MONMOUTH JUNCTION, N.J., Sept. 5, 2017 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to prevent or treat deadly inflammation and organ failure in critically-ill and cardiac surgery patients around the world, announced the key results of three posters, accepted and presented last week in Orlando, Florida at the Military Health System Research Symposium (MHSRS), the premier U.S. scientific meeting focused on medical advances that address the unique medical needs of the warfighter.
- CytoSorb®: Traumatic Brain Injury (TBI) and Hemorrhagic Shock: Traumatic brain injury and severe blood loss leading to shock are two of the leading individual causes of death in combat and civilian trauma. The combination of these two injuries are very common, dramatically increasing the risk of death and long-term disability in survivors. In collaboration with Drs. Todd McKinley and Richard Rogers at the Indiana University Health System, CytoSorb blood purification was administered following direct cortical impact to the brain, an hour of hemorrhagic shock, and subsequent resuscitation in a rat trauma model. Treatment led to a reduction in a panel of key inflammatory cytokines during the treatment period that persisted for three days following the injury. More importantly, CytoSorb treatment resulted in more than a doubling of survival, from 41% in the sham treated group (N=17), to 86% survival in the CytoSorb treated group (N=14), that was highly statistically significant, p<0.01. These data have opened up an entirely new treatment strategy using CytoSorb for these life-threatening conditions which today have few therapeutic options.
- K+ontrol™: Crush Injury and Hyperkalemia: Trauma and crush injury to soft tissue can lead to rapid cell death and the release of a flood of intracellular potassium into the bloodstream. In compromised patients, very high levels of potassium in the blood, or severe hyperkalemia, can lead to dangerously irregular heartbeats called arrhythmias, and sudden cardiac death. This is particularly common in combat casualties, everyday civilian trauma, and mass casualty events such as earthquakes and terrorist bombings. Normally, hemodialysis is the definitive therapy to treat hyperkalemia. However in remote locations, during prolonged field care in combat, in areas that lack modern medical facilities, or in situations where the numbers of victims outstrip available dialysis equipment and supplies, there is a major need for simple, but effective ways to rapidly treat severe hyperkalemia. In collaboration with Dr. Ian Stewart from Travis Air Force Base, and Dr. James Ross at Oregon Health and Science University, the company has successfully developed a new blood purification approach to treat hyperkalemia that does not require dialysate or extra fluids. In a porcine model of severe hyperkalemia, where the pigs had no kidney function and potassium was infused intravenously at a constant rate to mimic crush injury, the new system was able to reduce potassium from severe hyperkalemia levels of approximately 7.9-8.5 mEq/L seen in the control animals, where several animals developed spontaneous near fatal cardiac arrhythmias, to a more normal to mild hyperkalemia range of 4.0-5.6 mEq/L that was sustained over 6 hours. The ability to simplify treatment and eliminate dialysate and replacement fluids removes an enormous logistical burden for military operations.
In addition, the company showcased another system to treat severe hyperkalemia that does not rely on blood purification at all, but instead uses a modified version of peritoneal dialysis which is widely used throughout the world to treat kidney failure patients. Peritoneal dialysis involves putting fluid into the abdominal cavity via a catheter, and utilizes the high surface area of the intestinal organs and abdominal wall as a natural dialysis membrane. Substances, such as potassium, ammonia, urea, and other toxins, flow from the blood, across this membrane, and into the fluid. Then the fluid is periodically drained and replaced. The new system uses our potassium binding sorbent to continuously bind and reduce potassium in the fluid (and indirectly from blood) without needing to replace the fluid. This is a system that can be implemented easily by medics or medically competent personnel in the field, requires no significant equipment, hardware, or electricity, and can be used in remote or mass casualty situations.
- HemoDefend™: Fresh Whole Blood and Universal Plasma Transfusion: Fresh whole blood (FWB) is considered by most military healthcare experts to be superior to blood component transfusions, such as packed red blood cells, in terms of its ability to restore blood volume and to stop bleeding in trauma. An additional advantage of FWB is that it can be directly given by a “walking donor” to the victim at the site of the accident, without the normal logistics and supply chain issues of refrigerated blood. Freeze-dried plasma is another important tool used to resuscitate trauma victims that can be easily carried without the need to refrigerate it. However, the presence of anti-A and anti-B blood group antibodies in both FWB and plasma can lead to dangerous transfusion reactions, therefore requiring very stringent blood-type and antibody level testing. The company highlighted data from the development of new sorbents under the HemoDefend™ brand that are capable of reducing these antibodies from both fresh whole blood and plasma in an ongoing R&D program.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to advance our CytoSorb®, HemoDefend®, and K+ontrol platforms for the treatment of traumatic brain injury, shock from severe blood loss, and severe hyperkalemia from massive trauma. These are life-threatening conditions that have killed and continue to kill both civilians and military servicemembers of our country and allies, and represent new markets where we can help to potentially save lives. We are grateful for the funding support that has helped us to rapidly and successfully develop these new therapies with our collaborators and are committed to translating these exciting advances from animal models to the bedside as quickly as possible.”
Funding of the traumatic brain injury and shock program was funded by an intramural grant from the Indiana Clinical and Translational Science Institute at the Indiana University Health System. Funding of the hyperkalemia program is managed by USAMRMC through the DOD SBIR program, under Contract No. W81XWH-12-C-0038, and a Defense Health Agency SBIR Phase I Contract No. W81XWH-16-C-0080. Funding of the Fresh Whole Blood program is under a Phase II SBIR contract from National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, and U.S. Special Operations Command (USSOCOM) under Contract No. HHSN268201600006C. Funding of the Universal Plasma program is being funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA), U.S. Army Medical Research and Materiel Command (USAMRMC), Fort Detrick, MD 21702 under contract W81XWH-17-C-0053. The views expressed herein are those of the authors and do not necessarily reflect the official policy or position of the U.S. Government, the Department of Defense, the Departments of the Army and Air Force, or the named individual institutions. CytoSorb is approved in the European Union, but not yet approved in the U.S. HemoDefend and K+ontrol are under advanced development.
The MHSRS is the Department of Defense’s premier scientific meeting. It provides a venue for presenting new scientific knowledge resulting from military-unique research and development. The MHSRS is the only military or civilian meeting that focuses specifically on the unique medical needs of the Warfighter.
The MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Medical Simulation and Information Sciences, and Military Infectious Disease.
The MHSRS is an annual four-day educational symposium that draws approximately 2,300 attendees. For more information, visit the MHSRS website.
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 44 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. 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. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety and efficacy of free hemoglobin reduction with intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the Company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 27,000 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 approximately $20 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 32 issued U.S. 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, and follow us on Facebook and Twitter.
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 3, 2017, 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.
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