The NucleoCapture blood-purification column received a second FDA Breakthrough Device Designation for severe, refractory systemic lupus erythematosus, following an earlier designation in sepsis. The extracorporeal therapy is intended as an adjunct to standard care and works by selectively removing cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs), key drivers of inflammation, thrombosis, autoimmunity, and organ injury—offering a non-immunosuppressive option for patients who have failed other treatments.
NucleoCapture uses biocompatible, highly porous beads coated with recombinant human histone H1.3, a protein with very high DNA-binding affinity, to capture cfDNA/NETs from plasma. Santersus is advancing clinical programs across autoimmune disease, critical care, organ transplantation, and neurodegenerative disorders (eg, Alzheimer disease), and is preparing pivotal trials in the United States and Europe. A recent Series A financing is aimed at accelerating regulatory approvals and commercialization, with the company highlighting the potential for meaningful outcome improvements where current options are limited. The Breakthrough designation also enables enhanced FDA interaction and potential expedited review, which could speed access for patients if pivotal data are positive.
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Reference: Jacobus N. Santersus AG Announces FDA Granted NucleoCapture Breakthrough Device Designation. Pharmaceutical Executive. Published August 29, 2025. Accessed October 28, 2025. https://www.pharmexec.com/view/santersus-ag-announces-fda-granted-nucleocapture-breakthrough-device-designation
