CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase I: 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, NeoMatRx, KARA & Associates, and Captain David Tanen MD, FAAEM, FACMT (USN, Ret.) have formed a team of medical development experts to address this important medical need. During this Phase I Base project, the team will identify functional and discriminatory program requirements and specifications, along with success criteria; perform additional laboratory studies to ensure that Nanostasis™ overcomes the challenges unique to the combat environment; produce a clear plan for practical deployment in the far-forward operational environment; and, produce a formal regulatory advisory letter. During the Phase I option, the team will additionally develop a quality systems plan for Nanostasis™ manufacturing and production and initiate the process for early pre-submission guidance from the FDA. The result of the Phase I project will be a clear plan for practical deployment in the far-forward operational environment, with emphasis on challenges unique to military medicine. In Phase II and beyond, the team will perform the additional preclinical and clinical research necessary to achieve FDA approval and drive the technology into full commercial sales.