Core Insights - SeaStar Medical Holding Corporation is focusing on the commercialization of QUELIMMUNE therapy for critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis [1][2] - The QUELIMMUNE therapy received approval in February 2024 under a Humanitarian Device Exemption, demonstrating safety and probable clinical benefit for a limited population of critically ill children [2] - The therapy aims to reduce destructive hyperinflammation that can lead to organ failure and increased mortality rates [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [4] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [4] - The company has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [6] Therapy Details - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more who are treated in the ICU with Renal Replacement Therapy (RRT) [2] - The therapy was commercially launched in July 2025, following its approval [2] - The therapy addresses the urgent need for effective treatments in pediatric patients with few options available [2][3] Clinical Context - AKI is characterized by a sudden loss of kidney function and can result from various conditions, including sepsis and severe trauma [3] - Destructive hyperinflammation associated with AKI can lead to multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [3] - The company is conducting a pivotal trial of its Selective Cytopheretic Device (SCD) therapy in adult patients with AKI, impacting over 200,000 adults in the U.S. annually [6]

Group 1 - SeaStar Medical Holding Corporation announced a public offering of 6,153,847 shares of common stock at a price of $0.65 per share, with potential additional gross proceeds of up to $4 million from short-term warrants [1][4] - The Series A warrants will expire in five years, while the Series B short-term warrants will expire in 18 months, both having an exercise price of $0.65 per share [2] - The offering is expected to close around June 23, 2025, pending customary closing conditions [2] Group 2 - H.C. Wainwright & Co. is the exclusive placement agent for the offering [3] - The gross proceeds from the offering are anticipated to be approximately $4 million before deducting fees and expenses [4] - The net proceeds will be used for general corporate purposes [4] Group 3 - 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 acute kidney injury in pediatric patients [7] - The company’s Selective Cytopheretic Device therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process [7] - SeaStar is conducting a pivotal trial for its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [7]

Core Insights - The U.S. Department of Defense (DoD) has awarded a $2 million grant to the Autonomous Reanimation and Evacuation (AREVA) Research Institute for a study on SeaStar Medical's Selective Cytopheretic Device (SCD) therapy aimed at reducing hyperinflammation in patients with severe burns, inhalation injuries, and sepsis [1][2] - The research study is set to begin in July 2025 and will last for three years, focusing on the application of SCD therapy in military and civilian trauma cases [2][4] - The SCD therapy is designed to neutralize overactive immune cells and mitigate cytokine storms, which can lead to severe inflammation and organ failure [5] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on improving care for critically ill patients at risk of organ failure, with its first product, QUELIMMUNE, receiving FDA approval in 2024 [6] - The SCD therapy has received six Breakthrough Device Designations from the FDA and is currently undergoing pivotal trials for adult acute kidney injury patients requiring continuous renal replacement therapy (CRRT) [6] - The collaboration with AREVA is seen as a significant opportunity to advance military medicine and improve outcomes for patients suffering from trauma-related conditions [3][4] Research and Development - The grant will facilitate the purchase of SCD therapy for the research study, which aims to enhance organ recovery and potentially reduce the need for dialysis in patients with severe acute inflammatory conditions [2][3] - The Geneva Foundation will provide operational support for the research program, ensuring its success and accelerating innovation in military medicine [3][8] - The study will evaluate the effectiveness of SCD therapy in optimizing recovery for critically wounded service members and may have broader applications in treating various acute and chronic diseases [4][5]

Core Insights - SeaStar Medical has received a second reimbursement award from the U.S. Centers for Medicare & Medicaid Services (CMS) for expenses related to the NEUTRALIZE-CRS clinical trial, highlighting the potential life-saving capabilities of its technology [1][2] - The company is focused on its Selective Cytopheretic Device (SCD) therapy, which aims to improve health outcomes for critically ill patients, particularly those with Acute Kidney Injury (AKI) [2][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [5] - The company's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 for treating life-threatening acute kidney injury (AKI) in pediatric patients [5][6] - The SCD therapy has received Breakthrough Device Designation from the FDA for six therapeutic indications, facilitating a potentially expedited approval process [6] Clinical Trials - The NEUTRALIZE-AKI pivotal trial is assessing the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU, with 50% enrollment completed and full enrollment expected by the end of 2025 [3] - The primary endpoint of the NEUTRALIZE-AKI trial is a composite of 90-day mortality or dialysis dependency compared to a control group [3] - The NEUTRALIZE-CRS trial is evaluating the SCD therapy's ability to reduce hyperinflammation in patients with acute heart failure and worsening renal function, with funding from a $3.6 million NIH grant [4] Market Potential - The SCD therapy addresses a significant unmet need in the treatment of AKI, which affects over 200,000 adults in the U.S. annually [6] - The company is engaging a third-party reimbursement policy expert to analyze the feasibility of obtaining reimbursement coverage upon potential FDA approval for the SCD therapy in adult patients with AKI [2]

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding its infusion pump products [1][3]. Group 1: FDA Warning and Impact - On April 22, 2025, ICU received a warning letter from the FDA, citing unauthorized changes to two of its infusion pump products, labeling them as "adulterated" and "misbranded" [3]. - The FDA indicated that the 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 FDA's announcement, 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].

Financial Data and Key Metrics Changes - The company reported a fourfold increase in net revenue for the first quarter of 2025, achieving $293,000 compared to approximately $68,000 in the fourth quarter of 2024 and $0 in the first quarter of the previous year [31][34] - The net loss for the first quarter of 2025 declined to $3,700,000 compared to a loss of $12,700,000 in the first quarter of 2024 [34] Business Line Data and Key Metrics Changes - The Quellimmune therapy saw increased adoption, driving revenue growth, with all existing customers purchasing the therapy during the quarter [31][32] - The company anticipates a total annual U.S. market opportunity of approximately $100,000,000 based on a pediatric AKI population of about 4,000 patients [14] Market Data and Key Metrics Changes - The adult AKI market represents a significant opportunity with over 200,000 adults affected, translating to a total annual market opportunity of about $4,500,000,000 in the U.S. [9][18] - The company is focusing on the top 50 pediatric sites in the U.S. for Quellimmune therapy adoption, with a strong interest from these institutions [15][16] Company Strategy and Development Direction - The primary goal for 2025 is to grow the customer base for Quellimmune therapy and complete the neutralized AKI pivotal trial [5][11] - The company aims to file a PMA for the adult AKI indication in 2026, contingent on positive trial results [27][37] - The strategic goal includes expanding the addressable market to target other critical unmet medical needs for treating destructive hyperinflammation [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future opportunities for SeaStar Medical, highlighting the potential to capture a significant portion of the adult AKI market [37] - The company is focused on maintaining careful attention to spending while pushing forward with its commercial launch and clinical trials [30][34] Other Important Information - The neutralized AKI trial has reached the 50% enrollment milestone, triggering an interim analysis by the independent Data Safety Monitoring Board [10][21] - The company has received breakthrough device designations for five other indications, indicating a robust pipeline for future growth [28] Q&A Session Summary Question: How many sites are currently activated for the adult clinical trial? - The company currently has 15 activated sites and plans to activate another five over the next three months [39] Question: What's the total number of pediatric hospitals that you have as customers currently? - The company has six commercially active sites and multiple others moving through the IRB process [41] Question: What sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? - The growth is attributed to the experience of existing sites and word-of-mouth, with hospitals actively engaging in adopting Quellimmune therapy [42][44] Question: How important are the two additional breakthrough designations? - The company views cardiac surgery as a significant opportunity and plans to pursue additional clinical trials funded by grants and investigator-initiated studies [48][51]

Financial Data and Key Metrics Changes - The company reported a fourfold increase in net revenue for the first quarter of 2025, achieving $293,000 compared to approximately $68,000 in the fourth quarter of 2024 and $0 in the first quarter of the previous year [31][34] - The net loss for the first quarter of 2025 declined to $3,700,000 compared to a loss of $12,700,000 in the first quarter of 2024 [34] Business Line Data and Key Metrics Changes - The Quellimmune therapy saw increased adoption, driving revenue growth, with all existing customers purchasing the therapy during the quarter [31][32] - The company anticipates that sales will be lumpy initially but expects an overall trend of revenue increases as more hospitals adopt Quellimmune therapy [31] Market Data and Key Metrics Changes - The pediatric AKI market is estimated to have about 4,000 patients annually in the U.S., representing a total annual market opportunity of approximately $100,000,000 [12][13] - The adult AKI market is significantly larger, with over 200,000 adults affected, translating to a total annual market opportunity of about $4,500,000,000 in the U.S. [7][18] Company Strategy and Development Direction - The primary goal for the year is to grow the customer base for Quellimmune therapy, focusing on top pediatric medical facilities [13][15] - The company is also focused on penetrating the adult AKI market and expanding its pipeline with additional breakthrough device designations for various indications [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future opportunities for SeaStar Medical, particularly in capturing a significant portion of the adult AKI market [37] - The company is committed to providing life-saving therapy to critically ill patients and plans to file a PMA in 2026 if clinical trial results are supportive [37] Other Important Information - The Neutralize AKI trial has reached the 50% enrollment milestone, which will trigger an interim analysis by the independent Data Safety Monitoring Board [9][21] - The company has strengthened its balance sheet with new capital and maintained careful attention to spending [30] Q&A Session Summary Question: How many sites are currently activated for the adult clinical trial? - The company currently has 15 activated sites and plans to activate another five over the next three months [39] Question: What is the total number of pediatric hospitals that you have as customers currently? - The company has six commercially active sites and multiple others moving through the IRB process [40] Question: What sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? - The growth is attributed to the experience of existing sites and word-of-mouth, with hospitals showing interest in adopting Quellimmune therapy [42][44] Question: How important are the two additional breakthrough designations and how are you prioritizing the regulatory processes? - The company views cardiac surgery as a significant opportunity and plans to pursue additional clinical trials, potentially funded by grants [46][48]

Financial Performance - SeaStar Medical reported a revenue of $0.293 million for the three months ended March 31, 2025, compared to no revenue in the same period in 2024, marking a significant increase as commercial sales of QUELIMMUNE began in July 2024 [152]. - The net loss for the three months ended March 31, 2025, was $3.772 million, a 70% reduction from the net loss of $12.697 million in the same period in 2024 [152]. - The net loss for the three months ended March 31, 2025, was approximately $3.8 million, a decrease of $8.9 million compared to a net loss of $12.7 million for the same period in 2024 [160]. - Net cash used in operating activities was $2.7 million for the three months ended March 31, 2025, compared to $3.5 million for the same period in 2024, reflecting a decrease of $0.8 million [171]. Expenses - Research and development expenses rose by 43% to $2.431 million for the three months ended March 31, 2025, compared to $1.697 million in the same period in 2024 [152]. - General and administrative expenses decreased by 25% to $1.684 million for the three months ended March 31, 2025, down from $2.253 million in the same period in 2024 [152]. - Clinical trial costs rose by $0.7 million due to the expansion of the NEUTRALIZE-AKI pivotal trial from 5 to 16 clinical trial sites, contributing significantly to the increase in R&D expenses [155]. - General and administrative expenses decreased to approximately $1.7 million for the three months ended March 31, 2025, down from $2.3 million in 2024, a reduction of about 26% [157]. Cash and Funding - The company had cash reserves of $5.3 million as of March 31, 2025, an increase from $1.8 million as of December 31, 2024 [136]. - Cash and cash equivalents as of March 31, 2025, were $5.3 million, an increase from $1.8 million as of December 31, 2024 [163]. - Net cash provided by financing activities was $6.1 million for the three months ended March 31, 2025, primarily from the issuance of new shares and pre-funded warrants [172]. - The company anticipates significant future funding requirements to support ongoing clinical development and commercialization efforts [168]. - The company has raised concerns about its ability to continue as a going concern due to insufficient cash to meet working capital and capital expenditure requirements for at least the next twelve months [164]. Accumulated Deficit - SeaStar Medical has an accumulated deficit of $143.3 million as of March 31, 2025, compared to $139.6 million as of December 31, 2024 [135]. - The accumulated deficit increased to approximately $143.3 million as of March 31, 2025, compared to $139.6 million as of December 31, 2024 [162]. Regulatory Approvals and Market Potential - SeaStar Medical received FDA approval for its pediatric SCD therapy under a Humanitarian Device Exemption on February 21, 2024, and shipped its first commercial units in July 2024 [125]. - The SCD therapy has been awarded Breakthrough Device Designation for six therapeutic indications, facilitating a potentially expedited approval process [126]. - The company aims to capture a sizable market for its SCD therapy, targeting over one million patients annually facing life-threatening hyperinflammatory conditions [134]. - SeaStar Medical has generated approximately $0.5 million in revenue from the sale of commercialized pediatric SCD products to date [140]. Company Classification - The company will remain an Emerging Growth Company (EGC) under the JOBS Act until the earliest of the last day of its first fiscal year following the fifth anniversary of the Business Combination, total annual gross revenue of at least $1.235 billion, or being deemed a "large-accelerated filer" with at least $700.0 million of outstanding securities held by non-affiliates [178]. - The company has issued more than $1.0 billion in non-convertible debt securities during the previous three years, which may affect its EGC status [178]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [179].

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]