SeaStar Medical has submitted an application seeking a humanitarian device exemption (HDE) approval from the US Food and Drug Administration (FDA) to use its Selective Cytopheretic Device (SCD) for the treatment of children with acute kidney injury (AKI).
An extracorporeal device, SCD has been designed to be used with continuous renal replacement therapy (CRRT) to selectively target hyperactive neutrophils and monocytes.
Using immunomodulating technology, the device removes the cytokine storm that causes organ failure, inflammation and possible death in critically ill patients.
The new SCD technology sequesters and neutralises activated toxic neutrophils and provides a new treatment approach for systemic inflammatory response syndrome.
The company stated that the FDA has accepted the HDE application and will start reviewing it.
SeaStar Medical CEO Eric Schlorff said: “The FDA’s acceptance of the HDE application represents an important step forward in helping paediatric specialists care for these critically-ill children.
“We believe use of the SCD holds tremendous promise for these patients and look forward to working closely with the FDA in the review of our application.”
The submission of the HDE application is based on data obtained from the company’s open-label, multi-centre pilot clinical study of SCD in paediatric patients with AKI.
The study was designed to evaluate SCD’s safety and feasibility in paediatric patients with AKI and multi-organ dysfunction (MOD) that required CRRT.
The device was found to be safe for use in paediatric patients.
The study met its endpoints of safety as well as reduced mortality and dialysis dependence in patients treated with SCD at day 60.
Last month, SeaStar Medical and LMF Acquisition Opportunities reported data from the SCD 005 clinical study of SCD in Covid-19 patients with multiple organ failure admitted to the intensive care unit (ICU).