The latter is an involved surgery where blood flow to the body, with the exception of the brain, is completely stopped for up to 45 minutes while the body is rapidly cooled to lower metabolism and oxygen usage.
| MONMOUTH JUNCTION, N.J., Aug. 28, 2019 /PRNewswire/ -- CytoSorbents, Inc. (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, highlights recent published studies on CytoSorb in multiple applications.
Improvements in Hemodynamic Stability during Cardiac Surgery The company-sponsored U.S. REFRESH 2-AKI pivotal study, designed to support U.S. FDA approval of CytoSorb, is evaluating the intraoperative use of CytoSorb to reduce the severity or incidence of acute kidney injury following complex cardiac surgery including valve replacement surgery and aortic reconstructive surgery with hypothermic cardiac arrest (HCA). The latter is an involved surgery where blood flow to the body, with the exception of the brain, is completely stopped for up to 45 minutes while the body is rapidly cooled to lower metabolism and oxygen usage. This procedure, and the restoration of oxygenated blood flow to the body, often results in a systemic inflammatory response that can lead to intraoperative and postoperative hemodynamic instability that can complicate the surgery and lead to negative outcomes. A large, single center, retrospective study was recently published in 336 patients who had undergone aortic surgery involving hypothermic circulatory arrest (HCA) entitled, “Haemadsorption improves intraoperative haemodynamics and metabolic changes during aortic surgery with hypothermic circulatory arrest”. In the study, 168 patients with CytoSorb hemoadsorption used intraoperatively during cardiopulmonary bypass were matched by propensity score to 168 patients receiving standard therapy without CytoSorb (control). The use of CytoSorb significantly reduced the requirement for artificial blood pressure support using vasopressors (p=0.043), with a more stable acid-base balance and lower lactate levels throughout the procedure. CytoSorb use also significantly decreased the need for transfusion of packed red blood cells (p=0.021) and fresh frozen plasma (p=0.001), but increased the use of prothrombin complex concentrate (p=0.004). A trend to improved 30-day mortality (CytoSorb: 4.8%; Control: 8.8%) was observed but not statistically significant. The authors concluded that the use of CytoSorb in the setting of acute aortic surgery with HCA significantly reduces the need for vasopressors, the amount of transfusion, and improves acid-based balance. Improvements in microcirculation in septic shock Achievement of adequate systemic blood pressure is essential to maintain oxygen delivery and blood flow to vital organs to reduce the risk of organ failure in life-threatening illnesses such as sepsis. In multiple studies, in many different applications, CytoSorb has been used to help stabilize blood pressure and wean patients off of artificial blood pressure support using vasopressors. In addition to maintaining systemic blood pressure, there is an expanding understanding that microcirculation, or blood flow through the fine network of blood vessels that feed individual cells of the organ, is often severely compromised in critical illness, and that restoration of microcirculation is important to maintain or improve organ function. Another piece to the puzzle of how CytoSorb works has been uncovered in one of the first published, prospective, observational pilot studies to evaluate microcirculation in sepsis patients entitled, “Changes in cytokines, haemodynamics and microcirculation in patients with sepsis/septic shock undergoing continuous renal replacement therapy and blood purification with CytoSorb”. Researchers used advanced videomicroscopy techniques in nine patients with sepsis or septic shock in kidney failure on renal replacement therapy treated with CytoSorb to demonstrate a significant increase in the number and density of small vessels with blood flow (p<0.01). This key improvement in microcirculation was associated with a significant improvement in a composite index of global organ function called the Sequential Organ Failure Assessment (SOFA) score (12±3 to 10±1 at 24 hours, p=0.039), and a significant decrease in the cytokine, IL-8, after 24 hours of treatment (p<0.05 versus at 6 hours). Future studies using more than one 24-hour CytoSorb treatment are planned. HLH Guideline Recommendations Hemophagocytic lymphohistiocytosis (HLH) is a deadly and severe hyperinflammatory syndrome that is caused by an overactivation of immune cells. It typically manifests with a sepsis-like syndrome with high fever and rapidly progressive organ failure in the context of a very high cytokine storm and levels of inflammatory biomarkers such as ferritin. The presentation of inherited primary HLH, and secondary HLH triggered by infection or malignancy, is virtually indistinguishable from cytokine release syndrome (CRS) seen in CAR T-cell and other cancer immunotherapies, and macrophage activating syndrome in autoimmune diseases. In the report, “Recommendations for the management of hemophagocytic lymphohistiocytosis in adults”, current members of the working group “HLH in Adults” of the Histiocyte Society published guideline recommendations based on expert opinion supported by the best available evidence from studies supporting the individual statements on the treatment of HLH. Citing specific case evidence on the CytoSorb extracorporeal cytokine adsorber in the guidelines on salvage treatment of relapsed and refractory HLH, authors state, “the use of cytokine adsorption columns may aid in rescuing critically ill patients from a deleterious cytokine storm.” This represents one of the first examples of CytoSorb being included into medical practice guidelines. Summary Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “The body of published evidence on the use of CytoSorb in life-threatening illnesses in critical care and cardiac surgery continues to grow. These conditions are often so physiologically complex with such high variability between patients, that despite decades of clinical studies by other companies that have failed, they have defied treatment. Because of this, one in three patients will often die, despite the best supportive medical care, and those that survive are often dead or back in the hospital in the following year. The expanding library of approximately 125 different published papers by independent researchers using CytoSorb continues to highlight the benefit to patients, and that the broad-spectrum activity of CytoSorb is uniquely different. We remain committed to conducting the clinical studies that will make CytoSorb a standard of care in many different applications worldwide.” 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 58 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 reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting 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 67,000 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 $26 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 blood purification technology protected by many issued U.S. and international patents and multiple applications pending, 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. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 7, 2019, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and Twitter Cytosorbents Contact: Investor Relations Contact: U.S. Public Relations Contact:
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