SeaStar Medical Completes Enrollment of SCD 005 Trial to Evaluate Safety of Selective Cytopheretic Device (SCD) in AKI as well as ARDS Patients with COVID-19

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This study builds on previous studies and continues to validate the SCD’s therapeutic approach.

SeaStar Medical, a medical technology company delivering novel therapeutic solutions to improve organ function, announced today that the company has completed enrollment of the SCD 005 study to evaluate the safety of the Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI) and/or acute respiratory distress syndrome (ARDS) with COVID-19 infection. This study builds on previous studies and continues to validate the SCD’s therapeutic approach. Findings are expected later this year.

“Completing enrollment of the trial marks an important milestone on our journey to establish the SCD as a novel, significant treatment option in addressing the severe consequences of systemic inflammation,” said Eric Schlorff, CEO of SeaStar Medical. “Systemic inflammation is a driver of organ dysfunction and damage, as we have seen with COVID-19 patients. The SCD has the potential to be a groundbreaking treatment option for critically ill patients.”

The SCD 005 study is an open label, multi-center study to assess the clinical activity, safety and tolerability of the SCD among patients with ARDS prior to CRRT and/or AKI with CRRT who develop COVID-19 infection. The primary endpoints include reducing mortality rates and dialysis dependency, and increasing ventilation free survival. Find more information about the SCD trial here on the ClinicalTrials.gov website.

“We are grateful for the support of the SCD 005 investigators who recognize the potential benefits of the differentiated SCD therapy, ” said Dr. H. David Humes, inventor of the SCD technology and board member of SeaStar Medical. “We look forward to continuing to work with leading institutions for our upcoming pivotal AKI study.”

About the SCD

The Selective Cytopheretic Device (SCD) is an investigational, extracorporeal therapeutic approach that selectively sequesters the cells responsible for inflammation, stopping a cytokine storm before it causes lasting damage. It addresses systemic inflammation by targeting leukocytes, the critical effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.

In addition to the SCD 005 trial, the device has been studied in children with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). Results from that study were published in Kidney International Report.

About SeaStar Medical

Denver-based SeaStar Medical is a privately held medical technology company that has redefined how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. Its extracorporeal therapies target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalance immune responses. For more information visit seastarmedical.com or visit us on LinkedIn or Twitter.

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