Core Insights - SeaStar Medical Holding Corporation is focusing on the commercialization of QUELIMMUNE therapy for critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis [1][2] - The QUELIMMUNE therapy received approval in February 2024 under a Humanitarian Device Exemption, demonstrating safety and probable clinical benefit for a limited population of critically ill children [2] - The therapy aims to reduce destructive hyperinflammation that can lead to organ failure and increased mortality rates [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [4] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [4] - The company has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [6] Therapy Details - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more who are treated in the ICU with Renal Replacement Therapy (RRT) [2] - The therapy was commercially launched in July 2025, following its approval [2] - The therapy addresses the urgent need for effective treatments in pediatric patients with few options available [2][3] Clinical Context - AKI is characterized by a sudden loss of kidney function and can result from various conditions, including sepsis and severe trauma [3] - Destructive hyperinflammation associated with AKI can lead to multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [3] - The company is conducting a pivotal trial of its Selective Cytopheretic Device (SCD) therapy in adult patients with AKI, impacting over 200,000 adults in the U.S. annually [6]

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jackie Cossmon - ConsultantEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFONicholas Sherwood - Equity Research Associate Operator Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Con ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jackie K ...

April 28, 2025 News release BioPorto A/S to host first quarter 2025 earnings webcast for investors COPENHAGEN, DENMARK, April 28, 2025 (GLOBE NEWSWIRE) – BioPorto A/S (BioPorto or the Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), announced today that, in connection with the release of its Interim Report for the first quarter 2025, CFO Niels Høy Nielsen will present financial results for Q1 2025 at a webcast for investors on May ...