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 ...

Financial Performance - Net losses for the years ended December 31, 2024, and 2023 were $24.8 million and $26.2 million, respectively, with a decrease of 5.3% in net loss year-over-year [362][378]. - The net loss decreased to $24.8 million in 2024 from $26.2 million in 2023, attributed to a $5.0 million reduction in other expenses [388]. - The company had an accumulated deficit of approximately $139.6 million as of December 31, 2024 [362]. - As of December 31, 2024, the accumulated deficit reached $139.6 million, up from $114.7 million in 2023 [390]. - Other income (expense) improved to an expense of $7.0 million in 2024 from $12.0 million in 2023, mainly due to a $4.2 million decline in losses from convertible notes [384]. Revenue and Sales - The pediatric SCD, QUELIMMUNE, received FDA approval on February 21, 2024, and the first commercial units were shipped in July 2024, generating approximately $0.1 million in revenue by December 31, 2024 [368][380]. - The company expects revenue to fluctuate as QUELIMMUNE is introduced to pediatric hospital customers and is focused on generating future revenue from product sales and potential collaborations [368][369]. Expenses - Research and development expenses increased by $3.1 million, or 52.4%, from $6.0 million in 2023 to $9.1 million in 2024, primarily due to clinical trial costs and increased personnel expenses [370][381]. - Total operating expenses rose by $3.8 million, or 26.5%, from $14.2 million in 2023 to $18.0 million in 2024 [378]. - General and administrative expenses increased by 7.7% to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased payroll and accounting costs [383]. Cash Flow and Financing - Cash and cash equivalents were approximately $1.8 million as of December 31, 2024, compared to $0.2 million in 2023 [363]. - Cash used in operating activities rose to $16.0 million in 2024 from $10.3 million in 2023, driven by increased clinical trial activities [393]. - Cash provided by financing activities increased to $17.7 million in 2024 from $10.4 million in 2023, primarily from the issuance of new shares and convertible notes [394]. - The company raised approximately $23.5 million through registered direct offerings and "At-the-Market" offerings since the effectiveness of its shelf registration on December 22, 2023 [396]. - The company had cash of $1.8 million as of December 31, 2024, compared to $0.2 million in 2023, indicating a need for additional funding [391]. Clinical Trials - The pivotal clinical trial for the adult SCD is currently underway with 94 patients enrolled as of March 25, 2025 [355]. - The increase in clinical trial expenses was driven by the Neutralize-AKI Adult SCD study, which had 14 clinical trial sites enrolled by the end of 2024 [381]. Future Outlook and Concerns - The company has incurred net losses since its inception in 2007, raising concerns about its ability to continue as a going concern [364][365]. - Future funding requirements will depend on the progress of clinical trials and the ability to secure additional capital, with no committed external sources currently available [400]. Regulatory and Compliance - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing it to delay compliance with new accounting standards until it no longer qualifies as an EGC or opts out of the transition period [413]. - The company will remain an EGC until it has total annual gross revenue of at least $1.235 billion or meets other specified criteria [415]. - The company is not required to provide an auditor's attestation report on internal controls due to its EGC status [414]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [419]. Obligations and Arrangements - The company has total contractual obligations of $574,000, all of which are due within one year [417]. - In October 2024, the company entered into a financing arrangement for an insurance policy premium amounting to $0.7 million, to be paid in 10 monthly installments through August 2025 [418]. - The company entered into various convertible credit agreements with an institutional investor, which included detachable warrants [416]. - The company assumed 229,520 Private Placement warrants as part of the Business Combination [416].

Financial Data and Key Metrics Changes - The company reported a net revenue of $134,000 for 2024, marking the first product revenue from the launch of Quellimmune in Q3 2024 [37] - The net loss for 2024 decreased to $24.8 million from $26.2 million in 2023, with approximately $6.9 million of the loss attributed to non-cash items [40] - The company raised approximately $25 million in 2024 and an additional $6 million in February 2025, improving its balance sheet by reducing debt and liabilities [34][35] Business Line Data and Key Metrics Changes - Quellimmune therapy has shown a 60% higher survival rate in pediatric acute kidney injury patients compared to standard care, with nearly 80% of patients surviving with Quellimmune [16] - The number of pediatric hospitals adopting Quellimmune doubled from Q3 to Q4 2024, with further increases noted in early 2025 [17] - The company anticipates a total addressable market of approximately $100 million for Quellimmune, with expectations of significant market penetration over time [20] Market Data and Key Metrics Changes - The adult AKI market is estimated to be 50 times larger than the pediatric market, with around 200,000 patients annually facing organ failure without FDA-approved treatment options [21] - The projected market opportunity for adult AKI is approximately $4.5 billion, with significant revenue upside expected even with modest market penetration [22] Company Strategy and Development Direction - The company aims to expand its product offerings beyond pediatric AKI to address larger markets, including chronic dialysis and cardiorenal syndrome [21][30] - The strategic shift to a direct sales model is intended to enhance control over the sales process and improve relationships with healthcare providers [36] - The company is focused on completing the adult AKI pivotal trial and preparing for a PMA filing following the trial's completion [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing significant market opportunities and the potential for growth driven by the successful launch of Quellimmune and ongoing clinical trials [42] - The company is committed to improving clinical outcomes and addressing unmet medical needs in nephrology, as evidenced by recent awards and recognitions [11] Other Important Information - The company received its fourth breakthrough device designation for chronic dialysis and has been recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation [9][11] - The neutralized AKI pivotal trial is progressing with 94 of the anticipated 200 subjects enrolled, with an interim analysis expected after reaching 100 patients [23][24] Q&A Session Summary Question: Update on NEUTRALIZE AKI trial enrollment and interim analysis timeline - Management confirmed that 94 patients have been enrolled and anticipates reaching 100 patients in April, with the interim analysis expected around July or early August [45][49] Question: Plans to expand sales force capabilities in 2025 - The company is currently right-sized for the small market and has a healthy pipeline of new accounts, focusing on operational support and training for hospital staff [50][51] Question: Learnings from initial hospital activations and typical conversion timelines - The company has learned to streamline the IRB process and emphasized the importance of early collaboration between ICU doctors and nephrologists to save time [57][58]

Financial Performance - Net revenue for the year ended December 31, 2024, was $0.1 million, compared to no net revenue for the year ended December 31, 2023, due to the initiation of QUELIMMUNE therapy sales[5] - Net revenue for the year ended December 31, 2024, was $135,000, compared to $0 in 2023, indicating a significant increase[26] - Net loss for the year ended December 31, 2024, was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with net loss per share decreasing from $30.26 to $6.63[11] - The net loss for the year ended December 31, 2024, was $24.830 million, a slight improvement from a net loss of $26.232 million in 2023[26] - The company reported a loss from operations of $17.842 million for the year ended December 31, 2024, compared to a loss of $14.210 million in 2023[26] Expenses - Research and development expenses increased to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs[6] - Research and development expenses rose to $9.105 million in 2024, up from $5.973 million in 2023, reflecting a 52.3% increase[26] - General and administrative expenses rose to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased headcount and legal expenses[7] Clinical Trials and Approvals - The NEUTRALIZE AKI pivotal trial has enrolled 94 patients to date, with a target of 200 patients, and includes prestigious clinical sites such as Stanford Medical Center and Cleveland Clinic[8] - QUELIMMUNE therapy was approved by the FDA for pediatric patients with acute kidney injury, impacting approximately 4,000 patients annually[4] - SeaStar Medical was awarded a $3.6 million grant from the National Institutes of Health for a clinical trial evaluating SCD therapy in patients with chronic heart failure[8] Capital and Assets - The company secured approximately $31 million in capital during fiscal 2024, improving its balance sheet and reducing debt[8] - Total assets increased to $4.658 billion as of December 31, 2024, compared to $3.513 billion in 2023, representing a growth of 32.5%[24] - Total liabilities decreased to $6.841 billion in 2024 from $17.383 billion in 2023, a reduction of 60.7%[24] Cash Flow and Share Issuance - Cash at the end of the period increased to $1.819 million from $176,000 in 2023, marking a substantial rise[27] - Cash flows from operating activities resulted in a net cash used of $16.007 million in 2024, compared to $10.285 million in 2023[28] - The company raised $17.441 million from the issuance of shares, net of offering costs, in 2024, compared to $4.742 million in 2023[28] - The weighted-average shares outstanding increased to 4,920,156 in 2024 from 1,532,418 in 2023, indicating a significant increase in share issuance[26] Customer and Recognition - The company has added five commercial customers for QUELIMMUNE therapy and is expanding its customer pipeline[4] - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to pediatric AKI treatment[8]

Core Insights - SeaStar Medical Holding Corporation reported significant progress in 2024, including the approval and commercial launch of QUELIMMUNE therapy, and the expansion of clinical trials for its Selective Cytopheretic Device (SCD) therapy [2][3] Financial Performance - Net revenue for the year ended December 31, 2024, was $0.1 million, a notable increase from no revenue in 2023, attributed to the launch of QUELIMMUNE therapy [3][4] - The net loss for the year ended December 31, 2024, was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with net loss per share decreasing from $30.26 to $6.63 [8][21] - Cash, cash equivalents, and short-term investments at December 31, 2024, were $1.8 million, excluding proceeds from a $6 million financing completed in February 2025 [8][22] Business Developments - The company received its first product approval for QUELIMMUNE therapy, specifically for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 children annually [3][15] - SeaStar Medical added 14 new clinical sites for the NEUTRALIZE AKI pivotal trial, with 94 out of the anticipated 200 patients enrolled [2][3] - The company was awarded its fourth Breakthrough Device Designation for SCD therapy, which is expected to expedite the review and approval processes [2][3] Research and Development - Research and development expenses increased to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [5][6] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3][5] Awards and Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving the lives of pediatric patients with AKI [3][9]

Core Insights - SeaStar Medical Holding Corporation has made significant progress in 2024, including the approval and commercial launch of its QUELIMMUNE therapy, and is positioned for a transformational year in 2025 [2][3] Business Highlights - The FDA granted approval for QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 pediatric patients annually [3] - QUELIMMUNE therapy has been adopted by five customers, with a growing pipeline of prospective customers [3] - The NEUTRALIZE AKI pivotal trial has enrolled 94 out of the anticipated 200 patients, with participation from prestigious medical centers [3][12] - SeaStar Medical received its fourth Breakthrough Device Designation for the Selective Cytopheretic Device (SCD) therapy, aimed at treating chronic systemic inflammation in end-stage renal disease patients [3] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3] - The company was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric patients with AKI [3] Financial Performance - For the year ended December 31, 2024, net revenue was $0.1 million, a significant increase from no revenue in 2023, attributed to the initiation of QUELIMMUNE sales [5] - Research and development expenses rose to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [6] - General and administrative expenses increased to $8.9 million in 2024 from $8.2 million in 2023, primarily due to higher headcount and legal expenses [7] - The net loss for the year was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with a net loss per share of $6.63 compared to $30.26 in the previous year [9][23] Balance Sheet Improvements - The company improved its balance sheet by adding approximately $31 million in capital and reducing debt and liabilities [4] - Cash and cash equivalents at December 31, 2024, were $1.8 million, reflecting a significant increase from $176,000 at the end of 2023 [20]

Core Insights - SeaStar Medical Holding Corporation is set to report its fourth quarter and year-end 2024 financial results on March 27, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE, approved by the FDA in 2024 [2] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure and potential loss of life [2] - QUELIMMUNE (SCD-PED) is the only FDA-approved product for life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [2] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for four therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [2] - 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 [2]

Company Overview - SeaStar Medical has been awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric acute kidney injury (AKI) treatment [1][4] - The company's QUELIMMUNE Selective Cytopheretic Device for Pediatrics (SCD-PED) is the first and only FDA-approved therapeutic device for treating pediatric AKI due to sepsis [2][9] - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product approved in 2024 [9] Industry Context - Approximately 4,000 children in the U.S. with AKI, primarily due to sepsis, require continuous kidney replacement therapy (KRT) annually, with a mortality rate of around 50% [3] - The standard of care for AKI has not changed significantly over the past decades, leading to stagnant patient outcomes [3] - AKI can lead to severe complications, including chronic kidney disease and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [6] Recognition and Impact - The Corporate Innovator Award recognizes companies that address unmet medical needs in nephrology, with past recipients including major pharmaceutical companies [4] - SeaStar Medical's QUELIMMUNE device has been noted for its role in saving children's lives and preventing long-term dialysis [4] - The National Kidney Foundation emphasizes the importance of innovation in improving patient outcomes in kidney care [11]

Core Viewpoint - SeaStar Medical Holding Corporation has successfully closed a registered direct offering, raising approximately $6 million through the issuance of 3,529,412 shares of common stock and accompanying warrants [1][3]. Offering Details - The combined offering price for each share of common stock and accompanying warrants was set at $1.70, with pre-funded warrants priced at $1.699 [2]. - The pre-funded warrants have an exercise price of $0.001 per share and are exercisable immediately upon issuance, while the warrants have an exercise price of $1.70 per share and require shareholder approval for exercise [2]. Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may include working capital and capital expenditures [3]. Regulatory Compliance - The securities were offered under a shelf registration statement on Form S-3, which was filed with the SEC on December 8, 2023, and declared effective on December 22, 2023 [4]. - The warrants issued in the concurrent private placement were offered under Section 4(a)(2) of the Securities Act of 1933 and have not been registered under the Act or applicable state securities laws [5]. Company Overview - SeaStar Medical is a commercial-stage therapeutic medical technology company focused on developing extracorporeal therapies aimed at reducing excessive inflammation in vital organs [7]. - The company is innovating solutions for critically ill patients by targeting effector cells that drive systemic inflammation [7].