CytoSorbents Enrolls First Patient into Pivotal U.S. REFRESH 2-AKI Trial Using CytoSorb® During Complex Cardiac Surgery
MONMOUTH JUNCTION, N.J., April 24, 2018 — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced first patient enrollment into the pivotal U.S. REFRESH 2-AKI trial. Focused on patients undergoing complex cardiac surgery, the REFRESH 2-AKI trial is designed to evaluate the safety and efficacy of intraoperative CytoSorb use to reduce post-operative acute kidney injury (AKI), the primary endpoint of the study.
Dr. Eric Mortensen, Chief Medical Officer of CytoSorbents stated, "Achievement of the first patient enrolled is an important milestone that has occurred in parallel with the rapid expansion of our clinical operations team and final FDA Investigational Device Exemption (IDE) approval of the study. We anticipate an acceleration in the pace of the trial, with a key focus on enrollment, study execution, and onboarding new sites to our program."
Dr. Mortensen continued, "Postoperative AKI remains a common adverse event following cardiac surgery that has significant long-term health and cost consequences. It is associated with increased hospitalization, progression to chronic kidney disease requiring dialysis, and higher post-surgical mortality. At present, there are no approved therapies to reduce the incidence or severity of AKI in high risk cardiac surgery patients. We believe that intraoperative CytoSorb use has the potential to reduce factors that cause either direct and indirect kidney injury. If successful, we believe the data from the pivotal REFRESH 2-AKI trial will provide the efficacy, safety, and cost-effectiveness data to support FDA approval, reimbursement, and adoption here in the U.S. and abroad."
The REFRESH 2-AKI trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy to reduce AKI, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery. The trial will enroll up to 400 patients undergoing elective, non-emergent open-heart surgery for either valve replacement, or aortic reconstruction with hypothermic cardiac arrest. Control patients will receive standard of care during surgery, while Treatment patients will receive standard of care with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit that are intended to reduce toxic inflammatory mediators and renal toxins such as plasma free hemoglobin and activated complement, during surgery. Other secondary and exploratory endpoints include time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators, and mortality at 30 days, for example. A synopsis of the trial protocol is available at www.clinicaltrials.gov.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 45 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. 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 that can lead to post-operative complications, including multiple organ failure. CytoSorbents recently initiated its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 35,000 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. Its technologies have received non-dilutive grant, contract, and other funding of nearly $22 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique patented blood purification technology including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.