SeaStar Medical Announces First Pediatric Patient Treated In A Commercial Setting With Its FDA-Approved QUELIMMUNE Therapeutic Device

7/23/24 8:36:31 AM ET

Medical/Dental Instruments

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SeaStar Medical Holding Corporation (NASDAQ:ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT). With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA's approval of QUELIMMUNE.

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SeaStar Medical Reaches Milestone of 100th QUELIMMUNE Commercial Device as Shipments Begin to its Third Hospital Customer
DENVER, Nov. 15, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has begun shipping QUELIMMUNE™ to a third hospital customer. 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. "Within weeks of implementing our direct sales model we have added two commercial customers, underscoring our team's ability to assist hospitals with the Humanitarian Use Device (HUD) requirements and seamlessly fulfill their o
11/15/24 8:30:00 AM ET
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SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update
DENVER, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU) ("SeaStar Medical" or the "Company"), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2024, and provides a business update. "We are delighted to report market demand and our first commercial sales of QUELIMMUNE™, our pediatric SCD that was cleared for sale by FDA in February 2024," said Eric Schlorff, SeaStar Medical CEO. "During the third quarter, we recognized $67,500 of revenue from shipping QUELIMMUNE directly to one
11/13/24 5:05:22 PM ET
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FDA Grants Breakthrough Device Designation for SeaStar Medical's Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the receipt of a Breakthrough Device Designation from the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) for the Company's patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodial
11/6/24 9:00:00 AM ET
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