Revenue Growth
Achieved a fourfold increase in first quarter revenue compared to the fourth quarter of 2024. This was driven by increased adoption of QUELIMMUNE therapy.
FDA Breakthrough Device Designations
Granted two new breakthrough device designations by the FDA for addressing hyperinflammation in adult and pediatric cardiac surgery, expanding the pipeline.
Enrollment Progress in NEUTRALIZE-AKI Trial
Reached 50% enrollment in the NEUTRALIZE-AKI trial for adult patients with AKI and CRRT, triggering a prespecified interim analysis.
Expansion of Customer Base
Added a nationally recognized Children's Hospital as a new QUELIMMUNE customer and are in talks with several others.
Commercial Strategy and Market Opportunity
Outlined a strategy to focus on top 50 pediatric sites in the U.S. and a $4.5 billion total annual market opportunity in the adult AKI market.
Cost Management
Managed resources effectively, resulting in lower sequential operating expenses and a strengthened balance sheet with new capital.