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CytoSorbents Faces Regulatory Challenges for DrugSorb-ATR

Story Highlights
  • CytoSorbents announced FDA and Health Canada regulatory updates for DrugSorb-ATR.
  • The company plans to address regulatory concerns through appeals, aiming for decisions by 2025.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
CytoSorbents Faces Regulatory Challenges for DrugSorb-ATR

Elevate Your Investing Strategy:

An update from Cytosorbents ( (CTSO) ) is now available.

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.

Spark’s Take on CTSO Stock

According to Spark, TipRanks’ AI Analyst, CTSO is a Neutral.

Cytosorbents’ overall stock score reflects significant financial challenges and a weak valuation outlook, primarily driven by declining revenues, negative cash flows, and high leverage. Despite positive technical indicators and strategic initiatives mentioned in recent earnings calls, the stock’s fundamental weaknesses weigh heavily on its overall attractiveness.

To see Spark’s full report on CTSO stock, click here.

More about Cytosorbents

CytoSorbents Corporation is a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery. The company specializes in proprietary blood purification technologies using biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids. Their products, including CytoSorb, are used in various applications such as reducing severe bleeding during cardiothoracic surgery and removing inflammatory agents in critical illnesses.

Average Trading Volume: 111,306

Technical Sentiment Signal: Buy

Current Market Cap: $80.77M

For detailed information about CTSO stock, go to TipRanks’ Stock Analysis page.

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