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ICUI.US
id: 1314
SeaStar Medical (ICU) FDA Approval Issues Case
D. Colorado
Court1:24-cv-01873
Case number31 Oct 2022
Class period Start26 Mar 2024
Class period End06 Sept 2024
Lead Plaintiff motion deadline- $ICU stockholders filed a claim against SeaStar Medical for overstating FDA approval chances for SCD and hiding financial issues.
- After the news in May 2023, $ICU dropped by over 30%.
- SeaStar investors can join this case to be notified about potential recovery.
Case Details:
After the merger, SeaStar Medical told investors that its lead product, the Selective Cytopheretic Device, was on track for FDA approval.
The company claimed it had met all the requirements for a Humanitarian Device Exemption, which would speed up the approval process for treating rare conditions.
However, in May 2023, the FDA rejected the application.
After the news, $ICU dropped by over 30%.
Based on these events, $ICU investors filed a claim against SeaStar Medical, accusing the company of the following:
- SeaStar overstated the likelihood of FDA approval for its key product, the SCD.
- The company concealed serious financial reporting issues, leading to the need for restatements.
Considering all the representations, investors suspect SeaStar Medical overstated FDA approval chances for SCD and hid financial issues.
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements,
Financial Misrepresentation,
Failure to Disclose
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
09 May 2023
Filing date
05 July 2024
Lead Plaintiff Deadline
06 September 2024
Judge
Hon. Regina M. Rodriguez