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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 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.
SeaStar Medical (Nasdaq: ICU) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Initial commercial sales of QUELIMMUNE™ for pediatric AKI and sepsis patients.
2. Enrollment of 42 subjects at 9 sites in the NEUTRALIZE-AKI pivotal trial for adults.
3. CMS granted Category B coverage for certain trial expenses.
4. Completed a $10 million financing and retired nearly all outstanding debt.
5. Q2 2024 net loss of $3.2 million, or $1.03 per share.
6. Cash balance of approximately $6.9 million as of July 31, 2024.
The company expects U.S. regulatory approval for the SCD in adults with AKI in H1 2026, with commercial launch in H2 2026.
SeaStar Medical Holding (Nasdaq: ICU) has announced the first commercial treatment of a pediatric patient with its FDA-approved QUELIMMUNE™ therapeutic device. This milestone meets the FDA's August 20, 2024 deadline for initiating patient treatments. QUELIMMUNE is designed to treat acute kidney injury (AKI) in pediatric patients weighing 10 kg or more with sepsis or septic conditions requiring kidney replacement therapy (KRT).
Clinical trials have shown promising results, with a 77% survival rate and no dialysis dependency at 60 days for treated children. This is significant given that approximately 4,000 children with AKI require continuous KRT annually in the U.S., with a mortality rate of about 50%. The company aims to improve outcomes and reduce long-term complications for these severely ill children.
SeaStar Medical Holding (Nasdaq: ICU) has received a Category B Coverage Letter from CMS for its NEUTRALIZE-AKI pivotal trial, evaluating the Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). This coverage is expected to accelerate medical site activations and cover a portion of the trial costs. The trial aims to enroll up to 200 adult patients with AKI at up to 30 clinical sites, with 38 patients already enrolled across 10 active centers.
CEO Eric Schlorff anticipates that CMS reimbursement will provide substantial overall cost savings and accelerate patient enrollment. The company plans to conduct an interim analysis after reaching the 90-day primary endpoint in 100 enrolled subjects. SeaStar Medical views the adult AKI market as a multibillion-dollar opportunity, given its population is 50 times larger than pediatric AKI.
SeaStar Medical (Nasdaq: ICU) has announced the initial commercial sale of its QUELIMMUNE™-Pediatric to U.S. distributor Nuwellis. QUELIMMUNE, a patented cell-directed extracorporeal therapy, targets highly activated neutrophils and monocytes responsible for hyperactive immune responses in pediatric acute kidney injury (AKI) patients. The device is FDA-approved under a Humanitarian Device Exemption to treat pediatric AKI in patients weighing 10 kilograms or more. Initial studies show QUELIMMUNE has a probable benefit in reducing mortality and dialysis dependency. SeaStar Medical anticipates a significant commercial rollout by Q4 2024, with prestigious pediatric hospitals expected to meet HDE requirements this quarter. The company is also enrolling patients in the NEUTRALIZE-AKI trial for adults, presenting a multibillion-dollar market opportunity.
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