Nuwellis makes and sells the Aquadex System, a medical device that removes excess fluid from patients with fluid overload — a condition common in heart failure, post-cardiac surgery, and pediatric patients. The system works through ultrafiltration, drawing blood from the patient, filtering out excess water and sodium, and returning the cleaned blood. The key clinical advantage over diuretics (the standard of care) is precise, controllable fluid removal, which matters especially for the 10–40% of heart failure patients who develop diuretic resistance. The Aquadex System has three components: a reusable console, a single-use blood circuit, and a single-use catheter. Nuwellis sells directly to hospitals, academic medical centers, and children's hospitals through a U.S. field sales force. Revenue comes from console sales (capital) and recurring consumables purchased each time the device is used — consumables drive the majority of revenue and are the primary indicator of adoption. Nuwellis serves three patient segments: pediatrics (~40% of revenue), critical care (~32%), and heart failure (~17%). The pediatric segment is a particular focus given Aquadex's FDA clearance for patients as small as 20 kg. Nuwellis is also building an outpatient heart failure business, aided by a 2025 reimbursement increase that raised facility reimbursement from ~$413 to ~$1,639 per day. Nuwellis also recently acquired Rendiatek, a urine output monitoring device, to deepen critical care account relationships.
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