Santersus has received its second Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its blood purification technology, NucleoCapture, this time for the treatment of severe, treatment-resistant systemic lupus erythematosus (SLE).
The US FDA previously granted NucleoCapture Breakthrough Device status in 2022 for use in sepsis patients, making this the second recognition of the technology’s potential across multiple disease areas.
According to the US FDA, the latest designation covers use of NucleoCapture as “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.”
How does the device work?
NucleoCapture is an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from plasma. NETs are increasingly understood to drive inflammation, thrombosis, autoimmunity, and organ damage.
The Swiss company boasts that, unlike conventional immunosuppressive therapies, the device offers a non-immunosuppressive approach, targeting the underlying drivers of severe autoimmune and inflammatory conditions.
The expanded recognition underscores the technology’s potential in a wide range of conditions. Santersus is pursuing clinical programs in critical care (sepsis and septic shock), autoimmune diseases (SLE and related disorders), organ transplantation (to prevent graft injury), and neurodegeneration (including Alzheimer’s disease).
To advance toward regulatory approval, Santersus is preparing pivotal trials in the US and Europe. The company is also completing its Series A financing round to support the development and commercialization of its efforts.
“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.”
