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SeaStar Medical Provides Regulatory Update Related to its HDE Application for Pediatric Selective Cytopheretic Device
DENVER, May 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, May 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that it has received a letter from the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) regarding the Company’s Humanitarian Device Exemption (HDE) application for its pediatric Selective Cytopheretic Device (SCD), which is designed to treat critically ill children with acute kidney injury (AKI) on continuous kidney replacement therapy (CKRT). In the letter, the FDA indicated that the application is not approvable in its current form but outlined specific guidance as to how the application may be amended and resubmitted successfully. “We are disappointed by the FDA’s decision not to approve our HDE application at this time. After a series of collaborative meetings and correspondence over the past 10 months, and repeatedly being responsive to the Agency’s recommendations, this determination is surprising,” said Eric Schlorff, SeaStar Medical CEO. “My heart goes out to the critically ill children and their families who could have benefited from immediate access to the SCD. Only about one-half of children in the ICU with AKI requiring CKRT survive, and those who do are at risk of long-term life-threatening conditions, such as chronic kidney disease. “We believe that each of the current deficiencies cited by the Agency in their letter are readily addressable. However, we intend to initially request FDA’s administrative review and submit an appeal if needed. In parallel, we plan to implement other mitigations, where appropriate, and continue working with CBER with the goal of achieving pediatric HDE approval,” he added. The Agency’s decision letter on the pediatric HDE does not affect the Company’s pivotal clinical trial with the SCD in adults with AKI, which is currently underway. About the Selective Cytopheretic DeviceThe Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CKRT and remove the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification to...