SeaStar Medical Holding Corp Stock Price, News & Analysis

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, has announced an upcoming CEO interview. Eric Schlorff, the company's CEO, will appear on the Benzinga All Access Show today, April 30, 2025, at approximately 10:50 am Eastern Time.

The live interview will be broadcast on YouTube, and viewers can access it through the provided link. For those unable to watch the live broadcast, a recording will be made available afterward on SeaStar Medical's website in the investor relations section, specifically on the Events and Presentations page.

SeaStar Medical (Nasdaq: ICU) has received two new FDA Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, targeting systemic inflammatory response in both adult and pediatric cardiac surgery patients. The designations aim to prevent post-operative complications in high-risk populations.

The potential market includes approximately 45,000 patients annually - 15% of 300,000 adult cardiac surgery patients and one-third of 40,000 pediatric congenital heart surgery patients. These new designations bring SeaStar's total to six, highlighting the critical need for effective hyperinflammation treatment.

The company is currently commercializing QUELIMMUNE for pediatric acute kidney injury treatment and conducting the NEUTRALIZE-AKI pivotal trial for adult patients. SeaStar's six Breakthrough Device Designations, granted between April 2022 and March 2025, cover treatments for Adult AKI, cardiac surgery inflammation, cardiorenal syndrome, ESRD, and hepatorenal syndrome.

SeaStar Medical (Nasdaq: ICU) reported its Q4 and full-year 2024 financial results, marking significant progress in its commercial and clinical initiatives. The company achieved $0.1 million in net revenue for 2024, following the FDA approval and launch of QUELIMMUNE therapy for pediatric acute kidney injury patients.

Key highlights include: enrollment of 94 out of 200 patients in the NEUTRALIZE AKI pivotal trial, securing a fourth Breakthrough Device Designation, and adoption of QUELIMMUNE by five customers. The company raised approximately $31 million in capital and reduced debt.

Financial results show R&D expenses increased to $9.1 million from $6.0 million in 2023, while G&A expenses rose to $8.9 million from $8.2 million. The company reported a net loss of $24.8 million ($6.63 per share) compared to $26.2 million ($30.26 per share) in 2023. Cash position stood at $1.8 million as of December 31, 2024, with an additional $6 million raised in February 2025.

SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 27, 2025, after market close.

The company will host a webcast and conference call to discuss the results and business progress. A replay will be available until April 3, 2025, accessible via webcast or by calling 1 (609) 800-9909.

SeaStar Medical (Nasdaq: ICU) has been awarded the 2025 Corporate Innovator Award from the National Kidney Foundation for their groundbreaking QUELIMMUNE Selective Cytopheretic Device. The device received FDA approval in February 2024 as the first therapeutic solution for treating pediatric Acute Kidney Injury (AKI) due to sepsis.

Each year, approximately 4,000 children with AKI in the U.S. require continuous kidney replacement therapy, facing a 50% mortality rate. Of those who survive, 10-25% experience long-term complications including chronic kidney disease and lifetime dialysis dependency.

The award will be presented during the NKF Spring Clinical Meetings in Boston from April 9-13, 2025. This recognition places SeaStar Medical among notable past recipients including Keryx Biopharmaceuticals, Janssen Pharmaceuticals, Merck, Otsuka Pharmaceuticals, Relypsa, and UnitedHealth Group.

SeaStar Medical (Nasdaq: ICU) has closed a previously announced registered direct offering priced at-the-market, raising $6 million in gross proceeds. The offering included 3,529,412 shares of common stock (or pre-funded warrants) at $1.70 per share to a single institutional investor.

The transaction included warrants for an additional 3,529,412 shares in a concurrent private placement. The pre-funded warrants have a $0.001 exercise price with no expiration, while the additional warrants have a $1.70 exercise price, exercisable upon shareholder approval with a five-year term. The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures. H.C. Wainwright & Co. served as the exclusive investment bank for the offering.

SeaStar Medical (Nasdaq: ICU) has announced a $6 million registered direct offering with a single institutional investor. The offering includes 3,529,412 shares of common stock (or pre-funded warrants) at $1.70 per share, along with warrants to purchase an additional 3,529,412 shares in a concurrent private placement.

The pre-funded warrants will have a $0.001 exercise price with immediate exercisability, while the additional warrants will have a $1.70 exercise price, exercisable upon shareholder approval with a five-year expiration. The offering is expected to close around February 3, 2025.

The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures. H.C. Wainwright & Co. is serving as the exclusive financial advisor for this offering.

SeaStar Medical (Nasdaq: ICU) has expanded its customer base by shipping QUELIMMUNE™ to a fifth hospital, a California medical center known for pediatric research. QUELIMMUNE, their Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury (AKI) and sepsis.

The company is actively pursuing additional hospital clearances through institutional review board (IRB) approvals, with more than a dozen new medical centers in discussion and seven advancing in the IRB process. Several existing customers have already placed reorders in 2025.

QUELIMMUNE operates under FDA approval through a Humanitarian Device Exemption for children weighing 10kg or more requiring renal replacement therapy. The device uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery and eliminating future dialysis needs. The SCD has received FDA Breakthrough Device Designation in four indications.

SeaStar Medical (Nasdaq: ICU) has activated its 15th site, Mayo Clinic, for the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI). The trial has currently enrolled 76 subjects, with 6 new enrollments since the start of 2024.

The study aims to evaluate 200 adults with AKI in ICU receiving continuous renal replacement therapy (CRRT). The primary endpoint focuses on 90-day mortality or dialysis dependency compared to standard CRRT care. The company expects a Data Safety Monitoring Board recommendation on interim results by mid-2025 after analyzing the first 100 subjects.

The SCD, which has FDA Breakthrough Device Designation for adults with AKI, targets proinflammatory neutrophils and monocytes during CRRT to reduce hyperinflammation. SeaStar Medical estimates the annual U.S. market opportunity for SCD in adult AKI at $4.7-6.3 billion.