Cytosorbents (CTSO) AI Stock Analysis

• Market Cap: $67.78M
• Dividend Yield: N/A
• Average Volume (3M): 234.68K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.75
• Revenue Growth: -7.81%
• EPS Growth: 65.39%
• Country: US
• Employees: 149
• Sector: Healthcare
• Sector Strength: 52
• Industry: Medical - Devices
• EPS (TTM): 0.03
• Shares Outstanding: 62,761,806
• 10 Day Avg. Volume: 103,810
• 30 Day Avg. Volume: 234,682
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 1.52
• Enterprise Value/Revenue: 3.08
• Enterprise Value/Gross Profit: 4.24
• Enterprise Value/Ebitda: -6.25
• 1Y Price Target: $1.00
• Price Target Upside: 12.36% Upside
• Rating Consensus: Hold
• Number of Analyst Covering: 1

• Rating: 46 Neutral
• Price Target: $1.00 ▲(12.36% Upside)

Cytosorbents' overall stock score is primarily impacted by its challenging financial performance and valuation concerns. While there are some positive aspects in sales growth and restructuring efforts, the regulatory challenges and high debt levels significantly weigh down the score.

Positive Factors

Cash Management

The company conducted an equity rights offering for gross proceeds of approximately $7.3M, resulting in a total pro forma cash position of $17.1M.

Commercial 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.

Product Revenues

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.

Negative Factors

Regulatory Challenges

The company received a denial letter from the FDA regarding the 510(k) de novo application for DrugSorb-ATR during coronary artery bypass grafting surgery.

Regulatory Uncertainty

The company has not disclosed the specific issues related to the FDA denial, making it difficult to evaluate the chances of a successful appeal.

Revenue Decline

Product revenues fell by approximately 3% year-over-year and 5% quarter-over-quarter due to falling direct sales in Germany.

Cytosorbents Business Overview & Revenue Model

Company Description

Cytosorbents Corporation (CTSO) is a medical technology company focused on developing and commercializing innovative products for critical care and cardiac surgery. The company specializes in blood purification technology, particularly through its flagship product, CytoSorb, which is designed to remove harmful substances from the bloodstream during severe inflammatory conditions. Cytosorbents operates primarily in the healthcare sector, targeting hospitals and medical facilities that require advanced treatment options for patients experiencing life-threatening conditions.

How the Company Makes Money

Cytosorbents generates revenue primarily through the sale of its CytoSorb devices and related products to hospitals and healthcare providers. The company employs a direct sales model in certain markets, while also working with distributors and partners to expand its reach. Key revenue streams include the sale of disposable CytoSorb cartridges, which are used in conjunction with the device for blood purification during critical care treatments. The company has established significant partnerships with medical institutions and research organizations, which not only enhance its product visibility but also facilitate clinical studies that can lead to broader adoption of its technologies. Additionally, Cytosorbents may explore opportunities for reimbursement from healthcare payers, further contributing to its earnings potential.

Cytosorbents Financial Statement Overview

Summary

Cytosorbents faces significant financial challenges, including declining revenues, persistent losses, and increased financial leverage. While there are slight improvements in cash flow management, the company remains unprofitable with high debt levels. Continued focus on cost management and revenue growth is essential to improve financial stability and performance.

Income Statement

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

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

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	33.48M	35.59M	31.08M	29.36M	40.11M	39.45M
Gross Profit	24.30M	25.13M	21.95M	15.40M	29.06M	28.40M
EBITDA	-16.49M	-19.26M	-27.88M	-32.77M	-21.62M	-9.71M
Net Income	-9.75M	-20.72M	-29.25M	-32.81M	-24.56M	-7.84M
Balance Sheet
Total Assets	47.99M	47.37M	52.96M	63.23M	89.52M	89.95M
Cash, Cash Equivalents and Short-Term Investments	10.20M	3.28M	14.13M	22.14M	52.14M	71.42M
Total Debt	27.06M	26.89M	18.31M	18.25M	13.82M	1.03M
Total Liabilities	36.40M	36.26M	29.48M	27.86M	26.94M	10.73M
Stockholders Equity	11.59M	11.11M	23.48M	35.38M	62.58M	79.22M
Cash Flow
Free Cash Flow	-10.29M	-14.71M	-22.59M	-34.69M	-18.29M	-7.29M
Operating Cash Flow	-9.78M	-14.43M	-21.66M	-28.23M	-14.01M	-5.61M
Investing Cash Flow	-601.55K	-669.43K	-936.24K	-6.46M	-4.28M	-1.68M
Financing Cash Flow	6.90M	9.33M	14.47M	4.96M	715.20K	66.35M

Cytosorbents Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 0.89
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

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 0.89 is below the 20-day moving average (MA) of 0.99, below the 50-day MA of 1.06, and below the 200-day MA of 1.00, indicating a bearish trend. The MACD of <0.01 indicates Negative momentum. The RSI at 41.39 is Neutral, neither overbought nor oversold. The STOCH value of 41.78 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CTSO.

Cytosorbents Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
FONR	77 Outperform	$95.34M	12.38	5.00%	―	0.29%	-22.13%
Sector *	60 Neutral	HK$19.34B	4.28	-1.43%	3.28%	13.32%	-14.38%
SRTS	58 Neutral	$52.61M	48.68	-1.62%	―	3.30%	-112.70%
XTNT	57 Neutral	$80.80M	―	-9.80%	―	15.16%	-39.18%
HYPR	57 Neutral	$98.86M	―	-77.26%	―	-9.59%	8.78%
NSPR	51 Neutral	$103.88M	―	-123.51%	―	7.60%	-0.78%
CTSO	46 Neutral	$67.78M	―	-68.84%	―	-7.81%	65.39%

Cytosorbents Corporate Events

CytoSorbents Faces Regulatory Challenges for DrugSorb-ATR

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.

CytoSorbents Appeals FDA Denial of DrugSorb-ATR

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.

CytoSorbents Confirms Director Elections at Annual Meeting

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.

Cytosorbents Announces Expiration of Series B Warrants

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.