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SeaStar Medical Holding Corporation (Nasdaq: ICU) generates news that centers on its development and commercialization of therapies based on its patented Selective Cytopheretic Device (SCD) technology for critically ill patients. Company press releases highlight progress with its first commercial product, QUELIMMUNE (SCD-PED) therapy, which is approved by the U.S. Food and Drug Administration under a Humanitarian Device Exemption for life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients receiving Renal Replacement Therapy.
News updates frequently cover commercial adoption milestones for QUELIMMUNE, including new top-rated children’s hospitals that begin using the therapy and real-world outcomes reported through the SAVE Surveillance Registry. These releases often describe survival data, safety findings such as zero device-related adverse events, and registry enrollment updates that may influence the therapy’s market opportunity.
Investors following ICU news also see regular coverage of clinical development for SCD therapy in adult AKI and cardiovascular indications. This includes announcements related to the NEUTRALIZE-AKI pivotal trial in adults with AKI requiring continuous renal replacement therapy, DSMB recommendations, enrollment progress, and the initiation of studies such as the NEUTRALIZE-CRS trial in patients with acute chronic systolic heart failure and cardiorenal syndrome awaiting LVAD implantation.
Additional SeaStar Medical news items include regulatory and FDA interactions, such as Breakthrough Device Designations for multiple therapeutic indications and adjustments to post-approval surveillance requirements for QUELIMMUNE. Corporate updates, including reverse stock split actions, equity financings, financial results, and executive appointments, are also disclosed through press releases and associated SEC filings. For readers tracking ICU, the news stream provides insight into commercial traction, clinical trial status, regulatory milestones, and key corporate decisions that shape the company’s SCD-based therapy platform.
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.
SeaStar Medical (Nasdaq: ICU) has activated its 14th hospital site for the NEUTRALIZE-AKI pivotal trial, evaluating their Selective Cytopheretic Device (SCD) in acute kidney injury patients. Currently, 70 of 200 planned subjects are enrolled, with 24 in Q4. The company expects Data Safety Monitoring Board interim results by mid-2025 after the first 100 subjects complete the 90-day primary endpoint.
The company estimates the U.S. addressable market for SCD in adult AKI at $4.7-6.3 billion, with trial costs around $15 million. The SCD has FDA Breakthrough Device Designation for adults with AKI, and received Category B coverage from CMS for certain expenses in July 2024. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD plus CRRT versus CRRT alone.
SeaStar Medical (Nasdaq: ICU) estimates a U.S. total addressable market of $25 to $33 billion for its Selective Cytopheretic Device (SCD) across five clinical indications. The company's device, which targets inflammatory cells during continuous renal replacement therapy, has received FDA Breakthrough Device Designation in three indications: adult AKI, hepatorenal syndrome, and cardiorenal syndrome with LVAD. The largest market opportunity is in Cardiorenal Syndrome with no LVAD at $13.1-17.4 billion.
The company recently received FDA approval for QUELIMMUNE™ (SCD-Pediatric) for treating critically ill children with AKI and sepsis. The adult AKI pivotal trial, NEUTRALIZE-AKI, has enrolled 69 out of 200 planned subjects, evaluating 90-day mortality and dialysis dependency as primary endpoints.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company focused on hyperinflammation solutions, has announced an upcoming business update conference call scheduled for December 11, 2024, at 4:30 p.m. ET / 1:30 p.m. PT.
Participants can pre-register to receive a conference passcode and unique PIN for immediate access. Those who don't pre-register can dial 866-777-2509 (U.S.) or 412-317-5413 (international) and request the SeaStar Medical call.
A live webcast will be available, and a replay can be accessed for 48 hours after completion by dialing 877-344-7529 (U.S.), 855-669-9658 (Canada), or 412-317-0088 (international) with conference ID 3855739.
SeaStar Medical (Nasdaq: ICU) announces the activation of its thirteenth site, Sentara Norfolk General Hospital, in the NEUTRALIZE-AKI pivotal trial. The trial enrolled nine new patients in November, reaching 65 total subjects. The study aims to evaluate the safety and efficacy of the company's Selective Cytopheretic Device (SCD) in 200 adult patients with acute kidney injury (AKI) in ICU receiving continuous renal replacement therapy.
Enrollment rate has doubled in Q4's first two months compared to previous quarters. The company estimates annual peak sales of approximately $1 billion for SCD in the AKI indication, which affects about 210,000 U.S. patients annually. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD+CRRT versus CRRT alone.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, will present at NobleCon20, Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference.
The presentation is scheduled for Wednesday, December 4, 2024, at 12:00 p.m. Eastern time (9:00 a.m. Pacific time) in Boca Raton, Fla. The company will provide an overview of its proprietary solutions aimed at reducing the consequences of hyperinflammation on vital organs.
A webcast of the presentation will be available on the company's website starting December 5 and will be archived for 90 days.
SeaStar Medical has begun shipping QUELIMMUNE to its third hospital customer, marking the milestone of 100 therapeutic devices shipped since its commercial launch in July. QUELIMMUNE, the company's Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury and sepsis. The company is on track to make QUELIMMUNE available in 4-5 leading pediatric hospitals by end of 2024. The device requires hospital-specific IRB approval and integration with existing hemodialysis equipment. Treatment typically requires 3-7 days, with daily cartridge replacement. Recent data presented at Kidney Week 2024 showed projected cost savings driven by lower expected death rates and shorter hospital stays versus standard care.