We are making great strides to introduce a new option because we believe patients who are fighting the toxic and life-threatening effects of hyper inflammation can benefit from the reparative effects generated by the SCD.
October 13, 2020
SeaStar Medical, a medical technology company delivering novel therapeutic immunomodulating solutions to improve organ function, today announced it will present Phase II clinical trial outcomes of its Selective Cytopheretic Device (SCD) at the virtual American Society of Nephrology (ASN) Kidney Week 2020 meeting which will take place October 22-25, 2020.
The presentation will report on the feasibility and safety of the first-ever application of the SCD technology in critically ill children with acute kidney injury (AKI). The SCD has been tested in adults where it was associated with improved survival and reduced dialysis dependency at 60 days. This prompted an application for a Food and Drug Administration (FDA) Orphan Products grant to support a multi-center pediatric study in the U.S.
“We are proud to share the results of our pediatric clinical trial,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “Pediatric AKI is rare, impacting less than 4,000 children per year, and it is often associated with increased morbidity and mortality. There are few therapeutic options for these children. We are making great strides to introduce a new option because we believe patients who are fighting the toxic and life-threatening effects of hyper inflammation can benefit from the reparative effects generated by the SCD.”
The analysis of data will be presented by the primary investigator of the study, Dr. Stuart L. Goldstein of Cincinnati Children’s Hospital Medical Center. Dr. Goldstein is the director of the Center for Acute Care Nephrology and a professor at the Cincinnati College of Medicine, Department of Pediatrics.
Title: Outcomes from the Use of the Selective Cytopheretic Device (SCD) in Critically Ill Children with Acute Kidney Injury (AKI) Receiving CRRT: A Report of the Multi-Center Pediatric SCD (pSCD) Study
Session: Friday, October 23, 2020, 05:00 PM EDT – 07:00 PM EDT
Abstract #: FR-OR04
About the Selective Cytorpheretic Device (SCD)
The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and remove the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. The device works with hemofiltration systems to enable precise fluid and solute balance control to selectively target and transition pro-inflammatory monocytes to reparative and reduce activated neutrophils. This unique immunomodulation approach may reverse injury and eliminate the need for CRRT going forward.
SeaStar Medical has received the designation of a Humanitarian Use Device (HUD) for the SCD. It is now in the application phase with the FDA Center for Devices and Radiologic Health (CDRH) for the Humanitarian Device Exemption (HDE).
About SeaStar Medical
Denver-based SeaStar Medical is a privately held medical device company that has redefined how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs through novel solutions and services. SeaStar Medical’s focus is on removing pro-inflammatory mediators, known as cytokines, or transforming key immune system messengers from pro-inflammatory to reparative physiology. SeaStar Medical’s next-generation technologies rely on science and innovation to build upon existing purification technologies to provide life-saving solutions to critically ill patients. For more information visit seastarmedical.com or visit us on LinkedIn.
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