MONMOUTH JUNCTION, N.J., Nov. 1, 2017 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using blood purification to treat life-threatening injury and infection in critically-ill and cardiac surgery patients around the world, announced the award of a Defense Health Agency Phase II Small Business Innovation Research (SBIR) contract managed by the U.S. Army Medical Research and Materiel Command (USAMRMC) to optimize new treatment approaches for severe hyperkalemia that do not require blood purification. This award, valued at a total of $999,871 over 29 months, follows the successful completion of the previously announced $150,000 Phase I SBIR for the program.
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 researchers at Travis Air Force Base and Oregon Health and Science University, the company is developing new approaches to treat severe hyperkalemia, which can be performed in the field by a trained medic, with limited materials and without electricity, and without the need for blood purification. The group has already demonstrated laboratory proof-of-concept of two new concepts, and will be evaluating the technologies in large animal models of severe hyperkalemia as part of the Phase II program.
Funding of this Phase II SBIR award is managed by the United States Army Medical Research and Materiel Command (USAMRMC), and supporting acquisition office, the U.S. Army Medical Research Acquisition Activity (USAMRAA) under Contract No. W81XWH-17-C-0142. The views, opinion and/or findings contained in this press release are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. In conducting research using animals, the investigator(s) adhered to the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and the principles set forth in the current version of the Guide of Care and Use of Laboratory Animals, National Research Council.
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 $21 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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