Exhibit 99.1 SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business Updates DENVER, CO (May 14, 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 ended March 31, 2025, and provided business updates on key initiatives. "This is our second full quarter of the QUELIMMUNE lau ...

Core Insights - SeaStar Medical Holding Corporation reported a significant four-fold increase in net revenue for QUELIMMUNE therapy, indicating strong customer commitment to improving outcomes for pediatric patients with Acute Kidney Injury (AKI) [2][4] - The company is expanding its technology into the adult AKI market, with the NEUTRALIZE-AKI trial now 50% enrolled, aiming for a Premarket Approval (PMA) application in 2026 [2][3] - SeaStar Medical received two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, enhancing its potential for expedited approval and favorable reimbursement [4][16] Financial Performance - For the first quarter of 2025, net revenue was approximately $0.3 million, a significant increase from $68 thousand in the previous quarter [4][5] - The net loss for the quarter was approximately $3.8 million, or $0.44 per share, a notable improvement compared to a net loss of $12.7 million, or $4.73 per share, in the same period last year [9][27] - Cash and cash equivalents increased to $5.3 million as of March 31, 2025, up from $1.8 million at the end of 2024, following a registered direct offering [10][21] Research and Development - Research and development expenses rose to $2.4 million in Q1 2025 from $1.7 million in Q1 2024, primarily due to increased clinical trial costs for the NEUTRALIZE-AKI trial [6] - General and administrative expenses decreased to approximately $1.7 million in Q1 2025 from $2.3 million in Q1 2024, attributed to lower accounting and legal costs [7] Business Developments - The QUELIMMUNE therapy has been adopted by three new customers, including a nationally recognized children's medical center [4][3] - The NEUTRALIZE-AKI trial is a pivotal study evaluating the SCD therapy's safety and efficacy in adult AKI patients, with results expected to be reported in 2026 [13][16] - SeaStar Medical was awarded the NKF 2025 Corporate Innovator Award for its contributions to improving pediatric AKI treatment [4][16]

Core Points - SeaStar Medical has reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, allowing for an interim analysis by the independent Data Safety Monitoring Review Board (DSMB) [1][2] - The NEUTRALIZE-AKI trial is evaluating the Selective Cytopheretic Device (SCD) therapy for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT) [2][4] - The trial aims to enroll up to 200 patients, with the primary endpoint being a composite of 90-day mortality or dialysis dependency [4][5] - The SCD therapy has shown improved treatment outcomes in prior studies compared to standard care, and the interim analysis will assess its safety and efficacy [3][4] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved by the FDA in 2024 for a rare condition of AKI in pediatric patients [9] - The company has received Breakthrough Device Designation from the FDA for its SCD therapy across six therapeutic indications, facilitating a faster approval process [9][7] - The SCD therapy targets over-active immune cells to mitigate hyperinflammation, with potential applications in various acute and chronic kidney and cardiovascular diseases [8][9] Clinical Trial Details - The NEUTRALIZE-AKI trial has enrolled 100 patients so far, with the interim analysis focusing on the primary endpoint after 90-day follow-up [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The DSMB will conduct the interim analysis and may recommend adjustments to the trial based on the results, including potential sample size re-estimation [5]

Core Insights - SeaStar Medical Holding Corporation is set to report its first quarter financial results on May 14, 2025, after market close, followed by a webcast and conference call to discuss the results and business progress [1][2]. Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][2]. - The company's first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024, specifically for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [2]. - SeaStar's Selective Cytopheretic Device (SCD) therapy has been granted Breakthrough Device Designation by the FDA for six therapeutic indications, which may facilitate a faster approval process and better reimbursement conditions upon commercial launch [2]. - The company is currently 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, with no effective treatment options available [2].

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning letter from the FDA regarding unauthorized changes to its infusion pump products [1][3]. Group 1: FDA Warning and Impact - 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, labeling them as "adulterated" and "misbranded" [3]. - The FDA's letter indicated that these modifications could significantly affect the functionality of the devices, particularly concerning the infusion delivery profile and alarm functionality, raising safety and efficacy concerns [3]. - Following the news of the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on the same day [4]. Group 2: 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]. - Investors are encouraged to contact Pomerantz LLP for more information about the class action [2]. Group 3: Pomerantz LLP Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering significant damages for victims of securities fraud and corporate misconduct [5].

Core Viewpoint - The formation of Otsuka ICU Medical LLC represents a significant partnership aimed at enhancing the IV solutions supply chain in North America, with an estimated combined production capacity of 1.4 billion annual units, thereby increasing supply chain resiliency and fostering innovation in the market [1][2][3]. Company Overview - ICU Medical, Inc. is a leader in the development and sale of innovative medical devices, focusing on providing clinically essential medical devices that enhance patient care [6]. - Otsuka Pharmaceutical Factory, Inc. has over 75 years of experience in developing, manufacturing, and selling IV solutions, positioning itself as a key player in clinical nutrition [5]. Joint Venture Details - The joint venture, Otsuka ICU Medical LLC, combines OPF's extensive manufacturing capabilities across 16 production sites in Asia with ICU Medical's strong presence in North America, particularly in Austin, Texas [3]. - The partnership aims to introduce new PVC-free technologies to the North American market, enhancing the product offerings available to customers [3]. Market Impact - The collaboration is expected to provide increased stability and choice in the North American IV solutions market, delivering enhanced economic and clinical value to customers [3]. - The joint venture is positioned to improve global supply resiliency, which is critical in the healthcare sector [3].

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 ...