Nuwellis Inc (NASDAQ: NUWE) is a medical device company that develops and commercializes ultrafiltration therapy systems for the treatment of fluid overload. Revenue comes from the sale of the Aquadex System, which includes a console device and single-use disposable blood sets, sold on a transactional basis to hospitals and critical care centers. The company operates in two clinical end markets: adult patients with heart failure or post-cardiac surgery fluid overload, and pediatric patients requiring fluid management or kidney replacement therapy. Nuwellis received FDA 510(k) clearance to treat pediatric patients weighing 20 kg or more in February 2020. A dedicated pediatric kidney replacement therapy device, branded Vivian, targeting patients weighing 2.5 kg and above, is in development, funded in part by a $1.7 million grant from the National Institutes of Health. As of the 10-K filed March 11, 2026, the company reported going-concern conditions, with management disclosing sufficient capital only through the end of Q2 2026 and a stated need to raise additional capital to fund operations through the end of fiscal year 2026.

Revenue model

Transactional product sales of the Aquadex System console and single-use disposable blood sets to hospitals. Revenue is recognized under ASC Topic 606 when customers obtain control of products. No subscription or recurring contract revenue model is described in the filing.

Products and services

Aquadex System: an ultrafiltration device cleared for adult and pediatric (20 kg or more) patients with fluid overload, including those with heart failure, post-cardiac surgery conditions, ECMO therapy, solid organ transplantation, and kidney replacement therapy. Vivian: a dedicated continuous renal replacement therapy (CRRT) device in development for pediatric patients weighing 2.5 kg and above, partially funded by a $1.7 million NIH grant.

Customers and end markets

Hospitals and critical care centers, specifically cardiac surgery programs treating patients post-CABG, valve repair, VAD implant, and other cardiac procedures, as well as heart failure cardiologists. Pediatric end market includes neonates and children with acute kidney injury (AKI), with an estimated 10,300 children suffering from AKI annually, including over 1,800 neonates, per the FY2025 10-K filing.

Value-chain role

Commercial-stage medical device manufacturer relying on third-party contract manufacturers for production of the Aquadex System. Maintains proprietary IP including patents, trade secrets, and know-how. Operates its own direct salesforce targeting hospital-based clinicians.

Geographic exposure

No specific geographic revenue breakdown is provided in the excerpts. Operations and commercialization appear U.S.-focused based on FDA clearance references and salesforce descriptions in the filing.

Source: SEC 10-K, filed 2026-03-11

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