Nuwellis (NUWE) Investor presentation summary

Commercial performance and growth

• Achieved 26% year-over-year revenue growth in Q1 2026, with strong momentum across pediatric, critical care, and heart failure segments.

• Pediatrics and critical care now account for approximately 75% of revenue, with pediatric adoption accelerating in leading children's hospitals.

• Three strategic commercial hires and new leadership appointments, including a new CFO and Chief Commercial Officer, have strengthened the team.

• Operational initiatives reduced monthly cash burn by about 60% in Q4 2026, and unprofitable international operations were exited.

• Outpatient reimbursement increased significantly, creating a predictable, recurring revenue stream and improving hospital economics.

Product innovation and clinical expansion

• Aquadex is a clinically proven, low-volume ultrafiltration therapy for precise fluid removal in critically ill patients, adopted in ICU, cardiac surgery, and pediatric programs.

• Pediatric FDA pre-submission is underway to expand Aquadex's indication to patients as small as 5kg, supported by over 10 years of clinical experience.

• The ULTRA-Peds study demonstrated 87% survival in pediatric patients treated with Aquadex, with full data publication expected in 2026.

• Vivian, a next-generation pediatric renal support platform, is in development with NIH grant support, targeting patients as small as 2.5kg.

• ClarityPRIME, an automated urine output and electrolyte monitoring system, expands the platform into the fluid monitoring market.

Market opportunity and adoption drivers

• Total U.S. addressable market for the platform exceeds $4.2 billion, spanning critical care, heart failure, pediatrics, and fluid monitoring.

• Fluid overload is a major driver of mortality, readmissions, and ICU costs in both adult and pediatric populations.

• Aquadex is now used in 47 of the top U.S. children's hospitals, reflecting strong physician-driven demand and integration into NICUs, PICUs, and CVICUs.

• Precision fluid management is increasingly adopted due to its association with reduced mortality, lower AKI risk, and fewer readmissions.