Honored with Frost & Sullivan’s Global Product Leadership Award for leading the critical-care immunotherapy segment in blood purification, CytoSorbents Corporation is currently distributing its EU-approved CytoSorb cytokine adsorber in 75 countries around the world.  CytoSorb® is helping to treat life-threatening conditions in the intensive care unit and cardiac surgery.  One major application is the reduction of cytokine storm, with the goal of reducing severe inflammation and serious complications such as organ failure—the leading cause of death in the ICU today, while improving patient outcomes and reducing overall costs of critical care.  Another newer application is the reduction of antithrombotic agents, often called “blood thinners,” during open heart surgery, with the goal of reducing unwanted perioperative bleeding.

“There were many factors that led to our selection of CytoSorb® for the Global Product Leadership Award,” said Frost & Sullivan Research Analyst Aish Vivek. “Among the most important was the recognition that this innovative product is surprisingly well-positioned to help solve two long-standing, difficult, and tightly linked fundamental problems with hospital medicine today. These include the high rates of death from common critical illnesses such as sepsis that have no approved treatment, and the resulting staggering costs and losses in critical care that are financially crippling hospital networks and healthcare systems throughout the world.”

Analyst Vivek continued, “Further strengthening CytoSorb’s position is the scarcity of viable competition in the lucrative and vast global critical care and cardiac surgery markets, the strong physician usage and revenue growth, and the external validation from well-respected industry partners, such as Fresenius Medical Care and Terumo Cardiovascular, and government funding agencies. As a high margin, single-use product that works with existing blood pumps in hospitals, CytoSorb® also has an attractive business model that is expected to drive early and significant profitability of the company.”

As CytoSorbents expands its footprint worldwide, it is also pursuing U.S. and Health Canada approval of its technologies through two similar clinical trials in cardiac surgery.  The first is the pivotal U.S. and Canadian STAR-T trial, under the auspices of FDA Breakthrough Designation, to remove the blockbuster drug, ticagrelor (Brilinta®), and perioperative bleeding risk, during urgent and emergent cardiothoracic surgery. This trial completed in August 2023, with topline data expected by the end of 2023. If positive, the Company plans to submit for U.S. FDA and Health Canada approval for DrugSorb-ATR for this indication shortly thereafter. The second is the pivotal STAR-D trial, also under the auspices of a second FDA Breakthrough Designation, to remove the blockbuster drugs, Eliquis® and Xarelto®, during open heart surgery as well. This trial was paused to complete the STAR-T trial, but is expected to resume in the near future. The total addressable market in the U.S. and Canada for DrugSorb-ATR for these indications is estimated to exceed $1 billion.

CytoSorbents aims to be in the elite company of fast growing medical device companies, with rapid growth fueled by CytoSorb and potentially DrugSorb-ATR, industry leading product gross margins in excess of 80%, and GAAP profitability in the near future, with a ground-breaking therapy that can help to save lives.

CytoSorbents is covered by 6 analysts from Cowen & Co., Jefferies, H.C. Wainwright, B. Riley, Dawson James, and Zacks. The Company is led by an experienced and capable management team focused on growth and increasing shareholder value.

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