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- **Revenue Mixed but Pro Forma Growth**: Q3 revenue $2.2M (-6% YoY), but pro forma +7% excluding one-time items. Sequential rise 29% driven by consumables and console sales.
- **Product Innovation Driving Adoption**: New 24-hour circuit and dual-lumen catheter expand outpatient use; 92% survival rate in pediatrics highlights clinical impact.
- **Financial Challenges and Strengths**: Gross margin decline to 65.2% due to manufacturing costs, but strong cash position ($3.1M) and $5.9M equity raise support growth.
- **Strategic Shifts**: Exiting international markets, transitioning manufacturing, and advancing outpatient care model to drive long-term growth.

**【CEO Summary Section】**
- **Q3 Momentum and Strategic Focus**: Highlighted progress in critical care, pediatrics, and heart failure with Aquadex therapy adoption. Introduced new 24-hour Aquadex circuit and dual-lumen catheter to enhance flexibility and scalability.
- **Pediatric Innovation**: Advanced Vivien CRRT system development with U.S. patent allowances and 92% survival rate data from ULTRA-Peds registry.
- **Operational Shifts**: Transitioned manufacturing to KDI, exited European operations, and raised $5.9M in equity to support U.S. growth.
- **Outpatient Expansion**: Delivered first Aquadex therapy in hospital-based outpatient setting under new CMS code, signaling proactive care model.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q3 revenue $2.2M (-6% YoY), pro forma growth 7% excluding one-time SeaStar sales. Sequential increase 29% driven by 15% rise in consumables utilization and 4x U.S. console sales.
- **Gross Margin**: 65.2% (vs. 70% YoY) due to under-absorbed fixed overhead; expects margin expansion post-KDI transition.
- **Expense Growth**: Operating expenses $4.1M (+30% YoY) from sales force rebuild and R&D investments. Net income $0.56/share vs. $73.23 prior year (adjusted for reverse split).
- **Liquidity**: $3.1M cash, debt-free, with $5.9M raised in Q3 and June to support 2026 strategy.

**【Closing Remarks】**
- **Future Focus**: Emphasized three growth engines (critical care, pediatrics, outpatient heart failure) and thanked departing CFO Rob Scott for his contributions.

Nuwellis, Inc.(NUWE)-20251112-2025 Q3 Earnings call transcript

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