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SeaStar Medical Adds Fifth Hospital Customer for QUELIMMUNE
DENVER, Jan. 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage therapeutic medical device company developing
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, Jan. 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage therapeutic medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has shipped QUELIMMUNE™ to a California medical center recognized as a world leader in pediatric research and treatments, increasing commercial customers to five. QUELIMMUNE is the company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis. “We are delighted that QUELIMMUNE is now available to treat severely ill children at yet another prominent academic medical center,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “We are actively working to secure additional hospital clearances by gaining institutional review board (IRB) approvals for using QUELIMMUNE within their facilities. Currently, we are engaged with more than a dozen new medical centers, with seven of these hospitals advancing into the IRB approval process. Additionally, I’m pleased to report that several of our current customers have reordered QUELIMMUNE for their institutions since the beginning of this year.” “We know of no other commercially available therapy that can modify the inflammatory process once it’s triggered to help repair the damage caused by an overactive immune system. It’s gratifying to expand access to our potentially lifesaving therapy to more pediatric patients as we make headway in our goal of having more than 20 hospitals utilizing QUELIMMUNE this year,” said Eric Schlorff, SeaStar Medical CEO. QUELIMMUNE is being commercialized following U.S. Food and Drug Administration (FDA) approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with renal replacement therapy (RRT). QUELIMMUNE was approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. Acute Kidney Injury (AKI) and HyperinflammationAKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditi...