Law Offices of Howard G. Smith announces an investigation on behalf of SeaStar Medical Holding Corporation (“SeaStar” or the “Company”) (NASDAQ: ICU) investors concerning the Company’s possible violations of federal securities laws.

On May 9, 2023, SeaStar disclosed that it had received a letter from the Center for Biologics Evaluation and Research (“CBER”) of the U.S. Food and Drug Administration (“FDA”), rejecting the Company’s Humanitarian Device Exemption (“HDE”) application for its pediatric Selective Cytopheretic Device (“SCD”) because “the application [wa]s not approvable in its current form[.]” The Company also stated that it had engaged in “a series of [purported] collaborative meetings and correspondence over the past 10 months” with the FDA, had made repeated responses “to the Agency’s recommendations,” and that there were “current deficiencies cited by the Agency in their letter[.]”

On this news, SeaStar’s stock price fell $0.77, or $39.7%, to close at $1.17 per share on May 10, 2023, thereby injuring investors.

Then, on March 27, 2024, SeaStar announced that it had “determined that certain complex financial instruments required accounting treatment that differed from [its] previous judgment,” and that, due to the reporting of non-cash accounting items, the Company would need to restate financial statements for the fiscal year 2022 and the first three quarters of fiscal year 2023.

On this news, SeaStar’s stock price fell $0.04, or 4.8%, to close at $0.71 per share on March 27, 2024, thereby injuring investors further.

If you purchased SeaStar securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847 or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240710095127/en/