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WebsiteIntroduction
SEASTAR MEDICAL HOLDING CORP (NASDAQ: ICU) is a commercial‐stage healthcare company headquartered in Denver, Colorado. Since its founding in 2018, SeaStar Medical has focused on developing cell-directed extracorporeal therapies to address hyperinflammation in critically ill patients, integrating patented technology into existing hemodialysis systems.
Corporate Structure
According to its LinkedIn profile, SeaStar Medical employs between 2 and 10 people, reflecting a compact team of specialists in biomedical engineering, clinical research, and regulatory affairs. The company’s leadership oversees product development, clinical trials, and commercial partnerships for its flagship technology, the Selective Cytopheretic Device (SCD), and its first commercial product, QUELIMMUNE (SCD-PED).
Medical device by Luke Chesser
Recent Developments and News
On June 24, 2024, the U.S. Food and Drug Administration (FDA) approved QUELIMMUNE (SCD-PED) for life-threatening acute kidney injury due to sepsis in pediatric patients. The device has since earned Breakthrough Device designation for six additional therapeutic indications. SeaStar initiated a pivotal trial in 2025 for its SCD therapy in adult patients with acute kidney injury requiring continuous renal replacement therapy (CRRT).
In its Schedule 13G/A filed on August 14, 2025, SeaStar disclosed that Armistice Capital, LLC and Steven Boyd collectively hold 1,466,096 shares, or 4.99% of outstanding common stock. The company submitted an 8-K on September 24, 2025 (Acc-no: 0001193125-25-215608) reporting items under Sections 8.01 and 9.01.
Financial and Strategic Analysis
| Metric | Value (as of 2025-09-25) |
|---|---|
| Share Price | $0.6758 (-45.50%) |
| Volume | 654,962 |
| 52-Week Range | $0.3050 – $4.5590 |
| Market Capitalization | $34.61 million |
| Revenue (TTM) | $766,000 |
| Net Income (TTM) | – $14.67 million |
| Diluted EPS (TTM) | – 1.85 |
| Price/Sales (TTM) | 28.08 |
| Price/Book (MRQ) | 10.36 |
| Enterprise Value/Revenue | 38.75 |
| Total Cash (MRQ) | $6.3 million |
| Levered Free Cash Flow (TTM) | – $10.1 million |
SeaStar Medical’s revenue remains nominal relative to its operating expenses, resulting in recurring net losses. The company’s strategic value proposition centers on its patented SCD platform, which aims to neutralize hyperinflammation. Breakthrough Device designations may expedite regulatory reviews and support favorable reimbursement when new indications gain approval.
Market Position and Industry Context
SeaStar Medical competes in the medical equipment manufacturing sector, specifically in extracorporeal therapies for hyperinflammation. There are currently no alternative FDA-approved treatments for cytokine storm mitigation in critically ill patients. The adult acute kidney injury market in the U.S. affects over 200,000 patients annually, presenting a significant addressable opportunity if the pivotal trial in CRRT patients demonstrates clinical benefit. ICU shares trade near the lower end of their 52-week range and below the 200-day moving average.
TL;DR
On September 25, 2025, ICU shares closed at $0.6758, down 45.50%, following pre-market declines. SeaStar Medical awaits key readouts from its adult AKI pivotal trial and continues expansion of QUELIMMUNE commercial sites. Upcoming regulatory milestones and trial results will shape the company’s outlook.
