CytoSorbents Gains Regulatory Approval for CytoSorb® in Taiwan

CytoSorbents, Inc., a prominent player in treating severe medical conditions in intensive care units and cardiac surgery, has secured regulatory approval for its CytoSorb® device in Taiwan. The Taiwan Food and Drug Administration (TFDA) has sanctioned CytoSorb® for the extracorporeal removal of cytokines, bilirubin, and myoglobin from patients' blood. Additionally, the device is approved for removing the antithrombotic drugs Brilinta® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Janssen/Bayer) during cardiothoracic surgeries to minimize perioperative bleeding. CytoSorb will be distributed in Taiwan by Hemoscien Corporation.

Bettina Sabisch, Vice President of International Distributor Sales at CytoSorbents, expressed excitement over this milestone, highlighting the arduous and complex approval process. She emphasized the significance of collaborating with Hemoscien and leveraging its established customer relationships in Taiwan to introduce CytoSorb® to patients in need.

Tom Juan, Managing Director of Hemoscien Corporation, stressed the critical need for effective therapies to combat infections and prevent organ failure. He believes that advanced blood purification devices like CytoSorb® can complement traditional pharmaceuticals by restoring balance in peripheral blood homeostasis. With the successful application of CytoSorb in various countries for treating critical illnesses, Juan is confident in their ability to market and support the device in Taiwan’s ICU sectors, ultimately saving lives.

CytoSorb® is not only approved in Taiwan but also in the European Union and distributed across 75 countries. It functions as an extracorporeal cytokine adsorber, significantly reducing “cytokine storm” in several critical illnesses, including sepsis, septic shock, trauma, acute respiratory distress syndrome, burn injuries, and pancreatitis. These conditions often lead to severe inflammation, organ failure, and death. As a liver support therapy, CytoSorb® helps manage acute liver diseases by removing liver toxins and cytokines. It is also effective in treating rhabdomyolysis and removing myoglobin. The device is used during cardiothoracic surgery to eliminate antithrombotic drugs and inflammatory mediators, thereby reducing postoperative complications such as severe bleeding and multiple organ failure. By March 31, 2024, more than 237,000 CytoSorb devices had been utilized globally.

Taiwan, with its population of around 24 million, provides universal healthcare through its National Health Insurance System, supported by nearly 400 medical centers and regional hospitals. The country is known for its progressive healthcare system, characterized by high medical standards, advanced technology, and quality care. Critical illnesses, including sepsis, remain significant challenges in Taiwan. For instance, there are approximately 150,000 new sepsis cases annually, with mortality rates as high as 30%, primarily due to diseases like pneumonia, the third leading cause of death in Taiwan.

Hemoscien Corporation, established in 2008 as a spinoff from Smile Group Corp., specializes in hemo-epuration services. With a strong partnership with Infomed S.A. since 1998, Hemoscien has captured over 50% market share in ICU hemo-therapy. The company is committed to addressing unmet medical needs in ICU care and advancing regenerative medicine and immune therapies.

CytoSorbents Corporation, headquartered in Princeton, New Jersey, is at the forefront of treating life-threatening conditions in intensive care and cardiac surgery through blood purification. CytoSorb, the company’s flagship product, was initially launched in the European Union and has since received FDA Emergency Use Authorization in the U.S. for adult COVID-19 patients with severe respiratory failure. The company’s unique blood purification technologies are supported by extensive funding and are protected by numerous patents. CytoSorbents continues to develop and market products based on its innovative polymer adsorption technology.