PRINCETON, N.J., Sept. 9, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the U.S. Army Medical Research Acquisition Activity, with funding from the Combat Casualty Care Research Program, awarded the Company a two-year grant (W81XWH-22-1-0235) valued at $1,977,024 to optimize development of the HemoDefend-BGA™ adsorber to a fully-finished, commercial device that will be evaluated in a pre-clinical porcine study for safety and efficacy. This Combat Casualty Care Research Program-funded research is a direct follow on to earlier development work funded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs.
The HemoDefend-BGA adsorber can rapidly remove >99% of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
Dr. Maryann Gruda, Principal Investigator and Senior Director of Biology at CytoSorbents stated, “This funding from the U.S. Army will be used to complete the development of our anti-A and anti-B blood group antibody reduction technology. Through prior awards, we have worked to optimize the efficiency, robustness, and form factor of our HemoDefend-BGA adsorber, and look forward to taking what we believe is a transformative technology into large animal testing, where we will evaluate the safety and efficacy of universal plasma generated by HemoDefend-BGA. We are excited to begin this portion of the development program.”
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents indicated, “Our HemoDefend-BGA program has the potential to address a global need for universal plasma in both civilian and combat casualty care. This priority initiative continues to advance, benefitting from more than $11M in government contracts. Once the pre-clinical study and requisite benchtop testing are successfully completed, we plan to file a U.S. FDA pre-submission package to pursue human clinical trials with the goal of bringing this life-saving technology to the market.”
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This award was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the U.S. Department of Defense (DoD), through the DoD Defense Health Program (DHP), Congressionally Directed Medical Research Programs (CDMRP), Defense Medical Research and Development Program, Joint Program Committee 6 Combat Casualty Care Research Program (CCCRP/JPC-6), Battlefield Resuscitation for Immediate Stabilization of Combat Casualties (BRISCC), in the amount of $1,977,024 under Award No. W81XWH-22-1-0235. The award is expected to optimize development of the HemoDefend-BGA adsorber via a preclinical animal study to evaluate safety and efficacy entitled “Demonstration of the Safety and Efficacy of Field-Ready Blood Group Antibody (BGA) Adsorber in a Porcine Universal Transfusion Model.” The content of this press release is solely the responsibility of the authors and any opinions, interpretations, conclusions, or recommendations expressed in this material are those of the author(s) and are not necessarily endorsed by the Department of Defense.
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company’s technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the 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 marketed and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, 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, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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