SeaStar Medical Announces CMS Coverage for Medicare and Medicaid Eligible Patients with Cardiorenal Syndrome Awaiting LVAD in Investigational Trial of SCD Therapy

Core Insights - SeaStar Medical has received a second reimbursement award from the U.S. Centers for Medicare & Medicaid Services (CMS) for expenses related to the NEUTRALIZE-CRS clinical trial, highlighting the potential life-saving capabilities of its technology [1][2] - The company is focused on its Selective Cytopheretic Device (SCD) therapy, which aims to improve health outcomes for critically ill patients, particularly those with Acute Kidney Injury (AKI) [2][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [5] - The company's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 for treating life-threatening acute kidney injury (AKI) in pediatric patients [5][6] - The SCD therapy has received Breakthrough Device Designation from the FDA for six therapeutic indications, facilitating a potentially expedited approval process [6] Clinical Trials - The NEUTRALIZE-AKI pivotal trial is assessing the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU, with 50% enrollment completed and full enrollment expected by the end of 2025 [3] - The primary endpoint of the NEUTRALIZE-AKI trial is a composite of 90-day mortality or dialysis dependency compared to a control group [3] - The NEUTRALIZE-CRS trial is evaluating the SCD therapy's ability to reduce hyperinflammation in patients with acute heart failure and worsening renal function, with funding from a $3.6 million NIH grant [4] Market Potential - The SCD therapy addresses a significant unmet need in the treatment of AKI, which affects over 200,000 adults in the U.S. annually [6] - The company is engaging a third-party reimbursement policy expert to analyze the feasibility of obtaining reimbursement coverage upon potential FDA approval for the SCD therapy in adult patients with AKI [2]