Seastar Medical Holding Corp. operates as a holding company whose subsidiaries manufacture and supply medical devices. The company was founded on June 6, 2007 and is headquartered in Denver, CO.
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- SeaStar Medical reported second-quarter 2026 net revenue of $615,000, an 82% year-over-year increase driven by expanded adoption of QUELIMMUNE therapy for pediatric acute kidney injury. - The NEUTRALIZE-AKI pivotal trial has enrolled 223 of 339 targeted adult patients, with a primary endpoint of 90-day mortality or dialysis dependence and PMA submission targeted for late 2027. - The company doubled its hospital customer base to 20 of the 50 premier U.S. children's hospitals and completed the FDA-required 50-patient SAVE safety registry. - Management highlighted the adult AKI market as approximately 50 times larger than the pediatric market, positioning the selective cytopheretic device for significant future expansion.
- The FDA approved a significant reduction in mandatory enrollment for SeaStar Medical's SAVE Surveillance Registry from 300 to 50 patients, based on compelling safety data from the first 21 patients treated with QUELIMMUNE therapy. - Real-world data from pediatric patients with acute kidney injury and sepsis showed zero device-related adverse events and improved survival rates of 71% at 90 days compared to historical 50% survival rates. - The reduced surveillance requirement is expected to accelerate adoption of QUELIMMUNE therapy at pediatric medical centers and expand market opportunities in the estimated $100 million U.S. pediatric AKI market. - SeaStar Medical outlined ambitious 2026 milestones including doubling their customer base to 15 additional children's hospitals and completing enrollment in their adult AKI pivotal trial targeting a potential $4.5 billion market.
- The AREVA Institute secured a prestigious $2 million Department of Defense grant to evaluate SeaStar Medical's Selective Cytopheretic Device therapy for treating severe burns, inhalation injury, and sepsis in warfighters. - The three-year study, beginning July 2025, was selected as one of only four projects from 160 submissions to the Military Burn Research Program, highlighting the innovative potential of extracorporeal immunomodulation. - SeaStar Medical's SCD therapy is designed to neutralize destructive hyperinflammation and cytokine storms, potentially improving survival rates in both combat casualties and civilian patients with severe trauma and infection. - The device works alongside continuous renal replacement therapy to selectively target inflammatory immune cells and may reduce the need for dialysis while promoting long-term organ recovery.
- SeaStar Medical has reached the halfway point in its NEUTRALIZE-AKI pivotal trial, enrolling 100 of the planned 200 adult patients with acute kidney injury requiring continuous renal replacement therapy. - The trial is evaluating the company's Selective Cytopheretic Device (SCD) therapy, which has received FDA Breakthrough Device Designation for treating AKI, a condition affecting over 200,000 adults annually in the U.S. - An independent Data Safety Monitoring Review Board will conduct a prespecified interim analysis of the trial's primary endpoint, with findings expected in Q3 2025.
- Dr. Michele Balas from UNMC College of Nursing will present research on implementing the ABCDEF Bundle in intensive care units at the NIH Pragmatic Trials Collaboratory Grand Rounds. - The landmark BEST ICU study examines behavioral economic and staffing strategies to increase adoption of evidence-based ICU practices that represent the standard of care. - This multisite PCORnet® Study aims to accelerate the translation of proven ICU interventions into clinical practice, addressing a significant implementation gap in critical care medicine.
- SeaStar Medical has successfully closed a $6 million registered direct offering, strengthening its financial position to advance its cell-directed extracorporeal therapy development. - The company is developing innovative technologies targeting systemic inflammation through extracorporeal therapies that modulate effector cells causing tissue damage and cytokine release. - This funding aims to support SeaStar Medical's commercialization efforts and continued development of its SCD (Selective Cytopheretic Device) product candidates for inflammatory conditions.
- The FDA has approved SeaStar Medical's IDE application for SCD-ADULT to assess safety and efficacy in reducing inflammation in adults with acute heart failure. - The feasibility study will enroll 20 patients across up to five clinical sites, supported by a $3.6 million NIH grant to Innovative BioTherapies. - SCD-ADULT targets hyperinflammation in cardiorenal syndrome patients awaiting LVAD implantation, potentially improving their eligibility for the procedure. - SeaStar Medical estimates a $1 billion addressable U.S. market for SCD-ADULT in cardiorenal syndrome, highlighting a significant commercial opportunity.
- SeaStar Medical's Selective Cytopheretic Device (SCD) has been granted Breakthrough Device designation by the FDA for treating inflammation in end-stage renal disease (ESRD). - The SCD targets and neutralizes pro-inflammatory cytokines, aiming to mitigate hyperinflammation and improve clinical outcomes in ESRD patients. - This designation will expedite the development and review process of the SCD, potentially offering a new therapeutic option for ESRD patients with limited alternatives. - The SCD represents a novel approach to managing inflammation in ESRD, addressing a critical unmet need in this patient population.
- SeaStar Medical estimates a $25 to $33 billion U.S. market for its Selective Cytopheretic Device (SCD) across five indications, pending FDA approvals. - The SCD has received FDA Breakthrough Device Designation for adult AKI, hepatorenal syndrome, and cardiorenal syndrome with LVAD, facilitating faster development. - NEUTRALIZE-AKI, the pivotal trial for adult AKI, has enrolled 69 of 200 planned subjects, assessing mortality and dialysis dependency. - QUELIMMUNE, the SCD-Pediatric device, has already gained FDA approval for treating critically ill children with AKI and sepsis.
- SeaStar Medical's Selective Cytopheretic Device (SCD) has received its fourth FDA Breakthrough Device Designation for treating chronic systemic inflammation in end-stage renal disease patients undergoing chronic hemodialysis. - The designation expands SeaStar Medical's addressable U.S. patient population to 745,000 annually, targeting over 480,000 individuals requiring in-center hemodialysis. - The SCD aims to improve survival and quality of life for ESRD patients, who currently face a 42% five-year survival rate, by selectively targeting pro-inflammatory neutrophils and monocytes. - The Breakthrough designation provides enhanced access to FDA resources, potentially accelerating development and market access for the SCD, offering a differentiated market position.
