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SeaStar Medical Submits Investigational Device Exemption (IDE) Application to FDA to Study a Novel Therapy to Reduce Hyperinflammation in Adult Acute Kidney Injury Patients
Building upon demonstrated clinical success, the pivotal study will evaluate the Selective Cytopheretic Device in adults with AKI requiring CKRT DENVER, Jan.
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"Building upon demonstrated clinical success, the pivotal study will evaluate the Selective Cytopheretic Device in adults with AKI requiring CKRT DENVER, Jan. 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has submitted an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a pivotal study to evaluate the effectiveness of the Company’s Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The randomized, controlled study is expected to enroll 200 subjects, with a primary endpoint of a composite of 90-day mortality and dialysis dependency of SCD patients compared to the control group. Details of the study design will be provided upon IDE approval by the FDA. The study is anticipated to begin in the first quarter of 2023 with interim results expected in the fourth quarter of 2023 and topline results and submission for Pre-market Approval (PMA) in the third quarter of 2024. “We are pleased to take this important step in our journey towards creating the new standard of care in reducing harmful hyperinflammation. The FDA has demonstrated continued support in the SCD in granting breakthrough therapy status in adults and a substantive review of a Humanitarian Device Exemption (HDE) for pediatric AKI patients,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “Now we aim to prove efficacy and attractive health care economics when the therapy is used to treat adults with AKI.” The SCD, the company’s innovative platform therapy, is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients. The therapy currently is delivered through continuous CKRT to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis. The SCD received Breakthrough Device Designation by the FDA in May 2022. Approximately 6 million cases of adult AKI are diagnosed annually in the U.S. The SCD has demonstrated s...