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SeaStar Medical Holding (ICU)
NASDAQ:ICU
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SeaStar Medical Holding
(NASDAQ:ICU)
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Rating:33Underperform
Price Target:―
SeaStar Medical Holding faces significant financial challenges, with negative equity and reliance on external financing posing risks to its financial health. Technical indicators show bearish momentum, and valuation metrics highlight ongoing losses, contributing to a low overall stock score.
Positive Factors
Innovative Product
The patented Selective Cytopheretic Device (SCD) offers a unique approach to treating acute kidney injury, providing a competitive edge in the biotechnology sector.
Revenue Introduction
The introduction of revenue in 2024 marks a critical milestone, indicating initial market acceptance and potential for future growth.
R&D Collaborations
Ongoing R&D collaborations could lead to new product developments and partnerships, enhancing long-term growth prospects.
Negative Factors
Negative Equity
Negative equity indicates potential solvency issues, posing risks to financial stability and limiting the company's ability to invest in growth.
Reliance on External Financing
Dependence on external financing can strain financial resources and increase vulnerability to market fluctuations, impacting long-term sustainability.
Low Profit Margins
Low and negative profit margins reflect operational inefficiencies, which may hinder the company's ability to achieve sustainable profitability.
SeaStar Medical Holding (ICU) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$16.81M
Dividend YieldN/A
Average Volume (3M)2.40M
Price to Earnings (P/E)―
Beta (1Y)-0.18
Revenue GrowthN/A
EPS Growth87.87%
CountryUS
Employees19
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.18
Shares Outstanding27,914,597
10 Day Avg. Volume4,893,890
30 Day Avg. Volume2,397,859
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap-0.09
Enterprise Value/Revenue-1.93
Enterprise Value/Gross Profit-2.00
Enterprise Value/Ebitda0.10
Forecast
1Y Price Target
$2.00Price Target Upside233.33% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering1
SeaStar Medical Holding Business Overview & Revenue Model
Company DescriptionSeaStar Medical Holding (ICU) is a medical technology company focused on developing and commercializing innovative therapies for acute and chronic conditions, particularly those affecting the kidneys and immune system. The company's core product is the Selective Cytopheretic Device (SCD), a patented therapeutic device designed to treat acute kidney injury (AKI) and other inflammatory conditions by selectively targeting and modulating activated leukocytes in the bloodstream.
How the Company Makes MoneySeaStar Medical Holding makes money through the sale and licensing of its Selective Cytopheretic Device (SCD) to hospitals, healthcare providers, and potentially through partnerships with other medical technology companies. Revenue is primarily generated from the commercialization of its patented therapies targeting acute kidney injury and other inflammatory conditions. The company may also derive income from ongoing research and development collaborations and potential future expansions into additional therapeutic areas.
SeaStar Medical Holding Earnings Call Summary
Earnings Call Date:Aug 13, 2025
(Q1-2025)
| % Change Since: |
Next Earnings Date:Nov 12, 2025
Earnings Call Sentiment Positive
The earnings call reflects significant progress in revenue and FDA approvals, alongside challenges in trial enrollment and operational delays. The company remains optimistic about future opportunities in both pediatric and adult markets.Q1-2025 Updates
Positive Updates
Significant Revenue Growth
SeaStar Medical reported a fourfold increase in first-quarter revenue compared to the fourth quarter of 2024, driven by the increased adoption of QUELIMMUNE therapy.
FDA Breakthrough Device Designations
The company received two new breakthrough device designations from the FDA for their SCD therapy, expanding their pipeline indications to address hyperinflammation during adult and pediatric cardiac surgery.
NEUTRALIZE-AKI Trial Progress
The NEUTRALIZE-AKI trial for adult patients reached a 50% enrollment milestone, triggering an interim analysis by the Data Safety Monitoring Board.
Pediatric Market Expansion
QUELIMMUNE therapy has been adopted by multiple new nationally recognized children's hospitals, indicating growing market penetration.
Strong Market Potential for Adult AKI
The adult AKI market presents a $4.5 billion annual opportunity, with plans to file a PMA in 2026.
Negative Updates
Enrollment Challenges
The enrollment for the NEUTRALIZE-AKI trial has been slower than anticipated, requiring additional sites to meet enrollment goals.
Operational Delays
The adoption process for QUELIMMUNE therapy at new pediatric sites can be lengthy due to the required post-approval surveillance registry and IRB approvals.
Financial Losses
Despite revenue growth, SeaStar Medical reported a net loss of $3.7 million for the first quarter of 2025.
Company Guidance
During the SeaStar Medical first quarter 2025 financial results call, the company provided several key metrics and guidance. They achieved a fourfold increase in revenue compared to the fourth quarter of 2024, reaching $293,000, primarily driven by increased adoption of their QUELIMMUNE therapy. The NEUTRALIZE-AKI trial for adult acute kidney injury (AKI) reached a 50% enrollment milestone, with expectations to complete enrollment by year-end 2025. The market opportunity for adult AKI is estimated at $4.5 billion annually in the U.S., based on approximately 200,000 adult patients. SeaStar Medical is also pursuing breakthrough device designations for additional indications and aims to file a premarket approval (PMA) application for adult AKI in 2026. Their strategy includes expanding their customer base, with six pediatric sites commercially active and more in the pipeline. The company is also focused on maintaining fiscal discipline, reporting a reduced net loss of $3.7 million in Q1 2025, compared to $12.7 million in Q1 2024.SeaStar Medical Holding Financial Statement Overview
Summary
SeaStar Medical Holding is in a precarious financial position with negative equity and ongoing operational struggles. Despite some revenue growth, the company faces significant profitability challenges and relies heavily on external financing, highlighting potential liquidity risks.Income Statement
The income statement reveals significant challenges. The company reported its first revenue in 2024, but the gross profit margin is low, and the net profit margin is negative due to substantial losses. EBIT and EBITDA margins are also negative, indicating ongoing operational struggles. Although there is a revenue introduction, past years show no revenue, and the trajectory needs monitoring.30
Negative
Balance Sheet
The balance sheet shows financial instability with negative stockholders' equity, indicating potential solvency issues. The debt-to-equity ratio cannot be calculated due to negative equity, which is a significant concern. Total liabilities exceed total assets, and the equity ratio is negative, suggesting poor financial health and high financial risk.20
Very Negative
Cash Flow
Cash flow analysis indicates strained liquidity with no free cash flow and operating cash flow issues. The operating cash flow to net income ratio is negligible, reflecting difficulty in converting revenue to cash. Financing cash flow is positive, indicating reliance on external financing to sustain operations, which is risky if not managed well.25
Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 766.00K | 135.00K | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 739.00K | 135.00K | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -14.39M | -24.58M | -11.14M | -11.61M | -4.38M | -5.24K |
| Net Income | -14.67M | -24.83M | -26.23M | -23.01M | -4.60M | -3.28M |
Balance Sheet | ||||||
| Total Assets | 8.38M | 4.66M | 3.51M | 3.04M | 603.00K | 2.91M |
| Cash, Cash Equivalents and Short-Term Investments | 6.30M | 1.82M | 176.00K | 47.00K | 510.00K | 2.81M |
| Total Debt | 0.00 | 574.00K | 9.08M | 8.83M | 2.62M | 83.00K |
| Total Liabilities | 5.04M | 6.84M | 17.38M | 23.80M | 76.77M | 74.49M |
| Stockholders Equity | 3.34M | -2.18M | -13.87M | -20.76M | -2.82M | -71.58M |
Cash Flow | ||||||
| Free Cash Flow | -15.36M | -16.01M | -10.29M | -7.79M | -5.11M | -5.57M |
| Operating Cash Flow | -15.36M | -16.01M | -10.29M | -7.79M | -5.11M | -5.57M |
| Investing Cash Flow | 0.00 | 0.00 | 0.00 | 0.00 | -105.57M | 0.00 |
| Financing Cash Flow | 20.48M | 17.65M | 10.41M | 7.33M | 2.82M | 4.89M |
SeaStar Medical Holding Technical Analysis
Negative
0.60
Price Trends
0.82
Negative
0.88
Negative
1.32
Negative
Market Momentum
<0.01
Positive
37.87
Neutral
38.66
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ICU, the sentiment is Negative. The current price of 0.6 is below the 20-day moving average (MA) of 0.88, below the 50-day MA of 0.82, and below the 200-day MA of 1.32, indicating a bearish trend. The MACD of <0.01 indicates Positive momentum. The RSI at 37.87 is Neutral, neither overbought nor oversold. The STOCH value of 38.66 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ICU.
SeaStar Medical Holding Risk Analysis
SeaStar Medical Holding disclosed 57 risk factors in its most recent earnings report. SeaStar Medical Holding reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
SeaStar Medical Holding Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
58 Neutral | $15.05M | 0.77 | 72.91% | ― | -82.24% | ― | |
43 Neutral | $61.26M | -0.28 | 145.02% | ― | -3.49% | 27.88% | |
40 Underperform | $11.10M | -0.41 | ― | ― | ― | 9.63% | |
34 Underperform | $16.38M | -0.26 | ― | ― | 1943.07% | 80.97% | |
33 Underperform | $16.81M | ― | 1475.93% | ― | ― | 87.87% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
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SeaStar Medical Holding Corporate Events
Private Placements and FinancingBusiness Operations and Strategy
SeaStar Medical Secures $6M Through Equity Agreements
Neutral
Feb 3, 2025
On January 31, 2025, SeaStar Medical Holdings entered a Securities Purchase Agreement with an institutional investor, issuing shares and warrants in both a registered direct offering and a concurrent private placement, expecting gross proceeds of approximately $6 million. The funds are intended for general corporate purposes, potentially impacting its operational capabilities and market strategy by enhancing working capital and capital expenditures.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.