CytoSorbents Delivers Strong Q3 2025 Results with Business Updates and Future Plans

CytoSorbents Reports Strong Q3 2025 Financial Performance

CytoSorbents Corporation (NASDAQ CTSO), recognized for its innovative blood purification solutions in critical care and cardiac surgery, has reported notable financial achievements for the third quarter of 2025. The company’s revenue reached $9.5 million, reflecting a 10% increase from $8.6 million in Q3 2024. This growth is primarily attributed to impressive sales performance in distributor territories and strong direct sales outside of Germany.

Financial Highlights

During Q3 2025, CytoSorbents enjoyed significant improvements in its gross margin, which increased to 70% compared to 61% in the same quarter last year. The improvement in gross margin is a result of two main factors: a previously planned production slowdown to balance inventory and a temporary manufacturing issue that was resolved in Q3 2024. The company's operating loss significantly reduced to $2.9 million from $4.8 million year-over-year, indicating a solid operational efficiency trend. Net loss for the quarter stood at $3.2 million, stable at $0.05 per share, similar to Q3 2024.

As of September 30, 2025, total cash and equivalents amounted to $9.1 million, indicating a decline from $11.7 million at the end of Q2 2025. The net cash burn during the quarter was recorded at $2.6 million. With the recent amendment to the credit agreement with Avenue Capital Group, the company secured an additional $2.5 million in cash which is expected to bolster its financial position further.

Strategic Business Developments

The recent implementation of a strategic workforce and cost-reduction program is aimed at optimizing operations and accelerating the path to cash-flow breakeven, anticipated in Q1 2026. This initiative involves a workforce reduction of approximately 10% and realignment of production and operating costs, likely incurring an estimated charge of up to $900,000 in severance and restructuring costs.

Furthermore, the amended credit agreement allows for an extension of the interest-only payment period until December 31, 2026, ensuring financial stability while the company navigates through the challenges leading to FDA marketing approval for DrugSorb-ATR.

Progress Towards Regulatory Approval

On the regulatory front, CytoSorbents has taken significant steps for its DrugSorb™-ATR antithrombotic removal system. A new De Novo application has been planned to be submitted to the U.S. FDA in Q1 2026, following a formal meeting anticipated in late Q4 2025 or early Q1 2026. This application will include new real-world data demonstrating the device's effectiveness, which were not available during the initial review.

Dr. Phillip Chan, CEO of CytoSorbents, expressed satisfaction with the progress made in Q3 2025, highlighting the remarkable sales growth, operating improvement, and strides toward regulatory approval for DrugSorb-ATR. He emphasized the importance of maintaining financial flexibility to support the company's strategic initiatives moving forward.

Clinical Data and Future Directions

Recent publications and clinical data have underscored the positive impact of CytoSorb’s therapies globally. For instance, on September 10, 2025, a webinar hosted by Dr. Chan highlighted CytoSorb's role in managing sepsis and septic shock in critical care settings. Pairing CytoSorb with traditional therapies, the clinical insights presented affirm the technology's efficacy and its impact on improving patient outcomes.

CytoSorbents continues to be committed to expanding its clinical research and enhancing the functionality of its products. These developments not only bolster patient care in critical situations but also contribute significantly to defining the company’s strategic growth trajectory in the coming months and years.

As we look forward, CytoSorbents anticipates a robust response from the market and continued support from its shareholders as it strives to lead in blood purification technologies for high-risk health conditions. Stay tuned for further updates during the upcoming Q3 2025 earnings conference call scheduled for November 13, where more detailed discussions on future plans are expected.