Core Insights - SeaStar Medical has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a second hospital, marking a significant step in its direct sales model [1][2] - The company aims to have QUELIMMUNE available in four to five leading pediatric hospitals by the end of 2024, highlighting its growth strategy and market penetration efforts [2] Product Overview - QUELIMMUNE is designed for critically ill children with acute kidney injury (AKI) and sepsis, and it has received FDA approval under a Humanitarian Device Exemption (HDE) [1][3] - The device is expected to reduce hospitalization costs by approximately $30,000 per patient, primarily due to lower death rates and shorter hospital stays compared to standard care [3] Economic Impact - The cost of treating pediatric patients with AKI on continuous renal replacement therapy (CRRT) exceeds $460,000 per hospitalization, indicating a substantial market opportunity for QUELIMMUNE [3] - The device's implementation could lead to significant healthcare savings while providing critical care to very sick children [2][3] Regulatory and Operational Aspects - QUELIMMUNE requires Institutional Review Board (IRB) approval from each hospital before commercial sales can occur, which includes training for critical care teams [5] - The company is actively working to secure additional IRB clearances and expand its customer base under HUD requirements [2][5] Clinical Development - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the SCD's safety and effectiveness in adults with AKI, with the adult version of the device receiving FDA Breakthrough Device Designation [8] - The SCD technology aims to modulate the immune response in patients, potentially improving long-term organ recovery and reducing the need for future renal replacement therapy [7][8] Company Background - SeaStar Medical is focused on developing innovative medical technologies that address excessive inflammation in critically ill patients, with a commitment to improving patient outcomes through its proprietary therapies [9]

SAN CLEMENTE, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq: ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced the time of its third quarter 2024 earnings release and conference call. The Company will release its third quarter 2024 results on Tuesday, November 12th, 2024 at approximately 4:00 p.m. ET (1:00 p.m. PT) and will be conducting a conference call concerning those results at 4:30 p.m. ET (1:30 p.m. PT) on Tuesday, November ...

Core Insights - SeaStar Medical's QUELIMMUNE™️ demonstrates potential cost savings and improved outcomes for pediatric patients with acute kidney injury (AKI) [1][2] - The device has shown a projected cost savings of approximately $30,000 per hospitalization compared to historical averages for children not treated with QUELIMMUNE [2][3] - QUELIMMUNE therapy achieves cost neutrality starting at 6 days of treatment, with a high survival rate of 77% in treated children [3] Company Overview - SeaStar Medical is a commercial-stage medical device company focused on reducing hyperinflammation's impact on vital organs through innovative therapies [6] - The Selective Cytopheretic Device (SCD) is designed to target proinflammatory cells and promote organ recovery, having received FDA Breakthrough Therapy Designation for multiple indications [5] - QUELIMMUNE, the pediatric version of the SCD, was approved under a Humanitarian Device Exemption in February 2024 for critically ill children with AKI [5] Industry Context - The American Society of Nephrology's Kidney Week 2024 serves as a platform for presenting advancements in nephrology, with over 12,000 professionals expected to attend [4] - Acute Kidney Injury (AKI) poses significant healthcare challenges, often leading to multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4]

Core Insights - SeaStar Medical presented new data on QUELIMMUNE at the ASN Kidney Week 2024, highlighting its cost-saving benefits for treating pediatric acute kidney injury (AKI) [1][2] - QUELIMMUNE demonstrates significant cost neutrality starting at 6 days of therapy, with projected savings of approximately $30,000 per hospitalization compared to standard care [2][3] - The device has shown a high survival rate of 77% in treated children, compared to a control survival rate of around 50% [3] Company Overview - SeaStar Medical is a commercial-stage medical device company focused on reducing hyperinflammation's impact on vital organs through innovative therapies [7] - The Selective Cytopheretic Device (SCD) is a patented technology that targets proinflammatory cells, aiming to improve outcomes in critically ill patients [6] - QUELIMMUNE, the pediatric version of the SCD, received FDA approval in February 2024 under a Humanitarian Device Exemption for use in children with AKI and sepsis [6] Industry Context - Acute Kidney Injury (AKI) poses significant healthcare challenges, often leading to multi-organ dysfunction and increased healthcare costs due to prolonged hospital stays and reliance on dialysis [5] - The ASN Kidney Week is a major event in nephrology, attracting over 12,000 professionals to discuss advancements and challenges in kidney health [4]

Core Insights - SeaStar Medical Holding Corporation has taken full responsibility for the direct sales, marketing, and distribution of its therapeutic device QUELIMMUNE, aimed at treating pediatric acute kidney injury (AKI) due to sepsis or septic-like conditions [1][2] - The company is focused on a successful commercial rollout of QUELIMMUNE, with initial demand exceeding expectations from its first customer, Cincinnati Children's Hospital [2][5] - SeaStar Medical anticipates recognizing 100% of revenue from QUELIMMUNE sales in the U.S., which is projected to be 3x-4x times more revenue per unit compared to previous arrangements [2][5] Company Overview - SeaStar Medical is a commercial-stage medical technology company that develops proprietary solutions to mitigate hyperinflammation's effects on vital organs [6] - The company specializes in cell-directed extracorporeal therapies that target effector cells driving systemic inflammation, which can lead to tissue damage and imbalanced immune responses [6] Product Details - QUELIMMUNE, also known as the Selective Cytopheretic Device (SCD) Pediatric, is designed to reduce hyperinflammation during continuous kidney replacement therapy (CKRT) [4][5] - The device has received FDA approval under a Humanitarian Device Exemption (HDE) for use in critically ill children with AKI, showing a 77% reduction in mortality rate and no dialysis dependency at Day 60 in clinical studies [5][4] - Each year, approximately 4,000 children in the U.S. require CKRT for AKI, with a high associated mortality rate of around 50% [5] Future Outlook - The company is streamlining relationships with pediatric hospitals to facilitate the integration of QUELIMMUNE into existing treatment protocols [2] - SeaStar Medical is exploring new strategic partnerships to accelerate the adoption of QUELIMMUNE technology among critically ill pediatric patients [2]

The pace of patient enrollment has significantly accelerated following a summertime slowdown DENVER, Oct. 18, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that 51 subjects have been enrolled in its NEUTRALIZE-AKI pivotal trial, passing the halfway point toward the target of 100 subjects for performing an interim analysis on the t ...

Core Insights - SeaStar Medical Holding Corporation is presenting new analyses of clinical data supporting the immunomodulating effect of its Selective Cytopheretic Device (SCD) at the ASN 2024 Kidney Week [1][2] - The SCD has shown significant reduction in biomarkers related to inflammation in patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT) [2][3] - The SCD is designed to target proinflammatory cells and promote a reparative state, potentially aiding in long-term organ recovery [6][8] Company Developments - The SCD-Pediatric device, QUELIMMUNE™, received FDA approval as a Humanitarian Use Device in February 2024 for critically ill children with AKI [7] - The company is actively enrolling patients in its adult NEUTRALIZE-AKI pivotal trial and exploring other indications such as cardiorenal syndrome [3][8] - SeaStar Medical aims to have a significant presence at the ASN Kidney Week, showcasing multiple abstracts related to the SCD [3] Industry Context - ASN Kidney Week is a major event in nephrology, expected to attract over 12,000 kidney professionals globally, providing a platform for knowledge exchange and discussions on scientific advances [4] - Acute Kidney Injury (AKI) can lead to hyperinflammation, which may result in multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [5] - The SCD's unique immunomodulation approach may address the challenges posed by hyperinflammation in AKI and other related conditions [6][8]

DENVER, Oct. 09, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that management will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit hosted by M-Vest on Wednesday, October 16, at 12:00 p.m. Eastern time (9:00 a.m. Pacific time). The fireside chat will be hosted by Maxim Group analyst Anthony Vendetti. Reg ...

Core Insights - SeaStar Medical Holding Corporation is advancing its pivotal NEUTRALIZE-AKI trial, with total enrollment reaching 46 subjects in a recent 10-day period, aiming for 200 participants in total [1][2][3] - The trial evaluates the safety and efficacy of the Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) undergoing continuous kidney replacement therapy (CKRT) [1][3] - The primary endpoint of the trial includes a composite of 90-day mortality or dialysis dependency, with secondary endpoints assessing various health outcomes [3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing solutions to mitigate hyperinflammation effects on vital organs [7] - The company’s proprietary SCD device employs immunomodulating technology to target proinflammatory cells, potentially promoting long-term organ recovery [5][7] - The SCD-Pediatric device, QUELIMMUNE™, has received FDA approval for use in critically ill children with AKI and sepsis, indicating the company's commitment to expanding its product offerings [6] Industry Context - Acute Kidney Injury (AKI) is a significant health concern characterized by sudden loss of kidney function, often leading to hyperinflammation and multi-organ dysfunction [4] - The implications of AKI extend beyond immediate health risks, contributing to increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4]

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in SeaStar Medical Holding Corporation ("SeaStar Medical" or the "Company") (NASDAQ: ICU) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of SeaStar Medical investors who were adversely affected by alleged securities fraud between October 31, 2022 and March 26, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/ ...