Santersus AG Receives Second US FDA Breakthrough Device Designation for NucleoCapture in Systemic Lupus Erythematosus
Zurich, Switzerland, 26th Aug 2025 — Santersus AG today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its NucleoCapture(tm) blood purification technology for the treatment of severe, treatment-refractory systemic lupus erythematosus (SLE). This marks the second Breakthrough Device Designation awarded to NucleoCapture, following earlier recognition for the treatment of sepsis.
NucleoCapture is an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from patient plasma. NETs are increasingly recognized as key drivers of inflammation, thrombosis, autoimmunity, and multi-organ injury. By directly targeting this pathogenic pathway, NucleoCapture pr...