MONMOUTH JUNCTION, N.J., May 11, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader commercializing its CytoSorb® and other blood purification technologies to treat deadly conditions in critically-ill and cardiac surgery patients around the world, announced the U.S Army Medical Research and Development Command has awarded CytoSorbents a Defense Health Agency (DHA) Sequential Phase II Small Business Innovation Research (SBIR) contract, valued at $1,499,987 over 28 months, to advance development of the K+ontrol™ platform for the treatment of severe hyperkalemia induced by traumatic injury and acute kidney injury in austere medicine. This follows the successful completion of the previously announced Phase I and Phase II SBIR programs for this application, totaling approximately $1.15 million in previous contract funding.
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “We greatly appreciate the continued support of the Defense Health Agency and U.S. Army of our innovative sorbent treatments for life-threatening hyperkalemia in severe trauma patients. Together with our collaborators, we have made excellent progress in developing potassium-lowering therapies that can be implemented by a medic without electricity, and have the potential to save lives in many scenarios where standard dialysis is not possible. We look forward to advancing these technologies to clinical usage to help our wounded warfighters and other mass casualty trauma victims.”
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.
This Defense Health Agency Sequential Phase II SBIR contract is administered by the United States Army Medical Research and Development Command (USAMRDC), and supporting acquisition office, the U.S. Army Medical Research Acquisition Activity (USAMRAA) under Contract No. W81XWH21C0045. 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.
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 67 countries outside of the US, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death may be 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. CytoSorb® has been used in more than 131,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), 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 ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, DrugSorb™, ContrastSorb, 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 9, 2021, 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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