Nuwellis, Inc.

What they do

Nuwellis develops and sells the Aquadex FlexFlow and Aquadex SmartFlow systems, used for ultrafiltration therapy in adult and pediatric patients (20 kg or more) with fluid overload unresponsive to diuretics. The company generates revenue primarily from the sale of consoles and single-use blood filters and catheters in the U.S., selling directly to hospitals and clinics.

Revenue drivers

• U.S. circuit sales (blood filters and catheters) — Recurring revenue from single-use circuits is the primary long-term growth driver, with U.S. circuit average selling prices up approximately 5% year-over-year in Q2 2026.
• U.S. console sales (Aquadex systems) — Sale of Aquadex consoles to hospitals; nine consoles sold in Q2 2026 and 24 in H1 2026 (vs. five in H1 2025), expanding the installed base.
• International, service, and rental revenue — Smaller components of total revenue; U.S. revenue growth outpaced total company average, which included lower international, service, and rental revenue in H1 2026.

Recent performance

Q2 2026 net sales were $2.0 million, up 14% from $1.7 million in Q2 2025, with U.S. revenue up 17%. First-half 2026 net sales were $4.4 million, up 20% year-over-year, with U.S. revenue up 24%. Gross margin improved to 76% in Q2 2026 from 56% in the prior-year quarter, driven by pricing, product mix, and contract manufacturing transition. The company reported a net loss of $17.5 million for FY2025 and a net loss of $11.2 million for FY2024; quarterly revenue ranged from $2.0 million to $2.4 million in the last four reported quarters. As of June 30, 2026, total assets were $9.1 million, total liabilities $11.2 million, and cash and equivalents $3.9 million.

Strategy

Management's stated focus is on growing recurring circuit revenue, expanding the installed base of Aquadex consoles, and improving operating leverage. They plan to concentrate investments in pediatrics and critical care, where they see clinical differentiation and commercial opportunity. The company is evaluating complementary products and collaborations to leverage its commercial infrastructure with existing hospital customers. A proposed label expansion to patients weighing 5 kg or more (from 20 kg+) is being advanced following a successful FDA pre-submission meeting.

Risks

• Need for additional capital — The company believes it had sufficient capital only through Q2 2026 and stated it needs to raise additional capital to fund operations through the end of fiscal year 2026, creating a going concern risk.
• Nasdaq delisting risk — The company received a Nasdaq deficiency notice in June 2025 for a bid price below $1.00, and has used reverse stock splits (most recently 1-for-35 in June 2026) to regain compliance, which can impact stock liquidity and perception.
• Negative shareholder equity — As of June 30, 2026, shareholder equity was negative $2.1 million, with an accumulated deficit of $325.7 million, indicating persistent losses and financial instability.
• Execution risk in core markets — Growth depends on increasing console placements and circuit utilization in cardiorenal care, a market with established alternatives like diuretics, and any shortfall could hamper the company's path to profitability.

Outlook

Management expects the recent capital raise ($6.0 million in June and approximately $6.7 million in July 2026 from financing and warrant exercises) to extend its cash runway through Q2 2027. The company aims to continue double-digit revenue growth and gross margin expansion, with a focus on building recurring circuit revenue from the growing installed base. They plan to advance the Aquadex label expansion to lower-weight patients and selectively pursue new technologies to strengthen the cardiorenal platform.