Core Insights - SeaStar Medical Holding Corporation has received two new Breakthrough Device Designations from the FDA for its Selective Cytopheretic Device (SCD) therapy, aimed at treating systemic inflammatory response in adult and pediatric patients undergoing cardiac surgery [1][2] - The company has a total of six Breakthrough Device Designations, highlighting the critical need for effective therapies to treat hyperinflammation that can lead to organ failure [2][3] - SeaStar Medical's first commercial product, QUELIMMUNE, is in the initial launch phase, with plans for a PMA filing in 2026 following a successful clinical trial [2][7] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its SCD therapy designed to target proinflammatory cells and reduce hyperinflammation [6][7] - The SCD therapy is currently being commercialized under a Humanitarian Device Exemption for treating critically ill pediatric patients with acute kidney injury due to sepsis [2][7] - The company is conducting pivotal clinical trials for adult patients with acute kidney injury and is exploring additional indications for its SCD therapy [2][7] Market Opportunity - Approximately 15% of the 300,000 adults undergoing cardiac surgery annually are considered high risk and may benefit from SCD therapy [1] - Of the 40,000 pediatric patients undergoing congenital heart surgery each year, about one third could potentially benefit from the therapy [1] - The Breakthrough Device Designation facilitates faster access to the market, potentially improving reimbursement dynamics for SeaStar Medical's products [7] Regulatory Context - The FDA's Breakthrough Device Designation is intended to expedite the development and review process for devices that offer significant advantages over existing treatments [3][4] - SeaStar Medical's six designations were granted between April 2022 and March 2025, indicating a strong regulatory support for its innovative therapies [3][7] Technology Description - The Selective Cytopheretic Device (SCD) employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes, promoting a reparative state and potentially leading to long-term organ recovery [6][7] - The SCD is integrated with continuous renal replacement therapy systems, distinguishing it from other blood-purification tools [6]
FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac Surgery