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Cytosorbents Corp (CTSO)
NASDAQ:CTSO
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Cytosorbents (CTSO) AI Stock Analysis

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CTSO

Cytosorbents

(NASDAQ:CTSO)

Rating:43Neutral
Price Target:
$1.00
▲(17.65%Upside)
Cytosorbents faces substantial financial and regulatory challenges, reflected in declining revenues, high debt levels, and unfavorable valuations. Technical indicators and recent corporate events further suggest bearish conditions. However, there is some optimism from strategic plans to achieve breakeven and strong gross margins.
Positive Factors
Regulatory Potential
The regulatory approval of DrugSorb-ATR in the U.S. and Canada could make it the first device indicated for the removal of antithrombotic agents during cardiac surgery in these markets.
Revenue Growth
Product revenues increased by 25% year-over-year and 6% quarter-over-quarter, driven by a 28% increase in direct sales outside of Germany and a 22% increase in global distributor sales.
Sales Strategy
Management plans to revamp associated rep accounts and territories in Germany to boost sales and drive strong growth by the second half of 2025.
Negative Factors
Financial Performance
The company reported revenues and net loss that were below consensus estimates, with $9.2M in product revenues and a net loss of $0.14 per share.
Market Disruption
Short-term disruptions could impact topline revenues in the first quarter of 2025 due to the commercial reorganization in Germany.
Regulatory Challenges
The company received a denial letter from the FDA regarding the 510(k) de novo application for the use of DrugSorb-ATR during coronary artery bypass grafting surgery.

Cytosorbents (CTSO) vs. SPDR S&P 500 ETF (SPY)

Cytosorbents Business Overview & Revenue Model

Company DescriptionCytosorbents Corporation (CTSO) is a medical device company specializing in critical care immunotherapy. The company focuses on developing and commercializing innovative blood purification technologies to treat life-threatening conditions in the intensive care unit and cardiac surgery. Its flagship product, CytoSorb, is an extracorporeal cytokine adsorber designed to reduce cytokine storm and inflammation in patients suffering from sepsis, trauma, and other severe conditions.
How the Company Makes MoneyCytosorbents generates revenue primarily through the sale of its CytoSorb device, which is used in hospitals and medical institutions worldwide. The company sells directly to healthcare providers and through partnerships and distribution agreements with other medical device companies and distributors. Revenue streams also include licensing agreements and research grants. Cytosorbents may benefit from partnerships with pharmaceutical companies that complement their blood purification technologies, expanding their market reach and applications. Additionally, the company invests in ongoing research and development to enhance its product offerings and address new therapeutic areas, potentially driving future sales growth.

Cytosorbents Earnings Call Summary

Earnings Call Date:May 14, 2025
(Q1-2025)
|
% Change Since: 4.94%|
Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment Neutral
The earnings call presented a balanced view with strong operational progress and strategic investments offset by challenges in key markets and regulatory hurdles. The company's confidence in overcoming these challenges and achieving breakeven by the end of 2025 provides a cautiously optimistic outlook.
Q1-2025 Updates
Positive Updates
Solid Gross Margin Performance
The company maintained a gross margin of 71%, consistent with the 2024 average, despite a decrease in production volume.
Progress Toward Breakeven
The company is making meaningful operational progress, moving steadily towards near breakeven by the second half of 2025.
Positive International Sales Performance
Strong performances in international distribution and other direct sales markets helped offset temporary disruptions in the German market.
Successful Fundraising
The company raised $6.8 million through a shareholder rights offering and released $5 million of restricted cash, increasing available liquidity by $11.8 million.
New Leadership in Marketing
Tom Shannon joined as Vice President of Marketing for North America, bringing over 25 years of experience to support the potential launch of DrugSorb-ATR.
Promising Regulatory Path for DrugSorb-ATR
Despite a denial letter from the FDA, the company is confident in its appeal process for DrugSorb-ATR, citing strong data and potential resolution of remaining issues.
Negative Updates
Decline in Product Sales
Reported product sales were $8.7 million, representing a 3% year-over-year decline, primarily due to disruptions in the German market.
Challenges in German Market
Temporary disruptions in the German direct sales segment due to strategic reorganization affected overall sales performance.
Regulatory Challenges for DrugSorb-ATR
The FDA issued a denial letter for DrugSorb-ATR, citing remaining open issues that need resolution.
Extended Review Times in Canada
Health Canada's review of the DrugSorb-ATR application is experiencing delays, extending beyond target timelines.
Company Guidance
During the CytoSorbents' first quarter 2025 earnings call, several key metrics and guidance were provided. The company reported product sales of $8.7 million, a 3% year-over-year decline, although sales were flat when adjusted for constant currency. Gross margin remained steady at 71%, consistent with the 2024 average. The company aims to return its German sales to growth in the second half of 2025, following a strategic reorganization of its sales team. CytoSorbents reiterated its goal to approach breakeven by the end of 2025, supported by sufficient cash to fund initiatives. Additionally, CytoSorbents is preparing for the potential commercial launch of DrugSorb-ATR in the U.S. and Canada, with an initial market opportunity estimated at over $300 million. The company is pursuing an appeal process with the FDA after receiving a denial letter for DrugSorb-ATR, while also awaiting regulatory decisions from Health Canada.

Cytosorbents Financial Statement Overview

Summary
Cytosorbents is facing significant financial challenges with declining revenues, persistent losses, and increased debt levels. Despite slight improvements in cash flow management, the company remains unprofitable with high financial leverage and negative profit margins.
Income Statement
45
Neutral
Cytosorbents has experienced declining revenue over the past year, with a revenue decrease from $36.35M in 2023 to $35.59M in 2024. The gross profit margin improved slightly, indicating better cost management, but the company continues to operate at a loss with a negative net profit margin of -58.2% in 2024. The EBIT and EBITDA margins remain negative, reflecting ongoing operational challenges.
Balance Sheet
40
Negative
The balance sheet shows a concerning increase in debt levels, with total debt rising to $26.89M in 2024. The debt-to-equity ratio has increased significantly due to declining equity, indicating higher financial leverage and potential risk. The equity ratio has decreased, suggesting reduced financial stability. Return on equity remains negative, reflecting continued unprofitability.
Cash Flow
50
Neutral
The cash flow statement highlights a reduction in negative free cash flow, from -$22.59M in 2023 to -$14.71M in 2024, indicating some improvement in cash management. However, the operating cash flow remains negative, and the company continues to rely on financing activities to support operations. The free cash flow to net income ratio is unfavorable, reflecting ongoing cash flow challenges.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue35.59M36.35M29.36M40.11M39.45M
Gross Profit25.13M21.95M15.40M29.06M28.40M
EBITDA-19.26M-29.18M-30.00M-22.01M-9.71M
Net Income-20.72M-28.51M-32.81M-24.56M-7.84M
Balance Sheet
Total Assets47.37M53.26M63.23M89.52M89.95M
Cash, Cash Equivalents and Short-Term Investments3.28M14.13M22.14M52.14M71.42M
Total Debt26.89M18.31M18.25M13.82M1.03M
Total Liabilities36.26M29.99M27.86M26.94M10.73M
Stockholders Equity11.11M23.28M35.38M62.58M79.22M
Cash Flow
Free Cash Flow-14.71M-22.59M-34.69M-18.29M-7.29M
Operating Cash Flow-14.43M-21.66M-28.23M-14.01M-5.61M
Investing Cash Flow-669.43K-936.24K-6.46M-4.28M-1.68M
Financing Cash Flow9.33M14.47M4.96M715.20K66.35M

Cytosorbents Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.85
Price Trends
50DMA
1.03
Negative
100DMA
1.02
Negative
200DMA
1.01
Negative
Market Momentum
MACD
-0.05
Positive
RSI
33.62
Neutral
STOCH
2.11
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CTSO, the sentiment is Negative. The current price of 0.85 is below the 20-day moving average (MA) of 1.01, below the 50-day MA of 1.03, and below the 200-day MA of 1.01, indicating a bearish trend. The MACD of -0.05 indicates Positive momentum. The RSI at 33.62 is Neutral, neither overbought nor oversold. The STOCH value of 2.11 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CTSO.

Cytosorbents Risk Analysis

Cytosorbents disclosed 39 risk factors in its most recent earnings report. Cytosorbents 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

Cytosorbents Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
77
Outperform
$98.50M12.785.00%0.29%-22.13%
64
Neutral
$87.65M48.133.46%24.75%-61.29%
56
Neutral
$74.75M-113.95%8.49%6.09%
53
Neutral
$81.73M-67.86%0.34%6.20%
51
Neutral
$7.30B0.27-62.71%2.44%15.02%0.60%
50
Neutral
$79.83M-26.20%20.81%-498.66%
43
Neutral
$56.98M-94.65%-5.86%50.76%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CTSO
Cytosorbents
0.85
-0.35
-29.17%
FONR
Fonar
15.61
-2.39
-13.28%
NSPR
InspireMD
2.79
-0.18
-6.06%
XTNT
Xtant Medical Holdings
0.57
-0.10
-14.93%
SRTS
Sensus Healthcare
5.59
-0.42
-6.99%
HYPR
Hyperfine
1.06
-0.09
-7.83%

Cytosorbents Corporate Events

Product-Related AnnouncementsLegal ProceedingsRegulatory Filings and Compliance
CytoSorbents Faces Regulatory Challenges for DrugSorb-ATR
Negative
Jul 2, 2025

On July 2, 2025, CytoSorbents Corporation announced regulatory updates regarding its DrugSorb-ATR device. The U.S. FDA scheduled an appeal hearing for the company’s supervisory review, while Health Canada issued a Notice of Refusal for the Medical Device License application due to non-compliance issues. CytoSorbents plans to address these concerns through the appeals process, aiming for final regulatory decisions by the end of 2025. The company believes DrugSorb-ATR offers a unique solution for reducing perioperative bleeding in cardiac surgery, addressing a critical need in the U.S. and Canadian markets.

The most recent analyst rating on (CTSO) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Cytosorbents stock, see the CTSO Stock Forecast page.

Legal ProceedingsRegulatory Filings and Compliance
CytoSorbents Appeals FDA Denial of DrugSorb-ATR
Negative
Jun 24, 2025

On June 24, 2025, CytoSorbents Corporation announced its decision to appeal the U.S. FDA’s denial of its De Novo Request for DrugSorb-ATR, a device designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting. The company filed for a supervisory review on June 18, 2025, aiming to resolve deficiencies identified by the FDA and believes a final regulatory decision can be achieved in 2025. The appeal process involves engaging with FDA senior leadership and external experts, reflecting CytoSorbents’ confidence in addressing the FDA’s concerns. Meanwhile, the DrugSorb-ATR application with Health Canada is under advanced review, with a decision expected in 2025 despite delays.

The most recent analyst rating on (CTSO) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Cytosorbents stock, see the CTSO Stock Forecast page.

Executive/Board ChangesShareholder MeetingsBusiness Operations and Strategy
CytoSorbents Confirms Director Elections at Annual Meeting
Neutral
Jun 13, 2025

CytoSorbents Corporation held its 2025 Annual Meeting of Stockholders on June 12, 2025, where stockholders voted on several key matters. The election of five directors was confirmed, the compensation of named executive officers was approved on a non-binding basis, and the appointment of WithumSmith+Brown, PC, as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified. These decisions reflect the company’s ongoing governance and operational strategies, impacting its leadership structure and financial oversight.

The most recent analyst rating on (CTSO) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Cytosorbents stock, see the CTSO Stock Forecast page.

Delistings and Listing Changes
Cytosorbents Announces Expiration of Series B Warrants
Negative
Jun 11, 2025

On June 11, 2025, CytoSorbents Corporation announced that the 5-day volume weighted average price per share of its common stock was below the required minimum of $2.00, leading to the expiration of the Series B Right Warrants issued in a prior Rights Offering. Consequently, payments made for the exercise of these warrants will be refunded without interest or penalty.

The most recent analyst rating on (CTSO) stock is a Hold with a $1.00 price target. To see the full list of analyst forecasts on Cytosorbents stock, see the CTSO Stock Forecast page.

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: Jul 30, 2025