Company overview

Nuwellis serves patients whose excess fluid has not responded to medicines such as diuretics. Its Aquadex System filters fluid from the blood, a treatment called ultrafiltration. Hospitals and clinics, primarily in the United States, buy the consoles and disposable blood circuits and catheters through the company’s direct salesforce. These products generate most of its revenue, with pediatric and critical-care treatment accounting for the majority of the business.

Aquadex is Nuwellis’s only commercial product, so revenue depends on hospitals adopting it and continuing to use its disposable supplies. Its sales team trains and supports hospital staff. A small group of major customers accounts for a substantial share of sales. Nuwellis also relies exclusively on KDI Precision Manufacturing to assemble its consoles, blood circuits and catheters, while retaining product design, sales and customer support.

Healthcare providers pay Nuwellis for the products and seek reimbursement from insurers and other third-party payers for covered treatments; coverage varies. Aquadex is cleared for hospitalized adults and children who meet its minimum weight requirement and whose fluid overload has not responded to medical management. Nuwellis cannot promote uses outside FDA clearance, even though clinicians may choose such uses independently.