Core Insights - SeaStar Medical Holding Corporation has received FDA approval for an investigational device exemption to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD-ADULT) in adult patients with acute heart failure and worsening renal function [1][2] - The feasibility study will enroll 20 patients across five clinical sites and is funded by a 1 billion annually, presenting a significant commercial opportunity for SeaStar Medical [3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing solutions to mitigate hyperinflammation's effects on vital organs [8] - The company is developing cell-directed extracorporeal therapies that target inflammatory cells, aiming to reduce systemic inflammation and promote organ recovery [8] Technology Details - The Selective Cytopheretic Device (SCD) utilizes immunomodulating technology to target proinflammatory neutrophils and monocytes, potentially leading to long-term organ recovery and reducing the need for future renal replacement therapy [5] - The SCD has also received FDA Breakthrough Device Designation for other indications beyond cardiorenal syndrome with LVAD [6]
FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome