SeaStar Medical Holding Corporation - ICU STOCK NEWS

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.

SeaStar Medical (Nasdaq: ICU) announced the closing of its $10 million registered direct offering. The company issued 947,868 shares of common stock at $10.55 per share. Concurrently, unregistered warrants for an additional 947,868 shares were issued at the same price, exercisable immediately and expiring in five years. Gross proceeds totaled $10 million before fees and expenses. H.C. Wainwright & Co. acted as the exclusive placement agent. Funds will support general corporate purposes, including working capital and debt repayment. The stock offering was filed under an effective SEC registration statement, while the warrants remain unregistered under the Securities Act.

SeaStar Medical has announced a $10 million registered direct offering priced at-the-market under Nasdaq rules. The offering involves the sale of 947,868 shares of common stock at $10.55 each, along with unregistered warrants for the same number of shares, which are exercisable immediately and expire in five years.

H.C. Wainwright & Co. is acting as the exclusive placement agent. The offering is expected to close on July 11, 2024, subject to customary conditions. The net proceeds will be used for general corporate purposes, including working capital and capital expenditures.

The shares are offered under a previously effective shelf registration statement, while the warrants are issued in a private placement and are not registered under the Securities Act.

SeaStar Medical (Nasdaq: ICU) has finalized FDA labeling for QUELIMMUNE™, a device aimed at reducing hyperinflammation in pediatric patients with acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT). This approval under the Humanitarian Use Device (HUD) designation allows SeaStar to market QUELIMMUNE in the U.S. for children weighing 10 kilograms or more. Clinical results showed a 77% survival rate, with no dialysis dependency at 60 days and no device-related serious adverse events. The device is expected to be available for shipment this month, addressing a U.S. market of approximately 4,000 children annually.

SeaStar Medical announced that its Selective Cytopheretic Device (SCD) will be featured in two presentations at the 42nd Vicenza Course AKI-CRRT-ECOS and Critical Care Nephrology conference. The event takes place from June 11-13, 2024, in Vicenza, Italy. The SCD is a patented, cell-directed, extracorporeal device aimed at reducing hyperinflammation's impact on vital organs. One presentation, 'A Novel Selective Cytopheretic Device,' will be delivered by Dr. Stuart Goldstein from Cincinnati Children's Hospital. Another presentation, 'Cell-directed Therapy: Promising Approach to Sepsis and Other Dysregulated Immunological States, Including Acute Kidney Injury,' will be given by Dr. H. David Humes from the University of Michigan. Dr. Kevin Chung, SeaStar Medical's Chief Medical Officer, emphasized the honor of being invited by Dr. Claudio Ronco, a renowned expert in nephrology.

SeaStar Medical Holding (Nasdaq: ICU) has announced the addition of three new members to its Board of Directors: Jennifer A. Baird, Bernadette N. Vincent, and John Neuman. This transition follows their 2024 Annual Meeting of Stockholders on June 4, where Baird and Vincent were elected. Neuman joined the Board on June 5. The new directors bring extensive leadership, financial, and industry expertise. Concurrently, Bruce Rodgers and Richard Russell did not seek reelection, and Andres Lobo retired from Dow Chemical, resulting in his Board departure. This board restructuring aligns with SeaStar Medical's transition to a commercial-stage company.

Baird brings experience from healthcare and renewable energy sectors, Vincent from healthcare operations and non-profit kidney care, and Neuman from global financial accounting and mergers. Their combined expertise is expected to support SeaStar Medical's commercial growth and strategic objectives.

SeaStar Medical Holding (Nasdaq: ICU) has published a peer-reviewed article in Nature Scientific Reports detailing the mechanism of action of its Selective Cytopheretic Device (SCD) in immunomodulating excessive inflammation. The study, co-authored by Angela J. Westover et al., investigates SCD's evolving approach to treating organ dysfunction caused by hyperinflammation and cytokine storms by processing leukocytes extracorporeally. Key findings indicate that SCD's low calcium blood circuit aids in the selective adhesion and transformation of activated neutrophils and monocytes, reducing inflammation and promoting tissue repair. The device has shown potential in treating chronic inflammatory conditions like chronic heart failure, cirrhosis, and chronic kidney disease, and may reduce the progression of end-stage renal disease. SeaStar Medical aims to expand SCD’s applications to other high-value, underserved clinical conditions.