Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure[5] - The company's SCD therapy targets the upstream source of effector cells and neutralizes effector cells that release cytokines[28] - The SCD conveniently connects with existing continuous kidney renal therapy that is widely available in U S ICUs today[36] Clinical Data and Approvals - QUELIMMUNE is approved by the FDA as a Humanitarian Use Device (HUD) to treat pediatric patients with acute kidney injury and sepsis or septic condition weighing 10 kilograms and requiring kidney replacement therapy[22] - QUELIMMUNE clinical data in pediatric acute kidney injury shows a 77% survival rate at Day 60 compared to 50% with standard of care[42] - In adult AKI studies, 87.5% of pediatric patients had normal kidney function at Day 60[45] Market Opportunity - The total US annual market opportunity for the Adult AKI market is ~$4.5 billion, which is 50 times the size of the Pediatric AKI market (~$100 million)[24] - The adult acute kidney injury population is 50x larger than the pediatric population[18] Financials - As of May 14, 2025, the company has a market capitalization of $13.5 million[69]

Core Viewpoint - SeaStar Medical Holding Corporation has undertaken several transactions to ensure compliance with Nasdaq's continued listing standards after receiving a notification regarding non-compliance with market value requirements [2][3]. Group 1: Compliance and Financial Transactions - SeaStar Medical received a notification from Nasdaq on June 24, 2024, indicating non-compliance with the minimum market value requirement of $35 million [2]. - The Nasdaq Hearings Panel granted an extension until June 22, 2025, for the company to demonstrate compliance with an alternative requirement of $2.5 million in stockholders' equity [2]. - The company completed a $4.0 million public offering of common stock and warrants on June 23, 2025, and entered into a purchase agreement with Lincoln Park Capital for up to $15.0 million in common stock purchases over three years [6]. Group 2: Business Operations and Product Development - SeaStar Medical increased its customer count to six for its FDA-approved product, QUELIMMUNE, which reduces pediatric mortality by approximately 50% in patients with multiple organ failure [3][4]. - The company initiated a cost-cutting program in May 2025, expected to reduce operating expenses for the remainder of the fiscal year without materially impacting operations [3]. - Approximately $1.2 million in employee compensation and director fee liabilities were extinguished as certain employees and directors waived their rights to unpaid bonuses and fees [3]. Group 3: Product Overview and Clinical Trials - QUELIMMUNE therapy is designed for children with acute kidney injury (AKI) and sepsis, approved under a Humanitarian Device Exemption in February 2024, and launched commercially in July 2024 [4][10]. - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in 200 adults with AKI, focusing on 90-day mortality and dialysis dependency as primary endpoints [7]. - The SCD therapy aims to neutralize over-active immune cells and mitigate hyperinflammation, with potential applications in various acute and chronic kidney and cardiovascular diseases [9][10].

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].

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jackie Cossmon - ConsultantEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFONicholas Sherwood - Equity Research Associate Operator Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Con ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jackie K ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 o ...