CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR
FDA Appeal Decision: The FDA upheld its denial of CytoSorbents' De Novo application for the DrugSorb-ATR device, citing the need for additional information despite finding no safety issues with the device.
Path Forward Proposed: The FDA suggested a potential path forward for market authorization and the company is engaging in discussions to clarify this proposal while evaluating further appeal options within the FDA.
Device Purpose: DrugSorb-ATR aims to reduce perioperative bleeding in patients undergoing urgent coronary artery bypass graft surgery who are on blood thinners, addressing a significant risk faced by these patients.
Company Background: CytoSorbents specializes in blood purification technologies for critical care and cardiac surgery, with existing products like CytoSorb already approved in Europe and used globally.
Trade with 70% Backtested Accuracy
Analyst Views on CTSO
About CTSO
About the author
CytoSorbents (CTSO) Projects $37M Revenue for 2025, FDA Meeting Scheduled
- Financial Outlook: CytoSorbents anticipates fourth quarter and full-year 2025 revenues of approximately $9.2 million and $37 million, respectively, with expected gross margins between 73% and 75%, indicating stable growth potential in the market.
- FDA Meeting Scheduled: The company plans to hold a Pre-Submission Meeting with the FDA this month regarding DrugSorb®-ATR, with a De Novo application expected to be filed this quarter and a regulatory decision anticipated in mid-2026, paving the way for market entry.
- Research Publication: Results from the pivotal STAR-T study for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, reflecting the clinical relevance of the technology and potentially enhancing the company's reputation and market recognition in the medical community.
- Operational Improvements: The company is implementing various process improvements and a global strategic workforce and cost reduction program, expecting to accelerate its path to profitability and achieve approximately operating cash flow break-even in Q1 2026, thereby strengthening its financial health.
CytoSorbents Reports $37M in Q3 Sales; CEO to Join Virtual Discussion
- Strong Sales Performance: CytoSorbents achieved $37 million in high-margin sales over the trailing 12 months, reflecting robust market demand in critical care and cardiac surgery, thereby establishing a solid foundation for future growth.
- Accelerated Regulatory Progress: The company is actively pursuing FDA approval for DrugSorb™-ATR, with a key regulatory decision expected in mid-2026, which will provide crucial support for expanding its product line and market penetration.
- Executive Participation in Discussion: CEO Phillip Chan and CFO Peter J. Mariani will join a virtual discussion hosted by D. Boral Capital on December 15, offering insights into the company's recent financial performance and future strategies, aimed at bolstering investor confidence.
- Innovative Technology Outlook: CytoSorbents' blood purification technology is utilized in over 70 countries with nearly 300,000 devices used cumulatively, showcasing its broad application potential in treating life-threatening conditions and further solidifying the company's leadership in the medical technology sector.
Updated: CytoSorbents to Present at the Jefferies Global Healthcare Conference in London
Company Presentation: CytoSorbents Corporation will present at the Jefferies Global Healthcare Conference from November 17-20, 2025, with a specific presentation scheduled for November 18 at 12:30 PM GMT.
Product Overview: The company specializes in blood purification technologies for critical care, with its lead product, CytoSorb, approved in the EU and used in over 70 countries to remove toxins and inflammatory agents from blood.
Regulatory Developments: CytoSorbents is pursuing FDA approval for its investigational DrugSorb™-ATR system, aimed at reducing perioperative bleeding in high-risk surgeries, and has received Breakthrough Device Designations for specific anticoagulant removals.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's plans and regulatory submissions, cautioning that actual results may differ due to various risks and uncertainties.
HC Wainwright & Co. Upholds Neutral Rating for Cytosorbents (CTSO)
Analyst Recommendation: HC Wainwright & Co. maintains a Neutral recommendation for Cytosorbents (NasdaqCM:CTSO) as of November 14, 2025, with a projected one-year price target of $5.10/share, indicating a potential upside of 672.73% from its current price of $0.66/share.
Projected Revenue and EPS: Cytosorbents is expected to see a significant increase in annual revenue, projected at $122 million, which represents a 237.10% growth, alongside a projected non-GAAP EPS of 0.17.
Fund Sentiment: There are currently 73 funds reporting positions in Cytosorbents, reflecting an 8.96% increase in ownership over the last quarter, with total institutional shares rising by 1.15% to 18,005K shares.
Shareholder Activity: Notable changes in shareholder allocations include Avenir increasing its stake slightly, while Skylands Capital and Neuberger Berman Group both reduced their holdings significantly over the last quarter.
CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update
Financial Performance: CytoSorbents Corporation reported a 10% year-over-year revenue increase to $9.5 million in Q3 2025, with improved gross margins of 70% and a reduced operating loss of $2.9 million.
Strategic Initiatives: The company implemented a Workforce and Cost Reduction Program aimed at achieving cash-flow breakeven by Q1 2026, alongside an amended credit agreement providing an additional $2.5 million in funding.
Regulatory Progress: CytoSorbents submitted a De Novo pre-submission package for its DrugSorb™-ATR device to the FDA, with a formal application expected in Q1 2026 and a regulatory decision anticipated by mid-2026.
Clinical Advancements: Recent clinical data and presentations highlighted the effectiveness of CytoSorb's therapies in managing sepsis and anticoagulant removal during cardiac surgery, reinforcing the company's commitment to improving patient outcomes.
CytoSorbents to Participate at the Jefferies Global Healthcare Conference in London
Company Participation in Conference: CytoSorbents Corporation's CEO Dr. Phillip Chan and CFO Mr. Peter Mariani will attend the Jefferies Global Healthcare Conference in London on November 18-19, 2025, for one-on-one meetings with investors.
About CytoSorbents Corporation: The company specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery, with its lead product, CytoSorb®, approved in the EU and used in over 70 countries.
Regulatory Developments: CytoSorbents is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received FDA Breakthrough Device Designations but is not yet approved in the U.S. or Canada.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's plans and regulatory submissions, cautioning that actual results may differ due to various risks and uncertainties.
CytoSorbents (CTSO) Projects $37M Revenue for 2025, FDA Meeting Scheduled
- Financial Outlook: CytoSorbents anticipates fourth quarter and full-year 2025 revenues of approximately $9.2 million and $37 million, respectively, with expected gross margins between 73% and 75%, indicating stable growth potential in the market.
- FDA Meeting Scheduled: The company plans to hold a Pre-Submission Meeting with the FDA this month regarding DrugSorb®-ATR, with a De Novo application expected to be filed this quarter and a regulatory decision anticipated in mid-2026, paving the way for market entry.
- Research Publication: Results from the pivotal STAR-T study for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, reflecting the clinical relevance of the technology and potentially enhancing the company's reputation and market recognition in the medical community.
- Operational Improvements: The company is implementing various process improvements and a global strategic workforce and cost reduction program, expecting to accelerate its path to profitability and achieve approximately operating cash flow break-even in Q1 2026, thereby strengthening its financial health.
CytoSorbents Reports $37M in Q3 Sales; CEO to Join Virtual Discussion
- Strong Sales Performance: CytoSorbents achieved $37 million in high-margin sales over the trailing 12 months, reflecting robust market demand in critical care and cardiac surgery, thereby establishing a solid foundation for future growth.
- Accelerated Regulatory Progress: The company is actively pursuing FDA approval for DrugSorb™-ATR, with a key regulatory decision expected in mid-2026, which will provide crucial support for expanding its product line and market penetration.
- Executive Participation in Discussion: CEO Phillip Chan and CFO Peter J. Mariani will join a virtual discussion hosted by D. Boral Capital on December 15, offering insights into the company's recent financial performance and future strategies, aimed at bolstering investor confidence.
- Innovative Technology Outlook: CytoSorbents' blood purification technology is utilized in over 70 countries with nearly 300,000 devices used cumulatively, showcasing its broad application potential in treating life-threatening conditions and further solidifying the company's leadership in the medical technology sector.
Updated: CytoSorbents to Present at the Jefferies Global Healthcare Conference in London
Company Presentation: CytoSorbents Corporation will present at the Jefferies Global Healthcare Conference from November 17-20, 2025, with a specific presentation scheduled for November 18 at 12:30 PM GMT.
Product Overview: The company specializes in blood purification technologies for critical care, with its lead product, CytoSorb, approved in the EU and used in over 70 countries to remove toxins and inflammatory agents from blood.
Regulatory Developments: CytoSorbents is pursuing FDA approval for its investigational DrugSorb™-ATR system, aimed at reducing perioperative bleeding in high-risk surgeries, and has received Breakthrough Device Designations for specific anticoagulant removals.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's plans and regulatory submissions, cautioning that actual results may differ due to various risks and uncertainties.
HC Wainwright & Co. Upholds Neutral Rating for Cytosorbents (CTSO)
Analyst Recommendation: HC Wainwright & Co. maintains a Neutral recommendation for Cytosorbents (NasdaqCM:CTSO) as of November 14, 2025, with a projected one-year price target of $5.10/share, indicating a potential upside of 672.73% from its current price of $0.66/share.
Projected Revenue and EPS: Cytosorbents is expected to see a significant increase in annual revenue, projected at $122 million, which represents a 237.10% growth, alongside a projected non-GAAP EPS of 0.17.
Fund Sentiment: There are currently 73 funds reporting positions in Cytosorbents, reflecting an 8.96% increase in ownership over the last quarter, with total institutional shares rising by 1.15% to 18,005K shares.
Shareholder Activity: Notable changes in shareholder allocations include Avenir increasing its stake slightly, while Skylands Capital and Neuberger Berman Group both reduced their holdings significantly over the last quarter.
CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update
Financial Performance: CytoSorbents Corporation reported a 10% year-over-year revenue increase to $9.5 million in Q3 2025, with improved gross margins of 70% and a reduced operating loss of $2.9 million.
Strategic Initiatives: The company implemented a Workforce and Cost Reduction Program aimed at achieving cash-flow breakeven by Q1 2026, alongside an amended credit agreement providing an additional $2.5 million in funding.
Regulatory Progress: CytoSorbents submitted a De Novo pre-submission package for its DrugSorb™-ATR device to the FDA, with a formal application expected in Q1 2026 and a regulatory decision anticipated by mid-2026.
Clinical Advancements: Recent clinical data and presentations highlighted the effectiveness of CytoSorb's therapies in managing sepsis and anticoagulant removal during cardiac surgery, reinforcing the company's commitment to improving patient outcomes.
CytoSorbents to Participate at the Jefferies Global Healthcare Conference in London
Company Participation in Conference: CytoSorbents Corporation's CEO Dr. Phillip Chan and CFO Mr. Peter Mariani will attend the Jefferies Global Healthcare Conference in London on November 18-19, 2025, for one-on-one meetings with investors.
About CytoSorbents Corporation: The company specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery, with its lead product, CytoSorb®, approved in the EU and used in over 70 countries.
Regulatory Developments: CytoSorbents is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received FDA Breakthrough Device Designations but is not yet approved in the U.S. or Canada.
Forward-Looking Statements: The press release includes forward-looking statements regarding the company's plans and regulatory submissions, cautioning that actual results may differ due to various risks and uncertainties.
