CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase II: A20-137

Description

The Army seeks to develop a technology that prevents infected and traumatized combat wounds on service members from becoming septic during extended tactical operations in austere environments. Critical Innovations and subcontractors NDA Partners and Military & Health Research Foundation (MHRF), with consultants Captain David Tanen MD, FAAEM, FACMT (USN, Ret.), former Commander Denise Whitfield, MD, FACEP (USN), Dr. Gary Fong, PharmD, BCPS, BCIDP, and Dr. Loren Miller, MD, MPH, have formed a team of medical device experts to address this important medical need. During this Phase II project, our objectives will be to further advance the innovative Succor™ Combat Foam for Advanced Wound Care of Traumatized Tissue. This will include: 1) Developing a manufacture-ready device; 2) Producing a pilot run of production-equivalent devices for use in operational and GLP large-animal testing; 3) Performance of additional studies to demonstrate operational effectiveness and product stability; 4) Performance of a GLP comparative effectiveness study to evaluate Succor™ in an appropriate, combat-relevant, large-animal model; and 5) Maintaining all regulatory compliance requirements while preparing for upcoming regulatory and transition hurdles.