Advancement of a Cu-CMC nonwoven dressing for burns and expansion of the Cu-CMC platform

The long-term goal of this program is to establish a broad enabling antimicrobial technology aimed at providing a range of anti-infective materials for use by the military and sustained commercial development for the civilian market. Originally funded as a Direct to Phase II project aimed at developing a dressing for large area burn wounds, iFyber worked to develop an antimicrobial nonwoven dressing based on copper (Cu) and a hydrogel fibrous matrix based on carboxyxmethylcellulose (CMC). Our primary goal of this Sequential Phase II project is to advance our Cu-CMC nonwoven dressing through the FDA 510(k) pathway with oa commercial partner with a proven track record of transitioning biomedical innovations to acquisition in DoD.  In parallel, we will also use this funding opportunity to expand the Cu-CMC platform.  Our intent is to build on the successes of our initial Phase II project by providing the military and broader civilian markets with companion products that will protect the warfighter across the continuum of care (i.e., from the field, to trauma centers, to home), but will also broaden our product portfolio in a way that will enhance the commercial potential of this platform.  To achieve these goals, the following specific aims and research tasks are proposed:Aim 1: Transfer our lead product, a Cu-CMC nonwoven dressing, to our partners for advancementTask 1. Conduct a gap analysis.  Task 2: Final Product Design.Task 3: Design Transfer/Establish GMP Manufacturing. Task 4: Submit 510(k) Premarket Notification.  Aim 2: Expansion of the Cu-CMC product portfolio with prototypingTask 5: Prototyping of three additional Cu-CMC from factors.    Task 6: Characterize the physicochemical properties of the Cu-CMC prototypes.Aim 3: Down selection of Cu-CMC formulations using in vitro and in vivo modelsTask 7: Primary antimicrobial screening.  Task 8: Secondary screening.  Aim 4: Selection of lead formulations using advanced preclinical animal studiesTask 8: Pilot study on the three Cu-CMC formulations.   Task 9: Full infection studies on lead Cu-CMC formulations. Task 10: Wound healing and marker analysis on non-infected wounds.Task 11: Submit and conduct a presubmission with the FDA around the expanded Cu-CMC product family.