Cytosorbents (CTSO) Company Report

CytoSorbents expects preliminary unaudited fourth quarter 2025 revenue of approximately $9.2 million and full-year 2025 revenue of approximately $37.0 million, representing approximately 4% growth over full-year 2024.
The company anticipates fourth quarter 2025 gross margins in the range of 73% to 75% and a full-year 2025 gross margin of approximately 72%.
A De Novo Pre-Submission Meeting for DrugSorb®-ATR with the FDA is scheduled this month, with the De Novo Application filing expected this quarter and a regulatory decision anticipated in mid-2026.
CytoSorbents amended its credit agreement in November 2025, adding $2.5 million in cash and extending the interest-only period.
The company expects to be approximately cash-flow breakeven (excluding restructuring payments) for the first quarter of 2026 following a strategic workforce and cost reduction program.

Jan 12, 2026, 12:00 PM

Press Release

CytoSorbents Provides DrugSorb-ATR Regulatory Update and Financial Outlook

CTSO

Guidance Update

Debt Issuance

New Projects/Investments

CytoSorbents' core business, featuring its EU-approved CytoSorb product, generated $37 million in trailing 12-month revenue as of the end of the third quarter, with product gross margins of approximately 71%.
The company's investigational product, DrugSorb-ATR, which has received two FDA breakthrough device designations, is pursuing a De Novo 510(k) path for US approval to address perioperative bleeding in patients on blood thinners.
The FDA has confirmed no safety issues with DrugSorb-ATR and does not require another randomized controlled trial, instead requesting additional efficacy data.
CytoSorbents anticipates submitting a new De Novo application for DrugSorb-ATR following a January 2026 meeting with the FDA, with potential approval targeted for mid-2026 or sooner.
Financially, the company aims to reach cash flow break-even in Q1 2026 for its core business, having recently secured $2.5 million in immediate cash and an extended interest-only period through a credit agreement refinancing, with an additional $2.5 million available upon DrugSorb-ATR approval.

Dec 15, 2025, 4:00 PM

Transcript

CytoSorbents Provides Update on DrugSorb-ATR Regulatory Pathway and Financial Outlook

CTSO

Product Launch

Guidance Update

New Projects/Investments

CytoSorbents' DrugSorb-ATR product, designed for blood thinner removal, has received two FDA breakthrough device designations.
The company is pursuing a De Novo 510(k) pathway for DrugSorb-ATR in the U.S., with the FDA acknowledging no safety issues with the device.
A new De Novo submission, incorporating real-world evidence, is planned, with a pre-submission meeting with the FDA scheduled for January. The company anticipates potential FDA approval by mid-2026 or sooner.
The immediate U.S. market opportunity for DrugSorb-ATR, starting with the blood thinner Brilinta, is estimated at $300 million, with potential growth to over $1 billion.
CytoSorbents aims to achieve cash flow break-even in Q1 2026 for its core business and has secured a credit agreement amendment providing $2.5 million in immediate cash and extending its interest-only period.

Dec 15, 2025, 4:00 PM

Transcript

CytoSorbents Provides Update on DrugSorb U.S. Regulatory Pathway and Commercialization

CTSO

Product Launch

New Projects/Investments

Guidance Update

CytoSorbents is advancing its DrugSorb product through the De Novo 510(k) pathway in the U.S. for blood thinner removal, having received two FDA Breakthrough Device designations.
Despite the STAR-T trial missing its primary endpoint, the FDA has acknowledged no significant safety issues with the device and did not require another randomized controlled trial, instead requesting more efficacy data.
The company expects a meeting with the FDA in January 2026 to align on data for a new De Novo submission, with potential approval by mid-2026 or sooner, followed by a targeted pilot launch in the U.S..
CytoSorbents currently markets its CytoSorb product in Europe for critical care and cardiac surgery and has a pipeline of other products, including VetResQ, ECOS-300CY, and HemoDefend-BGA.

Dec 15, 2025, 4:00 PM

Transcript

CytoSorbents to Host Virtual Fireside Chat on Recent Performance and DrugSorb-ATR Progress

CTSO

Earnings

New Projects/Investments

CytoSorbents Corporation (CTSO) will participate in a virtual fireside chat on Monday, December 15, 2025, to provide additional insight into recent developments.
The discussion will build on the company's recent third-quarter earnings call, highlighting $37.0 million in trailing 12-month high-margin sales and a strengthened balance sheet.
Key topics include ongoing regulatory progress for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA), with a key regulatory decision expected in mid-2026.
DrugSorb™-ATR has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants (DOAC) apixaban and rivaroxaban in cardiothoracic surgery.

Dec 10, 2025, 12:00 PM

Press Release

CytoSorbents Targets Q1 2026 Cash Flow Break-Even and Mid-2026 DrugSorb-ATR FDA Decision

CTSO

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

CytoSorbents reported Q3 revenue of $9.5 million, a 10% increase year-over-year, with trailing 12-month core product sales reaching $37 million and gross margins at 70% for the quarter.
The company is targeting cash flow break-even in Q1 2026 and near-term profitability, supported by a strengthened balance sheet with $9.1 million in cash as of the end of Q3, and an additional $2.5 million from an amended credit agreement.
For its DrugSorb-ATR product, a new De Novo submission to the FDA is expected in Q1 2026, with a regulatory decision anticipated in mid-2026 for this device, which addresses a >$1 billion U.S. market opportunity.
CytoSorbents is undergoing a restructuring of its German sales team to drive growth and more consistent financial performance in 2026.

Nov 18, 2025, 12:30 PM

Transcript

CytoSorbents Updates on Financial Performance and DrugSorb ATR Approval Timeline

CTSO

Revenue Acceleration/Inflection

New Projects/Investments

Guidance Update

CytoSorbents reported record core product sales of $37 million on a trailing 12-month basis with 71% product gross margins, and Q3 revenue increased 10% to $9.5 million from the prior year.
The company is pursuing U.S. regulatory approval for DrugSorb ATR, a device with two FDA breakthrough designations and a >$1 billion total addressable market. A new De Novo submission is expected in Q1 2026, with a regulatory decision anticipated in mid-2026.
CytoSorbents aims to achieve cash flow break-even in Q1 2026 and near-term profitability, supported by $9.1 million in cash at the end of Q3 and an additional $2.5 million from an amended credit agreement.

Nov 18, 2025, 12:30 PM

Transcript

CytoSorbents discusses DrugSorb ATR approval timeline and Q1 2026 cash flow breakeven target

CTSO

Guidance Update

Product Launch

Revenue Acceleration/Inflection

CytoSorbents' flagship product, CytoSorb, achieved $37 million in trailing twelve-month core product sales with 71% product gross margins and is used in over 70 countries.
The company is actively pursuing U.S. and Canadian regulatory approval for its investigational device, DrugSorb ATR, designed to reduce bleeding in CABG surgery, with a regulatory decision expected in mid-2026.
DrugSorb ATR holds two FDA breakthrough device designations, and the company plans a new de novo submission in 2026, confident in addressing prior FDA concerns regarding efficacy, with no safety concerns raised.
CytoSorbents aims to achieve cash flow breakeven in Q1 2026 and near-term profitability, supported by $9.1 million in cash as of the end of Q3 and an amended credit agreement providing an additional $2.5 million.
Third-quarter revenue was $9.5 million, a 10% increase year-over-year, driven by strong distributor and other direct sales, while the German sales team is undergoing restructuring to return to growth in 2026.

Nov 18, 2025, 12:30 PM

Transcript

CytoSorbents Reports Q3 2025 Financial Results, Announces Cost Reduction, and Debt Amendment

CTSO

Earnings

Layoffs

Debt Issuance

CytoSorbents reported Q3 2025 revenue of $9.5 million, representing a 10% increase year-over-year, alongside a net loss of $3.2 million or $0.05 per share.
The company implemented a Workforce and Cost Reduction Program, including a 10% workforce reduction, with the goal of achieving cash-flow breakeven in Q1 2026.
An amended credit agreement provides an immediate additional $2.5 million in term loan capital and extends the interest-only period to December 31, 2026. An additional $2.5 million and further interest-only extension are available upon DrugSorb-ATR FDA marketing approval.
For DrugSorb-ATR, a new De Novo application is planned for submission in Q1 2026, with an anticipated FDA regulatory decision by mid-2026.

Nov 13, 2025, 9:34 PM

8-K

CytoSorbents Reports Q3 2025 Revenue Growth and Updates DrugSorb-ATR Regulatory Timeline

CTSO

Earnings

Guidance Update

Product Launch

CytoSorbents (CTSO) reported Q3 2025 revenue of $9.5 million, marking a 10% increase year-over-year, or 4% on a constant currency basis. The company's gross margin remained solid at 70%.
Trailing 12-month core product sales for CytoSorb as of September 30, 2025, reached a record $37.0 million. Sales growth without Germany was +17.3%, while Germany sales declined by 3.2%.
For its investigational device, DrugSorb-ATR, CytoSorbents expects to file a new De Novo application in Q1 2026, with a regulatory decision anticipated in mid-2026. The FDA affirmed no issues with device safety during the appeal of the original De Novo submission.
The company aims to achieve cash-flow breakeven beginning in Q1 2026. In Q3 2025, operating cash burn was $2.6 million, and cash, cash equivalents, and restricted cash totaled $9.1 million as of September 30, 2025.
An amended credit agreement will provide $2.5 million in November 2025 and extends the interest-only period to December 31, 2026, with an additional $2.5 million and further extension available upon FDA approval of DrugSorb-ATR in 2026.