MONMOUTH JUNCTION, N.J., Oct. 22, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the U.S. Air Force Materiel Command has awarded the Company a two-year contract valued at up to $2,959,747 as part of the Rapid Innovation Fund (RIF) to advance its program, entitled "K+ontrol Renal Support System for Reduction of Hyperkalemia," towards a U.S. clinical trial designed to support U.S. FDA regulatory approval.
Severe hyperkalemia, or dangerously high potassium levels in the blood, is a serious complication of trauma, crush injury, and prolonged limb ischemia. It is particularly relevant in military trauma, afflicting approximately 6% of U.S. combat casualties in the wars in Iraq and Afghanistan. Severe hyperkalemia can be rapidly fatal due to dangerous heart arrhythmias and sudden cardiac death in up to 65% of cases if not treated quickly. Dialysis is the standard of care therapy for severe hyperkalemia but is too complex and resource intensive to be practical for far-forward Role 1 and 2 medical care. Under a prior U.S. Army Small Business Innovation Research (SBIR) Phase II Enhancement award of approximately $0.5 million, CytoSorbents collaborated with leading researchers at Travis Air Force Base to develop a simple blood purification system to treat hyperkalemia. This system combined CytoSorbents' proprietary K+ontrol potassium sorbent with existing standard medical equipment. The collaborative research team successfully demonstrated the efficacy of this system in a porcine model of hyperkalemia. The current RIF award is designed to facilitate the scale-up and transition of the technology to human clinical studies.
Mr. Vincent Capponi, MS, Chief Operating Officer of CytoSorbents, stated, "The development of a simple, easy-to-use renal support system to treat severe hyperkalemia is a major milestone in our collaboration with the U.S. Army and Air Force. This new $3 million RIF award will allow us to further refine and optimize the technology for human treatment, and advance the technology towards human clinical trials and potential FDA approval. Our goal is to meet the special needs of our warfighters and civilians in mass casualty situations, and to help reduce preventable deaths."
Dr. Thomas Golobish, PhD, Senior Director of Polymer Development added, "We are excited to take this next major step in the development of the K+ontrol Renal Support System. A tremendous amount of effort and innovation has gone into the current prototype, and we look forward to working with our collaborators at Travis Air Force base to finalize a robust and integrated design that can be set-up quickly with minimal effort."
This Rapid Innovation Fund Award will be funded by the U.S. Air Force Materiel Command under Award No. HQ0034-18-BAA-RIF-0001. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the U.S. Air Force and the Department of Defense. The K+ontrol adsorber is not yet approved in the U.S. or elsewhere.
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 approximately $29 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.
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.
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