The U.S. Department of Defense granted Monmouth Junction, New Jersey-based CytoSorbents Corporation a $4,421,487 three-year contract to complete preclinical development of its HemoDefend-BGA plasma and whole blood adsorber.
The U.S. Department of Defense granted Monmouth Junction, New Jersey-based CytoSorbents Corporation a $4,421,487 three-year contract to complete preclinical development of its HemoDefend-BGA plasma and whole blood adsorber. This filter is designed to allow a “universal plasma” that can be given to anyone no matter their blood type. It essentially removes the anti-A and anti-B antibodies from the blood, basically making the blood “O” type, which can be given to anyone.
This grant is in addition to a previous $2,897,172 contract awarded by the Defense Health Agency Small Business Technology Transfer (STTR) Phase III award. The new award will be used for preclinical development, including final device design, device verification and validation testing, biocompatibility, and sterilization validation testing, to develop quality controls and to build clinical inventory.
The hope is to get the device to a point where the company can obtain investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to advance into clinical studies.
“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,” said Maryann Gruda, Principal Investigator and Director of Biology of CytoSorbents. “We believe the BGA adsorber will have a momentous impact on the availability of universal plasma and low tier O whole blood (LTOWB) to prevent unnecessary loss of warfighter and civilian life.”
CytoSorbents lead product is CytoSorb, which is approved in Europe and distributed to 65 countries globally. It is an extracorporeal cytokine adsorber that decreases the cytokine storm seen in severe inflammatory diseases, including COVID-19. It has received emergency use authorization (EUA) in the U.S. for critically-ill COVID-19 patients with imminent or confirmed respiratory failure. It has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. In other countries, it received CE-Mark label expansions for the removal of bilirubin in liver disease, myoglobin in trauma, and both ticagrelor and rivaroxaban during cardiothoracic surgery.
To date, the company has received more than $37 million in funding from the U.S. Defense Advanced Research Projects Agency (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 (HHS) and others.
On July 22, the company announced the pricing of its underwritten public offering of 5,263,158 shares of common stock at $9.50 per share, with a target of raising $50 million.
Philip Chan, chief executive officer of CytoSorbents, of the new contract, stated, “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.”
