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/ ...

Core Viewpoint - SeaStar Medical Holding Corporation is facing allegations of issuing materially false and misleading statements regarding its compliance controls and financial reporting, which may lead to a restatement of financial statements and overstated business prospects [1]. Group 1: Allegations and Compliance Issues - The complaint alleges that SeaStar and/or Legacy SeaStar had deficient compliance controls related to the Humanitarian Device Exemption (HDE) Application [1]. - It is claimed that the FDA was unlikely to approve the HDE Application in its current form, and the regulatory prospects of the selective cytopheretic device were overstated [1]. - SeaStar allegedly downplayed the severity of deficiencies in its financial controls while overstating efforts to remediate these issues [1]. Group 2: Financial Reporting Concerns - The company is accused of failing to properly account for the classification of certain outstanding warrants and a prepaid forward agreement [1]. - As a result of these issues, SeaStar is likely to restate one or more previously issued financial statements [1]. - The allegations suggest that the company's public statements were materially false and misleading throughout the relevant period [1]. Group 3: Class Action Participation - Shareholders who purchased shares of SeaStar during the class period from October 31, 2022, to March 26, 2024, are encouraged to register for participation in the class action [2]. - The deadline for seeking lead plaintiff status is September 6, 2024, and there is no cost or obligation to participate [2].

DENVER, Sept. 04, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports that it has now retired all long-term debt, which will be reflected on its balance sheet for the quarter ending September 30, 2024. "At the end of 2023, we reported more than $9 million in convertible notes and long-term interest bearing debt. As of to ...

NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of SeaStar Medical Holding Corporation (NASDAQ: ICU, ICUCW) between October 31, 2022 and March 26, 2024, both dates inclusive (the "Class Period"), of the important September 6, 2024 lead plaintiff deadline. SO WHAT: If you purchased SeaStar securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a cont ...

NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of SeaStar Medical Holding Corporation (NASDAQ: ICU, ICUCW) between October 31, 2022 and March 26, 2024, both dates inclusive (the "Class Period"), of the important September 6, 2024 lead plaintiff deadline. SO WHAT: If you purchased SeaStar securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a conti ...

Core Viewpoint - SeaStar Medical Holding Corporation is facing a class action lawsuit due to alleged violations of federal securities laws, with investors encouraged to file claims for losses incurred during the specified class period [1][3]. Group 1: Legal Action and Investor Information - The Portnoy Law Firm is representing investors who purchased SeaStar securities between October 31, 2022, and March 26, 2024, with a deadline of September 6, 2024, to file a lead plaintiff motion [1]. - Investors can contact the law firm for a complimentary case evaluation and to discuss options for recovering losses [2]. Group 2: Allegations Against SeaStar - The complaint alleges that SeaStar and its executives made false or misleading statements regarding compliance controls for the HDE Application, leading to exaggerated regulatory prospects [3]. - Specific issues cited include inadequate financial controls, potential restatements of past financial statements, and misleading public statements about the company's business and financial prospects [3]. Group 3: Financial Restatement Announcement - On March 27, 2024, SeaStar announced it would restate financial statements for the fiscal year ending December 31, 2022, and interim periods through September 30, 2023, affecting the accounting of certain outstanding warrants and a prepaid forward purchase arrangement [4]. - The CEO indicated that the restatement would not significantly impact operations or cash position, but was related to non-cash accounting items [4]. Group 4: Market Reaction - Following the announcement of the restatement, SeaStar's stock price fell by $0.04 per share, or 5.41%, closing at $0.70 per share on March 27, 2024 [5].

NEW YORK, Aug. 29, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of SeaStar Medical Holding Corporation (NASDAQ: ICU). Shareholders who purchased shares of ICU during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/seastar-medical-loss-submission-form/?id=98725&from=4 CLASS PERIOD: ...