Santersus AG today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its NucleoCapture™ 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™ provides a novel, non-immunosuppressive treatment option for patients with life-threatening disease who have exhausted current standard-of-care therapies.
According to the FDA designation letter:
“NucleoCapture is indicated for DNA plasma adsorption as an adjunct to standard therapy in patients with severe or life-threatening and refractory systemic lupus erythematosus, who have active disease despite current standard of care treatment.”
The granting of a second Breakthrough Device Designation underscores the breadth of NucleoCapture’s potential impact across multiple therapeutic areas. Santersus is advancing clinical development programs in:
- Critical Care: sepsis and septic shock
- Autoimmune Diseases: systemic lupus erythematosus and related conditions
- Organ Transplantation: prevention of graft injury and dysfunction
- Neurodegeneration: Alzheimer’s disease and other neurodegenerative disorders
Santersus is now preparing to initiate pivotal trials in both the U.S. and Europe. To support these milestones, the company is completing its Series A financing round, which will fund the advancement of NucleoCapture™ toward regulatory approval and commercialization.
This second FDA Breakthrough Device Designation validates our scientific approach and highlights the urgent unmet need for safe, targeted therapies in refractory autoimmune disease. We believe NucleoCapture™ has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited.
For more information, please visit www.santersus.com.