Nuwellis Q1 2025: Unraveling Contradictions in Outpatient Pipeline and REVERSE-HF Trial Timelines

Outpatient pipeline and reimbursement impact, REVERSE-HF trial enrollment and timeline, Vivian device development and clinical trial timeline, Phased 3 trial enrollment are the key contradictions discussed in Nuwellis' latest 2025Q1 earnings call.



Revenue Growth and Consumable Utilization:
- Nuwellis, Inc. generated $1.9 million in revenue for Q1 2025, representing a 3% increase year-over-year, supported by a 4% increase in consumables utilization and an increase in U.S. console sales.
- The growth was driven by increased consumable utilization in the pediatrics and heart failure segments, offset by a decrease in international sales.

Pediatrics and Heart Failure Revenue Increase:
- Pediatric and heart failure revenues increased by 38% and 28%, respectively, compared to the first quarter of 2024.
- Growth was primarily due to increased consumable utilization, with two new pediatrics accounts opened during the quarter.

Critical Care Revenue Decline and Recovery Anticipated:
- Critical Care revenue declined by 25% year-over-year, mainly due to a large customer acquiring excess inventory at the end of 2024.
- Recovery is expected in the coming quarter as the customer has begun repurchasing, indicating a one-time impact.

Outpatient Reimbursement Expansion and Market Opportunities:
- Aquadex therapy was reassigned to a new outpatient reimbursed level by CMS, increasing the facility reimbursement fee by 4x to $1,639 per day.
- This enhancement allows for expanded outpatient strategy, targeting an addressable market opportunity of approximately $773 million for future top-line growth.