CytoSorbents Eyes US Market with Cardiac Device, Tightens Finances

PRINCETON, NJ – January 12, 2026 – CytoSorbents Corporation is navigating a pivotal year, balancing a disciplined push toward profitability with a high-stakes regulatory campaign to bring its innovative DrugSorb®-ATR device to the lucrative U.S. market. In a recent business update, the blood purification specialist announced steady preliminary financial results for 2025 alongside critical progress in its dialogue with the U.S. Food and Drug Administration (FDA), setting the stage for a potentially transformative 2026.

The company reported preliminary full-year 2025 revenue of approximately $37.0 million, a modest 4% increase over 2024. More significantly, it signaled strengthening operational efficiency with expected fourth-quarter gross margins climbing to a range of 73% to 75%, up from 71% in the prior-year period. This financial tightening coincides with major advancements for its investigational DrugSorb®-ATR system, a device designed to reduce severe bleeding complications in cardiac surgery patients taking the common blood thinner ticagrelor.

Charting a Path to the U.S. Market

The centerpiece of CytoSorbents' near-term growth strategy is the regulatory journey of DrugSorb®-ATR. The company confirmed it has scheduled a Pre-Submission Meeting with the FDA this month to align on the requirements for a new De Novo Application, which it anticipates filing by the end of the first quarter of 2026. A final regulatory decision is expected by mid-2026.

This device addresses a critical unmet need. Patients on ticagrelor (marketed as Brilinta®) who require urgent coronary artery bypass graft (CABG) surgery face a serious dilemma. Standard guidelines recommend waiting three to five days after the last dose to perform surgery, allowing the drug to naturally clear from the body to prevent life-threatening bleeding. This delay, however, can increase the risk of cardiac events and prolong hospital stays. DrugSorb®-ATR is designed to be used during surgery to actively filter ticagrelor from the blood, potentially allowing surgeons to operate sooner and more safely.

"We look forward to our scheduled Pre-Submission Meeting with the FDA later this month to discuss the additional information planned for inclusion in our upcoming De Novo filing," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. He noted that substantial new real-world data has become available since the initial submission, demonstrating lower rates of severe bleeding when the device is used. "We believe this new information is consistent with recent FDA guidance emphasizing the value of real-world evidence in supporting benefit-risk assessments for investigational devices and, when combined with our STAR-T results, further strengthen the overall evidence base for our upcoming submission."

Bolstering its case is the recent acceptance of the pivotal STAR-T study results for publication in a top-tier cardiac surgery journal. The STAR-T trial, a multi-center, randomized, and controlled study, was designed specifically to evaluate the device's ability to reduce bleeding complications. The forthcoming publication will provide the clinical community with peer-reviewed data on its efficacy and safety, a crucial step in building physician confidence and driving adoption if approved. The device has already received two FDA Breakthrough Device Designations, which are intended to expedite the review of technologies that could provide more effective treatment for life-threatening conditions.

A Strategic Pivot Towards Profitability

While pursuing this ambitious U.S. market entry, CytoSorbents has undertaken a significant internal restructuring to fortify its financial health. In the fourth quarter of 2025, the company implemented a strategic workforce and cost reduction program. The impact of these measures is expected to be swift, with the company projecting it will be approximately cash-flow breakeven, excluding one-time restructuring costs, in the first quarter of 2026.

This move follows earlier cost-control initiatives from 2024 and is supported by a recent amendment to its credit facility. In November 2025, the company secured an additional $2.5 million in cash and extended its interest-only payment period through the end of 2026. The agreement is cleverly structured to align with its regulatory goals, providing for another $2.5 million in cash and a further interest-only extension contingent upon FDA marketing approval for DrugSorb®-ATR.

These actions paint a picture of a management team focused on creating a sustainable operational model that can support its long-term innovation pipeline without being entirely dependent on dilutive financing. "We expect that these initiatives along with our recently implemented global strategic Workforce and Cost Reduction program will accelerate our path to profitability," Dr. Chan commented on the operational changes.

Global Footprint and Foundation for Growth

The company's pursuit of the U.S. market is built upon a solid foundation of international experience. Its flagship product, CytoSorb®, has now been used in over 300,000 treatments across more than 70 countries where it is approved. The device, which uses the same core polymer bead technology as DrugSorb®-ATR, is a versatile blood purification cartridge used in intensive care units to remove a broad range of inflammatory toxins and other harmful substances in conditions like sepsis, acute liver failure, and severe trauma.

This extensive real-world use outside the U.S. provides a deep well of safety and performance data for the underlying technology. In Europe, CytoSorb is already approved for the removal of ticagrelor and another blood thinner, rivaroxaban, during cardiac surgery. The company's primary revenue source remains product sales in Europe, particularly Germany, where it is now implementing process improvements to its commercial team to reignite growth.

As CytoSorbents prepares for investor meetings during the J.P. Morgan Healthcare Conference week, it presents a multifaceted story. It is a company with an established global product and a clear path to financial stability, while simultaneously standing on the cusp of potentially entering the world's largest medical device market with a solution for a pressing clinical problem in cardiac surgery.