Cytosorbents Seeks FDA Approval for Blood Purification Device in Second Attempt

Cytosorbents prepares a new FDA submission for its DrugSorb-ATR device, targeting U.S. approval by mid-2026 while aiming for cash flow breakeven in Q1 2026.

The coming weeks are critical for Cytosorbents as the company prepares a renewed regulatory push in the United States. Following setbacks last year, the firm is finalizing a new submission for its DrugSorb-ATR blood purification system. This represents a pivotal second chance to secure a foothold in the valuable U.S. market.

Financial Milestones and Upcoming Report

Alongside its regulatory strategy, the company is sharply focused on improving its financial performance. Management has set a target to reach operational cash flow breakeven by the end of the first quarter of 2026. A cost-reduction initiative and workforce reductions implemented the previous year are intended to support this goal.

Investors will soon receive a clearer picture of the financial situation. The company is scheduled to release its fourth quarter and full-year 2025 results on Wednesday, March 25. A subsequent webcast will feature management discussing the financial statements and providing an updated business outlook.

The Path to U.S. Market Clearance

The device, designed to reduce bleeding during cardiac surgery, previously encountered regulatory obstacles with the U.S. Food and Drug Administration (FDA). An initial application for approval was rejected in April 2025, and a subsequent appeal failed in August of the same year. While the agency requested additional efficacy data, it emphasized that the device raised no safety concerns.

The current plan involves submitting an updated application by the end of the ongoing first quarter of 2026. This new filing will incorporate real-world clinical data alongside findings from the STAR-T study. A decision from the regulatory body is anticipated by mid-2026.