Santersus Receives Second FDA Breakthrough Device Designation for NucleoCapture in Systemic Lupus Erythematosus
Key Insights
Santersus AG has received its second FDA Breakthrough Device Designation for NucleoCapture (search) blood purification technology, this time for treating severe, treatment-refractory systemic lupus erythematosus (search).
The extracorporeal therapeutic apheresis device selectively removes cell-free DNA (search) and neutrophil extracellular traps (search) from patient plasma, providing a novel non-immunosuppressive treatment option.
NucleoCapture (search) is indicated as an adjunct to standard therapy for patients with severe or life-threatening refractory SLE who have active disease despite current standard of care treatment.
Santersus AG announced on August 26, 2025, that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its NucleoCapture (search) blood purification technology for treating severe, treatment-refractory systemic lupus erythematosus (search) (SLE). This represents the second Breakthrough Device Designation for NucleoCapture, following earlier recognition for sepsis (search) treatment.
Novel Mechanism Targets Pathogenic Pathway
NucleoCapture (search) is an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (search) (cfDNA) and neutrophil extracellular traps (search) (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 diseases who have exhausted current standard-of-care therapies.
According to the FDA designation letter, "NucleoCapture (search) is indicated for DNA plasma adsorption as an adjunct to standard therapy in patients with severe or life-threatening and refractory systemic lupus erythematosus (search), who have active disease despite current standard of care treatment."
Broad Therapeutic Potential
The granting of a second Breakthrough Device Designation underscores the breadth of NucleoCapture (search)'s potential impact across multiple therapeutic areas. Santersus is advancing clinical development programs across multiple treatment categories, including critical care for sepsis (search) and septic shock, autoimmune diseases including systemic lupus erythematosus (search) and related conditions, organ transplantation for prevention of graft injury and dysfunction, and neurodegeneration including Alzheimer's disease (search) and other neurodegenerative disorders.
Technology Platform and Clinical Development
The company's flagship patented therapeutic device utilizes blood purification technology based on biocompatible, highly porous polymer beads conjugated with proprietary human recombinant histone H1.3 (search) protein. As nature's ultimate DNA-binding and compacting protein, histone H1.3 has single-digit nanomolar DNA binding constants, making it a potent component of the innate immune defense system. During a single pass of NETs and cfDNA-contaminated blood through the NucleoCapture (search) device, over 95% of NETs are effectively removed.
Santersus is now preparing to initiate pivotal clinical 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 (search) 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," said Andrew Daniel Aswani, Chief Medical Officer of Santersus. "We believe NucleoCapture (search) has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited."
Company Background
Santersus AG is a privately held therapeutic apheresis company founded in 2017 with headquarters in Zurich, Switzerland and London, England. The company's medical objective is to revolutionize the ways in which we can control the human immune and inflammatory response to disease. NETs are fibers of decondensed DNA decorated with cytotoxic proteins that have been released from activated neutrophils and are now recognized as one of the major driving factors in the development of sepsis (search), lupus (SLE), COVID-19 (search), cancer, acute organ failure, autoimmune flares, and neurodegenerative diseases, including Alzheimer's disease (search).