Nuwellis, Inc. (NASDAQ: NUWE)

Nuwellis Inc. is dedicated to advancing cardiorenal care by enabling earlier safer and more controlled fluid management for patients. The company develops manufactures and commercializes medical devices used in ultrafiltration therapy including the Aquadex FlexFlow and the Aquadex SmartFlow systems. These systems are designed to remove excess fluid and salt from patients suffering from fluid overload who have not responded to diuretic therapy. Nuwellis operates primarily in the United States serving hospitals and healthcare providers that treat heart failure critical care and pediatric patients.

Nuwellis generates revenue from the sale of the Aquadex System which includes the console disposable blood circuits and disposable catheters. The company sells its products to hospitals health systems and outpatient clinics that use the system for ultrafiltration therapy. In 2025 approximately forty percent of revenue came from pediatric patients thirty two percent from critical care patients and seventeen percent from heart failure patients. The remaining revenue is derived from other clinical uses of the Aquadex System. Nuwellis maintains a field salesforce organized into ten sales territories across the United States to support customer adoption and training.

Nuwellis positions itself as a provider of ultrafiltration therapy for fluid overload a market where the standard of care is pharmacological treatment with diuretics. There are no direct competitors for the Aquadex System in the United States aside from diuretics. Indirect competition includes devices such as Baxters Prismaflex which is approved for continuous renal replacement therapy and Medtronics Carpediem system used in pediatric acute kidney injury. The company also notes the joint venture Mozarc Medical formed by Medtronic and DaVita as a potential competitor in kidney related therapies. Nuwellis competitive advantages stem from the ease of use of the Aquadex System which can be operated by any trained healthcare provider the precise control of fluid removal and the disposable single use circuit that reduces setup time. Clinical evidence shows that use of the Aquadex System reduces heart failure rehospitalizations shortens hospital stays and provides cost savings compared to diuretic therapy.

Nuwellis serves hospitals health systems academic medical centers and outpatient clinics that treat patients with fluid overload. The company focuses on institutions specializing in heart failure critical care and pediatrics. In 2025 the largest single customer accounted for thirteen point seven percent of total revenue. While specific customer names are not disclosed the base includes major hospital networks pediatric hospitals and critical care units across the United States.