from the multicenter ULTRA-Peds Registry supported the company’s discussions with the FDA. The study, accepted for publication in Pediatric Nephrology, evaluated 91 pediatric patients treated with Aquadex across seven children’s hospitals; 62% weighed less than 10 kilograms.
According to McCormick, 87% of patients survived their Aquadex treatment course, and 86.5% of procedures were completed without interruption.
Portfolio Expansion and Cash Runway
Nuwellis is adding products through distribution agreements that make use of its existing sales team. In August, it entered a co-promotion and distribution agreement with Atrility Medical for the AtriAmp postoperative cardiac rhythm monitoring device. McCormick said the companies had completed multiple joint sales and service calls and were developing a pipeline of accounts.
The company also secured exclusive U.S. distribution rights for the pediatric Zorro-Flow external urine collection system and expects to launch it in the first quarter of 2027, McCormick said.
Nuwellis expects to launch its Aquadex SmartView user interface in the first quarter of 2027 and Aquadex Pressure IQ in the first half of 2027. It is also continuing development of ClarityPRIME, an automated kidney function monitoring technology acquired through Rendiatech, while evaluating other potential applications.
Cash and cash equivalents totaled approximately $8.3 million at September 30, which management said provides runway through the second quarter of 2027. During the third quarter, Nuwellis raised $3.4 million in gross proceeds through a registered direct offering, received $3.3 million in gross proceeds from warrant exercises and generated $1.4 million in net proceeds from sales under its at-the-market program, Schultz said.
About Nuwellis (NASDAQ:NUWE)
Nuwellis, Inc. is a medical device company focused on fluid management therapies for patients with fluid overload. The company develops and commercializes ultrafiltration technologies designed to remove excess salt and fluid from the blood when conventional diuretic therapy may be inadequate or poorly tolerated. Nuwellis’ principal product is the Aquadex system, including the Aquadex FlexFlow system, a compact ultrafiltration platform used in hospital settings. The system is intended for temporary extracorporeal fluid removal in patients with conditions such as fluid overload associated with heart failure, renal dysfunction, and other critical-care needs.
