Workflow
FDA Approves Feasibility Study with SeaStar Medical's Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
ICUSeaStar Medical(ICU) Newsfilter·2025-01-13 13:30

Core Points - 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 3.6millionNIHgrantawardedtoInnovativeBioTherapies[2]−TheSCD−ADULTtargetshyperinflammationinpatientswithcardiorenalsyndrome,potentiallyimprovingtheirconditionforleftventricularassistdevice(LVAD)implantation[3]CompanyOverview−SeaStarMedicalisacommercial−stagemedicaltechnologycompanyfocusedondevelopingsolutionstomitigatehyperinflammation′seffectsonvitalorgans[8]−Thecompanyisdevelopingcell−directedextracorporealtherapiesthattargetinflammatorycells,aimingtoreducesystemicinflammationandpromoteorganrecovery[8]−ThetotaladdressableU.S.marketfortheSCD−ADULTincardiorenalsyndromeisestimatedtoexceed3.6 million NIH grant awarded to Innovative BioTherapies [2] - The SCD-ADULT targets hyperinflammation in patients with cardiorenal syndrome, potentially improving their condition for left ventricular assist device (LVAD) implantation [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] - The total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome is estimated to exceed 1 billion annually, presenting a significant commercial opportunity [3] Technology Details - The Selective Cytopheretic Device (SCD) is designed to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy, aiming to reduce hyperinflammation and promote organ recovery [5] - The SCD has received FDA Breakthrough Device Designation for multiple indications, including cardiorenal syndrome with LVAD [6]