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CytoSorbents Appeals FDA Denial of DrugSorb-ATR

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CytoSorbents Appeals FDA Denial of DrugSorb-ATR

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

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.

Spark’s Take on CTSO Stock

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

Cytosorbents faces significant financial challenges, which heavily impact its overall score. While technical indicators show mixed signals and recent earnings call and corporate events provide some optimism, financial stability remains a critical concern.

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

More about Cytosorbents

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care units and cardiac surgery through blood purification. The company utilizes proprietary blood purification technologies based on biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids. These technologies are used globally in various applications, including reducing severe bleeding during cardiothoracic surgery and removing inflammatory agents in critical illnesses.

Average Trading Volume: 105,100

Technical Sentiment Signal: Buy

Current Market Cap: $73.88M

See more data about CTSO stock on TipRanks’ Stock Analysis page.

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