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SeaStar Medical Holding (ICU)
NASDAQ:ICU
US Market
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SeaStar Medical Holding (ICU) AI Stock Analysis

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ICU

SeaStar Medical Holding

(NASDAQ:ICU)

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
Commercial and Regulatory Progress
The substantial potential of the SCD and early commercial and regulatory progress support a Buy rating for ICU.
Financial Performance
SeaStar reported 2Q25 results with revenue of $338K, up 13.6% from the previous quarter, and a gross margin of 92.0%, which was above estimates.
Regulatory Achievements
The FDA granted two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy.
Negative Factors
Capital Requirements
ICU will likely require significant capital to fund the trial, pursue regulatory approval, and support parallel development efforts across the SCD platform.
Financial Challenges
ICU reported lower revenue and higher operational expenses than expected, indicating potential financial challenges.

SeaStar Medical Holding (ICU) vs. SPDR S&P 500 ETF (SPY)

SeaStar Medical Holding Business Overview & Revenue Model

Company DescriptionSeaStar 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.
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
30
Negative
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.
Balance Sheet
20
Very Negative
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.
Cash Flow
25
Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue766.00K135.00K0.000.000.000.00
Gross Profit739.00K135.00K0.000.000.000.00
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 Assets8.38M4.66M3.51M3.04M603.00K2.91M
Cash, Cash Equivalents and Short-Term Investments6.30M1.82M176.00K47.00K510.00K2.81M
Total Debt0.00574.00K9.08M8.83M2.62M83.00K
Total Liabilities5.04M6.84M17.38M23.80M76.77M74.49M
Stockholders Equity3.34M-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 Flow0.000.000.000.00-105.57M0.00
Financing Cash Flow20.48M17.65M10.41M7.33M2.82M4.89M

SeaStar Medical Holding Technical Analysis

Technical Analysis Sentiment
Positive
Last Price0.92
Price Trends
50DMA
0.68
Positive
100DMA
0.96
Negative
200DMA
1.46
Negative
Market Momentum
MACD
0.04
Negative
RSI
61.05
Neutral
STOCH
67.09
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ICU, the sentiment is Positive. The current price of 0.92 is above the 20-day moving average (MA) of 0.81, above the 50-day MA of 0.68, and below the 200-day MA of 1.46, indicating a neutral trend. The MACD of 0.04 indicates Negative momentum. The RSI at 61.05 is Neutral, neither overbought nor oversold. The STOCH value of 67.09 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
57
Neutral
$13.14M0.71-162.42%-82.24%
51
Neutral
$7.85B-0.21-41.41%2.22%22.81%-2.01%
48
Neutral
$45.26M249.03%-3.49%27.88%
40
Underperform
$10.18M-64.18%3.99%
34
Underperform
$18.91M-9690.24%1943.07%80.97%
33
Underperform
$25.57M1475.93%87.87%
$10.20M-2264.31%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ICU
SeaStar Medical Holding
0.92
-3.97
-81.19%
PSTV
Plus Therapeutics
0.46
-1.05
-69.54%
ERNA
Eterna Therapeutics
1.33
-24.62
-94.87%
GOVX
GeoVax Labs
0.74
-3.78
-83.63%
ADXN
Addex Therapeutics
8.17
-3.31
-28.83%
SNSE
Sensei Biotherapeutics
8.07
-3.93
-32.75%

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.Date of analysis: Apr 21, 2025