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How SeaStar Medical Is Leveraging Its Breakthrough Medical Device Designation To Help Critically Ill Patients

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By Meg Flippin Benzinga

SeaStar Medical seeks to bring organ-saving and life-saving solutions to critically ill patients who are suffering from hyperinflammation. The company's first therapy, QUELIMMUNE, which was approved by the U.S. Food and Drug Administration last year, is designed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. 

SeaStar is also engaged in a trial evaluating the safety and efficacy of its second proprietary Selective Cytopheretic Device (SCD) therapeutic in adults with AKI. That trial already has half of the adults enrolled and represents a market opportunity Schlorff says is worth about $4.5 billion a year. SeaStar, which has received several Breakthrough Device Status designations from the FDA, is betting its therapy can be broadly applied to many serious, life-threatening conditions. 

Watch the full interview here: 
https://www.youtube.com/watch?v=zREelPU2KIk

Featured image by Annie Spratt on Unsplash.

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