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Early clinical trials showed the SCD could reduce mortality by up to ~15% in critically ill patients with AKI on CRRT. A pivotal U.S. trial involving over 340 patients was launched to confirm these findings. The device aims to modulate systemic inflammation during CRRT, potentially reducing deaths and long-term complications such as chronic dialysis dependence. No final results from the pivotal trial are publicly available as of June 2025. The company’s approach has been described as unique for targeting systemic inflammation—a key driver of poor outcomes in ICU patients—using an extracorporeal device added to standard care.
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