Santersus AG, a privately held therapeutic apheresis company, announced today that their medical device product, NucleoCapture, has been granted designation as a Breakthrough Device by The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA). The indication cited in the breakthrough designation is as an adjunctive treatment to antibiotics in patients with sepsis.
Santersus AG is focused on the development of devices used to cleanse patient blood of neutrophil extracellular traps (NETs), which have been recognized as a contributing factor in the development of sepsis and other conditions. The NucleoCapture device earned this breakthrough designation through its status as a first-in-class, fully-functional product designed to capture and remove circulating NETs from patient blood. NucleoCapture technology is safer than potential pharmacological interventions targeting NETs because it allows safe removal of NETs from blood without compromising the defensive function of neutrophils.
According to Dr. Andrew Aswani, Chief Medical Officer of Santersus, “Just a single pass of NET and cfDNA-contaminated blood through the NucleoCapture device results in over 95% removal of NETs. The FDA’s designation of NucleoCapture as a breakthrough device represents validation of our technology and its importance to patients around the world. It’s a unique strategy in the treatment of sepsis, and eventually, in other therapeutic areas as well.”
The NucleoCapture device has completed a First-in-Man clinical study designed to assess the safety and efficacy of therapeutic apheresis in patients with sepsis and septic shock. The device is undergoing clinical development for other indications including organ transplantation with the University of Oxford and Lund University. Santersus is also in clinical development for autoimmune diseases and long COVID-19.
Clinical proof-of-concept in sepsis and septic shock with subsequent CE Marking is the first step in Santersus’ rapid expansion. Additional clinical trials are planned for the US and Europe on sepsis and transplantation, the company’s second targeted indication. The company will be raising Series A finance capital to fund these trials in the coming months.
About Santersus AG
Santersus AG is a privately held therapeutic apheresis company founded in 2017 and based in Zurich, Switzerland. The company’s medical objective is to revolutionize the ways in which we can control the human immune and inflammatory response to disease. Santersus is focused on the development of 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 have been recognized as one of the major driving factors in the development of sepsis, COVID-19, cancer, acute organ failure, autoimmune flares, and neurodegeneration including Alzheimer’s disease.
The company’s flagship medical device product, NucleoCapture, was granted designation as a Breakthrough Device by the US Food & Drug Administration. NucleoCapture blood purification technology is based on biocompatible, highly porous polymer beads conjugated with proprietary human recombinant histone H1.3 protein. Histone H1.3 protein was created in nature to act as the ultimate human DNA binding and compacting protein. Histone H1.3 is a potent sensor and effector of the ancient, innate immune defense system with single digit nanomolar DNA binding constants. As a result, the single pass of NET and cfDNA-contaminated blood through the NucleoCapture device results in over 95% removal of NETs.
Santersus AG has a suite of patents that have been recently granted covering the NucleoCapture device.
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