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 Corporation develops and commercializes extracorporeal medical-device therapies for critically ill patients with organ failure driven by hyperinflammation. Its first commercial product, QUELIMMUNE (SCD-PED), is based on the company’s Selective Cytopheretic Device technology and is FDA approved for pediatric acute kidney injury associated with sepsis or a septic condition in patients requiring renal replacement therapy.
Recurring company updates cover QUELIMMUNE adoption by children’s hospitals, SAVE post-approval registry data, publications and conference presentations, and financial results. News also addresses clinical development of SCD therapy in adult acute kidney injury requiring continuous renal replacement therapy and in cardio-renal indications, as well as FDA Breakthrough Device and Humanitarian Device pathways for additional SCD uses.
SeaStar Medical (NASDAQ: ICU) has undertaken several measures to regain compliance with Nasdaq's listing requirements after receiving a notification of non-compliance in June 2024. The company completed a $4.0 million public offering and secured a $15.0 million purchase agreement with Lincoln Park Capital.
The company has expanded its customer base to six facilities for QUELIMMUNE, its FDA-approved product for pediatric patients with multiple organ failure, which has shown to reduce mortality by approximately 50%. Additionally, SeaStar implemented cost-cutting measures and restructured approximately $1.2 million in employee compensation liabilities. The company believes these actions have helped it meet the $2.5 million stockholders' equity requirement for continued Nasdaq listing, pending formal confirmation.
SeaStar Medical (NASDAQ: ICU) announced a two-part video series featuring their QUELIMMUNE therapy at Cincinnati Children's Hospital Medical Center. The first video, available June 24, 2025, features Dr. Stuart Goldstein and CMO Dr. Kevin Chung discussing QUELIMMUNE's potential to reduce destructive hyperinflammation in organ failure cases.
The second video, releasing June 26, 2025, showcases a patient testimonial from Kurt and his father, describing Kurt's rapid recovery from post-heart surgery complications using QUELIMMUNE therapy. Both videos will be accessible through SeaStar Medical's investor relations website.
SeaStar Medical (NASDAQ: ICU) has reached the halfway point in its NEUTRALIZE-AKI pivotal clinical trial, enabling a prespecified interim analysis of its SCD therapy for treating adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy. The trial's independent Data Safety Monitoring Review Board (DSMB) will analyze data from the first 100 of 200 planned patients, with findings expected in Q3 2025.
The interim analysis will evaluate safety and powering assumptions, remaining blinded to all parties except the DSMB. The therapy has received FDA Breakthrough Device Designation. The trial includes prestigious clinical sites such as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center, with previous studies showing improved treatment outcomes compared to standard care.
SeaStar Medical (Nasdaq: ICU) has announced it will release its first quarter 2025 financial results after market close on Wednesday, May 14, 2025. The company, which specializes in treatments for critically ill patients facing organ failure, will host a conference call and webcast at 4:30 p.m. ET / 2:30 p.m. MT on the same day to discuss the results and business progress.
Interested parties can access the call using Conference ID 2078693, with dial-in numbers 1 (800) 715-9871 for U.S. participants and 1 (646) 307-1963 for international callers. A replay will be available through May 20, 2025, at 1 (609) 800-9909.
SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, has announced an upcoming CEO interview. Eric Schlorff, the company's CEO, will appear on the Benzinga All Access Show today, April 30, 2025, at approximately 10:50 am Eastern Time.
The live interview will be broadcast on YouTube, and viewers can access it through the provided link. For those unable to watch the live broadcast, a recording will be made available afterward on SeaStar Medical's website in the investor relations section, specifically on the Events and Presentations page.
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.