SBIR-STTR Award

The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) seeks to develop dermal dressing technologies that provide multiple advantages over current wound dressings for treating dermal injuries caused by sulfur mustard. Critical Innovations, Battelle's Biomedical Research Center, and NDA Partners, with consultants Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.) and Dr. David Greenhalgh, MD, FACS, have formed a team of medical device experts to address this important medical need. During this Phase I project, our objectives will be to further advance the innovative Succor product. This will include: 1) On-boarding program requirements, goals, and schedule; 2) Gathering existing data on the efficacy of Succor for treatment of similar dermal injuries; 3) Formalizing a regulatory plan to obtain an FDA indication for HD dermal injury; 4) Preparing a draft research plan for subsequent small-animal studies; and, 6) Maintaining all regulatory compliance requirements while preparing for upcoming regulatory and transition hurdles (TRL 6).

The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) seeks to develop dermal dressing technologies that provide multiple advantages over current wound dressings for treating dermal injuries caused by sulfur mustard. Critical Innovations, Battelle's Biomedical Research Center, the U.S. Army Combat Capabilities Development Command Chemical Biological Center (DEVCOM CBC), and NDA Partners, with consultants Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.) and Dr. Christopher Burns, MD, FACS, 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 product. This will include: 1) On-boarding program-specific requirements, goals, and schedule; 2) Producing a pilot run of cGMP production-equivalent devices for use in program testing; 3) Demonstrating product stability, ruggedness, and readiness for the combat environment; 4) Performing a GLP live-animal study of Succor for Sulfur Mustard; and, 5) Maintaining all program-specific regulatory compliance requirements while preparing for upcoming regulatory and transition hurdles.