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News Release - July 31, 2020
CytoSorbents Awarded $4.4 Million Contract by the U.S. Department of Defense to Complete HemoDefend-BGA Adsorber Preclinical DevelopmentMONMOUTH JUNCTION, N.J., July 31, 2020 -- (Healthcare Sales & Marketing Network) -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the Assistant Secretary of Defense for Health Affairs, endorsed by the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP), has awarded the Company a three-year contract valued at up to $4,421,487 as part of a Peer Reviewed Medical Research Program Technology/Therapeutic Development Award to complete preclinical development of the HemoDefend™-BGA plasma and whole blood adsorber. The HemoDefend-BGA filter is designed to enable "universal plasma", or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products.
This award augments the previously awarded Defense Health Agency Small Business Technology Transfer (STTR) Phase 3 contract of $2,897,172. Funds provided by the CDMRP award will be allocated to complete preclinical development (e.g. final device design, device verification and validation testing, biocompatibility, and sterilization validation testing), establishment of quality documentation in conformity with CytoSorbents' certificated, full quality management and quality assurance system, and building clinical inventory. The goal of the program is to obtain investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to move forward with clinical studies.
Dr. Maryann Gruda, PhD, Principal Investigator and Director of Biology of CytoSorbents stated, "We are grateful for the U.S. Army's strong support and funding of our HemoDefend-BGA technology, which will help us advance it more rapidly to commercialization. We believe the BGA adsorber will have a momentous impact on the availability of universal plasma and low titer O whole blood (LTOWB) to prevent unnecessary loss of warfighter and civilian life."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents, "Hemorrhage from battlefield injuries and civilian trauma is a leading cause of preventable death. The broader availability of safe blood products that can help resuscitate patients is a key to survival. Our goal is to leverage this new award to rapidly bring the HemoDefend-BGA anti-A and anti-B adsorber to the markets globally to help save lives."
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. The U.S. Army Medical Research Acquisition Activity (USMRAA), 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office for this Award (No. W81XWH2010712). This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Material Command (USAMRMC).
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. Army and the Department of Defense.
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 65 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® has been used in more than 98,000 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 U.S. 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 $37 million from DARPA, the Defense Health Agency, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC), the U.S. Department of Health and Human Services, 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, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. 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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