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SeaStar Medical Reaches Interim Enrollment Target for NEUTRALIZE-AKI Pivotal Trial of SCD Therapy for Adult Patients with Acute Kidney Injury
Globenewswire· 2025-05-13 12:05
Core Points - SeaStar Medical has reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, allowing for an interim analysis by the independent Data Safety Monitoring Review Board (DSMB) [1][2] - The NEUTRALIZE-AKI trial is evaluating the Selective Cytopheretic Device (SCD) therapy for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT) [2][4] - The trial aims to enroll up to 200 patients, with the primary endpoint being a composite of 90-day mortality or dialysis dependency [4][5] - The SCD therapy has shown improved treatment outcomes in prior studies compared to standard care, and the interim analysis will assess its safety and efficacy [3][4] 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 a rare condition of AKI in pediatric patients [9] - The company has received Breakthrough Device Designation from the FDA for its SCD therapy across six therapeutic indications, facilitating a faster approval process [9][7] - The SCD therapy targets over-active immune cells to mitigate hyperinflammation, with potential applications in various acute and chronic kidney and cardiovascular diseases [8][9] Clinical Trial Details - The NEUTRALIZE-AKI trial has enrolled 100 patients so far, with the interim analysis focusing on the primary endpoint after 90-day follow-up [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The DSMB will conduct the interim analysis and may recommend adjustments to the trial based on the results, including potential sample size re-estimation [5]
SeaStar Medical to Report First Quarter Financial Results on May 14, 2025
Globenewswire· 2025-05-07 14:00
Core Insights - SeaStar Medical Holding Corporation is set to report its first quarter financial results on May 14, 2025, after market close, followed by a webcast and conference call to discuss the results and business progress [1][2]. Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][2]. - The company's first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024, specifically for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [2]. - SeaStar's Selective Cytopheretic Device (SCD) therapy has been granted Breakthrough Device Designation by the FDA for six therapeutic indications, which may facilitate a faster approval process and better reimbursement conditions upon commercial launch [2]. - The company is currently 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, with no effective treatment options available [2].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of ICU Medical, Inc. – ICUI
GlobeNewswire News Room· 2025-05-05 16:47
Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning letter from the FDA regarding unauthorized changes to its infusion pump products [1][3]. Group 1: FDA Warning and Impact - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products, labeling them as "adulterated" and "misbranded" [3]. - The FDA's letter indicated that these 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 news of the FDA warning, 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].
ICU Medical, Inc. and Otsuka Pharmaceutical Factory, Inc. Complete Joint Venture to Bolster IV Solutions Manufacturing and Innovation in North America
Prnewswire· 2025-05-01 12:30
Core Viewpoint - The formation of Otsuka ICU Medical LLC represents a significant partnership aimed at enhancing the IV solutions supply chain in North America, with an estimated combined production capacity of 1.4 billion annual units, thereby increasing supply chain resiliency and fostering innovation in the market [1][2][3]. Company Overview - ICU Medical, Inc. is a leader in the development and sale of innovative medical devices, focusing on providing clinically essential medical devices that enhance patient care [6]. - Otsuka Pharmaceutical Factory, Inc. has over 75 years of experience in developing, manufacturing, and selling IV solutions, positioning itself as a key player in clinical nutrition [5]. Joint Venture Details - The joint venture, Otsuka ICU Medical LLC, combines OPF's extensive manufacturing capabilities across 16 production sites in Asia with ICU Medical's strong presence in North America, particularly in Austin, Texas [3]. - The partnership aims to introduce new PVC-free technologies to the North American market, enhancing the product offerings available to customers [3]. Market Impact - The collaboration is expected to provide increased stability and choice in the North American IV solutions market, delivering enhanced economic and clinical value to customers [3]. - The joint venture is positioned to improve global supply resiliency, which is critical in the healthcare sector [3].
SeaStar Medical Announces CEO Interview on Benzinga All Access to Occur Today at Approximately 10:50 am Eastern Time
Globenewswire· 2025-04-30 12:05
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]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ICU Medical, Inc. - ICUI
Prnewswire· 2025-04-28 22:32
Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding unauthorized changes to its infusion pump products [1][2]. Group 1: FDA Warning and Product Issues - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products [2]. - The FDA's letter described the pumps as "adulterated" and "misbranded," indicating that the changes could significantly affect the functionality of the devices, particularly their delivery profile and alarm functionality [2]. - Concerns were raised about the safety and efficacy of the devices due to these modifications, questioning the adequacy of ICU's regulatory disclosures [2]. Group 2: Stock Market Reaction - Following the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on April 22, 2025 [3]. Group 3: 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].
FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac Surgery
Globenewswire· 2025-04-08 12:05
Core Insights - SeaStar Medical Holding Corporation has received two new Breakthrough Device Designations from the FDA for its Selective Cytopheretic Device (SCD) therapy, aimed at treating systemic inflammatory response in adult and pediatric patients undergoing cardiac surgery [1][2] - The company has a total of six Breakthrough Device Designations, highlighting the critical need for effective therapies to treat hyperinflammation that can lead to organ failure [2][3] - SeaStar Medical's first commercial product, QUELIMMUNE, is in the initial launch phase, with plans for a PMA filing in 2026 following a successful clinical trial [2][7] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its SCD therapy designed to target proinflammatory cells and reduce hyperinflammation [6][7] - The SCD therapy is currently being commercialized under a Humanitarian Device Exemption for treating critically ill pediatric patients with acute kidney injury due to sepsis [2][7] - The company is conducting pivotal clinical trials for adult patients with acute kidney injury and is exploring additional indications for its SCD therapy [2][7] Market Opportunity - Approximately 15% of the 300,000 adults undergoing cardiac surgery annually are considered high risk and may benefit from SCD therapy [1] - Of the 40,000 pediatric patients undergoing congenital heart surgery each year, about one third could potentially benefit from the therapy [1] - The Breakthrough Device Designation facilitates faster access to the market, potentially improving reimbursement dynamics for SeaStar Medical's products [7] Regulatory Context - The FDA's Breakthrough Device Designation is intended to expedite the development and review process for devices that offer significant advantages over existing treatments [3][4] - SeaStar Medical's six designations were granted between April 2022 and March 2025, indicating a strong regulatory support for its innovative therapies [3][7] Technology Description - The Selective Cytopheretic Device (SCD) employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes, promoting a reparative state and potentially leading to long-term organ recovery [6][7] - The SCD is integrated with continuous renal replacement therapy systems, distinguishing it from other blood-purification tools [6]
ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo™ and Plum Duo™ Precision IV Pumps
Prnewswire· 2025-04-07 12:00
New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to the dual-channel Plum Duo™. ICU Medical also received 510(k) clearance for ...
SeaStar Medical(ICU) - 2024 Q4 - Annual Report
2025-03-27 21:15
Financial Performance - Net losses for the years ended December 31, 2024, and 2023 were $24.8 million and $26.2 million, respectively, with a decrease of 5.3% in net loss year-over-year [362][378]. - The net loss decreased to $24.8 million in 2024 from $26.2 million in 2023, attributed to a $5.0 million reduction in other expenses [388]. - The company had an accumulated deficit of approximately $139.6 million as of December 31, 2024 [362]. - As of December 31, 2024, the accumulated deficit reached $139.6 million, up from $114.7 million in 2023 [390]. - Other income (expense) improved to an expense of $7.0 million in 2024 from $12.0 million in 2023, mainly due to a $4.2 million decline in losses from convertible notes [384]. Revenue and Sales - The pediatric SCD, QUELIMMUNE, received FDA approval on February 21, 2024, and the first commercial units were shipped in July 2024, generating approximately $0.1 million in revenue by December 31, 2024 [368][380]. - The company expects revenue to fluctuate as QUELIMMUNE is introduced to pediatric hospital customers and is focused on generating future revenue from product sales and potential collaborations [368][369]. Expenses - Research and development expenses increased by $3.1 million, or 52.4%, from $6.0 million in 2023 to $9.1 million in 2024, primarily due to clinical trial costs and increased personnel expenses [370][381]. - Total operating expenses rose by $3.8 million, or 26.5%, from $14.2 million in 2023 to $18.0 million in 2024 [378]. - General and administrative expenses increased by 7.7% to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased payroll and accounting costs [383]. Cash Flow and Financing - Cash and cash equivalents were approximately $1.8 million as of December 31, 2024, compared to $0.2 million in 2023 [363]. - Cash used in operating activities rose to $16.0 million in 2024 from $10.3 million in 2023, driven by increased clinical trial activities [393]. - Cash provided by financing activities increased to $17.7 million in 2024 from $10.4 million in 2023, primarily from the issuance of new shares and convertible notes [394]. - The company raised approximately $23.5 million through registered direct offerings and "At-the-Market" offerings since the effectiveness of its shelf registration on December 22, 2023 [396]. - The company had cash of $1.8 million as of December 31, 2024, compared to $0.2 million in 2023, indicating a need for additional funding [391]. Clinical Trials - The pivotal clinical trial for the adult SCD is currently underway with 94 patients enrolled as of March 25, 2025 [355]. - The increase in clinical trial expenses was driven by the Neutralize-AKI Adult SCD study, which had 14 clinical trial sites enrolled by the end of 2024 [381]. Future Outlook and Concerns - The company has incurred net losses since its inception in 2007, raising concerns about its ability to continue as a going concern [364][365]. - Future funding requirements will depend on the progress of clinical trials and the ability to secure additional capital, with no committed external sources currently available [400]. Regulatory and Compliance - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing it to delay compliance with new accounting standards until it no longer qualifies as an EGC or opts out of the transition period [413]. - The company will remain an EGC until it has total annual gross revenue of at least $1.235 billion or meets other specified criteria [415]. - The company is not required to provide an auditor's attestation report on internal controls due to its EGC status [414]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [419]. Obligations and Arrangements - The company has total contractual obligations of $574,000, all of which are due within one year [417]. - In October 2024, the company entered into a financing arrangement for an insurance policy premium amounting to $0.7 million, to be paid in 10 monthly installments through August 2025 [418]. - The company entered into various convertible credit agreements with an institutional investor, which included detachable warrants [416]. - The company assumed 229,520 Private Placement warrants as part of the Business Combination [416].
SeaStar Medical(ICU) - 2024 Q4 - Earnings Call Transcript
2025-03-27 20:30
Financial Data and Key Metrics Changes - The company reported a net revenue of $134,000 for 2024, marking the first product revenue from the launch of Quellimmune in Q3 2024 [37] - The net loss for 2024 decreased to $24.8 million from $26.2 million in 2023, with approximately $6.9 million of the loss attributed to non-cash items [40] - The company raised approximately $25 million in 2024 and an additional $6 million in February 2025, improving its balance sheet by reducing debt and liabilities [34][35] Business Line Data and Key Metrics Changes - Quellimmune therapy has shown a 60% higher survival rate in pediatric acute kidney injury patients compared to standard care, with nearly 80% of patients surviving with Quellimmune [16] - The number of pediatric hospitals adopting Quellimmune doubled from Q3 to Q4 2024, with further increases noted in early 2025 [17] - The company anticipates a total addressable market of approximately $100 million for Quellimmune, with expectations of significant market penetration over time [20] Market Data and Key Metrics Changes - The adult AKI market is estimated to be 50 times larger than the pediatric market, with around 200,000 patients annually facing organ failure without FDA-approved treatment options [21] - The projected market opportunity for adult AKI is approximately $4.5 billion, with significant revenue upside expected even with modest market penetration [22] Company Strategy and Development Direction - The company aims to expand its product offerings beyond pediatric AKI to address larger markets, including chronic dialysis and cardiorenal syndrome [21][30] - The strategic shift to a direct sales model is intended to enhance control over the sales process and improve relationships with healthcare providers [36] - The company is focused on completing the adult AKI pivotal trial and preparing for a PMA filing following the trial's completion [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing significant market opportunities and the potential for growth driven by the successful launch of Quellimmune and ongoing clinical trials [42] - The company is committed to improving clinical outcomes and addressing unmet medical needs in nephrology, as evidenced by recent awards and recognitions [11] Other Important Information - The company received its fourth breakthrough device designation for chronic dialysis and has been recognized with the 2025 Corporate Innovator Award by the National Kidney Foundation [9][11] - The neutralized AKI pivotal trial is progressing with 94 of the anticipated 200 subjects enrolled, with an interim analysis expected after reaching 100 patients [23][24] Q&A Session Summary Question: Update on NEUTRALIZE AKI trial enrollment and interim analysis timeline - Management confirmed that 94 patients have been enrolled and anticipates reaching 100 patients in April, with the interim analysis expected around July or early August [45][49] Question: Plans to expand sales force capabilities in 2025 - The company is currently right-sized for the small market and has a healthy pipeline of new accounts, focusing on operational support and training for hospital staff [50][51] Question: Learnings from initial hospital activations and typical conversion timelines - The company has learned to streamline the IRB process and emphasized the importance of early collaboration between ICU doctors and nephrologists to save time [57][58]