Device for sepsis treatment receives FDA Breakthrough designation
Santersus, a therapeutic apheresis company, has received Breakthrough Device designation for its medical device product, NucleoCapture, 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 recognised 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 allows safe removal of NETs from blood without compromising the defensive function of neutrophils.
Dr. Andrew Aswani, chief medical officer of Santersus, said: “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’ 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.