CytoSorbents (CTSO.Q) has been awarded a three-year contract valued at $4,421,487 to complete a preclinical development of the HemoDefend plasma and whole blood adsorber by the assistant Secretary of Defence for Health Affairs, according to a press release.
The HemoDefend filter’s purpose is to enable plasma that can be universally administered to anyone regardless of blood type, and improve the safety of whole blood transfusions, by the removal of anti-A and anti-B antibodies.
“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,” said Dr. Phillip Chan, MD, PhD, and chief executive officer of CytoSorbents
The reward changes the previous awarded Defense Health Agency Small Business Technology Transfer (STTR) Phase 3 contract of $2,897,172. The funds will be used to complete preclinical development, consisting of final device design and verification, and validation testing, biocompatibability and sterilization validation testing. It will also be used to establishing quality documentation with CytoSorbents’ certified, quality management and quality assurance system, and building clinical inventory. The program’s overall goal is acquiring investigational drug exemption (IDE) approval from the U.S. Food and Drug Administration so they can move forward with 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. 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,” said Dr. Maryann Gruda, PhD, principal investigator and director of biology of CytoSorbents.