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SeaStar Medical Holding Corporation - $ICU STOCK NEWS

Welcome to our dedicated page for SeaStar Medical Holding Corporation news (Ticker: $ICU), a resource for investors and traders seeking the latest updates and insights on SeaStar Medical Holding Corporation stock.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect SeaStar Medical Holding Corporation's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

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SeaStar Medical Holding (Nasdaq: ICU) reported its Q1 2024 financial results and provided a business update. The company anticipates initial sales of Quelimmune™ Pediatric for addressing acute kidney injury (AKI) and sepsis in children in the coming weeks, targeting a U.S. pediatric AKI patient population estimated at 4,000 annually. The company has enrolled 31 subjects in its NEUTRALIZE-AKI trial for its Selective Cytopheretic Device Adult (SCD-ADULT) for adult AKI patients. SeaStar eliminated senior secured debt, ending Q1 with $5 million in cash. R&D expenses remained steady at $1.7 million, while G&A expenses decreased to $2.3 million. However, a significant net loss of $12.7 million was reported, largely due to non-cash losses from derivative financial instruments. The company also received several Breakthrough Device Designations for its SCD technology across various conditions.

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SeaStar Medical Holding (Nasdaq: ICU) has been awarded a $3.6 million NIH grant for a clinical trial to evaluate the Selective Cytopheretic Device Adult (SCD-ADULT) in patients with severe chronic heart failure (CHF). The grant aims to study SCD-ADULT as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with acute decompensated heart failure (ADHF). The company hopes this study will pave the way for FDA approval.

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SeaStar Medical Holding (Nasdaq: ICU) reports its 2023 financial results, highlighting the FDA approval for Quelimmune™ to treat pediatric patients with acute kidney injury and sepsis. The company is making progress in its NEUTRALIZE-AKI pivotal clinical trial for adult AKI patients. SeaStar Medical also filed its Form 10-K for 2023, with minimal impact on financials.
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SeaStar Medical Holding (ICU) will present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference to discuss their solutions for hyperinflammation on vital organs.
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SeaStar Medical Holding (ICU) announces the restatement of financial statements for 2022 and interim periods in 2023 due to accounting treatment changes. The restatement will not materially affect cash position or operations. The company continues its pivotal adult acute kidney injury study and prepares for the commercial launch of Quelimmune™ pediatric therapeutic device.
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SeaStar Medical Holding Corporation (ICU) announces updates on its NEUTRALIZE-AKI clinical trial for acute kidney injury patients and FDA approval for Quelimmune pediatric device. The company plans to conduct an interim analysis once 100 subjects reach the 90-day primary endpoint in the second half of 2024.
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SeaStar Medical Holding Corporation (ICU) sponsors an Industry Symposium on pediatric AKI at the 29th International Conference on Critical Care Nephrology. The company will showcase Quelimmune™ scientific background and clinical data for pediatric AKI due to sepsis or a septic condition on March 13, 2024. The event aims to address the challenges of AKI and multi-organ failure in children.
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SeaStar Medical Holding Corporation (ICU) announces publication of a manuscript discussing the role of chronic systemic inflammation in heart failure patients and the potential application of the Adult Selective Cytopheretic Device to improve outcomes. The manuscript reviews the positive effect of the device in a first-in-human case report, leading to a Breakthrough Device Designation from the FDA. SeaStar also received FDA approval for the Pediatric SCD for use in children with acute kidney injury.
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SeaStar Medical Holding Corporation (Nasdaq: ICU) receives FDA approval for SCD-PED, the first product in the Quelimmune product family, for pediatric use in acute kidney injury cases due to sepsis or septic conditions.
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SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced the issuance of Canadian Patent No. 2814586, expanding its international patent rights for the Selective Cytopheretic Device (SCD) technology. The new patent covers SCD cartridges for treating activated leukocytes and platelets, as well as their use in processing activated leukocytes and platelets. This development presents a significant opportunity to improve the treatment of dysregulated hyperinflammatory responses and potentially reverse organ injury. CEO Eric Schlorff highlighted the innovative and proven approach of SCD in targeting highly active inflammatory cells to quell hyperinflammatory responses resulting from various conditions.
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SeaStar Medical Holding Corporation

Nasdaq:ICU

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29.92M
35.55M
17.45%
1.44%
5.51%
Surgical and Medical Instrument Manufacturing
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United States of America
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