Phase II year
2020
(last award dollars: 2022)
Phase II Amount
$2,750,000
The Defense Health Agency seeks to develop a novel field-expedient, antimicrobial, anti-biofilm, hydrogel wound dressing for acute care of large burn wounds for use at the point of injury, thru medical evacuation, and during prolonged field care. Critical Innovations, KARA & Associates, the Ross Lab at OHSU, and Toxikon, with consultants Captain David Tanen, MD, FAAEM, FACMT (USN, Rt.) and former Commander Denise Whitfield, MD, FACEP (USN), have formed at team of medical device experts to address this important medical need. During this Direct to Phase II project, our objectives will be to further advance the innovative Succor product. This will include 1) On-boarding program requirements, goals, and schedule; 2) Selecting final Succor formulation; 3) Readying device for large-scale manufacture; 4) Performing GLP biocompatibility, cytotoxicity, and immunogenicity testing; 5) Conducting proof-of-concept evaluation of Succor compared to current standard-of-care in an appropriate combat-relevant, large-animal severe burn model; and, 6) Maintaining all regulatory compliance requirements and preparing for upcoming regulatory and transition hurdles (TRL 6).
