Welcome to our dedicated page for SeaStar Medical Holding news (Ticker: ICU), a resource for investors and traders seeking the latest updates and insights on SeaStar Medical Holding stock.
SeaStar Medical Holding Corp (ICU) is a medical technology innovator developing extracorporeal therapies to combat hyperinflammation's impact on vital organs. This page serves as the definitive source for verified company news and regulatory developments.
Investors and healthcare professionals will find timely updates on clinical trial progress, FDA regulatory milestones, and strategic partnerships shaping the future of inflammation management. Our curated news collection covers essential developments including product innovations, research collaborations, and market expansion efforts.
All content undergoes rigorous verification to ensure accuracy regarding SeaStar Medical's patented technologies and their clinical applications. Regular updates provide insights into the company's progress in commercializing therapies that target cytokine storms and immune system modulation.
Bookmark this page for streamlined access to breaking news about ICU's medical device advancements, peer-reviewed research findings, and healthcare sector initiatives. Check back frequently for objective reporting on developments impacting both patient care and investment considerations.
SeaStar Medical (Nasdaq: ICU) has received two new FDA Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, targeting systemic inflammatory response in both adult and pediatric cardiac surgery patients. The designations aim to prevent post-operative complications in high-risk populations.
The potential market includes approximately 45,000 patients annually - 15% of 300,000 adult cardiac surgery patients and one-third of 40,000 pediatric congenital heart surgery patients. These new designations bring SeaStar's total to six, highlighting the critical need for effective hyperinflammation treatment.
The company is currently commercializing QUELIMMUNE for pediatric acute kidney injury treatment and conducting the NEUTRALIZE-AKI pivotal trial for adult patients. SeaStar's six Breakthrough Device Designations, granted between April 2022 and March 2025, cover treatments for Adult AKI, cardiac surgery inflammation, cardiorenal syndrome, ESRD, and hepatorenal syndrome.
SeaStar Medical (Nasdaq: ICU) reported its Q4 and full-year 2024 financial results, marking significant progress in its commercial and clinical initiatives. The company achieved $0.1 million in net revenue for 2024, following the FDA approval and launch of QUELIMMUNE therapy for pediatric acute kidney injury patients.
Key highlights include: enrollment of 94 out of 200 patients in the NEUTRALIZE AKI pivotal trial, securing a fourth Breakthrough Device Designation, and adoption of QUELIMMUNE by five customers. The company raised approximately $31 million in capital and reduced debt.
Financial results show R&D expenses increased to $9.1 million from $6.0 million in 2023, while G&A expenses rose to $8.9 million from $8.2 million. The company reported a net loss of $24.8 million ($6.63 per share) compared to $26.2 million ($30.26 per share) in 2023. Cash position stood at $1.8 million as of December 31, 2024, with an additional $6 million raised in February 2025.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 27, 2025, after market close.
The company will host a webcast and conference call to discuss the results and business progress. A replay will be available until April 3, 2025, accessible via webcast or by calling 1 (609) 800-9909.
SeaStar Medical (Nasdaq: ICU) has been awarded the 2025 Corporate Innovator Award from the National Kidney Foundation for their groundbreaking QUELIMMUNE Selective Cytopheretic Device. The device received FDA approval in February 2024 as the first therapeutic solution for treating pediatric Acute Kidney Injury (AKI) due to sepsis.
Each year, approximately 4,000 children with AKI in the U.S. require continuous kidney replacement therapy, facing a 50% mortality rate. Of those who survive, 10-25% experience long-term complications including chronic kidney disease and lifetime dialysis dependency.
The award will be presented during the NKF Spring Clinical Meetings in Boston from April 9-13, 2025. This recognition places SeaStar Medical among notable past recipients including Keryx Biopharmaceuticals, Janssen Pharmaceuticals, Merck, Otsuka Pharmaceuticals, Relypsa, and UnitedHealth Group.
SeaStar Medical (Nasdaq: ICU) has closed a previously announced registered direct offering priced at-the-market, raising $6 million in gross proceeds. The offering included 3,529,412 shares of common stock (or pre-funded warrants) at $1.70 per share to a single institutional investor.
The transaction included warrants for an additional 3,529,412 shares in a concurrent private placement. The pre-funded warrants have a $0.001 exercise price with no expiration, while the additional warrants have a $1.70 exercise price, exercisable upon shareholder approval with a five-year term. The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures. H.C. Wainwright & Co. served as the exclusive investment bank for the offering.
SeaStar Medical (Nasdaq: ICU) has announced a $6 million registered direct offering with a single institutional investor. The offering includes 3,529,412 shares of common stock (or pre-funded warrants) at $1.70 per share, along with warrants to purchase an additional 3,529,412 shares in a concurrent private placement.
The pre-funded warrants will have a $0.001 exercise price with immediate exercisability, while the additional warrants will have a $1.70 exercise price, exercisable upon shareholder approval with a five-year expiration. The offering is expected to close around February 3, 2025.
The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures. H.C. Wainwright & Co. is serving as the exclusive financial advisor for this offering.
SeaStar Medical (Nasdaq: ICU) has expanded its customer base by shipping QUELIMMUNE™ to a fifth hospital, a California medical center known for pediatric research. QUELIMMUNE, their Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury (AKI) and sepsis.
The company is actively pursuing additional hospital clearances through institutional review board (IRB) approvals, with more than a dozen new medical centers in discussion and seven advancing in the IRB process. Several existing customers have already placed reorders in 2025.
QUELIMMUNE operates under FDA approval through a Humanitarian Device Exemption for children weighing 10kg or more requiring renal replacement therapy. The device uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery and eliminating future dialysis needs. The SCD has received FDA Breakthrough Device Designation in four indications.
SeaStar Medical (Nasdaq: ICU) has activated its 15th site, Mayo Clinic, for the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI). The trial has currently enrolled 76 subjects, with 6 new enrollments since the start of 2024.
The study aims to evaluate 200 adults with AKI in ICU receiving continuous renal replacement therapy (CRRT). The primary endpoint focuses on 90-day mortality or dialysis dependency compared to standard CRRT care. The company expects a Data Safety Monitoring Board recommendation on interim results by mid-2025 after analyzing the first 100 subjects.
The SCD, which has FDA Breakthrough Device Designation for adults with AKI, targets proinflammatory neutrophils and monocytes during CRRT to reduce hyperinflammation. SeaStar Medical estimates the annual U.S. market opportunity for SCD in adult AKI at $4.7-6.3 billion.
SeaStar Medical (Nasdaq: ICU) received FDA approval for an investigational device exemption (IDE) to study their Selective Cytopheretic Device (SCD-ADULT) in reducing inflammation in adult patients with acute heart failure and worsening renal function. The feasibility study will enroll 20 patients across up to five clinical sites, funded by a $3.6 million NIH grant awarded to Innovative BioTherapies.
The study will be led by SCD inventor Dr. H. David Humes, with SeaStar Medical acting as clinical research organization. The device received Breakthrough Device Designation from FDA's CBER in September 2023 for cardiorenal syndrome with LVAD. The company estimates the total addressable U.S. market for SCD-ADULT in cardiorenal syndrome at over $1 billion annually.
SeaStar Medical (Nasdaq: ICU) has expanded its commercial reach by shipping its QUELIMMUNE™ device to a fourth hospital customer, a prominent academic medical center. QUELIMMUNE is a Selective Cytopheretic Device (SCD) designed to treat critically ill children in ICU with acute kidney injury (AKI) and sepsis.
The device, approved by FDA under Humanitarian Device Exemption, has shown clinical benefits in reducing mortality and decreasing dialysis dependency. According to company data, AKI patients treated with SCD showed no dialysis dependency 60 days post-treatment, potentially saving approximately $100,000 per patient annually in dialysis costs. The average hospital cost per pediatric ICU patient with AKI requiring continuous renal replacement therapy exceeds $350,000.
QUELIMMUNE is approved for children weighing 10 kilograms or more who require renal replacement therapy. The SCD technology uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery.
