Financial Performance - SeaStar Medical reported net revenue of approximately $0.2 million for Q3 2025, up from $0.1 million in Q3 2024, reflecting sales of the QUELIMMUNE pediatric SCD therapy[6]. - Net revenue for the three months ended September 30, 2025, was $183,000, a significant increase from $68,000 in the same period of 2024, representing a growth of 169%[28]. - Gross profit for the nine months ended September 30, 2025, reached $773,000, compared to $68,000 for the same period in 2024, indicating a substantial increase[28]. - The net loss for the nine months ended September 30, 2025, was $9,246,000, an improvement compared to a net loss of $20,411,000 for the same period in 2024, showing a reduction of 54%[30]. - Total operating expenses for the three months ended September 30, 2025, were $3,748,000, down from $4,524,000 in the same period of 2024, reflecting a decrease of 17%[28]. - Research and development expenses for the nine months ended September 30, 2025, were $5,318,000, down from $6,367,000 in the same period of 2024, indicating a reduction of 17%[28]. Cash and Financing - The company raised $12.4 million in Q3 2025 through equity offerings and warrant exercises, strengthening its balance sheet[5]. - Cash at September 30, 2025, was $13.8 million, a significant increase from $1.8 million at December 31, 2024[11]. - Cash at the end of the period on September 30, 2025, was $13,763,000, a significant increase from $2,082,000 at the end of the same period in 2024[30]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was $21,449,000, compared to $13,220,000 for the same period in 2024, showing an increase of 62%[30]. Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial has adjusted total enrollment from 200 to approximately 339 patients, with 146 patients enrolled to date[4][5]. - SeaStar Medical initiated its first clinical site for the NEUTRALIZE-CRS trial, targeting 20 patients with acute chronic systolic heart failure[5]. - The company anticipates completing enrollment for the NEUTRALIZE-AKI trial by the end of 2026 based on current enrollment rates[4]. - QUELIMMUNE therapy demonstrated a 76% survival rate at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data[4]. Operational Metrics - General and administrative expenses decreased to approximately $1.9 million in Q3 2025 from $2.2 million in Q3 2024, attributed to lower franchise tax and legal fees[9]. - The company added three top-ranked children's hospitals to its customer base for QUELIMMUNE therapy, with fourth quarter orders already exceeding those of Q3 2025[3][4]. - Total assets as of September 30, 2025, amounted to $15,530,000, compared to $4,658,000 as of December 31, 2024, indicating a growth of 233%[26]. - Total liabilities remained stable at $4,066,000 as of September 30, 2025, compared to $6,841,000 as of December 31, 2024, reflecting a decrease of 40%[26]. - Research and development expenses decreased to $1.9 million in Q3 2025 from $2.3 million in Q3 2024, primarily due to lower consulting and personnel costs[8]. - The company reported a weighted-average of 26,393,400 shares outstanding for the three months ended September 30, 2025, compared to 4,086,871 shares for the same period in 2024[28].

Core Insights - SeaStar Medical Holding Corporation reported strong progress in the third quarter of 2025, highlighting growth in customer base and impressive survival results for its QUELIMMUNE therapy [2][3][4] Business Highlights - Three top-ranked children's medical centers adopted QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) [3][4] - QUELIMMUNE therapy demonstrated a survival rate of 76% at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data [4][14] - The company raised $12.4 million to strengthen its balance sheet and support future operations [5][11] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial is ongoing, with an interim analysis showing positive safety signals and no device-related safety issues [4][16] - Total enrollment for the NEUTRALIZE-AKI trial has been adjusted to approximately 339 patients, with 146 patients enrolled to date [4][16] - A new clinical trial for NEUTRALIZE-CRS therapy has been initiated, targeting patients with acute chronic systolic heart failure [4] Financial Performance - Net revenue for the third quarter of 2025 was approximately $0.2 million, compared to $0.1 million in the same period of 2024 [6] - Research and development expenses decreased to $1.9 million from $2.3 million year-over-year, while general and administrative expenses also saw a decline [8][9] - The net loss for the third quarter was approximately $3.5 million, or $0.13 per share, an improvement from a net loss of $4.5 million, or $1.10 per share, in the prior year [11][27] Market Position and Future Outlook - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening pediatric AKI due to sepsis, with significant market potential in both pediatric and adult applications [19] - The company is focused on expanding its market share and generating sales in the adult AKI market, which is significantly larger than the pediatric segment [5][19]

Core Insights - VSee Health, Inc. has secured FedRAMP Moderate authorization, allowing it to provide secure telehealth services to federal agencies and other clients [1] - The company is integrating advanced robotic assistance into intensive care units (ICUs), enabling remote clinicians to monitor and intervene in real-time, which could significantly enhance critical care delivery [1] Company Developments - The FedRAMP Moderate authorization positions VSee as a leader in HIPAA-compliant telemedicine solutions, expanding its market reach [1] - The integration of robotic assistance in ICUs represents a bold innovation in telehealth, potentially transforming how critical care is delivered [1] Industry Impact - The advancements in telemedicine and robotic assistance could set new standards for remote healthcare services, particularly in critical care settings [1] - VSee's initiatives may influence other companies in the telehealth sector to adopt similar technologies, driving industry-wide changes [1]

Core Insights - SeaStar Medical Holding Corporation will report its third quarter financial results on November 13, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure [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 pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating faster approval and better reimbursement dynamics [3] - A pivotal trial is currently underway for SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), affecting over 200,000 adults annually in the U.S. [3]

Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry, highlighting the effectiveness of QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] Group 1: Clinical Results - The first 21 pediatric patients treated with QUELIMMUNE therapy showed zero device-related adverse events or infections, with a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 [2][3] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [3] - For pediatric survivors without a history of end-stage renal disease (ESRD) or recent kidney transplant, 75% were dialysis-free at Day 28, and 82% at Day 90 [3] Group 2: Therapy Overview - QUELIMMUNE therapy is designed for children with AKI and sepsis, weighing 10 kilograms or more, and is administered in conjunction with Renal Replacement Therapy (RRT) [8] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, which can lead to organ failure [11] - QUELIMMUNE therapy was approved under a Humanitarian Device Exemption in February 2024, requiring participation in the SAVE Surveillance Registry for data collection [8] Group 3: Future Implications - The SAVE Surveillance Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with plans to collect data from up to 300 patients [4] - Initial results from the registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [4] - SeaStar Medical is also conducting a pivotal clinical trial (NEUTRALIZE-AKI) for adult patients with AKI requiring continuous renal replacement therapy [12]

Market Overview - Several companies have experienced significant losses during the recent market downturn, including SeaStar Medical Holding Corporation, Li Bang International Corporation Inc., Ambipar Emergency Response, Cemtrex, Inc., and BT Brands, Inc., reflecting the broader market's susceptibility to fluctuations [1][7] SeaStar Medical Holding Corporation (ICU) - The company's stock price plummeted over 55% to $0.55, a drastic decline from its year-high of $4.55, despite ongoing clinical trials for adult acute kidney injury [2][7] - The independent Data Safety Monitoring Board reported no device-related safety issues, supporting the potential clinical benefits of the NEUTRALIZE-AKI trial [2] Li Bang International Corporation Inc. (LBGJ) - The company experienced a nearly 45% drop in stock price to $0.74, despite reporting a revenue of approximately $4.7 million for the six months ending December 31, 2024, marking a 27% increase from the previous year's $3.7 million [3][7] Ambipar Emergency Response (AMBI) - The stock price decreased by 43% to $1.93, and the company recently filed its annual report on Form 20-F for the fiscal year ending December 31, 2024, with the U.S. Securities and Exchange Commission [4][7] Cemtrex, Inc. (CETX) - The company's stock price fell over 35% to $0.40, but it has signed letters of intent for two strategic acquisitions in the robotics and aerospace sectors, which are expected to boost total annual revenues to $100 million [5][7] BT Brands, Inc. (BTBDW) - The company experienced a 33% drop in stock price to $0.17, facing significant market challenges despite its long-standing presence in the quick-service restaurant industry since 1987 [6][7]

Core Insights - The independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial for the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) [2][3] - The trial's sample size has been re-estimated from 200 to 339 patients to strengthen statistical power, with 137 patients currently enrolled [3][4] - The SCD therapy has shown no device-related safety issues and a potential clinical benefit, as indicated by preliminary results from the QUELIMMUNE SAVE pediatric registry [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure [10] - The QUELIMMUNE therapy, based on the SCD technology, is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [10] - The company aims to drive shareholder value through successful execution of commercial efforts and completion of the NEUTRALIZE-AKI trial [4][10] Clinical Trial Details - The NEUTRALIZE-AKI trial's primary endpoint is a composite of 90-day mortality or dialysis dependency in patients treated with SCD therapy alongside standard care [3][10] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [3] - The trial will also explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome [3] Safety and Efficacy - The SCD therapy has been associated with zero device-related adverse events, consistent with its previously published safety profile [6] - Preliminary data from the SAVE Surveillance Registry indicates a potential reduction in loss of life by over 50% compared to historical data [7][5] - The therapy aims to neutralize over-active immune cells and mitigate destructive hyperinflammation, potentially leading to long-term organ recovery [9]

Core Insights - SeaStar Medical Holding Corporation announced preliminary results from the SAVE Surveillance Registry, focusing on QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] - The SAVE Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with data collection for the first 300 patients treated [2] - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more, approved under a Humanitarian Device Exemption [4][10] Group 1: SAVE Surveillance Registry - The SAVE Surveillance Registry is a Real-World Evidence program to validate QUELIMMUNE therapy's safety and efficacy [2] - Specific outcomes measured will include 90-day survival rates and dialysis dependency, with comparisons to a control group [2] - Initial results are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [2] Group 2: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, often caused by conditions like sepsis and severe trauma [3] - Destructive hyperinflammation in AKI can lead to multi-organ dysfunction and increased mortality risk [3] - Patients recovering from AKI may face complications such as chronic kidney disease or end-stage renal disease [3] Group 3: QUELIMMUNE Therapy - QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in mortality [5] - Among survivors, 87.5% had normal kidney function by Day 60 post-ICU discharge [5] - The therapy is integrated with existing CRRT systems to target pro-inflammatory cells and promote organ recovery [9] Group 4: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure [10] - QUELIMMUNE is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [10] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI, addressing a significant unmet medical need [10]

SeaStar Medical Holding (ICU) FY Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding - **Ticker Symbol**: ICU (NASDAQ) - **Focus**: Development of QUELIMMUNE Selective Cytopheretic Device for immune-related renal injuries, particularly in critically ill patients facing organ failure [1][2] Core Points and Arguments - **Technology and Approval**: QUELIMMUNE is FDA approved for treating acute kidney injury with sepsis in children under a humanitarian device exemption in 2024 [2][3] - **Market Potential**: - Pediatric AKI market is valued at approximately $100 million with around 4,000 patients in the U.S. - Adult AKI market is significantly larger, with over 200,000 patients annually, representing a market potential of around $4.5 billion [5][18] - **Clinical Studies**: - Pivotal study (NEUTRALIZE-AKI) is currently 60% enrolled, targeting multiple adult indications under breakthrough device designation [4][3] - Clinical data shows a 77% survival rate in pediatric patients treated with QUELIMMUNE, with no patients requiring dialysis after 60 days [12][11] - **Mechanism of Action**: The device targets activated neutrophils and monocytes to quell hyperinflammation without immunosuppression, effectively reducing cytokine storms [8][9][10] Pipeline and Future Indications - **Current Pipeline**: Focus on both pediatric and adult indications, including end-stage renal disease, chronic dialysis, and cardiorenal conditions [4][3] - **Future Studies**: A pivotal randomized controlled study is ongoing for adults, with a primary endpoint of all-cause mortality and dialysis dependency [19][22] Economic Impact and Health Economics - **Cost Savings**: The use of QUELIMMUNE in pediatric patients resulted in a median hospital stay reduction of about 3 days, leading to cost savings for hospitals [16] - **Reimbursement**: The trial has CMS reimbursement, indicating support for the economic viability of the treatment [20] Strategic Focus - **Target Hospitals**: Strategy to focus on the top 50 children's hospitals in the U.S., where 50% of acute kidney injury patients are treated [14] - **Sales and Distribution**: Control over sales and distribution to enhance customer experience and reduce costs [16] Financial Overview - **Market Capitalization**: As of August 12, the stock price was $0.73 with approximately 28 million shares outstanding [23] - **Recent Capital Raise**: Raised around $8.6 million in July 2025 to support ongoing initiatives [24] Conclusion - **Investment Opportunity**: SeaStar Medical presents a best-in-class technology with significant market potential in both pediatric and adult AKI, backed by promising clinical results and a clear strategic focus on commercialization and expansion [25]

Company Overview - SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [3] - The company's first commercial product, QUELIMMUNE, is based on its patented Selective Cytopheretic Device (SCD) technology and was approved by the FDA in 2024 [3] - QUELIMMUNE is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] Product and Technology - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications from the FDA, which may facilitate a faster approval process and better reimbursement dynamics [3] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the US annually [3] Upcoming Events - SeaStar Medical will participate in the HC Wainwright 27th Annual Global Investment Conference, with a presentation scheduled for September 5, 2025, at 7:00 am Eastern Time [1][2]