Nuwellis (NUWE) Investor presentation summary

Strategic positioning and market opportunity

• Positioned at a strategic inflection point with focus on critical care, pediatrics, and outpatient expansion, now representing about 80% of business and growing.

• U.S. platform opportunity exceeds $4.2B, spanning critical care, inpatient/outpatient heart failure, pediatrics, and fluid monitoring.

• Rapid expansion in outpatient care driven by a fourfold reimbursement increase, supporting recurring revenue and faster adoption.

• Portfolio expansion includes pending acquisition of Rendiatech for smart fluid monitoring, targeting a $1.4B market.

• Strategic growth plan emphasizes accelerating critical care, expanding outpatient pathways, advancing pediatric solutions, and portfolio collaborations.

Clinical innovation and product development

• Aquadex provides precise, predictable fluid removal and is foundational for addressing fluid overload in high-risk patients.

• Pediatric adoption of Aquadex is strong, with use in 47 of 130 top U.S. children's hospitals and integration into NICUs, PICUs, and CVICUs.

• Vivian, a dedicated pediatric solution for patients as small as 2.5kg, is in development with a $3M NIH grant and planned launch in 2028.

• ClarityRMS and ClarityPRIME systems will expand into real-time fluid monitoring, with a mid-2026 launch planned.

• Product development milestones for Vivian include clinical trials and regulatory submissions through 2027.

Clinical need and outcomes

• Fluid overload is a leading cause of hospital readmissions, increased mortality, and longer ICU stays across critical care, pediatric, and heart failure populations.

• Up to 40% of cardiac surgery patients experience acute kidney injury, highlighting the need for precise fluid management.

• Aquadex demonstrated 92% survival in pediatric patients with AKI or congenital kidney failure, with 66% surviving to hospital discharge.

• Early intervention and precise fluid management are supported by evidence for improved outcomes and reduced readmissions.