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 announced the launch of its pivotal NEUTRALIZE-AKI study, aimed at assessing the safety and efficacy of its Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) needing continuous kidney replacement therapy (CKRT). Starting in March, the randomized controlled trial will enroll up to 200 patients across 30 U.S. sites. The study's primary endpoint focuses on 90-day mortality and dialysis dependency, while secondary endpoints include Day 28 mortality and ICU-free days. Previous studies indicate the SCD may significantly reduce mortality rates, showcasing its potential as a life-saving solution for critically ill patients.
SeaStar Medical (Nasdaq: ICU) announced a conference call on February 15, 2023, at 4:00 p.m. ET to discuss significant business updates. Key topics will include FDA approval for a pivotal trial of its Selective Cytopheretic Device (SCD) aimed at treating adults suffering from acute kidney injury (AKI) due to hyperinflammation. Additionally, updates on the Humanitarian Device Exemption (HDE) submission for use in critically ill children will be shared. The conference call will be accessible via phone or through a live webcast, and a replay will be available for 48 hours post-call.
SeaStar Medical (Nasdaq: ICU) has received FDA approval for its investigational device exemption (IDE) to conduct a pivotal study of its Selective Cytopheretic Device (SCD). This 200-patient trial will evaluate the SCD's effectiveness in treating acute kidney injury (AKI) patients requiring continuous kidney replacement therapy (CKRT). Enrollment is set to begin in March 2023, with interim results anticipated in Q4 2023 and topline results by mid-2024. The SCD targets pro-inflammatory immune cells to mitigate hyperinflammation, a condition linked to high mortality rates in AKI patients. SeaStar aims to redefine treatment protocols in critical care environments.
SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present a company overview at the virtual Sequire Biotechnology Conference on February 2, 2023, at 3:30 p.m. Eastern Time. The conference will focus on SeaStar's innovative solutions aimed at mitigating hyperinflammation's effects on vital organs. Attendees can register for the event through the Sequire Biotechnology website. An archived webcast of the presentation will also be available on the SeaStar Medical website.
SeaStar Medical has submitted an investigational device exemption (IDE) application to the FDA for a pivotal study of its Selective Cytopheretic Device (SCD) aimed at treating adults with acute kidney injury (AKI) needing continuous kidney replacement therapy (CKRT). The study will enroll 200 participants, focusing on 90-day mortality and dialysis dependency rates. Interim results are expected by Q4 2023, with topline results and Pre-market Approval anticipated by Q3 2024. The SCD has previously shown promise in reducing mortality rates in critically ill patients.
SeaStar Medical Holding Corporation (Nasdaq: ICU) has signed an exclusive U.S. license and distribution agreement with Nuwellis, Inc. for its Selective Cytopheretic Device (SCD) to treat acute kidney injury (AKI) in children. Nuwellis will promote SCD to pediatric nephrologists and intensive care doctors. An FDA review for SCD's Humanitarian Device Exemption is anticipated in Q1 2023, with a potential U.S. launch in Q2 2023. The therapy aims to mitigate inflammation in critically ill pediatric patients, potentially reducing ICU stays and dialysis dependency.
SeaStar Medical (Nasdaq:ICU) has appointed Thomas R. Mullen as Vice President of Operations and Product Development. With over 30 years in the medical device field, Mullen aims to drive the growth and commercialization of SeaStar's innovative therapies targeting hyperinflammation in vital organs. He previously served as a consultant to the company since 2020 and brings extensive experience in operations and regulatory compliance. The company’s Selective Cytopheretic Device is currently under FDA evaluation for a Humanitarian Device Exemption for treating acute kidney injury, with potential commercialization expected in mid-2023.
SeaStar Medical Holding Corporation (Nasdaq: ICU) appointed Rick Barnett as Chairman of its Board of Directors. Barnett, a board member since January 2021, brings extensive experience in healthcare and medical device industries. He previously led Satellite Healthcare and currently serves on other boards. CEO Eric Schlorff highlighted that Barnett's commercial expertise will enhance the company's growth strategy as they approach a potential commercial launch of their SCD product candidate in Q2 2023. SeaStar Medical focuses on therapies to mitigate hyperinflammation risks in critical patients.
SeaStar Medical (Nasdaq: ICU) announced its Selective Cytopheretic Device (SCD) is included in the Consensus Statement for pediatric acute kidney injury (AKI) by the Pediatric Acute Disease Quality Initiative. The FDA is currently reviewing the HDE application for SCD, which expects completion by Q1 2023, with potential commercial launch in Q2 2023. This therapy aims to reduce inflammation and improve outcomes for critically ill children with AKI, a condition affecting approximately 4,000 pediatric patients annually in the U.S.
SeaStar Medical announced positive interim data for its Selective Cytopheretic Device (SCD) at the American Society of Nephrology Kidney Week 2022. The device is being tested in pediatric patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy. Interim findings indicate safety and an 83% survival rate, outperforming a historical 50% benchmark. The FDA is reviewing the SCD for a Humanitarian Device Exemption, with possible approval by Q1 2023 and a commercial launch anticipated in Q2 2023.
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