Nuwellis, Inc. Q2 2025: Unpacking Key Contradictions in Revenue, Clinical Trials, and Outpatient Expansion

Revenue impact and inventory build, outpatient clinic expansion, Phase 3 trial enrollment, outpatient treatment expansion, Reverse HF trial enrollment timeline are the key contradictions discussed in Nuwellis, Inc.'s latest 2025Q2 earnings call.



Revenue Decline and Sterilization Issue:
- Nuwellis reported revenue of $1.7 million in Q2 2025, a 21% year-over-year decline.
- The decline was primarily due to a temporary $400,000 product back order resulting from an industry-wide issue with their sterilization vendor.

Pediatric Segment Performance:
- Pediatric revenues increased by 23% compared to the second quarter of 2024.
- This growth was driven by strong demand for established hospital customers and new centers adopting Aquadex for patients with renal issues.

Outpatient Heart Failure Opportunity:
- Nuwellis is focusing on the outpatient opportunity in heart failure, expecting growth as hospitals set up or expand heart failure programs.
- The increased reimbursement from $413 to $1,639 per day for patients treated in hospital outpatient clinics is a key driving factor.

Manufacturing Transition and Cost Savings:
- Nuwellis is planning an orderly transition of manufacturing to KDI Precision Manufacturing, with go-live scheduled for October.
- This move is expected to result in meaningful operational efficiencies and cost savings over the next 12 months.

Termination of REVERSE-HF Clinical Trial:
- Nuwellis terminated the REVERSE-HF clinical trial, reallocating approximately $4 million to higher impact growth areas.
- The termination was not related to device performance or patient safety concerns, but rather a strategic decision aligning with investment focus and commercial opportunities.