NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of ICU Medical, Inc. (“ICU” or the “Company”) (NASDAQ: ICUI). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether ICU and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On April 22, 2025, ICU d ...

The partnership creates one of the largest global IV solutions manufacturing networks with combined production of an estimated 1.4 billion annual units and aims to bring additional supply chain resiliency and new innovation to the North American IV solutions market.SAN CLEMENTE, Calif. and TOKUSHIMA, Japan, May 1, 2025 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, and Otsuka Pharmaceutical Factory, Inc. (OPF), a su ...

Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [3] - The company’s first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024 for treating life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] - SeaStar's Selective Cytopheretic Device (SCD) therapy has been granted Breakthrough Device Designation by the FDA for four therapeutic indications, which may facilitate faster approval and better reimbursement dynamics [3] - The company is conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [3] Event Information - Eric Schlorff, CEO of SeaStar Medical, will be featured on the Benzinga All Access Show on April 30, 2025, at approximately 10:50 am Eastern Time [1] - The event will be broadcast live and available for later viewing on SeaStar Medical's investor relations website [2]

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding unauthorized changes to its infusion pump products [1][2]. Group 1: FDA Warning and Product Issues - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products [2]. - The FDA's letter described the pumps as "adulterated" and "misbranded," indicating that the changes could significantly affect the functionality of the devices, particularly their delivery profile and alarm functionality [2]. - Concerns were raised about the safety and efficacy of the devices due to these modifications, questioning the adequacy of ICU's regulatory disclosures [2]. Group 2: Stock Market Reaction - Following the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on April 22, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of ICU investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Insights - SeaStar Medical Holding Corporation has received two new Breakthrough Device Designations from the FDA for its Selective Cytopheretic Device (SCD) therapy, aimed at treating systemic inflammatory response in adult and pediatric patients undergoing cardiac surgery [1][2] - The company has a total of six Breakthrough Device Designations, highlighting the critical need for effective therapies to treat hyperinflammation that can lead to organ failure [2][3] - SeaStar Medical's first commercial product, QUELIMMUNE, is in the initial launch phase, with plans for a PMA filing in 2026 following a successful clinical trial [2][7] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its SCD therapy designed to target proinflammatory cells and reduce hyperinflammation [6][7] - The SCD therapy is currently being commercialized under a Humanitarian Device Exemption for treating critically ill pediatric patients with acute kidney injury due to sepsis [2][7] - The company is conducting pivotal clinical trials for adult patients with acute kidney injury and is exploring additional indications for its SCD therapy [2][7] Market Opportunity - Approximately 15% of the 300,000 adults undergoing cardiac surgery annually are considered high risk and may benefit from SCD therapy [1] - Of the 40,000 pediatric patients undergoing congenital heart surgery each year, about one third could potentially benefit from the therapy [1] - The Breakthrough Device Designation facilitates faster access to the market, potentially improving reimbursement dynamics for SeaStar Medical's products [7] Regulatory Context - The FDA's Breakthrough Device Designation is intended to expedite the development and review process for devices that offer significant advantages over existing treatments [3][4] - SeaStar Medical's six designations were granted between April 2022 and March 2025, indicating a strong regulatory support for its innovative therapies [3][7] Technology Description - The Selective Cytopheretic Device (SCD) employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes, promoting a reparative state and potentially leading to long-term organ recovery [6][7] - The SCD is integrated with continuous renal replacement therapy systems, distinguishing it from other blood-purification tools [6]

New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to the dual-channel Plum Duo™. ICU Medical also received 510(k) clearance for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One)e ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39927 SEASTAR MEDICAL HOLDING CORPORATION (Exact name of Registrant as specified in its Charter) Delaware 85-3681132 (State or other ...

SeaStar Medical Holding (ICU) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants Jackie Kosman - Investor Relations AdvisorEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFO Operator Good afternoon, and thank you for standing by. My name is Calvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Seastar Star Medical Year End twenty twenty four Financial Results Conf ...

SeaStar Medical Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates Webcast Today at 4:30 pm Eastern Time DENVER, CO., March 27, 2025 – SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months and year ended December 31, 2024, and provided business updates on key initiatives. ...

DENVER, March 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months and year ended December 31, 2024, and provided business updates on key initiatives. "Our significant accomplishment in 2024 position us well for a transformational year in 2025," said Eric Schlorff, SeaStar Medical ...