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ICU.US
id: 1283
SeaStar Medical (ICU) FDA Compliance Issues Case
D. Colorado
Court1:24-cv-01873
Case number10/31/2022
Class period Start03/26/2024
Class period End09/03/2024
Lead Plaintiff motion deadline- $ICU stockholder filed a claim against SeaStar Medical for hiding FDA compliance issues, which led to exaggerated prospects and financial errors.
- Following the FDA rejection announcement, $ICU fell by over 39% on May 10, 2023.
- SeaStar’s investors can join this case to be notified about potential recovery.
Case Details:
On April 22, 2022, while still operating as a SPAC, LMF Acquisition Opportunities announced a merger with SeaStar Medical.
On July 20, 2022, LMF and Legacy SeaStar announced that Legacy SeaStar had applied to the FDA to use their device for treating critically ill children with AKI.
Then, on October 18, 2022, following positive regulatory news about SCD, LMF stockholders approved the merger.
After that, on October 28, 2022, LMF completed its merger with Legacy SeaStar.
On May 9, 2023, SeaStar announced the FDA rejected its application for pediatric SCD due to deficiencies.
CEO Eric Schlorff mentioned ongoing efforts to address FDA recommendations over the past 10 months.
On this news, $ICU fell by over 39% on May 10, 2023.
Based on these events, a $ICU stockholder filed a claim against SeaStar and its leaders, accusing them of the following:
- SeaStar lacked proper compliance controls for its FDA application for the SCD.
- This led to doubts about FDA approval and overstated regulatory prospects.
- Financial control deficiencies were downplayed, leading to accounting errors and potential restatements.
Considering all the representations, investors suspect SeaStar hid FDA compliance issues, leading to exaggerated prospects and financial errors.
Case Status
Lead Plaintiff Appointed
Alleged Offence
Mismanagement,
Misleading Statements,
Omissions
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
03/27/2024
Filing date
07/05/2024
Lead Plaintiff Deadline
09/03/2024