MONMOUTH JUNCTION, N.J., Dec. 21, 2015 - CytoSorbents Corporation (CTSO), a leader in critical care immunotherapy commercializing its CytoSorb® extracorporeal cytokine adsorber to control deadly inflammation using blood purification, issued an update via Form 8-K on Friday, December 18, 2015 concerning its most recent discussion with representatives from both the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) branches of the FDA about the Company's Expedited Access Pathway (EAP) application. In this discussion, the FDA indicated that 28-day all-cause mortality would be the appropriate primary endpoint regarding CytoSorb and the treatment of sepsis. CDER noted that historically, in many other sepsis trials unrelated to CytoSorb, there has been a lack of utility or correlation in surrogate endpoints when predicting mortality improvement in sepsis outcomes. Given this feedback, the Company concluded there would be no significant time or cost advantage associated with pursuing the EAP designation for CytoSorb for the treatment of sepsis, and that a traditional IDE trial followed by a PMA application as originally planned by the Company is the preferable route to seek approval of CytoSorb for treatment of sepsis that would potentially also not require a post-market efficacy study required by the EAP. The FDA has offered to assist the Company with evaluation of its sepsis clinical trial design once submitted under a formal IDE.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "Based upon the criteria of the EAP program, we believed that it was possible to obtain EAP designation for CytoSorb® and pursue a registration trial using surrogate endpoints, rather than 28-day all-cause mortality – an endpoint that no sepsis treatment has been able to achieve in pivotal trials - for early market approval. We are obviously disappointed that this was not the case."
Dr. Chan continued, "However, based upon our positive clinical experience and the significant international research being conducted on CytoSorb® today, we continue to believe that CytoSorb® blood purification is one of the most promising treatments for sepsis. Unlike previous treatment attempts by other companies, CytoSorb® attacks sepsis from many different angles, such as a reduction of excessive pro-inflammatory cytokines and inflammatory mediators, a reduction in many pathogenic toxins, a stabilization of various key organ parameters such as hemodynamics, and a re-direction of the immune response to prevent cell-mediated injury of vital organs. We strongly believe the effectiveness of this broad approach is one of the reasons CytoSorb® adoption and usage in sepsis continues to grow."
Dr. Chan concluded, "CytoSorb® has been credited with successfully saving the lives of many patients all over the world. We remain committed to moving forward with our U.S. clinical program in sepsis under the traditional IDE pathway and appreciate the FDA's offer to review our future plans. In doing so, we hope to stem the tide of one of the top ten causes of death in the United States for which no approved therapy currently exists."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a commercial-stage, critical care focused immunotherapy company using its CytoSorb® blood purification technology to control severe, deadly inflammation -- with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome.
CytoSorb® is approved in the European Union with distribution in 32 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used safely in more than 8,000 human treatments to date.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company's websites: http://www.cytosorbents.com and http://www.cytosorb.com
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