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]

Core Insights - SeaStar Medical Holding Corporation has appointed Michael Messinger as Chief Financial Officer, bringing over 25 years of healthcare industry experience to the company [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [4] - The company's first commercial product, QUELIMMUNE (SCD-PED) therapy, is FDA approved for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [4] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [4] Leadership and Experience - Michael Messinger has extensive experience in financing and accounting for drug discovery and development organizations, previously serving as CFO of ContraFect Corporation [2] - He has successfully led companies through significant financial milestones, including a Nasdaq IPO and securing a $90 million contract with BARDA [2] Product and Market Potential - The QUELIMMUNE therapy has shown remarkable commercial results in pediatric AKI patients and aims to expand to address multiple indications [3] - SeaStar Medical 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 [4]

Financial Data and Key Metrics Changes - SeaStar Medical reported net revenue of approximately $183,000 for Q3 2025, an increase from $68,000 in Q3 2024, reflecting a significant growth trajectory [25] - The gross profit margin for Q3 2025 was approximately 92%, marking the first full quarter of cost of goods sold matched against Quellimune unit sales [26] - Operating expenses decreased to $3.7 million in Q3 2025 from $4.5 million in Q3 2024, primarily due to reduced consulting and personnel costs [26] - The net loss for Q3 2025 was approximately $3.5 million, or $0.13 per share, compared to a net loss of approximately $4.5 million, or $1.10 per share, in Q3 2024 [26][27] - Cash at September 30, 2025, was $13.8 million, a significant increase from $1.8 million at December 31, 2024 [27] Business Line Data and Key Metrics Changes - Quellimune revenue for the first half of Q4 2025 has already exceeded the total revenue for Q3 2025, indicating strong sales momentum [5][10] - The company added three top-ranked children's medical centers to its customer base, enhancing its market presence [4] Market Data and Key Metrics Changes - The total U.S. market for Quellimune therapy is estimated at about $100 million, with the company aiming to capture a significant portion of this market [15] Company Strategy and Development Direction - The company is focused on expanding the use of Quellimune therapy to more pediatric hospitals, with a goal of activating up to 20 new pediatric hospitals to drive product revenue [10] - SeaStar Medical is also pursuing the NEUTRALIZE-AKI trial, with plans to increase enrollment to 339 patients to enhance the statistical power of the study [18][19] - The launch of the NEUTRALIZE-CRS trial aims to evaluate SCD therapy in patients with chronic systolic heart failure, potentially broadening the application of their technology [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future growth opportunities for SeaStar Medical, emphasizing the life-saving potential of Quellimune therapy for critically ill patients [28] - The company is actively working to streamline the adoption process for new target accounts, aiming to reduce barriers to entry for Quellimune therapy [12] Other Important Information - SeaStar Medical raised over $12 million to strengthen its balance sheet and extend its financial runway [8] - The company is committed to reducing costs while achieving strong operational results [8] Q&A Session Summary Question: Update on patient enrollment and site activation for NEUTRALIZE-AKI trial - As of the call, 146 patients were enrolled with 17 sites activated, and the company is working to activate at least eight additional sites to meet the new target of 339 patients by December 2026 [35][36] Question: Details on the new cardiorenal trials - The company expects to enroll at least five sites for the new trial, aiming to complete enrollment of 20 patients within a year, subject to site activation pace [41][42] Question: Clarification on revenue targets for 2025 - Management confirmed that they are on target to achieve over $1 million in revenue for the full year 2025 [43][44]

Revenue Performance - SeaStar Medical reported a revenue of $0.9 million from the sale of QUELIMMUNE since receiving FDA approval in February 2024, with the first commercial units shipped in July 2024[149]. - For the three months ended September 30, 2025, revenue increased by 169% to $183,000 compared to $68,000 in the same period in 2024[159]. - Revenue for the nine months ended September 30, 2025, increased to $814,000, a 1097% increase compared to $68,000 for the same period in 2024[166]. - Gross profit for the nine months ended September 30, 2025, was $773,000, up 1037% from $68,000 in 2024[166]. Expenses and Losses - The company incurred a net loss of $3.472 million for the three months ended September 30, 2025, a decrease of 23% from a net loss of $4.478 million in the same period in 2024[159]. - Research and development expenses decreased by 21% to $1.85 million for the three months ended September 30, 2025, compared to $2.336 million in the same period in 2024[159]. - General and administrative expenses decreased by 13% to $1.898 million for the three months ended September 30, 2025, compared to $2.188 million in the same period in 2024[159]. - The total operating expenses for the three months ended September 30, 2025, were $3.748 million, a reduction of 17% from $4.524 million in the same period in 2024[159]. - Net loss for the nine months ended September 30, 2025, was approximately $9.2 million, a reduction of 55% compared to a net loss of $20.4 million in 2024[172]. - Total operating expenses for the nine months ended September 30, 2025, were $9.9 million, a decrease of 24% from $13.1 million in 2024[166]. Cash and Financial Position - As of September 30, 2025, the company had cash reserves of $13.8 million, a significant increase from $1.8 million as of December 31, 2024[145]. - The accumulated deficit as of September 30, 2025, was $148.8 million, up from $139.6 million as of December 31, 2024[144]. - The company recorded no provision for income taxes for the three months ended September 30, 2025, and September 30, 2024[164]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $9.5 million, a decrease of $1.8 million compared to $11.3 million for the same period in 2024[182]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $21.5 million, primarily from the issuance of new shares of common stock ($14.3 million) and proceeds from pre-funded warrants ($5.9 million)[183]. Clinical Development and Future Outlook - The company is conducting a pivotal clinical trial for its adult SCD therapy, which is crucial for future revenue generation[150]. - SeaStar Medical's SCD therapy has the potential to address a market of over one million patients annually facing life-threatening hyperinflammatory conditions[143]. - The company expects to incur significant expenses for the clinical development of its adult SCD and commercialization of QUELIMMUNE, necessitating additional funding[179]. - The company anticipates that its future funding requirements will depend on the progress of clinical trials and regulatory approvals[179]. Concerns and Commitments - The company has raised concerns about its ability to continue as a going concern due to insufficient cash to meet working capital and capital expenditure requirements for at least twelve months[175]. - As of September 30, 2025, the company has unused available capacity on the ATM Facility that allows for potential capital raising of approximately $2.2 million[176]. - The company does not plan to include potential cash proceeds from the exercise of warrants in its liquidity projections as of the date of the Quarterly Report[178]. - The company has no contractual obligations or commitments outstanding as of September 30, 2025[181]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay compliance with certain accounting standards[187].

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]