Zurich, Switzerland, twenty sixth Aug 2025 — Santersus AG in the present day introduced that the U.S. Meals and Drug Administration (FDA) has granted Breakthrough Gadget Designation to its NucleoCapture(tm) blood purification expertise for the remedy of extreme, treatment-refractory systemic lupus erythematosus (SLE). This marks the second Breakthrough Gadget Designation awarded to NucleoCapture, following earlier recognition for the remedy of sepsis.
NucleoCapture is an extracorporeal therapeutic apheresis column designed to selectively take away cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from affected person plasma. NETs are more and more acknowledged as key drivers of irritation, thrombosis, autoimmunity, and multi-organ harm. By straight focusing on this pathogenic pathway, NucleoCapture offers a novel, non-immunosuppressive remedy choice for sufferers with life-threatening illnesses who’ve exhausted present standard-of-care therapies.
In response to the FDA designation letter, “NucleoCapture is indicated for DNA plasma adsorption as an adjunct to plain remedy in sufferers with extreme or life-threatening and refractory systemic lupus erythematosus, who’ve lively illness regardless of present customary of care remedy.”
The granting of a second Breakthrough Gadget Designation underscores the breadth of NucleoCapture’s potential affect throughout a number of therapeutic areas. Santersus is advancing scientific improvement applications throughout a number of remedy classes, together with:
– Important Care: sepsis and septic shock
– Autoimmune Ailments: systemic lupus erythematosus and associated situations
– Organ Transplantation: prevention of graft harm and dysfunction
– Neurodegeneration: Alzheimer’s illness and different neurodegenerative issues
Santersus is now making ready to provoke pivotal scientific trials in each the U.S. and Europe. To help these milestones, the corporate is finishing its Sequence A financing spherical, which can fund the development of NucleoCapture towards regulatory approval and commercialization.
“This second FDA Breakthrough Gadget Designation validates our scientific strategy and highlights the pressing unmet want for secure, focused therapies in refractory autoimmune illness,” mentioned Andrew Daniel Aswani, Chief Medical Officer of Santersus. “We imagine NucleoCapture has the potential to remodel affected person outcomes throughout a variety of devastating situations the place present remedy choices are restricted.”
About Santersus
Santersus AG is a privately held therapeutic apheresis firm based in 2017 with headquarters in Zurich, Switzerland and London, England. The corporate’s medical goal is to revolutionize the methods through which we are able to management the human immune and inflammatory response to illness. Santersus specializes within the improvement of medical units used to cleanse affected person blood of neutrophil extracellular traps (NETs). NETs are fibers of decondensed DNA adorned with cytotoxic proteins which have been launched from activated neutrophils. NETs at the moment are acknowledged as one of many main driving components within the improvement of sepsis, lupus (SLE), COVID-19, most cancers, acute organ failure, autoimmune flares, and neurodegenerative illnesses, together with Alzheimer’s illness. These indications are both at the moment in scientific trials or deliberate for future trials.
The corporate’s flagship patented therapeutic machine, NucleoCapture®, has been additionally granted designation as a Breakthrough Gadget by the US Meals & Drug Administration for sepsis. NucleoCapture® blood purification expertise is predicated on biocompatible, extremely porous polymer beads conjugated with proprietary human recombinant histone H1.3 protein. As nature’s final DNA-binding and compacting protein, histone H1.3 has single-digit nanomolar DNA binding constants, making it a potent element of the innate immune defence system.
Consequently, throughout a single go of NETs and cfDNA-contaminated blood by way of the NucleoCapture® machine, over 95% of NETs are successfully eliminated.
Santersus AG holds a strong portfolio of lately granted patents defending the NucleoCapture® machine.
For extra info, go to: www.santersus.com | LinkedIn
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Media Contact
Group: Santersus AG
Contact Particular person: Aleksander Zaporoztsev
Web site: https://www.santersus.com
Electronic mail:
data@santersus.com
Nation:Switzerland
Launch id:32944
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