CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase II: A18-062

Description

The U.S. Army seeks to develop a novel systemic therapy for out-of-hospital management of combat-associated, non-compressible traumatic hemorrhage starting at the point-of-injury through en route care. Critical Innovations, Cayuga Biotech, Charles River, and consultants Captain David Tanen MD, FAAEM, FACMT (USN, Ret.), former Commander Denise Whitfield, MD, FACEP, and William David McGuinn, Jr., M.S., Ph.D., D.A.B.T have formed a team of medical development experts to address this important medical need. During this Phase II project, the team will develop chemistry, manufacturing, and control (CMC) to produce cGMP-compliant Nanostasis™ pilot lots; prepare regulatory and quality compliance materials to support a subsequent Nanostasis™ IND application; and, perform an initial Nanostasis™ GLP toxicology study in an appropriate live animal model. The result of this Phase II project will be having completed at least one Nanostasis™ GLP toxicology study in an appropriate live animal model (TRL 5), which will provide supporting data for a subsequent IND application toward initiation of human trials.