SeaStar Medical Holding Faces Investor Investigation Over Potential Securities Law Violations

The Law Offices of Frank R. Cruz has recently launched an investigation into SeaStar Medical Holding Corporation (NASDAQ: ICU) on behalf of investors who may have suffered losses due to potential violations of federal securities laws. The investigation focuses on the rejection of SeaStar’s Humanitarian Device Exemption (HDE) application by the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). The rejection letter stated that the application was not approvable in its current form.

SeaStar disclosed that it had been engaged in collaborative meetings and correspondence with the FDA over the past 10 months, responding to the agency’s recommendations. However, the FDA cited current deficiencies in their rejection letter. Following this news, SeaStar’s stock price experienced a significant decline of $0.77 per share or 39.7% on May 10, 2023, causing financial harm to investors.

In another setback, SeaStar announced on March 27, 2024, that it had identified complex financial instruments requiring different accounting treatment than previously determined. As a result, the company would need to restate its financial statements for fiscal year 2022 and the first three quarters of fiscal year 2023, due to the reporting of non-cash accounting items. This announcement led to a further decline in SeaStar’s stock price, dropping $0.04 per share or 4.8%.

SeaStar Medical Holding Corporation is a company that focuses on developing medical devices, including the pediatric Selective Cytopheretic Device (SCD). While the recent developments have impacted the company’s stock price and raised concerns among investors, SeaStar continues to work towards addressing the FDA’s concerns and rectifying its financial reporting.

Investors who have purchased SeaStar securities and wish to learn more about the investigation or have any questions regarding their rights or interests in this matter are encouraged to contact Frank R. Cruz of The Law Offices of Frank R. Cruz. The contact information includes the following: Frank R. Cruz, 2121 Avenue of the Stars, Suite 800, Century City, California 90067, phone number 310-914-5007, and email address Additional information can be found on their website at

Please note that this press release may be considered Attorney Advertising in some jurisdictions under applicable law and ethical rules.

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