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SeaStar Medical Holding Corporation (ICU) is a pioneering medical technology firm focused on developing proprietary solutions to mitigate the adverse effects of hyperinflammation on vital organs. The company specializes in creating and commercializing extracorporeal therapies that specifically target effector cells responsible for systemic inflammation. This inflammation often leads to direct tissue damage and the secretion of pro-inflammatory cytokines, which can trigger and sustain imbalanced immune responses.
SeaStar Medical's core business revolves around innovative treatments designed to alleviate the intense inflammatory responses seen in various medical conditions. Their primary product offerings include advanced renal therapy systems that aim to reduce the impact of cytokine storms, often observed in severe cases of infections and autoimmune diseases.
One of the company’s notable achievements includes successful clinical trials that have demonstrated the efficacy of their therapies in reducing inflammation and improving patient outcomes. SeaStar Medical is currently engaged in several research and development projects to expand the application of their therapies across multiple medical disciplines.
Financially, SeaStar Medical Holding Corp is well-positioned, with strategic partnerships that enhance their research capabilities and product distribution. The company is committed to advancing its technology through continuous innovation and maintaining strong relationships with healthcare providers and patients.
For investors and stakeholders, SeaStar Medical represents a promising opportunity in the medical technology sector, with a focus on addressing critical health challenges through cutting-edge science and compassionate care.
SeaStar Medical presented economic analysis data for its QUELIMMUNE device at ASN Kidney Week 2024, demonstrating significant cost-saving potential in treating pediatric acute kidney injury (AKI). The analysis revealed that hospitalization costs for pediatric AKI patients requiring CRRT averaged $461,736, while treatment with QUELIMMUNE could save approximately $30,000 per hospitalization. The device achieves cost neutrality after 6 days of therapy and shows a 77% survival rate in children ≥10 kg, compared to 50% with standard care. The company also presented data on ongoing trials including NEUTRALIZE-AKI and NEUTRALIZE-CRS, highlighting their expanding therapeutic applications.
SeaStar Medical announces Stanford Medicine's clearance to enroll subjects in the NEUTRALIZE-AKI pivotal trial for their Selective Cytopheretic Device (SCD). The trial now has 12 active sites with 52 enrolled subjects, including two recently added Department of Defense medical centers. The study will evaluate SCD's safety and efficacy in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT), aiming to enroll up to 200 adults. The primary endpoint focuses on 90-day mortality or dialysis dependency. The SCD previously received FDA Breakthrough Device Designation, and in July 2024, CMS granted Category B coverage for certain expenses in the trial.
SeaStar Medical Holding (Nasdaq: ICU) announces it has taken full responsibility for direct sales, marketing, and distribution of QUELIMMUNE™, its FDA-approved therapeutic device for treating pediatric acute kidney injury (AKI) due to sepsis. The company's CEO, Eric Schlorff, emphasizes their focus on a successful commercial rollout and their ability to fulfill customer demand. SeaStar Medical is streamlining relationships with Institutional Review Boards at pediatric hospitals and providing clinical training to integrate QUELIMMUNE into existing hemofiltration systems.
The company reports exceeding expectations with initial demand and multiple reorders from their first customer, Cincinnati Children's. By assuming direct distribution, SeaStar Medical will now recognize 100% of revenue generated from QUELIMMUNE sales in the U.S., corresponding to 3-4 times more revenue per unit. QUELIMMUNE, operating under the Humanitarian Device Exemption, has shown promising clinical results, including a 77% reduction in mortality rate and no dialysis dependency at Day 60 in pediatric AKI patients requiring continuous kidney replacement therapy.
SeaStar Medical Holding (Nasdaq: ICU) announces that its NEUTRALIZE-AKI pivotal trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target for an interim analysis. The trial evaluates the safety and efficacy of SeaStar's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
- Enrollment pace has accelerated since summer, with 5 subjects enrolled in October
- SCD received FDA Breakthrough Device Designation for adults with AKI
- Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses in July 2024
- SeaStar began shipping SCD Pediatric (QUELIMMUNE™) in July 2024
- The company extinguished all interest-bearing debt in September 2024
The NEUTRALIZE-AKI trial aims to enroll up to 200 adults at up to 30 clinical sites, with a primary endpoint of 90-day mortality or dialysis dependency.
SeaStar Medical Holding (Nasdaq: ICU) announces the presentation of new analyses of clinical data supporting the immunomodulating effect of the Selective Cytopheretic Device (SCD) at the American Society of Nephrology (ASN) 2024 Kidney Week. The data shows how the SCD significantly lowered biomarkers related to inflammation in critically ill patients with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
A poster presentation will highlight how SCD treatment significantly reduced the Neutrophil: Lymphocyte Ratio (NLR), a powerful biomarker linked to poor outcomes across various diseases. This provides further mechanistic clinical evidence of leukocyte immunomodulation in hyperinflammatory conditions such as AKI and sepsis.
The Company's pediatric SCD, QUELIMMUNE™, was approved by the FDA as a Humanitarian Use Device in February 2024. SeaStar Medical continues to enroll patients in its adult NEUTRALIZE-AKI pivotal trial and advance other indications like cardiorenal syndrome.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 16, 2024, at 12:00 p.m. Eastern time. The event, hosted by M-Vest, will feature a discussion with SeaStar Medical's management team, moderated by Maxim Group analyst Anthony Vendetti.
SeaStar Medical specializes in developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs. Interested parties can access the live and archived presentation webcast by registering for the M-Vest platform. The webcast link will be available in the Events & Presentations section of the SeaStar Medical website.
SeaStar Medical Holding (Nasdaq: ICU) announces the expansion of its NEUTRALIZE-AKI pivotal trial with the addition of two premier military medical facilities: Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR). This brings the total number of active clinical sites to 11, with 48 subjects enrolled to date. The trial is evaluating the safety and efficacy of SeaStar Medical's Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT).
The SCD has received FDA Breakthrough Device Designation for adults with AKI. In July 2024, CMS granted Category B coverage for certain expenses related to the trial. SeaStar Medical also began shipping its pediatric SCD, branded QUELIMMUNE™, in July 2024 following FDA approval. The company paid off all interest-bearing debt in September 2024.
SeaStar Medical Holding (Nasdaq: ICU) reports progress in its pivotal NEUTRALIZE-AKI trial, with four new subjects enrolled in 10 days, bringing total enrollment to 46. The trial evaluates the company's Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
- Trial aims to enroll up to 200 adults
- Primary endpoint: 90-day mortality or dialysis dependency
- Interim analysis planned at halfway point
- Company plans to expand trial sites to accelerate enrollment
The SCD is designed to reduce hyperinflammation in AKI patients, potentially improving outcomes and reducing healthcare costs. SeaStar Medical's pediatric version, QUELIMMUNE™, received FDA approval in February 2024 for children with AKI and sepsis.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management will engage in a fireside chat on September 11, 2024, at 9:00 a.m. Eastern time. Investors can access the webcast through the Events and Presentations section of SeaStar Medical's website.
The conference, scheduled for September 9-11, 2024, will be held at the Lotte New York Palace Hotel, offering both in-person and virtual attendance options. SeaStar Medical's management team will be available for one-on-one meetings throughout the event. Institutional investors and industry professionals interested in attending can register for either virtual or in-person participation.
SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, has eliminated all long-term debt, strengthening its financial position. The company, which develops proprietary solutions to reduce hyperinflammation's impact on vital organs, reported over $9 million in convertible notes and long-term interest-bearing debt at the end of 2023. This debt retirement will be reflected in the balance sheet for the quarter ending September 30, 2024. CEO Eric Schlorff stated that SeaStar Medical is now in its strongest financial position since going public nearly two years ago, enhancing its ability to advance its business plan and deliver potentially life-saving solutions to critically ill patients.
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