Core Viewpoint - SeaStar Medical Holding Corporation has announced a definitive agreement for the issuance and sale of 5,242,464 shares of common stock at a price of $0.763 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.638, aiming to raise approximately $4 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement for unregistered warrants [1][2]. - The gross proceeds from the offering are expected to be around $4 million, with net proceeds intended for general corporate purposes, including working capital and capital expenditures [2]. Group 2: Regulatory and Compliance Information - The shares are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The unregistered warrants are not registered under the Securities Act and cannot be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: 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 life-threatening acute kidney injury in pediatric patients [6]. - The company’s Selective Cytopheretic Device therapy has received Breakthrough Device Designation for six therapeutic indications, indicating a potential for expedited approval processes [6]. - SeaStar is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6].

Company Overview - Medical Holding Corporation (Nasdaq: ICU) has confirmed compliance with the minimum $2.5 million stockholders' equity requirement for continued listing on The Nasdaq Capital Market, closing the previously disclosed listing matter [1] - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product QUELIMMUNE approved in 2024 for pediatric patients with AKI due to sepsis [9] Product and Therapy Details - QUELIMMUNE therapy is designed for children with AKI and sepsis, showing a 77% survival rate compared to standard care, which represents a 50% reduction in loss of life [4] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize over-active immune cells and mitigate hyperinflammation, with applications in various acute and chronic kidney and cardiovascular diseases [7][8] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SCD therapy in 200 adults with AKI, focusing on 90-day mortality and dialysis dependency as primary endpoints [6] - The trial will also assess secondary endpoints including mortality at 28 days and major adverse kidney events at Day 90 [6] 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 [5]

DENVER, June 25, 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 that it has undertaken a series of transactions to ensure compliance with Nasdaq’s continued listing standards. Last year on June 24, 2024, SeaStar Medical received a written notification from Nasdaq’s Listing Qualifications Staff that it was not in comp ...

Cincinnati Children’s Hospital Medical Center Discusses QUELIMMUNE Therapy Adoption A Father and Patient Describe Their Real-Life Experience with the QUELIMMUNE Therapy DENVER, June 24, 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 that the QUELIMMUNE therapy will be featured in a two-part video series that will be ...

$4 million upfront with up to an additional $4 million of potential aggregate gross proceeds upon the exercise in full of short-term warrantsDENVER, June 20, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (the “Company” or “SeaStar Medical”) (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, today announced the pricing of a public offering of 6,153,847 shares of the Company’s commo ...

Coverage marks SeaStar Medical’s second award by CMS for reimbursement of medical expenses for Medicare and Medicaid patients in a clinical trial Stands out as rare award with less than 100 clinical trials covered annually DENVER, May 28, 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 that the U.S. Centers for Medic ...

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]

Indication Has Been Granted FDA Breakthrough Device Designation for Potential PMA FilingDENVER, May 13, 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 that it has successfully reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, enabling a per protocol prespecified interim analysis by the trial’s ...

DENVER, May 07, 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 that it will report its first quarter financial results after market close on Wednesday, May 14, 2025, and host a webcast and conference call to discuss its financial results and business progress. A replay of the call will be available after 7:30 pm ET ...

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]