Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at Noble Capital Markets' Emerging Growth Virtual Equity Conference on February 5, 2026 [1] - SeaStar Medical's QUELIMMUNE (SCD-PED) therapy is the first commercial product based on its patented Selective Cytopheretic Device (SCD) technology, approved by the FDA in 2024 [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company targeting critically ill patients with organ failure [3] - The QUELIMMUNE (SCD-PED) therapy is the only FDA-approved treatment for life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] Clinical Trials - The company is conducting the NEUTRALIZE-AKI pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT) [3] - This condition affects over 200,000 adults in the U.S. annually and currently has no effective treatment options [3]

Creating a scalable, AInative Virtual ICU platform that drives new recurring revenue and enterprise value. SAN JOSE, CALIFORNIA / ACCESS Newswire / January 29, 2026 / VSee Health, Inc. (Nasdaq:VSEE), a leader in enterprise telehealth and AI-powered virtual care, today announced a strategic partnership with DocBox, the first Augmented Intelligence platform for critical care, to create a next-generation Virtual ICU operating system for hospitals worldwide. ...

SeaStar Medical (NasdaqCM:ICU) 2026 Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding Corporation - **Ticker Symbol**: ICU - **Industry**: Biotech/Medical Devices - **Mission**: To stop organ failure and save lives through innovative therapies targeting hyperinflammation and acute kidney injury [2][3] Core Points and Arguments Product and Market Potential - **Product**: Quellimune, a selective cytophoretic device (SCD) for treating acute kidney injury (AKI) in pediatric patients [7][10] - **Market Size**: - Pediatric AKI market in the U.S. is approximately $100 million, with about 4,000 children affected annually [3] - Adult AKI market is significantly larger, estimated to be 50 times the pediatric market [3] - **Revenue Potential**: Expected annual revenue of $4-$5 million post-FDA approval for adult indications [3] Clinical Efficacy - **Survival Rates**: Clinical studies show a survival rate increase of 50%-77% for children with AKI treated with Quellimune [10] - **Long-term Outcomes**: Zero patients required long-term dialysis post-treatment, indicating effective kidney recovery [10][11] - **Safety Profile**: No serious adverse events or infections reported, highlighting a clean safety profile [12] Regulatory and Development Strategy - **FDA Designations**: Six breakthrough device designations received, facilitating expedited discussions with the FDA [2][9] - **Current Studies**: - Pivotal study for adult AKI (339 patients) underway, focusing on all-cause mortality and dialysis dependency as endpoints [16][27] - Additional studies for cardiorenal syndrome and bridging to left ventricular assist devices (LVAD) planned [20][21] Commercial Strategy - **Target Hospitals**: Focus on the top 50 children's hospitals in the U.S., aiming to capture 50% of the pediatric AKI market [12][13] - **Customer Growth**: Targeting 20-25 active customers by the end of 2026, up from 10 at the end of 2025 [13][25] - **Cost Savings for Hospitals**: Treatment costs for AKI patients are around $400,000; Quellimune can reduce ICU time and save hospitals between $39,000 and $46,000 per patient [15][28] Financial Health - **Cash Position**: Increased from $47,000 in 2022 to over $13 million as of September 30, 2025 [24] - **Market Capitalization**: Approximately $9 million, trading at or below cash value [25] - **Sales Projections**: Anticipated sales of $1 million for Quellimune by the end of 2025 [25] Additional Insights - **Organ Agnostic Approach**: The therapy targets neutrophils and monocytes, which function across various organs, indicating potential for broader applications beyond AKI [22] - **Educational Efforts**: Significant investment in medical affairs and education to promote understanding and adoption of the therapy [23] - **Reimbursement Strategy**: No reimbursement code required for pediatric use; reimbursement for adult patients is anticipated through CMS [29] This summary encapsulates the key points from the SeaStar Medical conference, highlighting the company's innovative approach to treating acute kidney injury and its strategic plans for growth and market penetration.

Core Insights - SeaStar Medical is focused on expanding the adoption of its QUELIMMUNE therapy for ultra-rare pediatric acute kidney injury (AKI) and advancing its Selective Cytopheretic Device (SCD) therapy for adult AKI, targeting a potential market of $4.5 billion [1][2] Group 1: QUELIMMUNE Therapy - The QUELIMMUNE therapy is designed for children with AKI and sepsis, approved under a Humanitarian Device Exemption, requiring participation in the SAVE Surveillance Registry [3] - Clinical studies show a 77% survival rate for patients treated with QUELIMMUNE, indicating a 50% reduction in loss of life compared to historical data [4] - The customer base for QUELIMMUNE has expanded to 10 top-rated children's hospitals, with expectations of achieving approximately $2 million in net product revenue in 2026 [8] Group 2: SCD Therapy Development - The SCD therapy is being advanced for adult AKI through the NEUTRALIZE-AKI pivotal trial, with enrollment completion expected by the end of 2026 [2][6] - The FDA has granted Breakthrough Device Designation for the SCD therapy in both adult AKI and acute chronic heart failure (CHF) with cardiorenal syndrome, facilitating a faster approval process [2][10] - The company is exploring broader applications of the SCD therapy, including its use in patients with CHF awaiting left ventricular assist device (LVAD) implantation [2][10] Group 3: Market Opportunities - The potential market for the SCD therapy in adult patients with AKI and CHF is described as a multi-billion-dollar opportunity in the U.S. alone [2] - The company aims to leverage rapid regulatory pathways to commercialize the SCD therapy across various hyperinflammatory conditions [2][10] - The successful outcome of the NEUTRALIZE-AKI trial could lead to a Premarket Approval application in 2027, with expectations for rapid approval and early adoption [2]

Core Viewpoint - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure, with a significant emphasis on its QUELIMMUNE therapy for acute kidney injury [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to addressing organ failure in critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury due to sepsis in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] Upcoming Events - Eric Schlorff, CEO of SeaStar Medical, will present at the Biotech Showcase 2026 Investor Conference on January 13, 2026 [1] - The live presentation will be accessible on the company's website, with a replay available for 30 days post-event [2] - SeaStar Medical's management will also engage with investors during the J.P. Morgan Healthcare Conference from January 12-14, 2026 [2] Clinical Trials - The company is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [3]

Core Viewpoint - U.S. stock futures are mostly lower, with Nasdaq 100 futures down approximately 0.1% [1] Group 1: Company Movements - SeaStar Medical Holding Corp (NASDAQ:ICU) shares fell 9.5% to $0.21 in pre-market trading following a 1-for-10 reverse split announcement [1] - Coincheck Group NV (NASDAQ:CNCK) decreased by 11% to $2.28 in pre-market trading [2] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) dropped 7.6% to $4.67 after a 30% increase on Tuesday [2] - Jet.AI Inc (NASDAQ:JTAI) fell 5.3% to $0.82 after a 28% decline on Tuesday, despite announcing a joint venture with Choo Choo Express for a 50-mw data center in Nevada [2] - Lifestance Health Group Inc (NASDAQ:LFST) declined 3.7% to $6.80 in pre-market trading [2] - Precision Drilling Corp (NYSE:PDS) fell 3.3% to $66.96 in pre-market trading [2] - Vasta Platform Ltd (NASDAQ:VSTA) decreased by 3.1% to $4.80 in pre-market trading [2]

Core Viewpoint - U.S. stock futures are mostly lower, with Nasdaq 100 futures down approximately 0.1% [1] Group 1: Company Movements - SeaStar Medical Holding Corp (NASDAQ:ICU) shares fell 9.5% to $0.21 in pre-market trading following a 1-for-10 reverse split announcement [1] - Coincheck Group NV (NASDAQ:CNCK) decreased by 11% to $2.28 in pre-market trading [2] - Ascent Solar Technologies, Inc. (NASDAQ:ASTI) dropped 7.6% to $4.67 after a 30% increase on Tuesday [2] - Jet.AI Inc (NASDAQ:JTAI) fell 5.3% to $0.82 after a 28% decline on Tuesday, despite announcing a joint venture for a 50-mw data center in Nevada [2] - Lifestance Health Group Inc (NASDAQ:LFST) declined 3.7% to $6.80 in pre-market trading [2] - Precision Drilling Corp (NYSE:PDS) fell 3.3% to $66.96 in pre-market trading [2] - Vasta Platform Ltd (NASDAQ:VSTA) decreased by 3.1% to $4.80 in pre-market trading [2]

Core Viewpoint - SeaStar Medical Holding Corporation announced a 1-for-10 reverse stock split effective January 5, 2026, to increase its stock price and regain compliance with Nasdaq's minimum bid price requirement of $1.00 [1][4]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every 10 pre-split shares into 1 post-split share, with stockholders receiving whole shares in lieu of any fractional shares [2]. - The reverse split will proportionately reduce the number of shares issuable upon the exercise of outstanding stock options and warrants, while also increasing their exercise prices accordingly [2]. Group 2: Stockholder Information - Stockholders will receive information regarding their share ownership from Continental Stock Transfer and Trust Company following the reverse stock split [3]. - Those holding shares through banks or brokers will have their positions automatically adjusted without needing further action [3]. Group 3: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE (SCD-PED) therapy, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [5]. - The company is conducting the NEUTRALIZE-AKI pivotal trial for its SCD therapy in adult patients, addressing a significant unmet medical need affecting over 200,000 adults in the U.S. annually [5].

Core Insights - The FDA has approved a reduction in the mandatory enrollment size for the SAVE Surveillance Registry from 300 patients to 50 patients, indicating confidence in the safety of the QUELIMMUNE therapy with fewer patients [1] - The QUELIMMUNE therapy, designed for pediatric patients with acute kidney injury (AKI) and sepsis, has shown promising efficacy data, including a survival rate improvement from 50% to 70% at 90 days [3][8] - The reduction in registry size is expected to facilitate smoother adoption of QUELIMMUNE therapy, potentially expanding its market opportunity in the pediatric AKI sector, estimated at $100 million in the U.S. [4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved in 2024 [12] - The QUELIMMUNE therapy utilizes the Selective Cytopheretic Device (SCD) to address hyperinflammation in patients, aiming to improve survival rates and reduce the need for dialysis [11] - The company has received recognition for its contributions to pediatric AKI treatment, including the 2025 Corporate Innovator Award from the National Kidney Foundation [9] Clinical Data - Preliminary results from the SAVE Surveillance Registry indicate zero device-related adverse events and a survival rate of 76% at Day 28 and Day 60, with a 71% survival rate at Day 90 [3][8] - Data from clinical studies show a 77% survival rate for patients treated with QUELIMMUNE compared to standard care, reflecting a 50% reduction in loss of life compared to historical data [8] - The SAVE Surveillance Registry has enrolled 32 pediatric patients to date, with the aim of confirming the safety of QUELIMMUNE therapy [2] Market Potential - The approval of QUELIMMUNE therapy is expected to enhance treatment options for pediatric patients with AKI, a condition that can lead to severe complications and increased healthcare costs [5][6] - The reduction in patient enrollment requirements is anticipated to accelerate the adoption of QUELIMMUNE therapy in medical institutions, thereby capturing a larger share of the pediatric AKI market [4]

Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at NobleCon21 on December 3, 2025, highlighting its advancements and products [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company with a focus on critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the U.S. annually [3]