SeaStar Medical Holding Corporation
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $19.6M
- Price
- $3.72
- % Change (Daily % change from the live per-ticker quote feed.)
- +16.61%
- Volume
- 1.4M
About
SeaStar Medical Holding Corporation, a medical device company, focuses on providing novel solutions and services to treat hyperinflammation and cytokine storm in critically ill patients. The company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. It is developing products in various therapeutic areas, including pediatric and adult acute kidney injury on CRRT; cardiorenal syndrome in congestive heart failure with and without LVAD; myocardial stunning in end stage renal disease; and hepatorenal syndrome. The company is based in Denver, Colorado.
Quick stats
Shares outstanding5.3M
Computed float—
Float / sharesUnknown
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001831868
AI Summary
AI-generated1/26
standardbullishregulatory
FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition
The FDA granted SeaStar Medical (Nasdaq: ICU) Breakthrough Device Designation for its Selective Cytopheretic Device therapy to treat hyperinflammation in adults with sepsis, the seventh such designation for the platform.
The designation accelerates development, assessment, and review for FDA approval; management expects to submit sepsis-subset data from the ongoing 339-patient NEUTRALIZE-AKI pivotal trial in the near term.
Sepsis affects an estimated 1.7 million U.S. adults annually and has no FDA-approved therapy targeting the dysregulated inflammatory response, a large unmet-need market for the company.
Red flags
- designation is not approval; sepsis indication still depends on NEUTRALIZE-AKI trial data
- company remains loss-making and flags capital-raising risk in forward-looking statements