SeaStar Medical Holding Corporation - ICU STOCK NEWS

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.

SeaStar Medical, a commercial-stage medical device company listed on Nasdaq as ICU, will present at the Virtual Emerging Growth Conference on June 12, 2024. CEO Eric Schlorff will conduct a fireside chat at 12:35 p.m. Eastern time to provide an overview of the company and its Selective Cytopheretic Device (SCD). The chat will also discuss recent company updates. Investors can submit questions in advance or attend the live event. An archived webcast will be available 48 hours post-event on SeaStar Medical's website.

SeaStar Medical Holding (Nasdaq: ICU) announced a 25-for-1 reverse stock split, effective June 7, 2024, at 5:00 PM EDT. The common stock will trade on a split-adjusted basis starting June 10, 2024, under the same ticker symbol 'ICU' but with a new CUSIP number 81256L203. This move aims to increase the market price of the stock to meet Nasdaq's $1.00 minimum bid price requirement. Each 25 pre-split shares will convert to 1 post-split share, and fractional shares will be rounded up to the nearest whole share. Shareholders of record will receive updates from Continental Stock Transfer and Trust Company.

SeaStar Medical Holding (Nasdaq: ICU) announced the publication of a manuscript in Transplantation Direct reviewing four case studies involving their Selective Cytopheretic Device (SCD). The device demonstrated effectiveness in stabilizing and improving the clinical status of critically ill patients aged 22 months to 71 years, suffering from multiorgan failure. These patients subsequently became eligible for stem cell or liver transplants or left ventricular assist device implantation. The study highlights SCD's potential in mitigating hyperinflammation and aiding organ recovery without causing serious adverse events. The company aims to further investigate SCD's benefits through additional clinical studies and secure market approvals.

SeaStar Medical Holding (Nasdaq: ICU) reported its Q1 2024 financial results and provided a business update. The company anticipates initial sales of Quelimmune™ Pediatric for addressing acute kidney injury (AKI) and sepsis in children in the coming weeks, targeting a U.S. pediatric AKI patient population estimated at 4,000 annually. The company has enrolled 31 subjects in its NEUTRALIZE-AKI trial for its Selective Cytopheretic Device Adult (SCD-ADULT) for adult AKI patients. SeaStar eliminated senior secured debt, ending Q1 with $5 million in cash. R&D expenses remained steady at $1.7 million, while G&A expenses decreased to $2.3 million. However, a significant net loss of $12.7 million was reported, largely due to non-cash losses from derivative financial instruments. The company also received several Breakthrough Device Designations for its SCD technology across various conditions.