Capital funding risk
The company expects to need additional capital to support operations and strategic initiatives.
- Scope
- Operating runway and growth investment
- Materiality
- high
Nuwellis, Inc.
Nuwellis, Inc. is a U.S.-based medical technology company focused on the Aquadex System, an ultrafiltration platform used to remove excess fluid from patients. Its business combines console systems, disposable blood filters and catheters, and related clinical support for hospitals and clinics, with sales centered in the United States and selected international markets.
−131,9 %
62,0 %
−211,9 %
−5,4 %
1.71
1.08
| % | |
|---|---|
| Aquadex console systems | 20% Capital equipment used to deliver ultrafiltration therapy in hospital settings. |
| Disposable circuits and blood sets | 60% Single-use blood filters and catheters used with Aquadex consoles. |
| Technical services and support | 10% Training, implementation, and clinical support provided to hospital customers. |
| International distributor sales | 5% Sales outside the U.S. through specialty distributors in selected markets. |
| Other product and development-related revenue | 5% Other device-related sales and commercial activity tied to the Aquadex platform. |
Nuwellis sells primarily to hospitals, health systems, and academic medical centers that treat fluid overload in...
- U.S. hospitals and health systemsprimary
Buy Aquadex consoles, disposables, and support for inpatient fluid management programs.
- Academic medical centersprimary
Use the system in advanced heart failure and critical care protocols where clinical evidence matters.
- Cardiac surgery programssecondary
Use ultrafiltration around post-cardiac surgery fluid management and recovery.
- Pediatric hospitalssecondary
Adopt the pediatric-cleared system for children needing kidney replacement or fluid therapy.
- International specialty distributorssecondary
Purchase products for resale to hospitals and clinics in their local markets.
Nuwellis is centered in the United States, where it sells through a direct salesforce and has ten sales territories...
- •United States is the core commercial market
- •Direct salesforce covers ten U.S. sales territories
- •International sales run through specialty distributors
- •Retained foreign jurisdictions include Singapore, Hong Kong, Israel, and Brazil
- •Geographic focus affects service, regulatory, and distribution needs
Nuwellis is prioritizing commercial investment in U.S. cardiac surgery, pediatric, and hospital-based outpatient...
01
Concentrate on the U.S. marketshort-term
The company believes U.S. demand offers the strongest near-term commercial opportunity and supportability.
02
Expand pediatric and cardiac surgery adoptionmedium-term
These clinical settings can increase utilization of the Aquadex platform and deepen hospital relationships.
03
Improve product performance and user experiencemedium-term
Device enhancements can support customer satisfaction, retention, and broader clinical use.
04
Broaden the platform beyond ultrafiltrationlong-term
Adjacent monitoring technologies could extend the company’s role in cardiorenal care.
Nuwellis depends on a concentrated customer base, third-party manufacturing, and continued access to capital, so...
Customer concentration
A limited number of customers account for a large share of revenue, so loss or reduced ordering can materially hurt sales.
- Scope
- Largest customer represented 13.7% of annual revenue
- Materiality
- high
Third-party manufacturing and supply chain
The company depends on external manufacturers and suppliers for commercial volumes and components.
- Scope
- Backorders, production delays, rationing
- Materiality
- high
Nasdaq listing compliance
The stock has faced minimum stockholders' equity and bid-price compliance pressure.
- Scope
- Potential delisting and trading restrictions
- Materiality
- medium
Clinical adoption and reimbursement
Hospitals must adopt ultrafiltration therapy and justify use versus competing treatments.
- Scope
- Heart failure, critical care, and pediatric programs
- Materiality
- high
Revenue recognition timing
Quarterly comparability
Warrant valuation
Non-cash earnings volatility
Long-lived asset impairment
Potential write-downs
Stock-based compensation
Reported SG&A and R&D
Income tax reserves
Net income and balance sheet
: 29.4.2026