ZÜRICH, CH / ACCESS Newswire / August 26, 2025 / 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 diseases 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 across multiple treatment categories, including:
- 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 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 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 has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited."
About Santersus
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. Santersus specializes in the development of medical devices used to cleanse patient blood of neutrophil extracellular traps (NETs). NETs are fibers of decondensed DNA decorated with cytotoxic proteins that have been released from activated neutrophils. NETs are now recognized as one of the major driving factors in the development of sepsis, lupus (SLE), COVID-19, cancer, acute organ failure, autoimmune flares, and neurodegenerative diseases, including Alzheimer's disease. These indications are either currently in clinical trials or planned for future trials.
The company's flagship patented therapeutic device, NucleoCapture®, has been also granted designation as a Breakthrough Device by the US Food & Drug Administration for sepsis. NucleoCapture® blood purification technology is based on biocompatible, highly porous polymer beads conjugated with proprietary human recombinant histone H1.3 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 defence system.
As a result, during a single pass of NETs and cfDNA-contaminated blood through the NucleoCapture® device, over 95% of NETs are effectively removed.
Santersus AG holds a robust portfolio of recently granted patents protecting the NucleoCapture® device.
For more information, visit: www.santersus.com | LinkedIn
Media Contact
Organization: Santersus AG
Contact Person Name: Aleksander Zaporoztsev
Website: https://www.santersus.com
Email: info@santersus.com
Country: Switzerland
SOURCE: Santersus AG
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/industrial-and-manufacturing/santersus-ag-receives-second-us-fda-breakthrough-device-designation-fo-1065959
